MPN NA Issue 7

N AMERIC AN EDITION

MEDICAL PLASTICS news

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Freudenberg Medical highlights its expertise in coatings and surface treatments HOW ROBOTS AND AUTOMATION ARE BENEFITTING OEMS THERMOFORMING IN FOCUS ADVANCES IN ADHESIVES

ISSUE 7

Jul/Aug/Sept 2018

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ADVANCING MEDICAL PLASTICS

CONTENTS MPN North America | Issue 7 | July/August/September 2018

Regulars

Features

3 Comment Lu Rahman asks what links Snapchat and the plastic surgery industry?

18 Robots & medical device: What’s the future?

Reece Armstrong explains

29 Reporting lines Dr Knoell Consult looks at clinical evaluation reports

22 Rising to the challenge Steris Finn-Aqua describes the VHP challenge for COP Aqua

30 The shape of things to come Ray Products examines thermoforming and medical device manufacture

5 News focus 13 Opinion Aaron Johnson, Accumold and Apple Rubber offer industry insight 16 Cover story Freudenberg Medical highlights the value of surface coatings 36 Back to the Future

25 Germ warfare Lu Rahman looks at some of the latest antimicrobial offerings 26 Innovation nation Reece Armstrong examines the innovation at the heart of the North American life science sector

33 Forming an attachment 3M outlines the role of adhesives in digital wearable medical devices

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CREDITS

EDITOR’S

comment

head of content | lu rahman deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi head of media sales plastics & life sciences | lisa montgomery head of studio & production | 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: North America: FREE UK and Europe: $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.

ISSN No:

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

Has Snapchat provided a boost to the plastic surgery industry?

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n the last issue of MPN Europe, I commented on the way in which a TV programme in the UK, Love Island, was being criticised for using contestants that had undergone cosmetic surgery as well as featuring commercials for breast surgery.

The global cosmetic surgery and procedure market is expected to hit $43.9 by 2025, according to Grand View Research. It’s hardly surprising that businesses want to take their slice of this sector if they can.

The opportunities offered by this market aren’t confined to Europe, or breast surgery. The latest influence to come under the spotlight for its effect on how we view our bodies, is Snapchat.

An article by Susruthi Rajanala in the JAMA Facial Plastic Surgery highlights the way in which Snapchat editing has gone beyond its puppy ears and flowery crown effect most of us have seen at some point. With its ability to smooth and offer youthful glamour to its photographs, the desire for this to extend into real life has now become a reality.

“Patients may seek surgery hoping to look better in selfies and social media,” writes Rajanala, adding, “Plastics surgeons first identified this trend in the 2017 Annual American Academy of Facial Plastics and Reconstructive Surgery (AAFPRS) survey. Current data show that 55% of surgeons report seeing patients who request surgery to improve their appearance in selfies,

up from 42% in 2015. The survey also noted an increase in patients sharing their surgical process and results in social media.”

This new craze, if is you can call it that - for people to appear as filtered version of themselves – is becoming known as ‘Snapchat dysmorphia’.

It would of course, be easy to point the finger at both the social medical industry and the plastic surgery sector.

I’m sure Snapchat was unaware of the potential possibilities of its users to appear permanently filtered. As for the plastic surgery sector, we need to weight up this wave of desire for procedures against the many processes that improve body image and mental well-being as a result. The American Society of Plastic Surgeons recently ran a piece on how men were turning to plastic surgeons for better body image and confidence, resulting in a positive self-image.

There is a fine line between what we may view as the harmful effects of social media on how we view our bodies, and the way many of us are looking at how we appear physically. This may drive the need to improve appearance because we feel inadequate, or a resulting procedure may improve the way we think we look. It’s a tricky one to fathom and will be interesting to watch over coming years. Of course, there’s every chance we’ll see a backlash against filters on and off our phone screens…who knows what will replace it?

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“

The American Society of Plastic Surgeons recently ran a piece on how men were turning to plastic surgeons for better body image and confidence, resulting in a positive selfimage.

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NEWS ANALYSIS

Why the hacking of medical devices is still big news Lu Rahman looks at some of the issues still affecting connected devices The vulnerability of medical devices to be hacked is nothing new. But picking up on news reports from the Black Hat security event that took place in Las Vegas at the beginning of August, it seems that these concerns continue to be top of the agenda where products such as pacemakers and implantable devices, are concerned.

The findings were brought to the fore by security experts, Jonathan Butts, QED Secure Solution, and Billy Rios, WhiteScope, during their presentation, Understanding and Exploiting Implanted Medical Devices. While acknowledging that benefits of these devices often outweigh the risks, the pair’s findings have been picked up on a global scale to highlight the need for increased work in this area.

Security Boulevard writer, Haidee LeClair, explained: “But there are still plenty of vulnerabilities out there, as well as—at least in some cases, according to Butts and Rios—resistance to acknowledging them and making necessary fixes.

“The two demonstrated that some devices they tested, including infusion pumps, pacemakers, and patient monitoring systems, had vulnerabilities that they found relatively easy to exploit remotely.”

While LeClair reports that “[Rios and Butts] have reported 500 advisories to vendors.

Most have been cooperative and worked with them on both “coordinated disclosure” of problems and fixing those problems.

“But they unloaded on one vendor— Medtronic, whom they said was both uncooperative and unresponsive. They said 18 months after they disclosed vulnerabilities in devices made by the company, there had been one patch but no real fix, and not even an acknowledgment that a fix was needed.”

In the UK, the Guardian reported that Butts and Rios had actually demonstrated how an implantable insulin pump could be hacked: “To take control of the pacemaker, Rios and Butts went up the chain, hacking the system that a doctor would use to program a patient’s pacemaker”.

It’s a worrying scenario but unfortunately one which we are used to reading in the medical device sector.

According to the Guardian, Butts and Rios contacted Medtronic over a year ago with their concerns. “In its cybersecurity alerts, the company said the attacks weren’t possible remotely, and failed to fully explain how wideranging the weaknesses were. A bulletin warning about the weakness that Rios and Butts used to reprogram the pacemaker, for instance, said only that an attacker ‘could influence’ the data sent to its software update system,” reported the newspaper.

MPN contacted Medtronic for a comment.

The company said: “Medtronic emphasizes the safety of its products. Product safety and quality are top priorities for Medtronic, and we have a strong product security program that leverages internal and external security and medical device experts, rigorous development processes and current practices to enable security and usability. We are, and continue to be, committed to delivering safe and effective devices to address our patients’ therapeutic conditions.

"It’s important to note, however, that the likelihood of a breach of a patient’s device is low, and we are not aware of any security breaches involving patients with our medical devices. All medical devices carry some associated risk, and, like the regulators, we continuously strive to balance the risks against the benefits our devices provide.

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"Additionally, we value collaboration and transparency with industry partners and the regulatory community, and we support FDA guidance on these matters. Medtronic is committed to a robust, coordinated disclosure process and takes seriously all potential cybersecurity vulnerabilities in our products and systems, and we consistently seek to improve these processes, in terms of our technical evaluation, required remediation and speed of disclosure. We follow formal processes, as required by the FDA and other regulators, for evaluating and mitigating the risks associated with all cybersecurity vulnerabilities.

"In the past, WhiteScope, LLC has identified potential vulnerabilities which we have assessed independently and also issued related notifications. We are not aware of any additional vulnerabilities they have identified at this time.”

