MPN EU Issue 42

EUROPEAN EDITION

MEDICAL PLASTICS news

+ INNOVATION: WHAT IS IT? IS IT ALWAYS GOOD? MED-TECH INNOVATION EXPO 2018 FOCUS ON EXTRUSION

SETTING THE STANDARD: NELSON LABS FOCUSSES ON SAFETY

ISSUE 41

March-April 2018

WWW.MEDICALPLASTICSNEWS.COM

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.

MED-TECH INNOVATION | expo

for a better future

MED-TECH

Ricoh Arena, Coventry UK INNOVATION | expo

CONTACT US TODAY UK: T +44 (1925) 750 320 | medical@ultrapolymers.co.uk | www.ultrapolymers.com Please visit our website to find your local contact details and country-specific supply restrictions

25 & 26 April 2018 Visit us on Stand F21

CONTENTS March-April 2018, Issue 41

Regulars

Features

5 Comment Lu Rahman examines the role of innovation

21 Playing it safe Why security issues are becoming key, the rise of femtech and Ultrapolymers explains why material innovation is crucial

7 News focus Why is China in the medtech spotlight?

28 High ďŹ ve Improvements to simplify catheter and stent production from Conair

8 Digital spy 11 News focus Chinaplas and NPE previews, and why do polymer stents fail?

17 Opinion Why you should involve materials experts early on 22 Cover story Nelson Labs explains why patient safety is paramount 50 04:2018

31 Setting the standard Dr Knoell Consult, examines biological evaluation and the challenges for the medical device industry 32 Go with the owy Sensirion, explains the importance of sensors for measuring lowest flow rates in medical devices 35 Reality bites Custom Case Group reveals why AR and VR may transform the medical device industry

37 Joint venture Okani Medical Technology is using Solvay PEEK for its latest knee implant 39 Top 5 tips On intellectual property protection from Adamson Jones 40 Medtech Innovation Expo Where science, technology and engineering meet 47 Inside information Cikautxo Medical OEM explains the benefits of integrated sensors in catheters 48 Trend setter Trend and insight at Medtech Europe

WWW.MEDICALPLASTICSNEWS.COM

3

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

SEALING MACHINES

HANDLING TRAYS

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

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

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

CREDITS head of content | lu rahman

EDITOR’S

comment

Innovation: Is it good or bad?

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.

But is innovation always good?

We assume that breakthroughs are to be applauded but is that so?

T

his issue has delved into innovation. The medtech and healthcare sectors are undoubtedly, continually innovating.

Whether it’s materials that help prevent the spread of bacteria, or digitally enabled devices that help improve both patient care and clinician’s time, or labs on chips that help us explore and ultimately treat, conditions such as diabetes, the sector pushes the boundaries with one single aim – to help improve our health.

But is innovation always good? We assume that breakthroughs are to be applauded but is that so? As technology increases, as we embed digital sensors into medical devices, and as we link increasing numbers of these devices to clinicians and hospitals, we also increase the risk of cyber attack. The more we advance, the more problems we create. In the case of connected devices, we continue to innovate to counteract hackers - are we just increasing our workload??

We think of innovation as improvement – but is it always? Take the drive for increased automation and smarter systems that comes with the Industry 4.0 movement. As we move to produce goods faster, more efficiently and with more cost-effectiveness, have we taken into account the effect on jobs, on the companies that might get left behind, and on sustainability?

I believe in innovation. But it does come with a price. While we work to create better materials and devices that benefit our well-being, we also need to ensure we develop systems and procedures that exhibit a corporate and social responsibility. Of course this isn’t easy. The medical plastics sector

is particularly hard to make part of the circular economy. However, it isn’t impossible.

Innovation is a crucial way for us to develop and is, ultimately good. But it’s when we take our eye off the ball that it can become less good. The creation of polymers has enabled the advancement of so many sectors and created goods affordable to the masses. It has created industry on a magnificent scale – the global plastics market is expected to reach 654.38 billion by 2020.

The medical plastics sector is astounding. Advances in orthopaedic products see the use of materials that are similar to bone and offer greater patient comfort. There are situations when plastic drug delivery devices offer advantages over glass – less breakage, improved manufacturing process ie no need to remove glass dust once produced. Plastic is a versatile material for a number of medical devices offering fewer infections and better patient comfort. However, despite examples like these, it is the images we are currently witnessing of plasticswamped oceans, that make many people remember.

Yes, as we develop innovative materials we need to develop innovative ways to recycle and re-use. Innovation leads to the need for more innovation but that doesn’t mean we should stop trying to reach the next step. Eventually we should end up with materials and products that take into account their whole life cycle and that of the planet. While we may feel dismayed at the images we see, it’s also a great opportunity to be part of a change, and innovation that will benefit us all on a global scale.

BPA Worldwide Membership

ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital) WWW.MEDICALPLASTICSNEWS.COM

5

NEWS FOCUS

Why is Chinese healthcare booming?

And why does it have its eye on Israeli healthtech, asks Lu Rahman

Thanks to a range of factors and conditions including a growing and ageing population, the healthcare market in China is on a serious upward trajectory

W

here healthcare is concerned, it seems that all eyes are on China. A report from McKinsey & Co says the country’s healthcare market is tipped to grow at an unprecedented CAGR of around 12% which will see it hit the $1 trillion mark by 2020 – in 2011 the sector was valued at $357 billion.

What’s the reason behind the boom?

Thanks to a range of factors and conditions including a growing and ageing population, huge R&D investment, and central and local government support, the healthcare market in China is on a serious upward trajectory.

The government in China has taken major steps to improve local healthcare infrastructure. According to a report by the Health Industry Summit, last October the Chinese government approved a blueprint called “Healthy China 2030”, pledging to build a healthy China in the next 15 years. By 2030, the size of the healthcare market is expected to reach $2.3 trillion. From pharmaceuticals to medical products to consumer health, China is one of the most attractive markets in the health industry, and is the fastest-growing of all the large emerging markets The research by McKinsey & Co points out the significant effect healthcare reforms have had on the system in China. It highlights three factors: “The continuation of economic and demographic trends, further health-care reform, and the policies

articulated in the government’s 12th five-year plan”.

The report explains that improvements in infrastructure, the widening of health insurance coverage and the support for innovation, will have strong appeal for multi-national companies.

It highlights how healthcare spend between 2006 and 2011 has more than doubled: “From pharmaceuticals to medical devices to traditional Chinese medicine, almost every health sector has benefited.”

MEDICAL DEVICES According to Export.gov: “The medical device market is one of the fastest growing market sectors in China with the industry maintaining double-digit growth for over a decade. In 2016, the medical device market reached $53.62 billion, an increase of 20.1% compared with 2015. 72.7% of this growth is fuelled by hospital procurements.”

The region has been an attractive proposition for US device companies for some time with companies such as Medtronic, Covidien and GE Healthcare looking to increase their Chinese presence. According to the McKinsey & Co report: “China’s rise to prominence has prompted organizational changes, too. A few companies, such as Baxter, have moved their Asia–Pacific regional headquarters to Shanghai. Some have even relocated to China the global headquarters for select units—GE’s X-ray business and Bayer’s general-medicine business, for example. Roche plans to make

Shanghai one of three global strategicoperations centers, alongside Basel and San Francisco. Many companies have changed their reporting lines so that China operations report directly to the chief executive or to the global head of pharmaceuticals or medical devices.”

ALL EYES ON CHINA BUT WHERE IS CHINA LOOKING? While the Chinese healthcare sector is booming, it’s interesting to learn that Chinese investors are eyeing up Israeli opportunities. Bloomberg’s Gwen Ackerman and Li Hui have labelled this move as the “Israel-China” romance and explain that medical device companies are turning to Israel “where company valuation are lower and enterpreneurs are hungry for new markets”.

It’s no surprise that along with many other countries, digital health is a growing market in Israel. According to a Start-Up Nation Central report investment in Israeli digital health companies in 2016 was up by 30% on the previous year. It’s hardly a shock to anyone in the healthcare sector. Recent trips to Medica in Dusseldorf highlight just how keen Israel is to embrace the healthtech and digital health markets.

Improved patient care and experience, the on-going desire to streamline hospital systems as well as create digitally-enabled devices, has been swooped upon by Israeli innovators.

As China’s population both expands and grow old, it’s no wonder that its healthcare investors increasingly see the benefits in forging business links with Israeli healthtech providers.

WWW.MEDICALPLASTICSNEWS.COM

7

DIGITAL SPY

DIGITAL

DIGITAL BREAKTHROUGH

spy

THE CATHETER THAT COULD CUT INFECTION RATES Nawar Al-Zebari is one of the finalists for The Inventor Prize, which seeks out the UK’s best new inventors and ideas.

DIGITAL BREAKTHROUGH

www.today.uconn.edu

Disappearing act: BIG POTENTIAL FOR

BIODEGRADABLE PRESSURE SENSOR

A

ccording to the University of Connecticut’s UConn Today, UConn engineers have come up with a biodegradable pressure sensor that could help doctors to monitor chronic lung disease, swelling of the brain, and other medical conditions before dissolving harmlessly into the body.

This means the patient wouldn’t have to undergo surgery to remove the sensor, which is a huge step forward.

Colin Poitras, UConn Today writes: “The small, flexible sensor is made of medically safe materials already approved by the US Food and Drug Administration for use in surgical sutures, bone grafts, and medical implants. It is designed to replace existing implantable

www.nesta.org.uk

pressure sensors that have potentially toxic components.

“Those sensors must be removed after use, subjecting patients to an additional invasive procedure, extending their recovery time, and increasing the risk of infection.”

He adds that the UConn sensor emits a small electrical charge when pressure is applied. It also has potential for use in tissue regeneration and monitoring patients with conditions such as glaucoma, heart disease, and bladder cancer.

The prize was launched in August 2017, in partnership with the Department for Business, Energy and Industrial Strategy. Inventors are invited to submit ideas for inventions that tackle a social issue.

Cambridge-based Al-Zebari, a medical material scientist, has created a catheter, the ‘NuCath’ from smart materials that can change shape accordingly.

According to Cambridge Network, the invention came about when a member of Al-Zebari’s family was diagnosed with cancer and he saw the flaws in their current catheter system, which became infected.

Fighting the infection hindered recovery – a problem that Al-Zebari found was not uncommon in such cases.

Al-Zebari told Cambridge Network: “As a medical researcher, I work with new ideas and innovations everyday. I had wanted to create something using smart materials for some time. When someone in my family became ill, I saw first-hand how the catheter system could be improved. My relative, who was already undergoing chemotherapy and radiotherapy, had to fight off an infection too. I hope by improving the catheter system, I can help patients beat their main health issue without the added threat of a urinary tract infection.”

Al-Zebari is one of ten shortlisted companies who have received £5,000 to help take the ideas to the next level. The winner will be announced in September this year and will be awarded £50,000.

The catheter aims to improve drainage and lower urinary tract infections which are a huge cost to the NHS each year.

DIGITAL SPY

www.carclo-ctp.co.uk

making work: ctp growth plans

C

arclo Technical Plastics (CTP) has opened a new manufacturing facility in Mitcham, Surrey.

CTP has worked with BD Medical – Pharmaceutical Systems on the development and scale-up of the BD Vystra disposable pen which is used for delivery of liquid pharmaceuticals.

The new 1,000 sq m facility is dedicated to the manufacture of this product and was opened by councillor Stephen Alambritas and deputy mayor Judy Saunders from the London Borough of Merton.

8

WWW.MEDICALPLASTICSNEWS.COM

CTP has invested significantly in new manufacturing space, injection moulding machines, ancillaries and specialist staff in Mitcham to support this and other projects.

CTP’s UK managing director, Patrick Ward, stated: “Carclo Technical Plastics is a specialist contract manufacturer of disposable diagnostic and drug delivery devices for the global medical industry. The Vystra device underpins CTP’s continued growth within this sector.”

DIGITAL SPY

DIGITAL EXPERTISE

www.formamedicaldevicedesign.com All things bright and beautiful: The role of colour on device design Forma Medical Design is carrying out some interesting work on colour and medical devices. The company has produced a white paper on this which is well worth a read (www.formamedicaldevicedesign. com/white-papers/color-medicalproducts/). In it the company explains why colour is hugely significant and can have both an emotional and psychological effect – this extends to medical device design.

Stipe explains how colour can be used to alter perception. “We perceive lightcoloured objects to weigh less than darkcoloured objects”, it says, or “to make a device appear smaller use a light colour around the periphery, a darker colour at the interior”.

Baby love: How a team of experts have created a device that could save millions of babies’ lives

DIGITAL SPY

FDA gives nod to new indication for Medtronic wearable www.medtronic.com

This expanded indication will enable patients to wear the sensor on the upper arm - delivering more flexibility and enhanced performance for users, as well as improved accuracy. The Guardian Sensor 3 is Medtronic’s newest and most accurate CGM to-date and is the only FDA approved sensor to control automated insulin delivery via a hybrid closed loop system - the MiniMed 670G system.

POINT

products. In appealing to consumers, colour has great importance.”

According to Dan Stipe, Forma Medical Design, “the delivery of health care is evolving to take into account the entire patient experience. Medical products and devices have a significant impact on that experience. Their colours can be calming and restorative, or they can be active and energising. Further, many medical products that were once used exclusively in controlled care settings are now being used in the home. In the home environment, medical products require aesthetics more in line with consumer

The US Food and Drug Administration (FDA) has approved a new arm indication for Medtronic’s GuardianSensor 3.

talking

“The performance of the Guardian Sensor 3 has been extremely impressive and this new arm indication now offers added convenience and flexibility for my patients who like to have as many options as possible to address their personal needs,” said Bruce Bode, MD, a specialist with Atlanta Diabetes Associates and a clinical associate professor at Emory University. “These continued enhancements demonstrate a keen focus on the part of Medtronic to deliver a positive patient experience in addition to optimising outcomes through technological advancements - that can prove to be just as meaningful for quality of life.”

WHO IS BEHIND THE DEVICE? Medilink East Midlands (EM) members – SurePulse Medical, electronic manufacturer Tioga and Capatex.