Earlier this year the FDA announced plans to enhance medical device safety. Its policies used real world evidence to create a framework for digital health devices.

Speaking about the decision, FDA commissioner Scott Gottlieb, said: “All medical devices have benefits and risks. And some of these risks are better understood once the device is more widely distributed and used under real-world conditions, in broader patient populations, and by a broader range of clinicians. Our aim is to ensure not only that devices meet the gold standard for getting to market, but also that they continue to meet this standard as we get more data about devices and learn more about their benefit-risk profile in real world clinical settings.”

One of the FDA’s key aims is to increase its understanding of cyber-security issues related to medical devices.

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DIGITAL

spy

MATERIAL UPDATE

TECHNOLOGY UPDATE

www.news.mit.edu

press print:

WALK THIS WAY:

3D-PRINTING TO DISRUPT IMPLANTS INDUSTRY

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he implementation of 3D printing technology in healthcare has created exciting developments, making medical technology which is often expensive at the time of market entry cheaper over time. 3D printing in medicine has started to revolutionize the field, especially with its declining cost and increased accessibility.

Albeit costlier than existing implant solutions in healthcare, the precision of end-product is what ensures the success of the 3D-printing medical devices. Designed from the thoroughly analyzed digital model, 3D implants leave no room for error compared with traditional techniques which usually require additional processing adding waste and extraction costs.

With enhanced precision, 3D printed medical implants such as orthopedic and dental implants have witnessed an impressive success rate in the last five years. Fact MR’s market study estimates sales of medical implants continue to dominate the market.

Customization is the current trend in medical implants market. Advances in 3D printers, materials and other technology have enabled manufacturers to design and deliver custom-made, high-resolution 3D-printed implants on patient demand.

In orthodontics, starting from designing common dental casting to metal bridges, dental crowns, and other dental implants, 3D printing has made dental implant surgeries better, faster and cost-effective.

Low cost prosthetic mimics natural walking

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rosthetic limb technology has advanced giving amputees a range of bionic options, including artificial knees controlled by microchips, sensor-laden feet driven by artificial intelligence, and robotic hands that a user can manipulate with her mind. But such high-tech designs can cost tens of thousands of dollars, making them unattainable for many amputees, particularly in developing countries.

Now MIT engineers have developed a simple, low-cost, passive prosthetic foot that they can tailor to an individual. Given a user’s body weight and size, the researchers can tune the shape and stiffness of the prosthetic foot, such that the user’s walk is similar to an able-bodied gait. They estimate that the foot, if manufactured on a wide scale, could

Minimally invasive roboticassisted surgeries are enhancing the efficiency of 3D printed medical implant procedures. With the increasing adoption of robotics in 3D printed implant procedures, rising FDA approvals, and high patient outcomes, the purported growth of the 3D-printing medical devices market at an impressive CAGR of 14.4% during 2017 – 2022 seems most credible.

The next generation of medical 3D printing is set to venture into a combination of 3D bioprinting and tissue engineering to revolutionize organ transplantation.

The custom-designed prostheses are based on a design framework developed by the researchers, which provides a quantitative way to predict a user’s biomechanical performance, or walking behavior, based on the mechanical design of the prosthetic foot. “[Walking] is something so core to us as humans, and for this segment of the population who have a lower-limb amputation, there’s just no theory for us to say, ‘here’s exactly how we should design the stiffness and geometry of a foot for you, in order for you to walk as you desire,’” says Amos Winter, associate professor of mechanical engineering at MIT. “Now we can do that. And that’s super powerful.”

DIGITAL UPDATE

www.corwave.com

Wave hello:

US patent office gives heart device thumbs up

C

orWave, a French medical technology company that develops innovative implantable cardiac support devices for patients suffering from heart failure, has obtained patent from the United States Patent and Trademark Office: ‘Implantable pump system having an undulating membrane’.

The patent describes the application of CorWave’s technology for blood pumping in a left ventricular assist device (LVAD), and specific designs related to using

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cost an order of magnitude less than existing products.

the wave membrane technology to make a blood pump.

This patent completes CorWave’s extended IP portfolio across four patent families.

CorWave wave membrane technology can mimic a pulse and produce blood flow velocity similar to that of a real heart. Closer to the natural functioning of the heart, CorWave pumps are said to have the potential to reduce the risk of complication and cost. Despite the numerous limitations of

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the current technologies, the LVAD market already represents about one billion of sales globally.

“This is a significant milestone for the company and the R&D group. We have been working hard at the forefront of the technological frontier to bring CorWave’s novel pumping technology to the LVAD space. The receipt of this patent reinforces the unique nature of the wave technology,” commented Carl Botterbusch, CorWave.

DIGITAL SPY

MATERIAL UPDATE

www.polyvisions.com

hot news

Flame retardant thermoplastic compound launched

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olyVisions has developed a highdurability, highly chemical resistant, flame retardant material designed for housings and enclosures in medical device and lab instrumentation applications.

DuraPET FR is a graft-modified polyester compound capable of withstanding temperatures from -40°F to more than 180°F. It is designed with enhanced chemical resistance to withstand continuous exposure to germicidal cleaning compounds that destroy the properties of other commonly used thermoplastics.

talking

POINT

PolyVisions says DuraPET is easy to mold due to its low shrinkage and excellent heat stability. It is currently used in parts ranging from 20 pounds to less than an ounce.

Molders have been able to use it in molds designed for PC/ABS and other materials.

DuraPET is also suitable for film and sheet extrusion.

“DuraPET FR achieves a combination of impact strength, chemical resistance and flame retardancy not available in any material at any price today,“said Scott Howard, CEO of PolyVisions.

Down the wire STUDY SHOWS WIRELESS PACEMAKERS COULD CUT PATIENT COMPLICATIONS Where has the research come from?

Cleveland Clinic. Its findings show that patients are less likely to experience complications using pacemakers that don’t use wires to connect the device to the heart.

Leadless pacemakers are small, self-contained devices that are placed directly into the heart using a catheter that is carried from the leg to the heart via the thigh’s femoral vein.

RESIN UPDATE

Staple ingredient: Solvay resin singled out www.solvay.us According to Solvay, its Ixef polyarylamide (PARA) resin has been perfect for the delivery of the high stiffness and biocompatibility that Reign Medical needed to develop its new Clench compression staple system – a single-use bone staple kit for orthopedic procedures targeting the hand and foot.

Reign Medical’s innovative Clench Staple System kit comprises a disposable sterile surgical tool set for fixating hand and foot bone fragments, osteotomy fixation and joint arthrodesis. Its design utilizes a patented threaded hub that allows surgeons to incrementally expand the implant for proper insertion, while retaining the mechanical properties of the Nitinol staples for continuous compression

across the fusion site after implantation.

The company specified Solvay’s Ixef GS1022 PARA, a 50% glass fiber-reinforced grade, for several components: the implant sizer, the drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits, and the threaded compressor that forces the staples fully open.

More than one million pacemakers are implanted each year globally. The first leadless pacemaker was introduced in 2014 and approved by the US FDA two years later.

Why are leadless pacemakers showing these results?

Conventional pacemaker models are connected to the heart using a wire that stretches from the shoulder vein to the heart. According to previous research, these wires are the most common source of complications for patients.

How did the study work?

The study compared short and mid-term complications between 718 patients receiving the Nanostim leadless pacemakers and 1,436 patients with conventional pacemakers.

At one month and up to 18 months, patients receiving the leadless pacemaker had fewer complications. They were found to eliminate lead and pocket complications, including infections.

What else do we need to know?

Looking at vascular complications, electrode dislodgement and generator complications, there were no significant differences between the two groups. The study did find however that those receiving leadless pacemakers had an increased risk of developing bleeding between the heart and the sac that surrounds it.

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MEDTEC CHINA

medtec china reaches international status

S

hanghai will be home to Medtec China this year from 26-28 September. This year’s event has a strong regulatory theme to will be reflect the growing global device market in China

Shanghai home to Medtec China this year from 26-28 September.

This year’s event has a strong regulatory theme to reflect the growing global device market in China

Medtec China 2018 will be launching a regulatory zone to address the international medical device industry in China.

The Chinese government is encouraging the internationalisation of local innovative medical device production to explore global opportunities.

Medtec China, dedicated to medical device design and manufacturing in China, aims to contribute to the acceleration of this development.

This year’s show will launch a new zone called Regulatory Street, supported by Shanghai Pudong Medical Device Trade Association, consultant companies and keynote speakers from North America, Europe and China, with regulatory updates for China, the US and the EU. Meanwhile, the China Chamber of Commerce of Medicines & Health Products Importers & Exporters (CCCMHPIE) will be holding a seminar to discuss the internationalisation of the medical device industry in China, and where are the challenges and opportunities.

REGULATORY STREET HELPS LOCAL BRAND GO GLOBAL With the rapid development of Chinese medical device manufacturing, more competitive products are being exported

to the US, EU and other regions around the world. Therefore, local regulation compliance and certification is important.

This regulatory zone was launched for this reason. Shanghai Pudong Medical Device Trade Association has offered its full support.

Exhibitors in Regulatory Street provide comprehensive regulatory consultant services including accessing markets in North America, Europe, Japan and Canada. For example, Dr. Knoell Consult offers client-specific strategic advice for the global registration of medical devices.

It assists companies in designing quality management systems and the associated support for preparation and up-keeping of technical documentations. As a leader in the medical device industry for a many years, WuXi AppTec provide testing plans which can be customised at any stage of the product development life cycle.

Meanwhile, Shanghai Huaxia Investment Management Co, specialises in enterprise registration, financial agents, trademarks, personnel and other one-stop business service SEMINARS FOR HIGH-END MEDICAL DEVICE PRODUCTION The five-year plan focuses on the development of an advanced domestic medical device industry. To speed up the internationalisation of high-end medical device production, the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) will be holding a seminar at Medtec China 2018 to share information about marketing in other countries and how to solve the challenges of this program.

Mindray, Neusoft, Shinva, United-Imaging, Sonoscape, WEGO, Yuwell, Fosun and Anke who are members of CCCMHPIE may join this meeting at Medtec China 2018.

DEBUTING COMPANIES More than 50 companies are going to debut at Medtec China 2018 and in all, 400 suppliers will congregate at this annual event to showcase exhibits of medical raw materials, components, tubing and extrusion, manufacturing equipment, contract manufacturing services, and regulatory consultant services for more than 10,000 decision makers, purchasing staff, R&D engineers, product engineers and quality inspectors from medical device manufacturers.

Debuting exhibiting companies include Wynca, a global supplier of silicon-based new material products; Shanghai BAODIE manufacturer specialising in high speed single/multi-layer medical tube/pipe extrusion lines and Arone, a precision mechanical manufacturer including medical devices, and electrical/electronic parts.

Era-contact (Suzhou) Co is from Germany and boasts proficiency at designing and assembling complex electrical systems. It also possesses high-level technology, such as resistance welding, hot melt injection, and glue packaging.

EG-MEDACYS is from the USA and is a medical device manufacturer with tooling, moulding, assembly and engineering services provided to medical device manufacturers, and biology, lab, consumable and consumer industries. www.medtecchina.com

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NEWS FOCUS

how to slash time to market for medical devices

Roger Mazzella, The Qt Company, looks at ways to address the lack of industry growth in the medical device sector

A

ccording to market research firm Evaluate, the medical device and technology (medtech) market will be worth $500 billion by 2021, and the need for affordable and safe medical devices continues to increase. This is primarily driven by population growth. Another factor is the rise of new and developing diseases which require aggressive monitoring and treatment methods.

In addition to the rise in industry-wide adoption high-tech developments like connected Internet of Things (IoT) devices and artificial intelligence (AI) software, the global medtech market should experience explosive growth – yet this is not the case. Although Evaluate predicts a 5% annual growth rate for the years ahead, many major players in this space had negative growth for the years previously. What’s the cause of this lack of industry growth and advancement and what role can we play to help solve it?

WHAT IS THE PROBLEM? The continued innovation and development of medical devices and accompanying technologies takes a significant amount of time, money, and resources. Additionally, these projects require various internal and external teams within software engineering, hardware engineering, product management, regulatory affairs, quality, marketing and other fields to work together simultaneously – which is not an easy task.

According to ScienceDirect, a platform for peer-reviewed scholarly literature covering healthcare and other sciencerelated industries, the average time-to-market for a medical device falls between three to seven years;

moreover, per a Stanford University study, the average cost of bringing an FDA-approved medical product from inception to release was $31 million.

For high-risk medical products, the cost would run over $90 million.

2.

Implement better regulatory and compliance strategies: Organizations that implement a strong regulatory and compliance strategy early in the development process will notice gains once they submit their product to the various Ministries of Health (ie, FDA, EU, Health Canada, etc.) for consideration. A good regulatory strategy will allow you to assess the risk of your device, understand what is required, and assemble the proper documentation needed to prove the device is safe for patients, doctors, nurses, and technicians, as well as being effective in its intended use.

3.

Partner with Industry Leaders: By merging technology expertise with regulatory best practices, medical device manufacturers can streamline the product development lifecycle. By working together, device creators and compliance experts can create diverse partner ecosystems that address resource limitations, navigate global compliance approvals, and elevate product development efficiency.

The establishment of these ecosystems is a key step in accelerating time to market for medical devices.

Many of these inventive medical devices have no predicate device currently on the market for comparison; as a result, both the costs and goto-market timeframe often surpass these averages. It is not the lack of technology or innovation that is holding back explosive growth in this market; rather, it is the time-to-market, and the associated costs, which are prohibitive.

How can we help solve this?

To accelerate the development and approval process of the devices, and speed their time-to-market, medical device manufacturers must immerse themselves in the current regulations practices to gather a clear understanding of the industry applications.

Furthermore, manufacturers must stay abreast of changing regulatory practices, specifically those covering development, which can mature even on a month-to-month basis.

To successfully drive this initiative, medical device manufacturers should: 1.

Implement better development approaches: Manufacturers need to leverage tools and techniques to develop their medical devices faster and more efficiently while continuing to bring to market safe and effective products. Two key focus areas should be expediting the development process and making the iterative prototyping process easier and more useful.

Qt’s joint program with The Emergo Group supports major and emerging medical markets’ certification and compliance efforts, including the FDA, EU, ISO and IEC, and allows medical device manufacturers to align their product development cycle with the regulatory certification cycle, making their overall time-to-market process faster and more efficient.