SurePulse has developed a platform for monitoring heart rates in newborn babies, the SurePulse Vital Sign. The device includes sensors, and a cap – manufactured by Capatex – which has been purpose-designed to be rapidly applied to a baby.

SurePulse Medical, Tioga and Capatex are all East Midlands-based companies and members of Medilink EM, the life science business support organisation.

WHAT WAS THE THINKING BEHIND THE DEVICE? Approximately 10% of newborn babies require some form of resuscitation at birth. In the event of this happening, the VS provides a continuous hands-free heart rate allowing hospital staff to swiftly and effectively provide medical support, without the need for a stethoscope.

HOW DID THE COLLABORATION COME ABOUT? It was a result of networking at Medilink EM events. Dr Darren Clark, chief executive of Medilink EM said: “It’s great to see our members coming together and creating ground-breaking advances in new-born resuscitation, particularly as this is an area which has seen little improvement in recent years. The success of this product and the innovative collaboration between organisations demonstrates once again that Medilink EM remains at the heart of the region’s life sciences sector.”

WWW.MEDICALPLASTICSNEWS.COM

9

We Deliver Global Results Our full design, manufacturing and assembly capabilities create total value solutions leading to cost improvement, reduced investment and increased efficiency.

Regardless of location, we achieve superior consistency by employing a common manufacturing footprint for all of our global facilities. And when client needs expand, our facility expansions mirror customer expectations. This logistical strength, along with the diversity of our employees, makes us the specialists in the development and manufacture of injection molded components.

Carclo is truly a global operation able to supply multinational companies with a consistency that others just can’t match.

Diagnostics Surgical Disposables Pharma Respiratory Clinical Medical Optics

Carclo Technical Plastics 47 Wates Way, Mitcham Surrey CR4 4HR, United Kingdom Tel: +44 208 685 0500

Email:

!!"#$%&'()*+,-./*012*(+-3+(452*462177---%

Turanka 98, 62700 Brno, Czech Republic

ctpsales@carclo-plc.com

www.carclo-ctp.co.uk 89:8#:;#8<---8<=8<

NEWS FOCUS

Shanghai surprise Chinaplas 2018 offers a wealth of informative features at this year’s show including Medical Plastics Connect and the Industry 4.0 Conference

D

evelopment of plastics and rubber technologies has rocketed in recent years.

Chinaplas, a leading trade fair, offers a global technology-focussed platform for those sectors. Not only will 4,000 exhibitors showcase their products and services at the event which takes places on April 24-27 at the National Exhibition and Convention Center, Hongqiao, Shanghai, there will also be a set of events running at the same time. These will include Medical Plastics Connect, 3rd Industry 4.0 Conference, Tech Talk and CMF Inspiration for Design x Innovation.

Experts from across the world will gather at the new venue in Shanghai to assess market trends and highlight innovative technologies.

MEDICAL PLASTICS CONNECT CREATES BUSINESS OPPORTUNITIES Chinaplas keeps pace with the fastchanging market and has taken an active role in promoting the application of medical plastics technology in medical devices, consumables and drug packaging for three consecutive years. More than 34,000 high-profile visitors in medical and pharmaceutical related industries have taken part in the show to broaden their knowledge and source new technologies and solutions.

Medical Plastics Connect is a range activities to present new and practical medical plastics solutions to visitors. International experts will be invited to share their knowledge on topics such as sterilisation-resistant materials, composite materials for pharmaceutical packaging, medical TPU and PEEK resins, precision tubing

solutions, cleanroom injection moulding technology, and more.

3RD INDUSTRY 4.0 CONFERENCE Industry 4.0 solutions facilitate business transformation. Chinaplas started organising a conference on this topic two years ago and received enthusiastic feedback. With continuing, full support from VDMA, the German Engineering Federation, the 3rd Industry 4.0 Conference will take place at Chinaplas 2018. Drawing on Industry 4.0 expertise, the topics of this conference will be far-reaching and practical. Participants can expect plenty of industry 4.0 factory casestudies and application discussions.

Participants will be inspired by the best proven German practices. At present, Arburg, EREMA, KUKA, KraussMaffei, RWTH Aachen University, Wittmann Battenfeld and other well-known enterprises have confirmed their presence as guest speakers. The conference is scheduled on April 24-25 (afternoon) and April 26 (morning).

TECH TALK TO COVER ADVANCED TECHNOLOGIES According to its organiser, Chinaplas is a sort of ‘annual tournament’ where companies compete for visitors’ attention. Tech Talk was introduced last year, allowing international exhibitors to launch products. The last event in in Guangzhou featured more

than 30 well-received talks, providing visitors with valuable knowledge. This year, Tech Talk will shed light on a range of topics, including: Smart Manufacturing which will offer insights into automation/robotics, micro-injection moulding, digitalisation/ informatisation, in-muold labeling, manufacturing execution systems (MES) and 3D printing; Innovative Materials which will look at lightweight, thin-wall moulding, microfoaming, multi-functionality, spray-free, anti-UV, anti-bacterial, and flameretardant materials; Green Solutions which will focus on sustainability and topics such as biodegradable materials, low VOCs, energy saving, and recycling.

Tech Talk” is scheduled on April 24-26, in both Hall 4.2 and Hall 8.2.

CMF INSPIRATION FOR DESIGN X INNOVATION Product design is increasingly grabbing people’s attention. Colour, material and finish (CMF) are vital for product design, and directly influence users’ product experiences. To create a delightful user experience, brand owners and processors must carefully choose the appropriate CMF technology for their products. Good CMF design reinforces a positive product image and is essential in building a successful brand.

Chinaplas is responding to market needs by launching CMF Inspiration for Design x Innovation, The event consists of two parts — the CMF Inspiration Wall, in Hall 6.2, will display a variety of plastic resources for CMF design, and the CMF Design Forum will be held in the morning of April 26 in Hall 8.2. Global leading plastics technology suppliers and CMF masters will talk about product innovations and the latest market trends.

WWW.MEDICALPLASTICSNEWS.COM

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.

See whatâ&#x20AC;&#x2122;s new at ENGEL booth 5.1E71 CHINAPLAS 2018 April 24-27 Hongqiao | Shanghai

www.engelglobal.com

NEWS FOCUS

New medical zone to feature at NPE The organiser of NPE2018 says this year’s event – which takes place on 7-11 May in Orlando, Florida – will allow visitors to track trends, innovation, new products and connect with industry leaders NPE2018 brings together all industry sectors, including vertical and peripheral markets, end markets, brand owners and recyclers. Held every three years, it attracts more than 65,000 plastics professionals and features industry-focussed education and leading suppliers of emerging technologies, equipment and materials for every phase of plastics processing – all in more than 1.1 million square feet of exhibit space.

Building on its most successful show in 2015, held in Orlando, Florida, NPE2018 anticipates even greater participation from up and down the global plastics supply chain when it returns this year.

NPE is produced by Plastics Industry Association (PLASTICS) which has announced that this year’s event debuts a new Medical Parts Processing Zone among the Technology Zones on the show floor located in the South Building. This new sector-specific zone focuses on plastics materials, processes and technology advances for medical devices and diagnostics in healthcare industries.

Propelling the demand for this specialised zone is the forecasted 3% growth in revenue from medical device manufacturing anticipated by 2023. This growth is centred

MEDICAL MANUFACTURING COMPANIES THAT ATTEND NPE INCLUDE: 3M | Alcon |B Braun Medical Bausch + Lomb | Bayer Healthcare Bemis Manufacturing | Boston Scientific | Bristol-Myers Squibb Cardinal Health | Colgate | Conair Johnson & Johnson | Kimberly Clark | Newell Rubbermaid Philips Healthcare | Siemens

around the emerging trend for using plastics in the medical and healthcare industries to create pioneering medical devices, equipment and treatment items.

“Breakthroughs in the use of plastics will drive future medical care efficiencies and bring life-saving advances to hospitals globally,” says Glenn Anderson, NPE2018 executive committee chair.

“The Medical Parts Processing Zone will connect new technology providers with equipment manufacturers to source medical innovations and support the business initiatives of vertical market attendees.”

The use of plastics in cleanroom technology is providing costeffective and environmentally friendly innovations to the medical industry.

It is imperative that sterile medical equipment is manufactured in a modern controlled environment. The equipment, supplies and solutions making this possible will be among the highlights in the zone and will give attendees the opportunity to explore options that meet the medical industry’s high business standards.

The medical breakthroughs of today would not be possible without plastics. From barrier technology to 3D-printed prosthetics to new

treatment methods, medical manufacturers can find the robotics, automation and supplies for tomorrow’s healthcare not only in the Medical Parts Processing Zone, but throughout the Technology Zones in the Material Science, Flexible Vinyl, 3D/4D Printing, Thermoforming and Processors zones.

NPE2018 will feature 11 Technology Zones to help to create discussions between the attendee and suppliers on the newest equipment, processes and education opportunities transforming the plastics industry.

Some of the highlights include the expanded Re|focus Zone and 3D/4D Printing Zone, all designed to address the growing market demands, highlight innovations and technologies and provide customised education.

NPE is a globally-recoignised trade show and conference serving the plastics industry, its verticals and end-user markets. This year’s event will provide access to industryleading and emerging suppliers from over 2,000 companies showcasing the latest products, processes and technology. With 65,000+ attendees from over 100 countries on the show floor, the event organisers says it is the best place for plastics industry attendees to boost their production and efficiencies.

$42.6 million - medical device manufacturing industry revenue 2.9% annual growth of medical device manufacturing industry projected to 2022 Medical supplies wholesalers account for an estimated 27% of the total industry market

WWW.MEDICALPLASTICSNEWS.COM

13

NEWS FOCUS

Study reveals why polymer stents failed MICROSCOPIC FLAWS IN MATERIAL STRUCTURE CAN LEAD TO STENT DEFORMATION AFTER IMPLANTATION, BY ANNE TRAFTON, MIT NEWS

M

any patients with heart disease have a metal stent implanted to keep their coronary artery open and prevent blood clotting that can lead to heart attacks. One drawback to these stents is that longterm use can eventually damage the artery.

Several years ago, in hope of overcoming that issue, a new type of stent made from biodegradable polymers was introduced. Stent designers hoped that these devices would eventually be absorbed by the blood vessel walls, removing the risk of long-term implantation.

At first, these stents appeared to be working well but after a few years these patients experienced more heart attacks than patients with metal stents, and the polymer stents were taken off the market.

MIT researchers in the Institute for Medical Engineering and Science and the Department of Materials Science and Engineering have now discovered why these stents failed. Their study also reveals why the problems were not uncovered during the development process: The evaluation procedures, which were based on those used for metal stents, were not well-suited to evaluating polymer stents.

“People have been evaluating polymer materials as if they were metals, but metals and polymers don’t behave the same way,” says Elazer Edelman, the Thomas D and Virginia W Cabot professor of health sciences and technology, MIT. “People were looking at the wrong metrics, they were looking at the wrong timescales, and they didn’t have the right tools.”

The researchers hope their work will lead to a new approach to designing and evaluating polymer stents and other types of degradable medical devices.

14

“When we use polymers to make these devices, we need to start thinking about how the fabrication techniques will affect the microstructure, and how the microstructure will affect the device performance,” says lead author Pei-Jiang Wang, a Boston University graduate student who is doing his PhD thesis with Edelman.

these regions are disrupted, potentially causing early loss of integrity in parts of the structure.

Edelman is the senior author of the paper. Other authors include MIT research scientist Nicola Ferralis, MIT professor of materials science and engineering Jeffrey Grossman, and National University of Ireland Galway professor of engineering Claire Conway.

When the stents become deformed, they can block blood flow, leading to clotting and potentially, heart attacks. The researchers believe that the information they gained in this study could help stent designers come up with alternative approaches to fabricating stents, allowing them to possibly eliminate some of the structural irregularities.

MICROSTRUCTURAL FLAWS The degradable stents are made from poly-l-lactic acid (pLLA), which is also used in dissolvable sutures. Preclinical testing did not reveal any cause for concern. In human patients the stents appeared stable for the first year, but then problems began to arise. After three years, over 10% of patients had experienced a heart attack, including fatal heart attacks, or had to go through another medical intervention.

That is double the rate seen in patients with metal stents.

After the stents were taken off the market, the team tried to figure out if there were any warning signs that could have been detected earlier. They used Raman spectroscopy to analyse the microstructure of the stents.

Ferralis and Grossman modified and optimised the technique for studying stents.

The researchers found that at the microscopic level, polymer stents have a heterogeneous structure that eventually leads to structural collapse.

While the outer layers of the stent have a smooth crystalline structure made of highly aligned polymers, the inner core tends to have a less ordered structure. When the stent is inflated,

“Because the non-uniform degradation will cause certain locations to degrade faster, it will promote large deformations, potentially causing flow disruption,” Wang says.

A SILENT PROBLEM Another reason these problems weren’t detected earlier, according to the researchers, is that many preclinical tests were conducted for only about six months. During this time, the polymer devices were beginning to degrade at the microscopic level, but these flaws couldn’t be detected with the tools scientists were using to analyse them. Visible deformations did not appear until much later.

“In this period of time, they don’t visibly erode,” Edelman says. “But by the end of three years, there’s a huge problem.”

The researchers believe their new method for analysing the device’s microstructure could help scientists better evaluate new stents as well as other types of degradable polymer devices.

“This method provides a tool that allows you to look at a metric that very early on tells you something about what will happen much later,” Edelman says.

Reprinted with permission of MIT News (http://news.mit.edu/)

WWW.MEDICALPLASTICSNEWS.COM

Specialist Kit Components Custom Made for You

MEDTEC Europe, 10B29

Does your new product need bespoke plastic kit components?

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

MicroExtrusion

Pastette® Disposable transfer pipettes in any format

We Speak

Plate Seals

Extrusion

For specific manufacturing and packaging requirements

W O R K W I T H T H E E X P E R T S TM • Global Leader in the Extrusion of PTFE, FEP, and Other Fluoropolymers and Thermoplastics

UN3373 Compliant Packaging

• Co-Extrusion • Single- and Multi-Lumen Tubing

Custom designed kits for clinical trials packs and diagnostic kits.