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ALL IN A DAY’S WORK WHAT IS HOLDING YOU BACK? I was at a manufacturing conference the other day listening to a conversation about design and innovation. One of the participants made a comment that struck me with one of those, “huh, why didn’t I think about that before?” moments. He was describing the design process he was working through and where it had hit a snag. What struck me was where he said he was stalled, and why.

As I reflected on his comments it got me thinking about how sometimes we fail to succeed just because we didn’t know the answer existed. I felt like an eager student in the back of the class waving my hand vigorously because I knew the answer. It also challenged my own thinking.

Perhaps I have the same problem with my own work. As the thoughts jostled in my head it led me to ask, “What is keeping me from being successful?”

1. Is it me?

If you’re like most engineers I know your plate is full. I’m guessing too that half of what’s on your plate isn’t in your specialized area of discipline in either. Sometimes you may be stifling your own efforts because there simply isn’t enough time in the day. We can all struggle with the constraints of the job that sometimes hinder creativity or

Sweet smell of

SUCCESS

exploration. Somehow, we need to see beyond ourselves and find a new way too look at a project, especially when we’re stuck or its out of our expertise. Look for those that can help point you in the right directions.

2. Is it my suppliers?

The reason the project had stalled in the opening story was his current supplier. He didn’t know it, but his project was doable, his supplier just did not have the knowledge or resources to fulfill his wishes. It occurred to me at that moment, if you’re following the common manufacturing path, with all the traditional resources and suppliers, you may just be limited.

The reason it hit me was because he was describing a challenge that I know we see every day at Accumold. His supplier, for whatever reason, did not pursue a secondary source or skill to solve his customer’s needs, he simply said it wasn’t possible.

But it was. You may have to push you suppliers or find other arrangements if what you need is critical to success.

3. Is it the system?

No need to mention there are obviously reasons why a particular design may not work but what if those barriers are somewhat self-inflicted?

Corporate risk mitigation, government regulations or even tradition all can have a say in your work. While there are genuine reasons these entities impose restrictions on our designs sometimes it’s worth asking why.

These barriers can be outdated or unnecessary and you just might have to make the case yourself.

Who knows, maybe you’ll be the one to change the future.

Always at the forefront of medical manufacturing, Aaron Johnson Accumold isn’t one to sit on his laurels. In this issue’s column, he looks at success, and how to improve it

SO HOW DO YOU PULL THIS ALL TOGETHER? It’s kind of like the question, “How do I know what I don’t I know?”

The beauty is, for most engineers, it’s only the relentless pursuit to know more, learn more, discover more that drives us forward. And like one manufacturer I know advises, push back on no until you’re convinced the answer really is no.

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OPINION

How to EMPOWER women in manufacturing For over 40 years Apple Rubber has been supplying the medical device sector with seals and sealing devices. The company recognises its standing in the industry and the responsibility it has towards gender issues in the workplace Between the sexual harassment cases highlighted by the media within the last year and the increased awareness that movements like the Women’s March and #TimesUp brought, women’s issues are definitely on the national radar. Within manufacturing however, there is still room for improvement: in 2016 women made up 47% of the American labor force, but only 29% of manufacturing employees. Deloitte reported these statistics, calling women in US manufacturing one of the “largest pools of untapped talent.”

Ensuring that women have equal employment opportunities in hiring decisions is not enough. On her presidential campaign trail, Hillary Clinton talked about how whether we do it subconsciously, there is still this built-in questioning about women’s executive ability.

Having a corporate culture that empowers women starts with leaders.

1. INVEST IN FAMILY BENEFITS FOR THE COMPANY Many working women still experience conflicting pressures from both their family and career. Creating a company culture reflective of female employees struggling with this issue will be an advantage.

Family benefits for manufacturing employees could include a range of programs: paid maternity or paternity leave, on-site care for young children, and flexible scheduling.

Scientific research supports that these programs are helpful to a woman’s overall potential as an employee: one study showed that women who took maternity leave longer than 12 weeks had lower rates of depression symptoms and better overall mental health than those who took shorter leaves.

2. CHANGE THE PERCEPTION OF WOMEN IN MANUFACTURING AT YOUR BUSINESS No matter how far we’ve come as a nation with empowering women, one female engineer still talks about how she expects the surprised looks on her male peers’ faces when she walks onto a construction site.

Stigma remains around the female presence in male-dominated fields like manufacturing and engineering.

Businesses can work to shift the perception of women’s roles in manufacturing. A large part of bridging this gender gap is educating the next generation of manufacturers. Your

company can create an internship program for female candidates, to encourage women’s participation and secure their presence around the plant.

Having women in leadership roles has an effect on corporate culture. Interns and new hires notice how a company encourages the professional advancement of its women, and veteran female workers are motivated by the success of their peers in executive positions.

This can be promoted by requiring gender parity amongst the candidates for an internal promotion.

3. HAVE A NO-TOLERANCE POLICY FOR HARASSMENT OR DISCRIMINATION This sends a strong message. A true zero tolerance policy involves immediate termination for any individual found guilty of any harassment charges brought against them. It requires investing in an HR system, capable of following up initial claims.

These employees must be able to observe principles of confidentiality and discretion, and include protection of those who file a report.

5. CONTINUE TO IMPROVE YOUR MANUFACTURING TECHNOLOGY Does this even have anything to do with women in manufacturing? Well yes, once you consider that traditionally women were limited in their asset to the industry because of the amount of physical work required.

Heavy lifting is one of the most common reasons for needing a man to occupy a labor role.

“Advanced manufacturing is about using technology and not so much physical work,” says Millie Ramirez, a production supervisor at Carey Manufacturing, a company that is breaking the manufacturing mold because women outnumber men on the factory floor.

Modern machinery more so relies on machine operations to get the job done rather than physical labor. If heavy lifting may still be required list qualifications in your job posting so that capable women can apply.

Another aspect of this would be having a secure enough dynamic between managers and employees so an individual feels comfortable enough to report a serious problem, and that doing so will not damage their career path.

4. SPONSORING WOMAN-TO-WOMAN MENTORSHIP PROGRAMS Since manufacturing is defined as a maledominated industry, another way to empower women would be to offer opportunities for them to support each other.

Mentorship programs offer employees the opportunity to share experiences. Studies of mentorship between women in engineering showed that these programs reduced anxiety in participants, and increased self- assurance and motivation.

Leadership support of these programs is important because it develops the selfefficacy of women in an industry where they are underrepresented. Depending on the gender ratio of your manufacturing business and the several departments within it, a woman may feel like she is her own support system. Mentoring programs act to supplement this.

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COVER STORY

Freudenberg Medical uses traditional coating methods, as well as methods such as plasma treatments to alter the surface properties of medical components

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ew materials and technological advances continue to proliferate the medtech industry at a rapid rate and suppliers strive to offer innovative solutions to meet the demands of increasingly complex components and devices. A range of specialized materials are used today and many of those materials are suitable for the intended finished use only after the application of a customized surface treatment. These treatments can be used to reduce friction, improve haptic properties, introduce chemical functionalities, and improve medium resistance of the materials. To meet this growing demand, Freudenberg Medical uses traditional coating methods like wet chemicals and parylene coatings, as well as methods such as plasma treatments in order to alter the surface properties of medical components.

Surface modifications allow a variety of customer needs to be addressed. Color coating, for example, is a surface modification which enables control of the base materials’ transparency and optical properties.

Plasma treatment is another modification option which will reduce friction. Silicone itself has a high friction coefficient and a plasma treatment will modify its friction properties. This can improve silicones manufacturability, particularly in automated assembly lines, as well as its ability to be used in low friction applications where gliding is necessary – such as with endoscopic catheters and the internal coating of flexible tubes used in cardiac pacemakers.

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Plasma coating Surface modifications such as plasma coating directly influence the surface energy of a component; this allows control and adjustment of the hydrophilic properties. Plasma processes enable multiple functionalities to be implemented within a single process; for example, plasma enables a bioactive layer with good adhesion to be applied to a substrate in a single step. The surfaces are plasma coated, activated, or plasma etched using environmentallyfriendly processes. A variety of component geometries can be altered with vacuum or atmospheric pressurized plasma, without solvent emissions or a time-consuming drying process. Small parts can be handled in bulk goods processes under a vacuum, while atmospheric pressure plasmas are well-suited for integration into existing process chains.

What is driving the need for coatings with silicone components? At the most basic level, ease of handling, so parts don’t stick to each other. The application or design property alternation is dictating what kind of coating process to apply. In accordance with different applications and different needs, each has an impact on the coating process or coating chemistry that is ultimately used to identify and apply the best performing coating based on the friction partners in the application.

Parylene coating Parylene coating is another popular, medically approved surface coating. Parylene coatings are hydrophobic, inert, transparent, nonporous, biocompatible, biostable, and have an outstanding barrier effect against moisture, chemicals, and gases.

These coatings also have a high dielectric barrier effect. Four different types of parylenes are produced.

The basic type is Parylene N (polypara-xylene), which is characterized by a good gap penetration capability and a low friction coefficient. Parylene C has high chemical resistance and provides an excellent barrier

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COVER STORY

Freudenberg Medical explores coatings and surface treatments for silicone and thermoplastic components effect against gases and moisture. Parylene D has long been used as a high-temperature parylene due to its continuous use at a temperature of 100º C. A new, fluorinated parylene, Parylene HT, is used at even higher temperatures (up to 350º C) and has the highest gap penetration capability, a high UV resistance, and the lowest friction coefficient.

Lubricous & hydrophilic coatings Lubricous coatings on medical components reduce the adverse effects of dynamic and static friction, increase the ability to repel water, and assist with ease of insertion or glide. The performance, accuracy and durability of components and products is increased.

Freudenberg Medical addresses the growing demand for high-performance hydrophilic coating solutions by offering expertise in customized coating design, surface activation, hydrogel chemistry, and a process development customization platform. By applying a systematic customization process to both standard and non-standard substrates, we target maximum coating performance that typically will outperform standard solutions available off-the-shelf. Thanks to integration of proven feasibility study routines and smart iterative design principles, high project success rates and short development times can be achieved.

Microstructures Surface texturing is the dimensional modification of an otherwise smooth surface with microstructures.

This technique creates an effect on technical parts by applying surface textures similar to the lotus effect.

The lotus effect refers to the self-cleaning properties exhibited by the leaves of the lotus flower. Dirt particles are picked up by water droplets due to the micro- and nanoscopic architecture on the surface, which minimizes the droplets adhesion to that surface. Silicone surfaces are very susceptible to dust and particle adhesion and when microstructures are applied to a silicone surface it further repels dirt and increases hydrophobicity. With microstructures the tackiness of a silicone surface is reduced and friction is reduced by 50-60%. This application works well on tubes as well as molded components.

Wet chemicals Wet chemical application methods include spraying, dip coating, and brushing. Bar coding and printing methods utilizing ink could also be considered wet chemical coatings. Spray coating is the most uniform method but also the most costly. Spray coating on a tube requires at least two to four different offset spray nozzles to achieve full coverage and results in a good amount of overspray as well as application within a cleanroom environment which adds additional cost.

Ask yourself, what does my application really require and what am I willing to pay for? If the component does not need to look optically perfect then the most expensive solution is not required. If a brushed application will be sufficient, why not use it. With brushing you will see the fiber texture in the coated surface. This is not as uniform as spray coating but also not as expensive.

Jeff Mohror, vice president and general manager of Freudenberg Medical’s Carpinteria Operation notes: “In many cases, our customers require specific material properties for their device and due to regulatory aspects we cannot modify the material chemistry. In these situations, a customized surface treatment allows us to provide customers with individualized solutions.”

The medtech field continues to expand to meet the demands of new treatments and the complexity of devices that are part of those solutions. It is important to find a production partner with the experience and capabilities to provide the right solution for these specialized needs. Surface engineering is one of the many areas in which Freudenberg Medical is maximizing the flexibility of its processes to achieve innovation that keeps pace with the challenges of the healthcare industry.

What is driving the need for coatings with silicone components? At the most basic level, ease of handling, so parts don’t stick to each other, says Freudenberg Medical

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ROBOTS & AUTOMATION

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ne of the biggest technologies currently used in industrial manufacturing is robotics. With a market value estimated to reach $40 billion by 2020, industrial robots are being used to ensure consistent quality production and to meet market demands.

In the US, companies are using robots to automate production to help them compete better in overseas markets. Within the global manufacturing market, the US is fourth largest supplier of robots. Interestingly some companies in the US are using robots to manufacture products at home, rather than overseas, helping to retain local employment.

More so, with rising labor costs across the US, robotics offer manufacturers a way to save on production costs by reducing human errors and workers’ idle time. In fact, a report from McKinsey&Company shows that since 1990, labor costs have increased by more than 100% while prices for robotics have fallen by over half.

Within the medical manufacturing industry robotics are being used across the entire production line, from assembly to inspection and packaging. Due to the strict regulations that try to ensure devices’ safety, manufacturers are under a lot of pressure to reproduce the same product, under the same stringent conditions time and time again.

Indeed, the introduction of robotics within medical device manufacturering is helping to “solve a variety of production challenges,” according to Wes Garrett, authorized system integrator account manager at Fanuc America. Garret states the popularity of robotics for medical device manufactures is due to the technology’s ability to solve production challenges, including, serialization, traceability, and a need to improve product quality and increase productivity.

Industrial robots offer manufacturers the consistency needed to reproduce devices time and time again. Robots can be programmed to produce identical products to precise specifications without mistakes.

More so, robots offer manufacturers a way to efficiently produce multiple products on the same line with little downtime. Automation technology supplier Acieta states that ‘a robot can change to different product or pack formats in just seconds’. This is a stark contrast to hard automation, where production lines need to be stopped in order to change programmes and tooling reconfigured for the next product type.

Reducing downtime is something which manufacturers strive for to achieve more efficient workflows, which ultimately affect profit. Robotics and automation manufacturer Fanuc responded with the development of its Zero Downtime Application, designed to help prevent unexpected downtime using predictive analytics.

The system works by continuously collecting and analysing data to help manufacturers track the health and maintenance performance of their robots during production, helping to avoid any unexpected downtime.

More so, the system analyses robot data to identify required maintenance tasks based on the usage of specific robots. Manufacturers can use this information to optimise their overall maintenance costs and schedule their robots accordingly. The system is an example of how manufacturers are moving closer to Industry 4.0 and the Industrial Internet of Things to achieve more productivity and efficient production lines.