• PTFE Etched Liners • Balloon Tubing • Multi-Layer Tubing • Heat-Shrink and Spiral Heat-Shrink Tubing

You define the specifications, size, branding and packaging

• NEW! Hydrophilic Coating

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

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

16 MPN_adv_86x265mm_Oct2017.indd 3

W W W . M11/10/2017 E D I C A10:31:57 LPLASTICSNEWS.COM

OPINION

M

edical device development may feel like you’re racing against the clock.

Delays negatively impact patients, budget and a company’s competitive advantage. From selecting medical-grade materials and confirming their availability, to meeting regulatory testing requirements, the development process is complex.

Integrating a medical materials expert early on streamlines the process and helps push your product across the finish line faster.

Along with speeding up the development process, a medical materials expert also provides visibility into regulatory testing and creative solutions, mitigates supply chain risks, demystifies material solution sets, and identifies cost-effective mechanical properties. With market trends accelerating and further convoluting the development process, having a materials expert on your team is important.

WHY DO YOU NEED A MATERIALS EXPERT? Yesterday’s materials won’t build the medical devices of tomorrow. Emerging trends like miniaturisation, sophisticated Point of Care (POC) diagnostics, multi-purpose packaging, and globalisation are increasing the complexity of parts and functional geometry.

This forces design engineers to make different material selections that enable their devices to do more. As users demand more from medical devices, the plastic resins used to create them must also meet and exceed expectations. A materials expert can help your team meet these demands by using less material to produce devices that have smaller physical footprints, are ergonomic and aesthetically pleasing, and yield accurate results.

Josh Blackmore of M Holland believes that medical device managers should involve materials experts early on to capitalise on globalisation and improve functionality

SMART PLASTIC SOLUTIONS ALSO REQUIRE HUMAN INGENUIT Plastics are instrumental in device innovation and serve multiple purposes. For example, controlled discreet 3D conductive pathways, created from resin compounds, power wifi and electro-mechanical test procedures using laser direct structuring. Other plastics can manage surface energy and allow microfluidic channels to improve conduction of liquids or repel water-based fluids for high release. A materials expert combined with a collaborative

Something of

SUBSTANCE

approach enhances the development process and improves your team’s overall medicalgrade material selection and understanding.

DEVICE SAFETY BEGINS WITH MATERIALS Medical device packaging is also crucial to ensuring accuracy and patient safety.

Along with being identifiable, trackable, and traceable, packaging must withstand external factors like sterilisation, as well as defend patients against adverse effects, like hospital-acquired infections. A materials expert can help select modern medicalgrade plastics that, when combined with laser engraving, can improve tracking, accelerate identification, and balance cost and supply chain risk screenings.

When selecting materials for medical device development, teams need to address several criteria. For example, is the device at risk from harsh chemical disinfectants? Or, is it possible to develop a needle shield for less than 50 pence? What about reducing or eliminating spring force for auto-injectors? Or, can you displace metal with plastic to make a reusable, durable device? How many autoclave cycles can a specific plastic material withstand? A materials expert can answer these questions, ensuring patient safety and saving you time and money by avoiding costly mistakes early on in the process.

CHALLENGING THE STATUS QUO It is time to challenge the status quo of developing products with conventional materials that only satisfy mechanical and functional requirements. A materials professional is an expert in determining specific resin(s), enabling desired technical features, and helping everyone navigate the changing regulatory landscape and regional supply chain availability. Risk-averse medical device teams often revert to materials used in previous designs because they are confident they will pass regulatory testing. Taking this approach, a materials expert is typically only brought in when problems arise, when is often too late to make changes. Instead, a medical materials professionals should participate from the start so they can help the team find new solutions and impart expertise on considerations for regulatory testing and global supply chain security.

Plastics will continue to be used to bring unique and complex technical aspects to life because they are suited to serve a range of needs while keeping up with regulations. However, for plastics to provide maximum value to the medical field, product designers, engineers, manufacturers, and materials professionals need to forge deeper partnerships.

CONCLUSION There is an opportunity for companies in the medical device space that recognise emerging trends and bring products with critical new features to life. Companies that work together, engage a materials professional early, and take a collaborative approach from product design through development and manufacturing will create products that meet demands and cut development time. These companies will shape product development standards and identify new solutions that result in high-quality devices trusted by patients and healthcare providers.

WWW.MEDICALPLASTICSNEWS.COM

17

COVER STORY

SETTING THE STANDARD:

NELSON LABS FOCUSSES ON SAFETY

M

edical plastics permeate the medical device industry with a remarkable diversity of application. They seem to be everywhere in healthcare: from protective barriers and low-risk device components (eg. instrument housings and handles) to devices of the highest potential risk (eg. permanent implants contacting the central nervous system).

The key advantages of plastics include the range of physical and material properties, ease of processing, relatively low costs, and great track record with safety. The benefits of plastics are available for various scenarios because we are able to understand and assess the risk associated on an application by application basis. There are some unique characteristics of plastics that manifest as a challenge in the context of medical devices with regard to protecting patient safety and obtaining regulatory approval.

INTRODUCTION OF LEACHABLES THROUGH THE MANUFACTURING PROCESS Perhaps the most significant challenge with plastics and biocompatibility is the complexity of the material itself – and how the integrity of the plastics becomes susceptible to possible contamination during the manufacturing process.

Consider the manufacturing pathway for a plastic material, with a process flow that may allow introduction of contaminants from several sources:

Thor Rollins, Piet Christiaens and Matthew R Jorgensen, Nelson Labs, explain why E&L testing offers an expedited path towards enhanced patient safety

18

 First, raw material manufacturers upstream synthesise monomers;  Second, polymer manufacturers use proprietary catalytic processes to convert monomers to polymers;  Third, if a masterbatch is used, compounders do an initial formulation of the polymer by adding polymer additives (such as primary and secondary anti-oxidants, UV-stabilisers, acid scavengers, and nucleating agents) to give the polymer a better protection or to obtain a better processability or functionality;  Some manufacturers may market these pellets as ‘medical grade’ but without guidance around the this term, medical grade certification is unclear and vague;  Finally, the converter may add other masterbatches to the raw material to give additional functionality or create a change in appearance, melts, and moulds the polymer pellets and concerts

WWW.MEDICALPLASTICSNEWS.COM

them into devices which are sold to the medical device manufacturer.

Each step along the manufacturing pathway has the potential to introduce undisclosed additives and impurities, unknown to those downstream. Because medical device plastics represent such a small share of the market compared with consumer goods, manufacturers may not be concerned or even aware that they can impact patient safety. Upstream processes may change without notice, resulting in a different formulation and leachables profile, while the appearance and functional properties of a plastic remain the same. Upstream processes also remain closely guarded trade secrets, making divination of a material profile impossible without testing.

RISKS OF THE UNKNOWN It is precisely the unknown nature of plastics’ formulation and impurity profile that introduces risk from a biocompatibility perspective. What additives or residual catalysts could be present that could leach out slowly over time? If the device in question is high risk like a permanent brain implant, knowledge of whether these compounds are there and, if they are, their toxicity is critical.

There are several options available to medical device manufacturers to address the risk of potentially toxic leachables.

One way is to perform a suite of in vivo animal tests. When indirect animal tests are used, samples of the final finished device are extracted separately in saline solution and cotton seed oil and, based on the final application of the device, the animals are exposed to these extracts.

The test is concluded when the animals are observed for adverse reactions to the extracts after a specified period of time.

Other tests involve implanting the device in an animal for a predetermined period of time, then performing histopathology on the animal. While animal tests have been used for decades as part of the strategy to address biocompatibility and are still generally accepted in the United States, there are questions regarding the sensitivity of animal tests and their applicability to humans. In scientific communities focused on the testing of medical devices, animal tests are sometimes considered as first-generation tests while currently there are second and third-generation options available.

COVER STORY

MITIGATING UNKNOWN RISKS USING E&L TESTING One of the more modern options available to address toxicological risks associated with potentially hazardous compounds which may migrate out of medical devices is extractable and leachable chemistry testing. Extractables are the compounds which may migrate out of medical device materials under conditions that are exaggerated (aggressive solvents at high temperatures) compared to clinical exposure. Leachables are those compounds which may migrate out of device materials when effort is made to mimic clinical exposure as closely as possible in terms of temperature, time, and solvents. Solvents used seek to mimic the environment in the body, which is composed of both polar and nonpolar liquids. Therefore a polar solvent (water), a non-polar solvent (hexane), and sometimes even a third mid-polar solvent are used as extraction solvents to ensure that leachable compounds across the polarity spectrum are captured. Often an aggressive â&#x20AC;&#x2DC;extractables approachâ&#x20AC;&#x2122; is first taken, with the view that if a device is found to be safe under conditions more aggressive than clinical use, then it certainly would be safe as actually used.

(ICP/MS) for metals, and if large nonvolatile molecules are a concern, liquid chromatography with mass spectrometry (LC/MS) for non-volatile compounds will need to be considered.

The details of the analysis of medical device extracts are a matter of lively scientific debate between industry and regulatory players; however, the key ideas are settled. Analysis of medical device extracts must both identify the compounds contained and measure the amount of compound present with sensitivity sufficient for toxicological assessment.

The requirement for simultaneous identification and quantification points towards chromatography with mass-spectrometry methods. Because a range of leachable compounds are possible, a set of analytical methods is needed: headspace gas-chromatography with massspectrometry (HS-GC/MS) for volatiles, direct injection GC/MS for medium and heavier compounds up to around 650 atomic mass units, inductively coupled plasma with mass-spectrometry

In addition to sparing animal life and providing more sensitive results, analytical chemistry for medical devices has several other advantages. For example, when a biological test like chronic toxicity fails, it is unknown why it failed and if that failure is truly relevant to the clinical use of the device with humans. However, chemistry results provide a roadmap to discovering the cause of a failure. One of the primary advantages of E&L is that it takes less time, and has the possibility of being expedited, because the time associated with testing and toxicological assessment is dependent mostly on scheduling and logistics, where the turn-around time for biological tests is fixed by the biological system itself. Another advantage is the typical cost of testing, especially in comparison to longer-duration animal tests.

Modern analytical chemistry coupled with large databases (either developed in-house by the testing laboratory or publically available) provides an excellent ability to identify compounds and measure their concentrations with sensitivity below widely accepted thresholds of toxicological concern.

When applied to medical devices, chemistry results provide a level of detail far surpassing the binary results obtained with animal testing. Chemistry studies are followed by a toxicological risk assessment, which is essentially the art of applying knowledge acquired by the chemistry study with past animal studies to the device at hand; the conclusion of the toxicological risk assessment is if the compounds from the device have either a low or high risk of causing negative biological outcomes. In this manner, the animal studies of the past are leveraged to their maximum extent to predict toxicological outcomes, sparing repeat testing.

THERE ARE SEVERAL OPTIONS AVAILABLE TO MEDICAL DEVICE MANUFACTURERS TO ADDRESS THE RISK OF POTENTIALLY TOXIC LEACHABLES, SAYS NELSON LABS TOXICOLOGY CONSIDERATIONS BEYOND E&L TESTING While chemistry testing for medical devices in support of biocompatibility has clear advantages when applied to addressing longer-term biological toxicological endpoints, it should be understood that these analytical methods are not an end-all answer that can stand alone to support patient safety.

Extractables and leachables chemistry testing does have some challenges and limitations. Testing strategies are designed to capture as many types of concerning compounds as possible, and they do an excellent job, but there can be small groups of compounds that present a potential risk that are not included. For example, analytical tests capable of capturing small anions are not commonly included in testing strategies. Not including anions means that molecules like nitrate, sulfate, and cyanide are not screened. Another gap is the dependence of toxicological impact on crystal structure or morphology.

Plastics in medical devices present an incredible opportunity for innovation that can lead to increased safety and quality of life; they can also present complex challenges from a biocompatibility perspective. The best way to ensure biocompatibility of a plastic containing medical device is to use a set of orthogonal and complimentary testing approaches that includes extractable and leachables chemistry testing. Chemistry testing can replace some of the longer and more burdensome animal tests with analytical results that are more detailed, sensitive, and actionable. In addition to being better from a scientific perspective, extractables and leachables chemistry testing also comes with cost- and timesavings to the manufacturer.

WWW.MEDICALPLASTICSNEWS.COM

19

HEXPOL TPE AB mediprene@hexpolTPE.com www.hexpolTPE.com

20

WWW.MEDICALPLASTICSNEWS.COM

FOCUS ON INNOVATION

As medical device design and technology offers us innovative products with increasingly sophisticated functionality, security issues are becoming key, says Lu Rahman

O

n a regular basis the medtech world offers technology-rich devices that benefit the health and well-being of us all. The smartphone has come to play a vital role in healthcare - both at clinician and patient level – so much so that we take for granted the extent of the technology it contains. The flip side of this is that we know digitally-enabled devices are vulnerable to attack from hackers and we’ve become all too used to hearing about the danger we could face should one of is fall victim to a cyber threat.

It’s unfortunate that as the rate of technological advance increases, so too does our vulnerability.

Last year the UK government launched a strategy on cyber-security in response to recent technological changes and the growing awareness surrounding the threat of cyber-attacks.

The Interim Cyber Security Science & Technology Strategy: Future-Proofing Cyber Security report highlights the technologies that will most impact cyber-security and develops policies to help the UK keep up with threats of cyber-attacks.

The report was developed in consultation with academia, industry, and science and technology experts. The report cites Internet of Things (IoT), data & information, automation, machine learning & AI, and human computer interaction as the key areas of focus.

More recently, the Royal Academy of Engineers released a new report examining the way in which health technology and medical devices, such as pacemakers, heart pumps and MRI scanners, are vulnerable to cyber attacks, and which could have ‘severe consequences’ for patient safety.

Commenting on this, Amir Abramovitch, security researcher at Cy-OT, said: “We know that a lot of Internet of Things (IoT) devices are insecure, and healthcare devices are no exception. In the last couple of years we have seen multiple vulnerabilities published for a variety of medical IoT devices. The main problem is that the worst-case scenario here is not data theft or malware infection, but death, and the scariest part is that some of these attacks can even happen remotely, where the attacker does not need to gain physical access to the device.

“The vulnerabilities span from simple vulnerabilities such as insecure storage of the Wi-Fi password and hard-coded secret credentials for remote maintenance, to more severe vulnerabilities such as communication interception (e.g. changing the dosage of a drug) and full-on denial-of-service (e.g. making the device stop functioning at all).

“This poses a threat, not only to corporate businesses, but to human life. The good news is that there are possible mitigations for these attacks, and they are quite easy to implement. The problem is that the companies making these devices do not understand the security implications of their poor design, and I hope they will learn it before it is too late.”

Global consulting firm North Highland recently conducted a survey on leaders in the healthcare and life science sectors.

It found that the biggest priority for those surveyed was cyber-security however, only 25% of respondents felt that they were prepared to address concerns over cyber-security.

IS BLOCKCHAIN THE ANSWER? There is increasing discussion about the way on which blockchain may provide a way to secure medical devices. According to a report by KPMG, “Blockchain’s potential for medical devices may be as great – or even greater – than its impact on the global financial services sector. Preventative maintenance of devices, a strengthened manufacturing process, digitized business processes and ‘smart contracts’, enhanced safety measures and evidence for value-based payments – these are just a few ways blockchain can disrupt the industry across the product lifecycle.”

The report details how several life sciences companies are looking into in blockchain technology. These include Philips Healthcare which has teamed up with Gem to create Gem Health26.

KPMG says that: “Several life sciences companies are already investing in blockchain capabilities.

Gem, a US-based startup, has partnered with Philips Healthcare to launch Gem Health26, a network for developing applications and shared infrastructure for a patient-centric approach to healthcare. Companies that are early adopters of this breakthrough technology could potentially enjoy significant first mover advantages in 2030.”

As devices offer increasing amounts of innovative design and technology, it’s clear that we need to ensure that their security is as high-tech as the device itself. With big business showing its support to find new ways to tackle cyber-security, it will be interesting to see how soon we truly get to grips with this issue.

WWW.MEDICALPLASTICSNEWS.COM

21

FOCUS ON INNOVATION

Woman’s hour THE TIME HAS COME TO TAKE NOTE OF THE FEMALE-FOCUSSED HEALTHTECH HITTING THE MARKET, SAYS LU RAHMAN

I

have to admit to being sceptical of some of the digital devices that pass our editorial desk. Do we really need a digital tampon or a connected nappy that tells us when we need to change our children? However, being female, I have taken a shine to the femtech movement that is growing by the month. I’m intrigued that a) the female medtech market seems to have largely gone ignored until now and b) that many of these companies are headed up by women with very clever ideas – why hasn’t this happened sooner?

It’s nothing new really. Women have been coming up with innovative concepts for years - it’s just that they’ve gone unnoticed.

Take Virginia Apgar, for instance.

Anyone who’s had a baby will be familiar with the Apgar score, the test that shows how a baby is doing post-birth. The test was devised in 1952 by Virginia Apgar.

It’s pretty amazing that given that Apgar was not only the first woman to become a full professor at Columbia University College of Physicians and Surgeons, as well as designing a test that millions of parents across the world are familiar with, we’d be hard pushed to find anyone who’s heard of its creator, other than obstetricians.

FEMALE-FOCUSSED DEVICES Over the last few years there has been a considerable sea-change.

More and more female-focussed devices have hit the shelves bringing the femtech movement to the fore.

With the range of devices on the market, it’s hard to select just a few to discuss. Now FDA-approved, the Aero-Form device, developed by Colombia University, is a wireless tissue expander designed for patients that plan to have reconstructive surgery following a mastectomy. It is also designed to be used by the patient at home.

When carrying out a mastectomy, a surgeon uses a silicon expander underneath the chest muscle.

These are then filled with saline injections so the tissue is stretched to make room for an implant. The Aeroform uses carbon dioxide which is compressed in a cartridge inside the device, instead to fill the expander. Gas delivery can be controlled by the patient.

“A hidden benefit of this device is the fact that the patient can play an active role in recovering her body after breast cancer. My patients have thoroughly enjoyed this role and I am confident that this will appeal to many women across the United States and around the world when widely

available,” said lead investigator Jeffrey Ascherman, MD, chief of the division of plastic surgery at Columbia University as reported on Curetoday.com FROM PREGNANCY TO BIRTH A range of products has sprung up aimed at female-specific issues.

This includes the Priya Ring. The growth of the bio sensor and what it can achieve has allowed this sector to flourish. With the ability to monitor temperature, heart rate, even sleep patterns, the technology has found a home in femtech devices such as fertility and pregnancy trackers.

Products such as the Priya Ring highlight how the market has taken advantage of technology.

Described as offering a ‘level of precision that no other ovulation prediction method can’, the ring device features a sensor that monitors temperature to detect changes that take place before ovulation, alerting the wearer when they are at their most fertile.

We spotted the Pregsense device at last year’s Medica.

The wearable monitoring device is being was showcased by wearables manufacturer Nuvo Group and is designed to allow expectant mothers to capture data about themselves and their baby.

The company hopes the device will give doctors insight into the

WWW.MEDICALPLASTICSNEWS.COM

condition of the pregnancy and result in a better experience for mothers. It is thought that the real benefit of the product may be in rural areas and developing countries where complications can lead to fatalities.

Oren Oz, CEO of Nuvo Group, said: “PregSense transforms pregnancy healthcare, delivering real-time care at a lower cost.

It’s the next major leap in remote healthcare, fulfilling a critical need for women who may not be able to get to the doctor as frequently due to location or finances.”

Brün is a labour monitoring device whose development has been supported by the department of biotechnology at the government of India, and Stanford University.

This technology aims to provide an easy to use and cost-effective tool to monitor vital parameters of the mother and foetus during labour. Again, the device should prove valuable in remote settings, particularly in India which experiences over 300,000 stillbirths a year.

The female aspect of medtech is exciting and given the range of devices available, and the applications they provide, the space offers promise and potential to improve female health on a global scale.

23

FOCUS ON INNOVATION

Why material in no for devic ed v ev

l a i c u r sc i n nt o e it m a p o l e

ULTRAPOLYMERS LOOKS AT POLYMER INNOVATION IN HEALTHCARE THROUGH INTER-MATERIAL REPLACEMENT

M

edical device manufacturers continuously strive to develop innovative products that are compliant with regulatory bodies and competitive.

Next-generation product development based on raw material innovation is one way OEMs can achieve this target.

Polymers offer properties such as durability, lightweight, chemical resistance, transparency and their ability to be easily shaped.

They can be combined with various additives to customise colour, modify impact strength or provide resistance to sterilisation methods. Reinforcement with glass fibre additives, surface modification or antimicrobial additivation are attributes available when working with polymers in demanding applications.

When advising on material selection, it is key to look at the main performance characteristics required of the device, taking into account any influencing

24

WWW.MEDICALPLASTICSNEWS.COM

FOCUS ON INNOVATION

factors, such as environment. Evaluating how the device will be processed, including which secondary operations will be required such as surface coatings, laser marking, bonding methods, printing etc. can also not be overlooked.

Getting input from all stakeholders at the earliest possible stage of the design process is important to ensure that the material most suited to the application is selected.

ENGINEERING MATERIALS ALTERNATIVES Designers have to evaluate the advantages and disadvantages associated with each resin type. In some cases, resins selected for historical reasons can exceed the design requirements and be over engineered for the specific end use. An example is where materials such as Polycarbonate (PC) and Polyethylene Terephthalate (PET) are commonly used because they fulfil particular needs such as transparency, physical and chemical properties. By exploring options such as INEOS Styrolution’s Zylar grades, clear and tough methylmethacrylate butadiene styrene (MBS) grades made by modifying a styrene acrylic copolymer (SMMA) with an impact modifier, significant advantages can be gained. Zylar is a transparent and easily colourable material, it has a 14- 30% density advantage over some other clear engineering materials and it provides processing advantages that can lead to reduced cycle times, improved production efficiency and reduced electricity consumption. Zylar is inherently hydrophobic therefore does not require pre-drying and is a noncorrosive material resulting in less wear on the processing moulds.

Looking at the trends in drug delivery, an opportunity arises for generic drug manufacturers when US patents expire.

Treatments can be made available to patients in developing countries, where limited access to medical facilities will drive an increase in self-administration.

Manufacturers will be urged to develop lower cost devices to deliver their drugs.

For replacement of over specified materials such as PC/ABS (blends of Polycarbonate and AcrylonitrileButadiene-Styrene) or ABS in drug delivery device components, polyolefins can provide an excellent combination of stiffness and toughness.

PVC ALTERNATIVES Where medical devices require flexibility, such as medical tubing or film, it is worth looking at why Polyvinyl Chloride (PVC) has been so successful. PVC was originally developed to replace rubber and glass to make flexible tubing and containers and began to dominate this market when the need for single use presterilised medical components increased.

PVC is the dominant material used for the storage of IV fluids, dialysis solutions, as well as blood and blood-derived products. It can be sterilised with steam, EtO (Ethylene Oxide) and via Gamma or E-Beam irradiation. PVC can be solvent bonded or joined together through high radio-frequency (RF) welding. The use of PVC in medical devices has however created discussion with many patients and hospitals demanding a safer, more environmentally-friendly option. PVC is a chlorinated plastic that forms dioxin when burned, which when released has been found to have toxic and carcinogenic effects.

Also concerning is that phthalates are used as plasticizers for flexible PVC, including for blood bags, IV bags, catheters, tubing. The plasticizer may migrate from the device to the patient through contact with the skin or mucous membranes. Studies on certain animals have shown reproductive and endocrine disrupting effects.

Manufacturers of medical devices are faced with a need to replace incumbent phthalate- and plasticizer-based materials. With regulatory changes coming, manufacturers have two choices; opt to switch to a different type of PVC, softened with a phthalate-free plasticizer, or choose to evaluate alternative polymer solutions.

For tubing and other flexible products, the main alternatives are usually silicone, ethylene vinyl acetate (EVA), polyesters, various polyolefins, elastomers and certain polyurethanes.

High density polyethylene (HDPE) is commonly used for IV solution containers. It is cost-effective, has a low sealing temperature and is recyclable.

Because of its polarity however, it cannot be sealed by RF welding.

EVA can be used for kink-resistant medical tubing, as well as for pharmaceutical bag applications where they are filled ascetically; as EVA can’t withstand steam sterilisation by autoclave. For infusion therapy, thermoplastic elastomers (TPEs) have been developed.

Ultrapolymers supplies the Marfran.

Med range of medical TPE and TPO compounds. These materials feature excellent transparency, are suitable for sterilisation using steam, Gamma and EtO and can be tailor-made to fit customers’ specific requirements.

Finally, thermoplastic polyurethane (TPU) combines excellent toughness with strength and barrier properties. TPU provides sealing through RF welding as well, however it is a more expensive choice.

Ultrapolymers has been working closely with LyondellBasell on development projects using Purell KTMR07, Lyondellbasell’s innovative, complete polyolefinic solution for use in flexible medical applications. Purell KTMR07, a Polybutene-1 (PB-1) material, is suggested to be used in a blend with Purell polypropylene (PP) to achieve the required property balance.

When blending PB-1 with PP, a homogenous single-phase polymer structure is achieved thanks to the very high compatibility between the two materials.

PB-1 can be used as an impact modifier, to achieve a reduction in glass transition temperature and to improve the optical properties of the PP-based solution.

This new solution is phthalate and plasticizer free and allows device manufacturers to offer product differentiation based on material innovation in next generation development programmes.

This Purell polyolefin blend is recyclable and does not require complicated separation, which could help hospitals in their efforts to reduce (PVC) waste.

Key application areas include intravenous and transfusion tubing, catheters, nasogastric and dialysis tubing, respiratory tubing and tubing for parenteral feed pumps. Also IV bags, dialysis bags and blood bags are amongst the key focus areas.

Various blend ratios have been proposed and successfully tested to produce medical tubing in a range of shore hardnesses. In parallel, a further evaluation of processing parameters required when working with a dry blend or compound of Purell KTMR07 and Purell PP has been performed (data is available on request).

Polymers have unique properties such as durability, lightweight, chemical resistance, transparency and their ability to be easily shaped

Another material option worth considering would be INEOS Styrolution’s Styroflex, a styrene thermoplastic elastomer (S-TPE). This is suitable for film and tubing applications as well as for injection moulding and combines transparency with toughness, tear resistance, excellent bondability to other materials, good barrier properties and is sterilisable.

25

2018.9.26-28 | Shanghai We Help You to Develop Business and Network with 10,000+ local Medtech Professionals in Growing China Medical Device Market

Book Y our Stand Now

The Leading Exhibition for Medical Device Design & Manufacturing in China Exhibitďź&#x161;

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

Visitďź&#x161;

Carina Li T: +86 10 5730 6163 E: Carina.Li@ubm.com

FOCUS ON INNOVATION

AMSilk, a global industrial supplier of synthetic silk biopolymers for medical devices, is partnering with Polytech Health & Aesthetics, the manufacturer of softtissue silicone implants, to begin the clinical study POSIS, the first-in-human clinical safety testing of silk-coated silicone SILKline breast implants in Europe. The study, which started with several patients in the first week at a number of medical universities in Austria, may be extended to further European countries for comprehensive testing.

Polytech’s silicone breast implants have been available to international customers for many decades, and demand has recently reached an all-time high, with the company selling over 200,000 silicone implants in 2016. As part of Polytech’s quality control system, all implants are produced under stringent quality guidelines and fulfill maximum safety requirements. To ensure consistent quality, the implants are produced manually, and are checked after each production step according to the highest standards.

The partnership with AMSilk marks the first time that bioengineered silk will be inside the human body. AMSilk’s unique silk coating forms a thin and flexible physical protein interface between the silicone surface of Polytech’s implant and the surrounding tissue.