To keep up with the pace of innovation, medical manufacturers must be able to change manufacturing lines when new products are needing to be developed. Robotics and automation are able to help manufacturers by offering modular systems that promote efficiency and workflow.

For example, motion control systems are able to help production lines assemble and move medical devices in a flexible workspace. More so, things such as force-control sensing and vision-guided systems can help manufacturers not only pick-and-place devices, but also ensure product safety by scanning and verifying barcodes.

One company that has benefitted from using robotics is medical device maker Tegra Medical. The company was facing reduced profits from a mixture of increased development costs and customer-demanded price cuts.

Tegra turned to Universal Robots to keep up with customer demands and to reduce costs. By using three devices from Universal Robots, Tegra was able to double throughput and free up 11 full time positions to tend to other processes.

The factory of the future is a term that has been discussed for a number of years but what exactly does it mean?

Reece Armstrong explains

Robotics and medical device manufacturers:

What’s the future?

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ROBOTS & AUTOMATION

Hal Blenkhorn, Tegra Medical’s director of engineering, said: “Being in the medical industry, we can’t change our process without notifying our customers and going through validation activity. But by simply replacing the operator with the robot, we just changed the handling of components in-between the processes. That was a huge win for us. With the UR robots, we only get a few rejects per day. Before, that number was significantly higher.”

“Now we’re able to run it with as little as two people.

Having this type of success out of the gate as firsttime rookies at this stuff has been phenomenal and totally unexpected. Our return on investment was less than two months, and we can even go further because we’re able to adapt the robots to other products so quickly,” says the CEO.

Another company who has benefitted from working with Universal Robots is contract manufacturer organisation Dynamic Group. An injection molder for the medical industry, employees at the company were finding it difficult to keep up with the labor-intensive process required when tending to an injection molding machining cycle. As a result, parts were becoming ruined due to the heat sensitive products that were being molded.

In the future, it looks like robotics are going to be needed more and more if manufacturers are going to be able to produce the kinds of sophisticated medical devices we’re seeing.

To change this, Dynamic Group installed three collaborative robotic arms that took over a number of repetitive tasks, resulting in improved product consistency and an increase of 400% production capacity.

Dynamic Group CEO Joe McGillivray, commented on the use of robotics, saying: “Universal Robots’ UR10 robot arm, gave us a perfectly consistent cycle; we went from having three operators on a single shift to being able to run three shifts per day with just one operator per shift. So we essentially quadrupled our production capacity and our scrap went from significantly high to near zero. It’s been an extremely successful application for us,” says McGillivray.

Chris Blanchette, executive director Global Accounts Fanuc America, is optimistic about the expected uptake in robotics by manufacturers.

“As medical devices become more sophisticated and production demands increase, robotics help to maximize throughput while maintaining quality. Small, sophisticated devices with precision assembly requirements can be difficult to assemble. Robotics offer a cost-effective solution for precision assembly, and when equipped with vision and other intelligence-based tools, they offer the flexibility to adapt to virtually any assembly process,” Blanchette said.

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26.07.2018 13:43:18

CONNECTED DEVICES

Wireless system can power devices inside the body New technology could enable remote control of drug delivery, sensing, and other medical applications

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esearchers from the Massuchusetts Institute of Technology, working with scientists from Brigham and Women’s Hospital, have developed a new way to power and communicate with devices implanted deep within the human body.

Such devices could be used to deliver drugs, monitor conditions inside the body, or treat disease by stimulating the brain with electricity or light.

The implants are powered by radio frequency waves, which can safely pass through human tissues. In tests in animals, the researchers showed that the waves can power devices located 10cm deep in tissue, from a distance of 1m.

WIRELESS COMMUNICATION Medical devices that can be ingested or implanted in the body could offer doctors new ways to diagnose, monitor, and treat many diseases. Traverso’s lab is now working on a variety of ingestible systems that can be used to deliver drugs, monitor vital signs, and detect movement of the GI tract.

by a pacemaker-like device implanted under the skin, which could be eliminated if wireless power is used. Wireless brain implants could also help deliver light to stimulate or inhibit neuron activity through optogenetics, which so far has not been adapted for use in humans but could be useful for treating many neurological disorders.

In the brain, implantable electrodes that deliver an electrical current are used for a technique known as deep brain stimulation, which is often used to treat Parkinson’s disease or epilepsy. These electrodes are now controlled

Currently, implantable medical devices, such as pacemakers, carry their own batteries, which occupy most of the space on the device and offer a limited lifespan. Adib, who envisions much smaller, battery-free devices, has been exploring the possibility of wirelessly powering implantable devices with radio waves emitted by antennas outside the body.

Until now, this has been difficult to achieve because radio waves tend to dissipate as they pass through the body, so they end up being too weak to supply enough power. To overcome that, the researchers devised a system that they call “In Vivo Networking” (IVN). This system relies on an array of antennas that emit radio waves of slightly different frequencies.

As the radio waves travel, they overlap and combine in different ways. At certain points, where the high points of the waves overlap, they can provide enough energy to power an implanted sensor.

“Even though these tiny implantable devices have no batteries, we can now communicate with them from a distance outside the body. This opens up entirely new types of medical applications,” said Fadel Adib, an assistant professor in MIT’s Media Lab and a senior author of the paper.

Because they do not require a battery, the devices can be tiny. In this study, the researchers tested a prototype about the size of a grain of rice, but they anticipate that it could be made even smaller.

“We chose frequencies that are slightly different from each other, and in doing so, we know that at some point in time these are going to reach their highs at the same time. When they reach their highs at the same time, they are able to overcome the energy threshold needed to power the device,” Adib says.

“Having the capacity to communicate with these systems without the need for a battery would be a significant advance.

These devices could be compatible with sensing conditions as well as aiding in the delivery of a drug,” said Giovanni Traverso, an assistant professor at Brigham and Women’s Hospital (BWH), Harvard Medical School, a research affiliate at MIT’s Koch Institute for Integrative Cancer Research, and an author of the paper.

With the new system, the researchers don’t need to know the exact location of the sensors in the body, as the power is transmitted over a large area. This also means that they can power multiple devices at once. At the same time that the sensors receive a burst of power, they also receive a signal telling them to relay information back to the antenna. This signal could also be used to stimulate release of a drug, a burst of electricity, or a pulse of light, the researchers say.

Other authors of the paper are Media Lab postdoc Yunfei Ma, Media Lab graduate student Zhihong Luo, and Koch Institute and BWH affiliate postdoc Christoph Steiger.

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CLEANROOMS

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ow temperature terminal surface sterilization

by Vapourised Hydrogen Peroxide (VHP) is becoming more common in pharmaceutical and medical device manufacturing applications. This development can be seen with sensitive drug products, such as ophthalmic injectables, or other heat or radiation sensitive medical devices. VHP is compatible with most plastic materials used in the industry, but there may still be some knowledge gaps particularly when dealing with novel applications or when a specific new material is being introduced.

A terminal surface sterilization process must not alter the device or packaging properties, to ensure that biocompatibility, device integrity, usability, and/or product shelf life are not compromised. Exposure to sterilant should be controlled and maximum allowed processing temperatures not exceeded. Also, the sterilizing agent must not penetrate inside a primary container of a drug delivery device.