The body

SMOOTH OPERATOR POLYTECH AND AMSILK ANNOUNCE START OF JOINT INTERNATIONAL CLINICAL STUDY FOR SILK-COATED MEDICAL IMPLANTS – THE FIRST TIME THAT BIOENGINEERED SILK WILL BE INSIDE THE HUMAN BODY

recognises the physical protein interface as a natural surface, leading to a much better biocompatibility.

In preclinical studies, SILKline silk-coated silicone breast implants resulted in superior tolerability.

Therefore, it is expected that minor postoperative complications and minimization of sometimes painful side effects that accompany traditional implants (eg. capsular fibrosis) will occur.

“With the new SILKline implants, Polytech plans to further increase the safety and tolerability standards of our products,” said Wolfgang Steimel, CEO of Polytech. “Working with AMSilk enables us to provide our customers the newest and best technology available to support patients’ wellbeing and satisfaction, combined with the objective to reduce complications with real innovative technology.”

The partnership with AMSilk marks the first time that bioengineered silk will be inside the human body

Jens Klein, CEO of AMSilk added: “Through our multi-year partnership with the experts at Polytech, we’ve created a new and groundbreaking product for the medical devices market. The SILKline implants are the first product providing our silk coating in the medical device sector – but other products utilising the extraordinary biocompatibility of our silk coatings will soon follow.”

WWW.MEDICALPLASTICSNEWS.COM

27

HIGH Bob Bessemer, Conair Group, says improvements in downstream extrusion control make catheter and stent production more repeatable and reliable than ever

W

hen it comes to production of medical plastic tubing for catheters and stents, predictable control of every factor in the extrusion process is essential.

The increasingly sophisticated uses of this micro-bore tubing demand that processors exercise the highest possible control over all key characteristics â&#x20AC;&#x201C; quality, precision, repeatability, traceability, cleanliness, and more.

Processors must do so while facing significant production challenges: micro-bore tubing sizes (less than 0.060â&#x20AC;? in diameter) for heart and brain catheters; multilumen structures for diagnostic, interventional, and therapeutic uses; increasingly complex bump profiles; and ever tighter tolerances for factors including ID, OD, concentricity, and elongation/ burst strength.

Years of development efforts by extrusion equipment makers like Conair have resulted in a steady stream of improvements that make production of medical plastic catheters and stents more predictable and controllable than ever before. At the same time, these improvements can help make off-line work, like QA, cutting, and finishing steps, a thing of the past.

IMPROVEMENTS TO SIMPLIFY CATHETER AND STENT PRODUCTION NEXT-LEVEL EXTRUSION PROCESS CONTROL Medical plastics processors know that repeatable extrusion starts well upstream with the fundamentals of material selection, blending, plastication, and die temperature and pressure control.

However, it is more recent and less-well-known downstream improvements that open the door to the next level of extrusion process control for medical grade tubing.

These improvements involve: Vacuum sizing; Temperature-controlled cooling; Digital monitoring of tube OD; Servo-driven pulling and cutting; Cleanroom-ready equipment; designs.

EXTRUSION

Let’s review these improvements one-by-one.

PRECISE, TEMPERATURECONTROLLED COOLING. Water-based cooling transfers heat out of extruded tubing and enables it to solidify.

However, controlling the rate at which cooling happens is essential to tubing quality. The latest vacuum cooling tanks enable precise control over water temperatures (to ±1 degree F) and flow rates so that optimal rates of heat

VACUUM SIZING. Instead of free extrusion, which relies on air pressure within the tube, vacuum sizing offers a more dependable way to control extrusion profile and roundness, including the size and shape of individual lumen. Creating a controllable vacuum sizing process for small-diameter, single- or multi-lumen medical tubing required equipment makers,

including Conair, to scale down previous vacuum sizing/cooling equipment, reduce water turbulence and provide finer, more precise vacuum control.

The result, for Conair, was the MedVac line of vacuum sizing/cooling tanks, part of its larger MedLine offering of cleanroom-ready auxiliary equipment.

MedVac vacuum/cooling tanks enable differential pressure to be applied

in two different ways, based on application requirements, giving processors more options for controlling microbore tubing production. The first way is to apply vacuum within the calibration die itself, which draws the profile wall of the extruded tube outward and shapes it against the surface of the tooling. The second way is to draw vacuum over the entire

transfer are maintained.

Precise temperature control preserves material properties and ensures consistency in tube sizing and quality. The latest vacuum/cooling equipment also gives processors greater control over where cooling is applied. For example, the calibration die and extruded tube can be fully immersed in cooling water or the die can be equipped with

a cooling water jacket.

Ultimately, the selection of sizing and cooling methods depends on the characteristics of the polymer and the extruded tube. Both can have a positive impact on tubing quality: the differential pressure environment available in vacuum sizing/ cooling tanks prevents negative effects on tube concentricity and surface finish, while precise

temperatures ensure the most predictable control of tube sizing.

For applications in environmentally regulated spaces (eg, cleanrooms), water-cooled condensers are the preferred choice for removing process heat from cooling water used in vacuum cooling/sizing tanks since they operate without air-circulation fans that can blow contaminants within the space.

DIGITAL OD MEASUREMENT AND MONITORING. Improved OD monitoring is another factor in the performance of the latest medical tube extrusion equipment. For example, during the cooling/sizing process in a MedLine cooling/sizing tank, an ultrasonic gauge can be used to monitor wall

SERVO-DRIVEN PULLERS AND PLANETARY CUTTERS. The addition of servo drives, with servo-rated low-backlash reduction gears and closed-loop feedback control, have dramatically improved the precision and controllability of the pullers that draw tubing through the

extrusion line. Specifically, servo controls enable pullers to respond more precisely to process feedback, enabling them to regulate speed and position in very fine increments. The added precision also improves the dimensional accuracy of the cutting process.

The introduction of micro

CLEANROOM-READY EQUIPMENT DESIGNS. None of these process innovations can help if you can’t employ them, right away, in a medical production environment like a cleanroom or white room. For that reason, Conair developed MedLine, a complete offering of over 40 models and 170 variations of cleanroom-

thickness and ‘hot’ OD, while an OD laser gauge, positioned downstream from the tank, generates final ‘cold’ OD dimensional data. Together, the information from these gauges can be used to help adjust puller speed and vacuum level within the tank, both of which are essential to maintaining consistency in critical

planetary cutters has also improved the quality and consistency of the cutting process. Planetary cutters use a spinning blade to make gentle, lathe-like cuts on even brittle, shatterprone tubing materials without causing tube deformation or generating particulates—things that more conventional fly-knife

ready auxiliaries. This range includes not only downstream extrusion equipment but also dryers, feeders and materialconveying systems, temperature-control equipment and more.

All MedLine equipment is compliant with ISO and FDA regulations, with basic QC, PM, and calibration documentation

tube dimensions. A bit further downstream, one additional monitoring tool, an automated vision system, can inspect finished tubing for gels and surface imperfections, then automatically identify, cut out, and remove ‘bad’ sections of tubing.

length of the cooling tank, then allow the increased differential pressure within the extruded tube to gently expand it outward, shaping the tube against sizing rollers as it is pulled through the tank. This approach also prevents cooling water from drooling out the orifices through which the tube enters and exits the tank.

The latest vacuum/cooling equipment also gives processors greater control over where cooling is applied

cutters cannot do.

Combining the inputs of in-line gauges and vision systems with servo pullers and software-based control systems makes new levels of extrusion automation possible.

provided for simpler, cleaner implementation.

MedLine equipment comes preconfigured, factory calibrated, and documented. In addition, it is built using materials suitable for cleanroom environments, ie, to help reduce the particulate load and make equipment easier to clean.

Development efforts by extrusion equipment makers have resulted in a stream of improvements that make production of medical plastic catheters and stents more predictable and controllable

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

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

8464 Distrupol Advert - Medical Plastic News - Q1 2016-Final.indd 1

Reliable, Clean, Economic LPKF’s production solutions – success through experience.

MT Connect: Nuremberg, April 11 – 12, 2018, Booth 10.0-521

LPKF WeldingQuipment GmbH Phone +49 (911) 669859-0 www.lpkf-laserwelding.com

30

WWW.MEDICALPLASTICSNEWS.COM

24/03/2016 09:33

STANDARDS & REGULATIONS

STANDARD

ISSUE

Dr Albrecht Poth, Dr Knoell Consult, examines biological evaluation and the challenges and consequences for the medical device industry

The important standards for biological evaluation and risk analysis of medical devices are explained in three parts.

ISO 10993-1 provides the framework and describes the general principles of the biological evaluation; ISO 10993-18 provides information on the qualitative and quantitative characteristics and finally ISO 10993-17 gives guidance on the derivation of the allowable limits for the leachable components of the medical devices. All the three major standards are going to be revised substantially For ISO 10993-1 “Evaluation and testing within a risk management process” the final draft international standard (F-DIS) has been published in January 2018.

The revision will include a change in the flow-chart describing the systematic approach of the biological evaluation including as an initial step the chemical characterisation. As a consequence Annex A 1 “Evaluation tests for consideration” of ISO 10993-1 has been revised by adding a new column including chemical characterisation as a test parameter. It will further include additional test parameters for certain device categories and additional toxicological endpoints for evaluation based on the US-FDA modified matrix as outlined in the US-FDA guidance document “ISO International Standard ISO 10993, Biological evaluation of medical devices Part 1: Evaluation and Testing” (2016). By including additional requirements it was discussed that chemical characterisation is the only mandatory testing requirement and all other toxicological endpoints will be evaluated on a case-by-case basis within a toxicological risk assessment.

A major revision of ISO 10993-17 on allowable limits for leachable substances is in works. The experts of TC 194 are discussing risk assessment approaches to use the concept of Threshold of Toxicological Concern (TTC), a concept which is already established and accepted for genotoxic pharmaceutic impurities. If it can be shown that an impurity is below the TTC, then it is assumed that the level of the chemical substance is of no significant risk and no further evaluation is required with regard to that impurity.

The TTC allows definition of threshold values for substances below which there is insufficient material available to cause a toxicological hazard and thus no further evaluation is required. The concept may also be applied more generally to unidentified contaminants. The inclusion of TTC in Part 17 would be a significant advance which will allow avoidance of unnecessary animal testing if chemical characterisation can demonstrate that leachables are below the TTC. This concept is planned to be implemented in the revisions of ISO 10993-17.

A major revision will also be made to ISO 10993-18 “Chemical characterization of materials” including the technical and scientific experience made during the last 10 years since its publication in 2005. A second Committee Draft (CD) was published in January 2018, including the choice of extraction types (exaggerated versus simulated-use extraction) and a better definition of the experimental requirements for investigating extractables and leachables. It will further include a description on the stepwise chemical characterisation process and the revisions needed to the associated flowchart. The revision

CHEMICAL REACTION: The changes of ISO standards will impact medical device manufacturers by putting more emphasis on chemical characterisations, says Dr Albrecht Poth will include approaches for setting analytical evaluation thresholds (AETs), recognizing that this will have to be developed in alignment with thresholds of toxicological concern (TTCs).

It can be foreseen, that the proposed step-wise chemical characterisation will be of more complexity especially for high risk devices, including more complex chemical analytical methods for structure elucidation of unknown chemical substances released but also the evaluation of release kinetics of chemical compounds from medical devices.

Based on the proposed revisions it can be foreseen that in future the chemical characterisation will be a key parameter in the assessment of the biological evaluation of medical devices within a risk management system. Toxicological hazard and risk assessments will also be key aspects not only for the evaluation of extractables and leachables but also for the evaluation of raw materials and their impurities.

Overall, the changes and adaptations of the ISO standards will impact the biological evaluation strategies of manufacturers of medical devices by putting more emphasis on chemical characterisations and sound toxicological evaluations. Thus, the era of the ‘tick-the-box of the flowchart’ mentality for animal studies in the medical device business is to be replaced by systematic evaluation approaches taking into account the chemical composition of the devices.

WWW.MEDICALPLASTICSNEWS.COM

31

GO WITH THE FLOW M

edical procedures and therapies are often faced by the same challenge: accurately measuring and controlling lowest flow rates down to the microlitre per hour range. In most of these cases the outcome of the therapy, as well as the wellbeing or even the survival of the patient strongly rely on the reliable and continuous drug administration in such low flow regimes. While various countermeasures have been evaluated and introduced, there is still room for improvement and for new technologies to be established. One novel development with tremendous potential is a single-use liquid flow sensor that is able to measure lowest flow rates

Susanne Jungmann, Sensirion, explains the importance of sensors for measuring and controlling lowest flow rates in medical devices and how they can be integrated effectively by manufacturers

and detect common failure modes quickly and reliably.

Ambulatory infusion pumps are experiencing increasing popularity in ambulatory and home care settings for the continuous delivery of highly-concentrated medication over several days. Flow rates range from single millilitres up to a few hundred millilitres per hour (ml/h). Portable ambulatory infusion treatments have been able to dramatically reduce the length of hospitalisation with its related costs, while at the same time greatly improving patient quality of life. For example, in the case of chemotherapy, it has been shown that continuous drug administration

has a beneficial pharmacodynamic impact on efficacy and toxicity, compared with traditional bolus injections every 24 hours.

A typical elastomeric pump consists of a pressurised reservoir exerting continuous force on the medication, an IV administration set including a pressure drop element (eg a thin capillary used as a restrictor) which determines the required flow rate, and an IV catheter or injection port. These pumps are often purely mechanical and designed as single-use devices for infusional chemotherapy, pain management, or chelation therapy. Their characteristic pressure

In paediatrics and neonatology, small and vulnerable patients receive special care and attention. Flow rates of 1 ml/h or even lower are typical due to the patientsâ&#x20AC;&#x2122; low body weights

32

WWW.MEDICALPLASTICSNEWS.COM

SENSOR TECHNOLOGY

profile is typically concave, ie. the generated flow rate at the beginning and at the end of the therapy is higher than in the middle.

The actual flow rates of elastomeric pumps are mainly influenced by two parameters: the differential pressure between the inlet and outlet of the restrictor and the resistance of the restrictor itself. While the inlet pressure is determined by the pressure profile of the pump’s reservoir, the outlet pressure is affected by several factors: the type of the injection site, the patient’s specific vein back pressure, as well as the difference in height between reservoir and injection site. The resistance of the restrictor is influenced by the viscosity of the medication which in turn is determined by the solution’s molecular composition and its temperature. In order to maximise temperature stability in spite of changing ambient temperatures, medical device manufacturers typically recommend to tape the restrictor to the patient’s skin at all times.

The currently established solutions, as described above, have a series of well-known shortcomings.

The required flow rate accuracy according to international standards is ±15% under very specific conditions. During a typical daily routine, it is challenging for a patient to adhere to the handling instructions that guarantee the specified performance.

In consequence the real life flow rates often deviate drastically from the intended values.

While higher flow rates may result in an increased toxicity of the therapy, lower flow rates will reduce the treatment’s efficacy. Both deviations will prevent an optimal therapeutic outcome.

Additionally, medication not administered due to lower flow rates and thus leftover in the reservoir, may require specialised waste management.

Especially at low flow rates, clogging of the very thin restrictor or at the injection site is difficult to detect quickly and reliably without a liquid flow sensor. In most cases, it takes hours for an occlusion to get detected by the patient or nursing staff. This again will prevent an optimal therapeutic outcome.

These effects can currently neither be monitored for direct feedback or remote support, nor can they be recorded for later analysis by the clinical staff. Therefore, many ambulatory infusion pump manufacturers are designing smart versions of their existing products.

One possible solution is the seamless integration of a single-use liquid flow sensor, like the LD20 from Sensirion, into the infusion set.

In paediatrics and neonatology, small and vulnerable patients receive special care and attention, not only from the nursing staff, clinicians and their parents, but also from the medical industry.

In this context, flow rates of 1 ml/h or even lower are typical due to the patients’ low body weights.

Consequentially, the known and inherent issues of the current infusion technology (start-up delays, flow-discontinuation and dependence on hydrostatic pressure) may have even more detrimental effects on the therapy outcome.

Administration of lifesaving drugs with a short half-life, for example adrenalin, must not be delayed or discontinued by the infusion technology in question. However, this happens frequently due to the compliance of the tubing and syringe plunger, the movement and vertical displacement of syringe pumps during transport of the patient, or the loading of a new syringe into the pumping device.

calculated on a daily basis. The sum of any fluid injected or ingested, be it drugs or nutrition, and the excreted fluid is not only critical to the well-being of the child but also limited.

Single-use liquid flow sensors, integrated into infusion sets, will enable medical devices not only to monitor the administered flow rates accurately, but also to detect the above mentioned common failure modes quickly and reliably.

Continuous urine flow measurements of critically ill patients require flow rates to be measured in the range of single millilitres up to 100 millilitres per hour.

Acute Kidney Injury (AKI) is a common complication (occurrence 20% - 30%) in critically ill patients in the ICU. The early detection and correct diagnosis of AKI currently receives a lot of attention in medical research and development.

Patient mortality and the risk to develop a chronic kidney disease drastically increases with AKI onset.

Nowadays, AKI can be diagnosed on the basis of laboratory data, including a change in serum creatinine or in the excretion of waste products of the kidney’s nitrogen metabolism.

At low flow rates, clogging of the very thin restrictor or at the injection site is difficult to detect quickly without a liquid flow sensor. This will prevent an optimal therapeutic outcome Research showed that the urine output of a catheterised patient is more sensitive than biochemical markers to changes in renal function. It exhibits a faster response than changes to the biochemical composition of the urine.

The standardised RIFLE classification (risk, injury, failure, loss, end-stage) is used by clinicians to increase the sensitivity and specificity of their AKI diagnosis. This classification states, that a decrease in urine output below 0.5 ml per kilogram body weight per hour for more than six hours is a first indication for an increased risk of acute renal failure.

The biggest issue faced today, when determining the urine output of a patient, is that it has to be measured and recorded manually in regular intervals by the ICU’s nursing staff. Only then can a further trend analysis be performed. The possibility of automatically and

continuously measuring and recording urine outputs would allow a timelier diagnosis and enable clinicians to recognise or even prevent AKI onset.

Again the LD20 single-use liquid flow sensor can solve this problem.

Common to all of the medical fields and applications described above, is that by using a single-use liquid flow sensor, important measurement data and vital signs could be acquired and stored automatically in the electronic patient data management system (PDMS). This solves the issue of timeconsuming, inaccurate, and cumbersome hand written medical charts and allows the timely detection of adverse effects. The data would be easily available for a retrospective analysis.

Above all, it would free-up time of the nursing staff to be spent on other tasks which still require personal attention.

The fluidic balance of a child or a neonate has to be observed and WWW.MEDICALPLASTICSNEWS.COM

33

POLYMER SOLUTIONS

FOR YOUR MEDICAL DEVICES We manufacture and compound rigid and soft polymer solutions for a variety of medical equipment including drug delivery devices, surgical instruments and equipment housings.

Large global infrastructure

Flexible and agile service model

ISO 13485 certified

Europe | Wassim Berrak wberrak@trinseo.com North America | Rob Haley rhaley@trinseo.com Asia Pacific | Vincent Huang vhuang@trinseo.com www.trinseo.com

World-Class Mouldmaking for MEDICAL. From Europe’s Finest Mouldmaker.

• Product Development/DFX • Material Flow Analysis • Conformal Cooling • Ultra-Precision, High-Cavitation Tooling • Mould Testing and Process Optimization Advanced and optimized mould design with scaled cavitation to meet the most demanding medical product requirements.

CHALLENGE AVENUE AND ACHIEVE THE BEST. Avenue – A GW Plastics Company | Finisklin Business Park, Sligo, Ireland | Tel: +353 (0)71 916 9510 | www.avenuemouldsolutions.ie

34

WWW.MEDICALPLASTICSNEWS.COM

EMERGING MARKETS

REALITY BITES Tim Jennings, Custom Case Group, explains why augmented and virtual reality technologies are primed to transform the medical device industry

A

ugmented reality (AR) and virtual reality (VR) have seen tremendous growth in the last several years, and the hype surrounding them is increasing as their possibilities continue to make themselves apparent. But AR and VR aren’t new. People have been using and improving them for quite some time. From early audiovisual flight simulators in the 1950s to the first VR headsets in the 1990s, devices that layer analytics or data onto the real world or create a new reality entirely have been in use for both entertainment and training purposes for decades.

The concept of manipulating reality might not be novel, but how it’s being executed is. Modern high-definition screens can render rich images that are nearly indistinguishable from inperson visuals, and the sheer power and ubiquity of today’s devices would have rendered users 20 years ago dumbstruck. Super-fast smartphones with expandable memory would put the computers of the early 2000s to shame, and they’re in almost every hand. Consumers and enterprises have access to a level of power that makes AR and VR more feasible and effective than ever before.

While the greatest inroads into the potential of AR and VR technologies have taken place in entertainment, AR and VR are making waves in the medical industry – offering potential to transform the entire medical device industry.

There are three key areas where AR and VR holds potential for the medical device industry in the coming years: PORTABILITY AR already exists on phones and wearables. Connected devices add a digital layer to the world around us through wireless networks, GPS data and image capture. AR apps aren’t novel anymore. Virtual reality headsets, once heavy and often burdened with a range of peripheral accessories and sensors, are now far more self-contained, and continue to get lighter and more portable.

Clinical skills training that would have previously taken place in a full simulation room covered floor to ceiling in specialised hardware can now happen with a headset paired with wearable connected devices to sense motion. Portable vital-signs-monitoring devices and automated diagnostic programs using smartphone-captured visuals are making practicing medicine possible anywhere.

Lightweight but durable plastics and polymers are vital to the comfort and usability of many of these devices, and materials innovation should pay off in coming years.

ACCESSIBILITY Accessibility can mean two things, and one is price. While the most sophisticated AR and VR technologies – like those that are used in detailed surgical simulations, for example – may cost a hefty sum, more mundane items like headsets and wearables continue to become more affordable.

VR headsets that would have been

under lock and key at a government facility 10 years ago are on sale for several hundred dollars to interested consumers – and the price is dropping every day, even as the technology becomes more sophisticated.

As manufacturers respond to rising demand and get smart with lighter materials and more economical designs, AR and VR technologies have the potential to be remarkably affordable (and therefore, accessible).

VERSATILITY From facility-sized systems that project a digital layer onto connected mannequins and simulated surgical devices to lightweight wearables that provide medical insights based on vital-signs monitoring, AR and VR devices vary widely in where and how they’re used. For the most part, the only true limitation of AR and VR is human creativity. Any medical scenario could potentially be simulated for learners, provided that someone is willing to program its functionality.

Paediatric cancer patients who are confined during chemo can travel anywhere with a headset.

The more that these technologies do, the more refined they become. The more refined they become, the more willing health care organisations will become to adopt them. This cycle is already underway, and staying aware of how AR and VR are evolving will be a crucial part of participating in the new reality that they’ll undoubtedly create in the coming years.

WWW.MEDICALPLASTICSNEWS.COM

35

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

Sharing Technology and Innovation

S FOCU 8: 1 IN 20 ealth rt H Sma and ring u t c ufa Man W

The leading Medical Technology event in Europe NE

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

Networking

Education

Innovation

Sourcing

Start-up Academy

ORTHOPAEDICS

JOINT VENTURES Okani Medical Technology is using Solvay Peek for its latest knee implant

O

kani Medical Technology, a Chinabased pioneer in artificial joint applications, has developed an allpolymer knee implant based on Solvay’s Zeniva polyetheretherketone (Peek). Okani’s novel ORGKnee implant is said to offer a longer service life at a lower cost than traditional metallic implant systems.

Okani evaluated Zeniva Peek’s suitability for the femoral and tibial tray components of its knee implant according to ISO 14243-1:2009, which simulates normal walking behaviour over ten years. The findings, which Okani presented at the Orthopaedic Research Society (ORS) 2018 Annual Meeting, indicates that the ORGKnee implant made of Zeniva Peek exhibited 50% less wear versus a metal implant as measured by material loss over 3 million cycles.

Okani selected Zeniva Peek for its ORGKnee implant due, in part, to the material’s success in spinal implant applications. Unlike implants made of cobalt chrome or titanium alloys, those moulded from Zeniva Peek exhibit a modulus similar to cortical bone, which can improve patient comfort, provide a more stable fixation over time and extend implant lifetime due to significantly reduced wear of the total knee-joint prosthesis.

Peek’s injection moulding capability makes largescale production of ORGKnee implants possible in a fraction of the time and cost it takes to make metal implants

Okani selected Zeniva PEEK for its ORGKnee implant due, in part, to the material’s success in spinal implant applications

“Peek’s injection moulding capability makes large-scale production of ORGKnee implants possible in a fraction of the time and cost it takes to make metal implants, which can take up to three months to manufacture, machine and polish using methods that can pose risks both to workers and the environment,” said Zhonglin Zhu, chief technology officer for Okani.

Another motivation that prompted Okani’s decision to work with Solvay was the polymer supplier’s reputation for partnering with highly innovative medical device companies.

“Okani’s implant is not only a perfect showcase for the unique properties of Zeniva Peek, but also for Solvay’s open innovation business model, which takes a collaborative approach to helping medical device customers foster innovation and optimize their technology,” said Jeff Hrivnak, global business manager for healthcare at Solvay’s Specialty Polymers Business Unit.

Okani’s ORGKnee implant enters pre-clinical trials this April before undergoing standard clinical trials by China’s Food and Drug Administration (CFDA) in September, 2018.

The company plans to commercially launch its ORGKnee solution in 2020 after CFDA approvals are complete.

WWW.MEDICALPLASTICSNEWS.COM

37

POLYMERS FOR DRUG DELIVERY OUR MEDICAL PORTFOLIO: · Barrier polymers

FIND OUT MORE VELOX.COM

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

17 – 19 APRIL 2018 Stuttgart, Germany Hall 9 · 9E38

CHINAPLAS COME AND VISIT US AT CHINAPLAS FROM 24TH – 27 TH APRIL AT NECC SHANGHAI.

DESMA 4.0 CONNECTING PRODUCTS AND PROCESSES.

SmartTraining

Find more information about our Industry 4.0 products online: www.smartconnect4u.biz

SmartFace

SmartRemain SmartTrace

24/7 38

WWW.MEDICALPLASTICSNEWS.COM

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

INTELLECTUAL PROPERTY

T

he field of medical devices is both highly innovative and one in which there are large numbers of existing patents and registered design rights. When developing new products, it is important to consider both your freedom to work in view of existing rights, as well as potential protection for your own products.

1 Freedom-to-operate As protection is often sought for even minor innovations in medical devices, there is a crowded field of pending and granted patent and design rights relating to all types of medical device. These existing rights can stand in the way of a medical device you intend to bring to market, or it may be possible to design around them.

Seeking advice during the development phase of your product enables potentially problematic patents and/or registered designs to be identified and analysed at an early stage, before significant amounts of money have been invested into tooling and equipment.

As specialist medical device patent attorneys, AdamsonJones offer medical technology expertise and helps clients build effective patent portfolios.

The company’s Katherine Wright shares her expertise

2 IP protection – is it possible and/or appropriate?

It is also important to consider whether a new device or process can be protected by a patent and/or by design rights, and whether trademark protection is appropriate for the product name or logo.

3 Discuss patent options early in the development process A patent can be used to protect a technical innovation or new manufacturing process.

Where patent protection is a possibility, discussions at an early stage in development about the potential protection that might be obtainable are crucial, as a patent application must be filed before the product is made public.

TOP 5 TIPS

on intellectual property protection for medical devices

Choosing the appropriate time to file a patent application is also important: too early, and there may be insufficient information available to file a strong application, but a delay until every aspect of the product is finalised risks a third party developing and seeking protection for a similar product in the meantime. Early and ongoing discussions with a patent attorney can help to identify the most appropriate point in the development of a technology to file a patent application.

4 Consider protecting the appearance of the product with a registered design Design rights protect the appearance of a product and may be applied for in conjunction with a patent application, to protect the appearance as well as the function of the product. Alternatively, a design right may be sought where the new development is not sufficiently innovative for an application for patent protection to be worthwhile, but where the appearance of the product is original.