Cyclo olefin polymer (COP) is used as material for syringes and other drug delivery devices for prefilled drug primary containers, syringe barrels, vials and bottles. COP syringes have specifically been successful when employed with sensitive protein drugs. Because of this, there have been several inquiries about compatibility of COP syringes and VHP (VH2O2) for use in drug delivery devices’ surface terminal sterilization process. One of the concerns has been to understand if VHP vapour can in any way penetrate the syringe wall as it was suspected that it might be possible for oxygen (O2) to penetrate due to lower oxygen barrier properties of COP and considering that VHP breaks down to water vapour and oxygen during sterilization exposure. Such application-specific material penetration studies for VHP and COP were not available.

Steris Finn-Aqua and Zeon agreed on a case study and developed a sterilsation challenge test plan. This plan included the selection of a suitable COP container for testing, developing a low concentration detection method for any hydrogen peroxide residual in WFI (water for injection) filled sample containers, and programming a series of sterilization challenge test cycles and conditions to achieve sufficient and representative VHP sterilant exposure under deep vacuum.

An analysis method by spectrophotometry using Toluidine Blue to determinate low concentrations of hydrogen peroxide in WFI water samples was developed

by VTT Expert Services, Finland. The calibration curve created for the analysis method provided a detection limit of 100ng/ml (ppb).

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Relatively large volume COP containers (Zeonex 690R, V=100 ml, Di=32,5mm, L=120mm, wall s=1,3mm) were selected to expose as large a surface area of material to VHP sterilization as possible, to ensure penetration testing to be representative. A total of six container tubes were used in the sterilization exposure testing such that a set of two tubes were exposed to one, three, and five times the exposure time of a VHP sterilization cycle. Test containers were placed in the chamber without any packaging. Positive and negative control samples were also provided to the laboratory as part of sampling.

Each container was filled with 50ml of WFI and the tube ends were sealed with applicable glue, rubber cap and tape to avoid leaking inside. Vaprox 35% hydrogen peroxide sterilant was used in the VHP terminal sterilizer (Steris VHP LTS-V-91515-S7) of 2.0m3 chamber volume including a mock-up load for creating representative cycle conditions.

The most challenging sterilization exposure cycle was configured to be equal to five consecutive deep vacuum (4 mbar), low temperature [+30…32 °C] sterilization exposures resulting in a total of 90 injection pulses, 87g of hydrogen peroxide in vapour state, 180 minutes of exposure time and 5h 29min of total cycle time.

Presence of hydrogen peroxide in post-exposure spectrophotometric analysis of the WFI samples was below the spectrophotometric analysis detection limit of 100ng/ml. Measurements by a Draeger hand-held peroxide sensor device were also taken directly on the tube surfaces right after each cycle’s end. The highest measured surface reading was 0.1ppm. All other measurements were below detection level of the sensor. No discolouration was detected either.

Low levels of surface residue on containers after the sterilization cycle indicate that COP’s hard and glass-like surface does not absorb significant peroxide.

Vapourised Hydrogen Peroxide (VHP) sterilization challenge testing for COP (cyclo olefin polymer) container material, by Juha Mattila, Steris Finn-Aqua

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CLEANROOMS

LEFT | The most challenging sterilization cycle graph ABOVE | Steris Finn-Aqua and Zeon agreed on a case study and developed a sterilization challenge test plan. This plan included the selection of a suitable COP container for testing

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inventing possibilities

ANTIMICROBIALS

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helsea Whyte in the New Scientist described a study carried out by the University of Hong Kong where volunteers used the subway for 30 minutes and then swabbed their hands. Upon analysis of the swabs, “the majority of microbes they picked up were common skin bacteria, and the most abundant non-bacterial organisms were yeasts.

In the morning rush hour, 140 species were detected, but by evening, many of those were no longer detectable and the populations of just 48 species had expanded to cover the entire system.”

The article also described how “the team also swabbed train surfaces, but they didn’t find much microbial DNA – perhaps because of the antibacterial coating that is applied to the surfaces of the Hong Kong subway”.

Antimicrobial products make a difference.

Infection control is big business. As the pharma sector seeks ways to tackle antimicrobial resistance (AMR), the medical device sector is developing ways to curb the spread of harmful bacteria in the healthcare environment.

The opportunities are evident. According to Marketsandmarkets, which projects the antimicrobial coatings market to reach $4.19 billion by 2021: “Healthcare is the key application of antimicrobial plastic... It is the largest application in the antimicrobial plastic market and accounts for more than one-third share of the market. The Asia-Pacific region dominated the market for health care application of antimicrobial plastic, followed by North America and Europe.”

Marketsandmarkets lists leading players in the market as including Bayer MaterialScience, The Dow Chemical Company, Clariant, Lonza Group, Parx Plastic, King Plastic Corporation, Biocote, Milliken Chemical and PolyOne Corporation.

A specialist in polymer solutions for healthcare markets, Foster recently introduced Combat antimicrobial masterbatches for blending with

medical device polymers. Components made with these antimicrobial polymer blends kill bacteria that lead to infections, including methicillinresistant staphylococcus aureus (MRSA) and carbapenem-resistant enterobacteriaceae (CRE).

Foster says that according to a survey by the Center for Disease Control (CDC), 4% of inpatients in US acute care hospitals contract at least one healthcare associated infection.

Device associated infections accounted for one in every four infections. In-dwelling devices, such as central venous catheters, are particularly susceptible to bacteria colonisation which can enter the bloodstream.

Ionic silver is successful at killing bacteria and preventing colonisation. Additives based on this chemistry are commonly melt blended directly into medical polymers for the manufacture on antimicrobial device components. However, evaluation of multiple custom compound formulations can be costly.

AMR as their functional substances can end up anywhere in the environment of the product creating more places for only the resistant bacteria to survive and proliferate. Taking AMR seriously, says Parx, means applying the technology only there where you want to use its benefits.

“This is really where our technology stands out,” explains Michael van der Jagt, CEO of Parx Plastics. “First of all our technology uses a body’s own element and on top of that our technology knows no migration, the performance is inert and intrinsic to the material surface. That means you have a targeted performance only on the surface where you want it and it does not end up elsewhere.”

Van der Jagt envisions this technology will be of particular use in high-infection risk applications with permanent implants such as in the orthopedic field.

Parx Plastics sees an important role for its technology in the quest to tackle AMR. Its antimicrobial technology for plastics and polymers is derived from bio-mimicry, a patented biocompatible technology inspired by nature.

The technology creates an intrinsic immune system in plastics that makes the surface resistant to biofilm formation and bacteria growth.

With a focus on infection prevention Parx Plastics believes it wise to consider the antimicrobial technology to use. Roughly all of the technologies today, it says, rely on a migration principle.

They have some active (and often toxic) substance migrating from the surface to act against bacteria.

However, these uncontrollable technologies contribute to

Lu Rahman looks at some of the latest antimicrobial offerings for medical device manufacture

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INNOVATION IN MEDTECH

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or medical device companies in the US, the start of 2018 was marked by an ongoing campaign to halt an industrywide excise tax before first payments were due.

US politicians and medical device OEMs led the charge against the tax, stating it would be responsible for a loss of jobs and would stem innovation in medical technologies.