Unlike when applying for a patent, there is a short grace period (six months) after a product has been made available to the public during which an application for a registered design right may be filed. In addition, registered designs are granted comparatively quickly, providing fast protection, but their validity is not tested unless and until the design right is asserted against an infringer.

5 Consider trade mark protection before a name or logo is finally fixed For any medical device, there are typically a number of companies producing goods that fulfil a similar need, and the ability to differentiate your product from those of your competitors through a distinctive brand is important. A trade mark is a sign, symbol or graphic which identifies products from a particular source, and registering your trade marks enables you to prevent a third party from being able to copy the name or logo associated with your product.

An application for a trade mark may be filed at any time, but there are certain limitations e.g. the trade mark may not be descriptive of the product. In addition, the trade mark application may be opposed by companies who hold similar marks. Although it is normally possible to overcome oppositions of this nature, perhaps through settlement or agreement to limit the trademark to a particular subset of goods, consideration of trade mark protection before a name or logo is finally fixed means that there may be some flexibility to modify or change a mark should it be found not to be allowable.

In summary Particularly in the crowded field of medical devices, freedom-to-operate and potential protection (patents, designs and trade marks) should be key aspects of any product development, considered alongside and helping to drive the development process.

Ideally, these issues should be considered at an early stage of product development, with regular reviews to ensure that significant time is not invested in technology already protected by a third party, and to ensure that the correct protection is being sought for your own innovations.

WWW.MEDICALPLASTICSNEWS.COM

It is also important to consider whether a new device or process can be protected by a patent

39

MED-TECH INNOVATION EXPO: WHERE SCIENCE, TECHNOLOGY AND ENGINEERING MEET This year, Med-Tech Innovation Expo returns to the Ricoh Arena in Coventry to represent the UK & Ireland’s medical technology sector on April 25 and 26. Reece Armstrong reveals what this year’s event has to offer Combining some of the UK and Ireland’s leading insightful thoughtleaders and innovative technology on offer, Med-Tech Innovation Expo is poised to bring together the medical engineering and manufacturing community across two action-packed days.

REWARDING EXPERIENCE New to this year’s show is the Editor’s Award for Business in Healthtech. The award will take place within the Medilink UK Healthcare Business Award, held in association with Med-Tech Innovation on 25 April.

Hosted by TV’s Dr Phil Hammond, the evening provides an opportunity for visitors to network and join together as a community with the aim of advancing healthcare.

The Editor’s Award for Business in Healthtech has been organised by the editorial team behind news brands Digital Health Age and Med-Tech Innovation News. Created to recognise achievements in business, the team will take into account the impact on unmet clinical needs, company growth and scale, as well as market share.

Speaking about the awards, head of content for Digital Health Age, Lu Rahman said: “We wanted to celebrate the pioneering companies that we read and write about every day. This award is our opportunity to commend those whose hard work has made the headlines across our brands over the past twelve months.

“We’re not just looking for one single contribution to healthtech – but rather, a sustained, ongoing effort to make healthcare provision easier, faster and more efficient through innovative tech.”

The Medilink UK Healthcare Business Award has attracted sponsors from some of the UK’s leading government, academic and business organisations, including the AHSN Network, HGF and GovGrant.

HIGH CALIBRE CONFERENCE Once again, the Med-Tech Innovation Conference will take place across the show’s two days, delivering a range of intelligent talks from blue-chip users, government officials and industry experts.

This year, the conference, hosted by Medilink UK, will examine the ways in which technology are expected to influence healthcare and life sciences in the years to come.

Karen Taylor, research director at Centre for Health Solutions, Deloitte UK, is kicking off the conference by predicting what the healthcare and life sciences sectors will look like in 2022.

40

Also speaking about where technology is taking us is Debbie Chinn, director of Solutions Assurance at NHS Digital, who will discuss the current and future trends of clinical risk management for health informatics.

Later in the day, Dr Chris Subbe, consultant physician & senior clinical lecturer will be sharing his thoughts on ‘What Social Networks taught us about the use of technology to make hospitals safe’.

Rounding out the day will be a talk on patient safety and quality of care from Janet Monkman, CEO at the Academy for Healthcare Sciences. Monkman will give a talk on the Life Sciences Industry Credentialing Register; the implications for any company accessing any NHS site, and how the register can benefit patient care and advance the healthcare science workforce.

The conference continues across the second day, with Alan Sumner, head of Public Affairs, Roche Diagnostics UK & Ireland, starting the morning.

With a passion for patient centricity and how patient outcomes can be improved, he will talk about the government’s Accelerated Access Review and how it can best serve patients.

A look at the mobile health landscape will be offered by Liz-AshallPayne, who launched the company ORCHA after being determined to offer guidance to app developers and to improve public, patient and organisational outcomes.

Visitors can also attend a number of inspiring stories of success from familyrun businesses including, Forte Medical and Salts Healthcare. Giovanna Forte, chief executive, Forte Medical and Philip Salt, chief executive, Salts Healthcare will be sharing their experiences of transforming a family business into a global success.

Visitors wanting to find out about upcoming changes and developments impacting businesses can attend a range of talks by representatives of government organisations. Dr Ian Campbell, director of Health & Life Sciences, Innovate UK, will provide an update on industrial strategy and the industrial strategy challenge fund, whereas John Wilkinson, director of Devices, Medicines and Healthcare Products Regulatory Agency will be discussing the new Medical Device Regulation – and the actions companies need to be taking.

Joel Haspel, partner, GE Healthcare Finnamore will also be presenting from a business perspective, giving a talk on Partnering for Artificial Intelligence Development and Delivery.

Unsurprisingly, innovation will be a key theme at this year’s conference.

Professor Mike Hannay, chair, National Network of Academic Health and Science Networks (AHSNs), will talk about the adoption and spread of Innovation in the NHS, and the role of AHSNs in addressing some of the biggest health challenges facing the UK. Mirren Mandalia, senior director New Ventures & Transactions (Medical Devices), Johnson & Johnson Innovation, will share his experience of advising healthcare startups and leading investments that J&J Innovation makes in exciting early-stage medical devices.

WWW.MEDICALPLASTICSNEWS.COM

MED-TECH INNOVATION EXPO PREVIEW

BLUE FROG DESIGN HELPED A MAN WITH PARAESTHESIA BY 3D PRINTING A STRUCTURE THAT STOPPED HIS CLOTHES FROM TOUCHING HIS UPPER BODY, REMOVING THE IRRITATION HE WAS EXPERIENCING Exhibitor Blue Frog Design (stand C8) will be showing off its latest innovation, highlighting how the company used 3D printing to help a patient with an ongoing skin condition.

The company worked alongside Medlink East Midlands to help a man who suffered from paraesthesia – a skin condition in which tingling, tickling, numbness or burning sensations occur with no apparent physical cause.

In this case, the man was experiencing a prickling sensation from the rib cage to the collar bone when his clothes touched his body.

Blue Frog Design was able to 3D print a structure that stopped his clothes from touching his upper body, removing the irritation and improving the man’s everyday living.

The company took a scan of the patient to identify the desensitised parts of his body from which the device could be placed on. The scan provided Blue Frog the precise data it needed to design the product.

Blue Frog was able to produce a device that followed the contours of the patient’s body in a minimally invasive way. The company used medical-grade material to 3D print the device, which is lightweight thanks to its lattice based design. The design also provides ventilation as air can flow through the device, the clothes and the body, helping to keep the patient cool.

Blue Frog believes that the product is an example of how useful 3D printing can be for the design and prototyping of medical devices.

WWW.MEDICALPLASTICSNEWS.COM

41

www.pmtgb.com

Static and Particle Contamination Control Biotech Medical Device Pharmaceutical

• Reduction of Yield Loss • Better Product Quality • Cleanroom Workflow Solutions

PMT (GB) Ltd. | Tel: +44 (0)1684 312950 | Fax:+44 (0)1684 312969 | email: info@pmtgb.com

HIGH PERFORMANCE for the healthcare sector

Plastics for demanding applications No matter what special feature you are looking for, we provide highperformance polymers for all kinds of applications. As a leader in distribution and compounding, we are strong in innovation and product development.

You can depend on our comprehensive technical support and uncompromising service all over the world.

Together we can overcome every challenge.

ALBIS (UK) Ltd. Parkgate Industrial Estate, Knutsford GB-Cheshire WA 16 8XW Phone: +44/(0)1565/755777 Fax: +44/(0)1565/755196 albisuk@albis.com In Ireland: ireland@albis.com www.albis.com

Ad MPN_124x190_0717.indd 1

42

18.07.17 16:30

WWW.MEDICALPLASTICSNEWS.COM

MED-TECH INNOVATION EXPO PREVIEW

RETURNING VISITORS Returning to Med-Tech Innovation Expo is a range of companies highlighting the strength of the medtech industry.

Product design consultancy, Renfrew Group International (stand B21), is back once again bringing its latest products for medical device design and development.

The company will be showcasing a number of products it has helped create across many fields, including prototypes of an artificial pancreas and a home dialysis system developed by medical device company Lucenxia.

Plastic injection moulding manufacturer, Boddingtons (stand E2), makes another appearance at Med-Tech Innovation Expo. It has recently expanded its production with a new plant offering expendable class 7 cleanrooms, 30 injection moulding machines and customer benefits such as disaster recovery safeguards.

Global supplier of stock OEM components, Qosina, is returning to the expo for the fourth consecutive year as it allows them the opportunity to meet with customers in person.

With over 40 years of experience specialising in the design and supply of fluid components to medical and scientific markets, West Group returns to Med-Tech Innovation Expo once again.

Anita Netherton from West’s marketing department, said: “West is a loyal supporter of Med-Tech Innovation Expo where it has found it to be the perfect place to showcase new products and touch base with existing customers. Come and see us on stand F2.”

TECHNOLOGY AT ITS BEST

SPOTLIGHT ON PLASTICS

This year, exhibitors will demonstrate a wealth of products, with many being shown or previewed for the first time.

With the international market for medical plastics being estimated to reach $33 billion by 2022, it’s no surprise that Med-Tech Innovation Expo will feature a number of the sector’s leading companies.

On stand F41, Vivaldi Software will be previewing its nextgeneration quality management software, used within a range of industries including life sciences, biotech and medical devices.

The new software can be used across any device and is intended to make work easier, save time and help users prepare for upcoming audits and manage documents and other essential information.

Nearby on stand F20, Zwick Roell will demonstrate its latest technology in parenteral drug-syringe testing equipment.

Process automation solutions provider, Festo (stand E38), will be showcasing a brandnew model highlighting the uses industry 4.0 components for medical devices.

This year, Raumedic (stand C52) will be presenting a range of products made from thermoplastics and silicone. The company’s portfolio includes products made from extruded moulding parts, to more complex solutions such as catheters and single-use cartridges for wearable patch pumps.

HTE Engineering Services will be presenting the theme of ‘Solving Medical Device Joining Problems’ at this year’s expo.

As first timers to the show, the company will be bringing its PulseStaking process to help medical device manufacturers join their polymer components. The process is used for joining components to plastic parts and offers advantages when compared to other joining methods.

On stand C21, Albis Plastics is participating at Med-Tech Innovation Expo to showcase its distribution portfolio of plastics for use in the healthcare sector.

The company has recently positioned itself to take advantage of the rapidly changing regulatory environment for medical devices. Albis Plastics’ Healthcare Business Development Team is helping the company support customer material enquiries, and find the right solution for its customers’ products.

Primasil Silicones will be celebrating 40 years at MedTech Innovation Expo by displaying its portfolio of silicone expertise.

The company’s team will be available to discuss any new silicone projects customers have and technical expertise will be on-hand at stand B10.

Vivaldi Software will be previewing its nextgeneration quality management software

Festo will be showcasing a -new model highlighting the uses industry 4.0 components for medical devices.

WWW.MEDICALPLASTICSNEWS.COM

43

industry 4.0 uncovered.

From automation and smarter machines, to predictive maintenance and increased efficiencies, NPE2018: The Plastics Show covers everything driving Industry 4.0â&#x20AC;&#x201D; bringing together all of the machines, technology, products and solutions advancing plastics manufacturing today.

Make plans to attend and discover new ways to maximize your operations and achieve success.

NPE2018 COVERS IT ALL.

REGISTER TODAY AT NPE.ORG

MED-TECH INNOVATION EXPO PREVIEW

CLEANROOM EXPERTISE At this year’s expo, visitors to the show floor can find out about how medtech companies are helping to keep components sterile for end-use.

Exhibiting at the expo are Connect 2 Cleanrooms, Monmouth Scientific, Steris AST and Guardtech Cleanrooms. All of these companies represent a market which is estimated to reach $5 billion by 2023.

On stand F44, Turbex will be promoting its highly controllable cleaning equipment for washing and drying medical instruments, prosthetics and consumables.

SECURITY AT THE FOREFRONT In 2017, the WannaCry incident proved to the UK that its healthcare industry wasn’t immune to attacks from cyber-criminals.

IntelliQA, C18, is highlighting the paramount importance of data security at Med-Tech Innovation Expo, in an era where healthcare is shifting toward further digitisation.

The company is presenting its software security testing tool, Micro Focus Fortify on Demand. The tool addresses application security rapidly and without the need for infrastructure investments on security staff.

Primasil Silicones will be celebrating 40 years at MedTech Innovation Expo by displaying its portfolio of silicone expertise

THE ENTIRE MEDTECH SECTOR REPRESENTED Visitors to Med-Tech Innovation Expo will find the entire breadth of technologies and products representing the medtech industry.

Maxon Motors (stand E12), is “looking forward to showcasing Maxon medical products as well as meeting existing customers and developing new relationships” according to Matt Dean, sales engineer.

Laser Proto (stand F10) is displaying its latest samples produced on metal sintering machines. Metal sintering is fast becoming the preferred manufacturing method for custom implants (created exactly for an individual) and surgical guides, allowing the design, development and manufacture of parts and devices which are beneficial to practitioners and patients alike.

Supplier of pouches, lidding, rollstock, and mounting cards for the global healthcare industry, Oliver Healthcare Packaging will be on stand D43.

Speaking about why the expo is a great event to showcase its services, Craig Thompson, commercial manager of Penlon, said: " “Med-Tech Innovation is the ideal opportunity for us to meet companies looking for the reassurance of working with an established UK partner. Penlon has 75 years’ experience manufacturing medical devices and an in-depth understanding of the sector, including the regulatory requirements. You will find us on stand C44 and we look forward to seeing you at the Ricoh Arena.”

If you’ve ever wanted to know about human factors with the medtech sector, then go visit Medical Device Usability on stand D11. The company will have specialists on-hand to discuss any requirements visitors may have about their medical device products.

Family-run business, Mintdale Engineering will be showcasing its automated production services for the medical device industry at stand G29.

If you’re interested in moulding simulation, FlowHow will be demonstrating the latest capabilities of its Moldex3D software at stand G41. The software is designed to provide professional injection moulding simulation to guide customers through design processs.

Carville (stand G4) will be showcasing its range of high accuracy diffusion bonded fluidic manifolds at the expo. Used widely in medical, life sciences and industrial applications, these products can help reduce manufacturing costs, assembly time and servicing requirements by incorporating system complexity into a single component.

WWW.MEDICALPLASTICSNEWS.COM

45

meliflex elastomer and polymer+ compounds dedicated to healthcare

Quality created for added value

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

46

meet us at Medtec 2018 Stand 9E10 April 17-19 Stuttgart - Germany Medical Technology Ireland 2018 Stand 55 September 26-27 Galway - Ireland

WWW.MEDICALPLASTICSNEWS.COM

CATHETERS

Inside information Cikautxo Medical OEM explains the benefits of integrated sensors in catheters

A

bout 10% of the western population will, at a certain stage in their life, be taken to a catheterisation laboratory for angioplasty surgery (stent placement), treatment of an arrhythmia or a heart valve replacement. This percentage is increasing with an aging population. Fortunately, most of these interventions can be carried out using minimally invasive procedures that are assisted by smart imaging and sensing catheters that are the ‘eyes and ears’ of the surgeon directly at the point of intervention.

The growing number of cables in the cath lab is rapidly becoming a problem. The interventionist increasingly has to deal with instruments that have electrical cables connected to them. These cables hamper the workflow, and can result in dangerous situations eg, when a cable hooks behind the rotating X-ray C-arm, or during an electrical cardioversion. Sensing smart catheters are consequently more and more demanded in the cath lab.

‘SENSING’ TRENDS IN CATHETERS To improve the success rate of the most important cardiovascular diseases but also for other type of surgeries, catheter manufacturers have started to add electronic sensing functionality to the instruments resulting in what is referred to as ‘sensing’ catheters. Here, different examples of catheters are distinguished based on their application disease. Some of the ongoing applications today are: Urology: Foley Catheter Temperature Sensors enable clinicians to accurately monitor urinary output and bladder temperature in addition to facilitating urine drainage. Commonly used also to monitor a patient›s body temperature during surgery.

Vascular: Vascular catheters with blood glucose measurement have the potential to become a standard of care for the management of blood glucose levels in the critical care units of the hospital. The near-continuous glucose measurements automatically transfer whole blood from a radial artery, peripheral vein, or central venous catheter to an external flowthrough glucose sensor. A vascular catheter with this type of sensor acquires a fresh blood sample every five to 15 minutes, measures the concentration of blood glucose, and then flushes the sample back into the bloodstream using flush solution. Standardisation of blood sample acquisition, analysis, and calibration will increase the accuracy and precision of the blood glucose measurement, a major

The US market for smart catheters used in the treatment of cardiovascular diseases. The European market prediction follows the same trend at approximately half the market value. advantage of those catheters compared to routine clinical methods.

On-going therapy: A whole new class of implantable devices is being developed with the purpose of delivering local and on-going therapy. These ‘electroceuticals’ stimulate or block nerves directly addressing organs.

The ‘sensing’ catheters are contributing to Indurtyy 4.0, where the Internet of Things (IOT) will also conquer the Internet of Medical Devices (IMD).

MANUFACTURING ‘SENSING’ CATHETERS “Customers are increasingly demanding sensor integration in our OEM catheter manufacturing activity. We are embedding different types of sensors, from the most common ones like temperature or pressure sensors, up to the most difficult ones, like position systems.

“Sensors are very fragile components that need to be carefully manipulated during the assembly in the catheter. Intensive tests are also made to validate the correct sensing functionality after the product final assembly.

“Our sensor R&D centre, IKERLAN, located only a few miles from our cleanroom facilities, mean we stay on top of the latest technologies in sensors, so we can help our customers to select the most appropriate solution for their needs,” says Iker Principe, CEO, Cikautxo Medical OEM.

Success stories: To improve the success rate of many cardiovascular diseases, catheter manufacturers have started to add electronic sensing functionality

WWW.MEDICALPLASTICSNEWS.COM

47

T

his year UBM announced that Medtec Europe, Stuttgart, would be a stand alone, European-focussed, medical technology event by integrating Medtec Ireland and Medtec Europe.

MEDTEC EUROPE

Trend setter Taking place in Stuttgart on 17-19 April, Medtec Europe showcases the key trends and insight across the entire medical technology supply chain

As of 2018 a dedicated stand for Irish and British companies will be available at Medtec Europe, aimed at offering participating companies greater opportunities to reach into bigger. There will also be seminars and presentations specifically tailored to the British and Irish markets in order to address the challenges of these markets.

The industry is developing a need for digitalisation and smart solutions throughout all segments of the medical device production chain. At Medtec Europe 2018 there will be dedicated areas for smart health and smart manufacturing including live demonstrations, expert speaking sessions, and exhibitors.

Last year saw the first Medical Device Manufacturing Conference at Medtec Europe, in partnership with the Fraunhofer IPA, and this will return for 2018.

A new addition to Medtec Europe for 2018 will be the Innovation Gallery. This is an area where exhibitors have the opportunity to present their latest products in an exclusive area, supported by guided “Innovation Tours”.

Market overview 3D PRINTING 3D printing technology is enabling the development of new products for use in a range of industries, including the healthcare sector, often more cost-effectively, efficiently and while providing properties not available with other manufacturing processes.

Although this is an emerging market, it is estimated the 3D printing industry is already worth approximately $5 billion with around 15% of the market – approximately $750 million – coming from the healthcare sector.

One of the main healthcare sectors to have benefited from advancements in 3D printing is the market for orthopaedic, spinal and other reconstructive implants. The main benefit of 3D printing is that it enables the creation of structures once considered impractical or prohibitively expensive compared with traditional manufacturing techniques.

3D printing enables the manufacture of reconstructive implants to specific pore size, interconnectivity and porosity requirements, while enabling the products to have more complex geometries. The geometry can include channels, lattice structures and organic shapes that would either be impossible to produce using traditional

48

WWW.MEDICALPLASTICSNEWS.COM

machining, moulding and casting techniques, or would be prohibitively expensive.

A key application for 3D printing is to enable the production of customised, patient-specific implants and surgical devices. For this application, imaging technology can be used to gather information about a patient’s medical condition and anatomy with the resulting data being used to produce a medical device built specifically for that person’s physiology.

PERSONALISED SOLUTIONS As medical device manufacturers look to implement 3D printing in their product design and manufacture, the companies are often partnering with the 3D printing market leaders in order to gain access to their proprietary technology.

One company that owns its own 3D printing technology is DePuy Synthes, which acquired the assets from Tissue Regeneration Systems earlier in 2017. The acquisition is intended to enable DePuy Synthes to create patient-specific, bioresorbable implants with a mineral coating for treating orthopedic and craniomaxillofacial conditions.

In addition to the acquisition, Johnson & Johnson is working through 50 strategic collaborations to harness 3D printing technology to develop patient-specific solutions that may improve clinical outcomes. For example, the company has recently launched TRUMATCH Titanium 3D-Printed Implants for use in facial reconstruction, which are distributed through an agreement with 3D printing company, Materialise. DePuy Synthes has worked with Materialise on developing products for craniofacial surgery since 2010. The new addition is designed as a personalized solution for orthognathic surgery and other craniofacial indications that integrates virtual surgical planning, intraoperative patientspecific tools and personalised implants to help improve accuracy and patient outcomes.

population of 2 million amputees in the US alone, the market for 3D printed prosthetics is significant, especially as most prostheses have to be replaced every three to five years ENHANCING COST EFFICIENCIES AND IMPROVING PROFITABILITY In addition to improving patient outcomes in the lucrative reconstructive surgery and prosthetics markets, 3D printing technology is of great interest to medical device manufacturers in terms of enhancing cost efficiencies and improving profitability. The advanced products produced by 3D printing can be sold at a higher price premium, while often being manufactured more efficiently and at a lower cost than traditional products owing to the fact that 3D printing reduces the amount of materials used to produce them. Another major benefit of 3D printing is that it enables rapid prototyping, which can significantly speed the development of medical device prototypes, while reducing development costs. According to Medtronic, in just one year, the company has saved up to nine years of research and development testing time using its seven in-house 3D printers to develop prototypes for testing.

MEDTEC EUROPE

3D printing is already having a significant impact on the prosthetics industry

3D BIOPRINTING One of the most advanced and exciting areas for 3D printing in the medical field is 3D bioprinting, whereby 3D printing is used to produce functional human tissues. As bioprinted tissues are created without dependence on integrated scaffolding or hydrogel components, they can have a tissue-like density with highly organized cellular features such as intercellular tight junctions and microvascular networks. Currently used in medical and pharmaceutical research for disease and treatment evaluation, 3D bioprinting can accelerate the drug discovery process, enabling treatments to be developed faster and at lower cost.

To register: www.medteceurope.com

The first 3D printed, customised, patient-specific reconstructive implants were launched in 2013

by Oxford Performance Materials and are sold by Zimmer Biomet. The OsteoFab cranial and facial implants are constructed with the use of a patient’s CT imaging data and computer aided design to determine the dimensions of each implant. The device is then manufactured via the OsteoFab 3D printing laser sintering process. The implant is attached to native bone with commercially available fixation systems.

Likewise, 3D printing is already having a significant impact on the prosthetics industry, where the devices can be made to perfectly match the patient’s proportions, be extremely lightweight, typically less than half the weight of conventionally made prosthetics, offer accurate skin tone and be produced at a fraction of the cost of traditional products. With The Amputee Coalition of America estimating that there are 185,000 new lower extremity amputations each year and an estimated

WWW.MEDICALPLASTICSNEWS.COM

49

Five key medical plastics players, according to report

1

Market.biz cites speciality chemicals expert Lubrizol as a key player

2

‘We create chemistry’ says BASF, which also appears on the list

3

MPN Jan/Feb cover star, Trinseo, also features on the list

4

2018 marks 100 years of the Celanese Corporation who features highly

5

Offering high performance plastics solutions, Ensinger is also a high ranker

04:2018 COLLABORATION CONTINUES FOR NEEDLE-FREE DRUG DEVICE

P

ortal Instruments and Takeda Pharmaceutical Company have teamed up to develop and commercialise Portal’s needle-free drug delivery device for potential use with Takeda’s biologic medicines. The Portal device was developed at the Massachusetts Institute of Technology (MIT) in the laboratory of Professor Ian Hunter. The technology has potential for applications across a range of biologic medicines that currently require administration through an injection.

program is currently evaluating the efficacy and safety of a subcutaneous formulation of vedolizumab in adults with moderately to severely active UC or CD. “There is a need for options to keep improving the experience for patients with life-long, chronic conditions that are managed with the intravenous infusions of biologic medicines,” said Stefan Koenig, global program & brand lead at Takeda.

TOOTH OF THE MATTER:

The first potential use of this device will be for with Entyvio (vedolizumab), for adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), which is currently administered through intravenous infusion. A Phase III clinical trial

Polymer helps reduce hand fatigue in dental device

S

olvay’s high-performance Radel R-5100 NT polyphenylsulfone (PPSU) has been used by SMACO to mould a more ergonomic hand piece for a new dental scaler designed to lower hand fatigue.

SMACO sought a lightweight polymer rather than metal for its hand piece in order to avoid the hand fatigue users commonly experience with heavier designs. However, many other medical-grade polymers it considered could not withstand the sterilisation techniques that the dental scaler would undergo, so they opted for the Solvay product.

Check out...

Episode 7 of the MedTalk Podcast This episode sees the come together to chat about the latest developments in the worlds of medtech, digital health, medical plastics and pharma. The team discuss the government’s latest plan to review three public health scandals. Fliss and Reece 50

delve into the details of what the plan means for products such as vaginal mesh and sodium valproate.

Dave plugs Med-Tech Innovation Expo and why it is the event to be at in April for the medical manufacturing and

WWW.MEDICALPLASTICSNEWS.COM

engineering communities.

Lastly, Fliss takes the Fear of Finding Out quiz to see if she has a fear of finding out bad news about her health.

You can listen to the latest episode on Soundcloud or iTunes.

Are you fit for the MDR? Get up and running!

The new European Medical Device Regulation (MDR) was adopted by the European Parliement on April 05, 2017 which will come into force after the publication in the offical journal. It will not only replace the current Medical Device Directive; experts anticipate drastically stricter regulation for virtually all medical device manufacturers in Europe. A variety of challenges for the manufactures but also for the other actors in the field of medical device are envisaged. Despite a transition period of 3 years timely start is recommended.

Our specialists and experts will provide modular support along the entire value chain of your products.

Visit our website at www.knoell.com for detailed information.

Is your business prepared for the changes? How extensive are your plans for implementing the changes in your processes and adapting your products to meet the new requirements? Or have you not made any preparations yet?

As specialists in the global approval of medical devices we will support you in all aspects of the MDR      

Implementation Quality management Risk management Clinical evaluation and clinical studies Post-market surveillance Biological and toxicological evaluation

Dr. Knoell Consult GmbH Dr. Albrecht Poth Business Development Medical Devices Tel +49 621 718858 092 apoth@knoell.com www.knoell.com