The strong opposition resulted in US Congress agreeing to pass a stopgap bill for the medical tax, which is now set to resume on 1 January 2020; a minor victory for an industry which is still actively trying to repeal the medical device tax. In fact, the most recent vote by the US House of Representatives saw strong bipartisan support to fully repeal the tax.

It seems that the threat to jobs and product development in the sector seemed to be too risky and with good reason - with a medical device market of $155 billion , the US is a world leader for life sciences and some of the most exciting developments regularly come from overseas.

The history of life sciences innovation in the United States can be traced all the way back to 1848 with the founding of the American Association for the Advancement of Science . However, the foundations of the United States’ approach to government and academic partnerships wasn’t apparent until after the second world war and the creation of the Research Triangle Park in the 1960s. Built in North Carolina between the region’s three universities, the park then saw technology giant IBM build a research facility there which has since contributed to the creation of over 40,000 jobs and 1,500 companies. The nation’s efforts to invest within life sciences has paid off and the US is now the global leader for the industry. Here are some of the areas in which the US is excelling within the industry.

Advanced academia The US has many major life sciences firms active within its borders but some of the most important developments are being made within the country’s academic establishments.

On the west coast, universities in California are utilising polymers, 3D printing and wearable technology to develop new ways at monitoring both the brain and the stomach.

Researchers at the University of California at Berkeley and the University of California at San Diego have developed a wearable device to monitor activity in the stomach.

By utilising 3D printing, the team were

26

able to produce an electrocardiogram (ECG) for the gastro-intestinal (GI) tract.

The device consists of a 3D printed portable box connected to 10 wearable electrodes.

Patients can use the system as well as an app to log activities such as meals and sleep. The device could lead to “new kind of medicine where a gastroenterologist can quickly see where and when a part of the GI tract is showing abnormal rhythms and as a result make more accurate, faster and personalized diagnoses,” according to, Armen Gharibans, first author of the study .

Elsewhere, a team at the USC Viterbi School of Engineering have developed a polymer-based material which could help record activities in deeper sub regions of the brain – potentially furthering research into brain mapping.

Other advancements include a 3D printed tool for helping to scan for pancreatic cancer by include University of Washington; a miniaturized sensor which sits on the tooth to read alcohol, glucose and salt levels from Tufts University, and a device that can quickly detect cancerous tumours during surgery from the University of Dallas at Texas.

Life sciences hub The most prominent region for life sciences companies in the US is Greater Boston, which has the largest cluster of the sector’s researchers in the country .

The region has a number of academic institutions such as Harvard and MIT, but it is also home to companies such as Boston Scientific, Abbott and Philips.

Boston’s strong position in the industry largely comes down to a 10-year $1 billion investment in Massachusetts’ life sciences in 2008 . This was to offer funding for things such as research grants, accelerators, infrastructure and also tax incentives for life sciences companies.

The results are obvious and Greater Boston now has the top three National Institutes of Health-funded hospitals in the US; one of the highest proportions of life sciences employment in the country and a high number of research and development establishments .

More so, Boston is the hub to the Life Sciences Corridor (LSC), which runs through Massachusetts and includes over 450 companies within the industry.

Within LSC is MassChallenge, the world’s largest start-up competition and accelerator. The accelerator has supported a range of start-ups across the healthcare industry and offers a range of access to lab space, manufacturing guidance, and networking within the digital health industry.

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INNOVATION IN MEDTECH

Digital Developments The quantified world has meant that some of the biggest technology companies are now leading the charge in changing the landscape of healthcare.

In the US, this is made evident by the work the FDA is doing through its Software Precertification (Pre-Cert) Pilot Program.

Designed to help the FDA put in place the right policies to promote safe and effective digital health products, the program includes nice companies, including Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.

The program gives the FDA access to data from the companies on the measures they are using to develop, test and maintain their products, as well as how they gather post- market data.

The aim is to have the FDA examine the software or digital 1. https://www.statista.com/statistics/248676/projected-size-of-the-us-medical-deviceindustry/ 2. http://www.us.jll.com/united-states/en-us/Research/JLL-US-Life-SciencesOutlook-2017.pdf?e89ae5d2-1063-4ad2-b303-bac0a93f4f1f 3. ibid 4. https://www.nature.com/articles/s41598-018-23302-9 5. https://www.timeshighereducation.com/news/which-universities-are-pushingboundaries-life-sciences 6. http://www.us.jll.com/united-states/en-us/Research/JLL-US-Life-SciencesOutlook-2017.pdf?e89ae5d2-1063-4ad2-b303-bac0a93f4f1f 7. http://budget.digital.mass.gov/bb/h1/fy10h1/prnt10/exec10/pbudbrief23.htm 8. http://www.us.jll.com/united-states/en-us/Research/JLL-US-Life-SciencesOutlook-2017.pdf?e89ae5d2-1063-4ad2-b303-bac0a93f4f1f 9. https://itif.org/publications/2018/03/26/how-ensure-americas-life-sciences-sectorremains-globally-competitive

health developer rather than the product, to see if companies can submit less information than currently required.

Apple has a number of initiatives pushing the company towards being a potential big player in the healthcare space. The last year has seen the company develop healthtech-driven clinics for its employees, research irregular heart rhythms via its Watch Series in conjunction with Stanford Medicine, and have the first medical device accessory for the Apple Watch cleared for use by the FDA. And with Amazon working on a secretive healthcare business, it will be no surprise if more major technology companies move into the sector.

What’s next Recent research shows that the US is losing ground due to aggressive competition from competing nations. International competitors have been found to be artificially inflating the US trade deficit in the sector by relying on the government to purchase drugs and devices to limit US firms’ export prices.

This is allowing other nations to benefit from better treatments without having to pay for costly research and development.

Funding cuts to biomedical research and potentially increased pricing policies are also negatively affecting the nation’s life sciences global position, especially start-ups.

ITIF senior fellow Joe Kennedy discussed the damages that would occur to the US if it were to lose its competitive edge in the life sciences industry: “Losing the competitive advantage in the life sciences would mean declines in jobs and incomes for many Americans and a larger trade deficit. Policymakers need to optimize policies affecting the life sciences sector so that the United States is in the best position to increase its global market share and competitiveness.”

Reece Armstrong examines the life science sector in North America and how innovation is at the heart of the market

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REGULATORY AFFAIRS

Reporting lines DR. ISABELLE LANG-ZWOSTA, DR KNOELL CONSULT LOOKS AT CLINICAL EVALUATION REPORTS – THE CHALLENGES AND CONSEQUENCES FOR THE MEDICAL DEVICE INDUSTRY

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rom the perspective of the European Commission, the ‘new’ medical devices regulation (MDR 2017/745) should ensure that medical devices are “safe and of high quality. This might only be achieved by strengthening the rules on placing devices on the market and tightening surveillance once they are available”. Having set this noble goal, a range of changes for the medical device industry lies ahead.

One of the major topics manufacturers of medical devices are struggling with is compliance with the requirements for clinical evaluations. Taking the requirements laid down in MEDDEV 2.7/1 Rev. 4 and the MDR together, it becomes obvious that submitting a clinical evaluation report containing the expert opinion of medical doctors in regard to the performance and safety of the device is no longer deemed appropriate, not even for low-risk and grandfathered devices!

Therefore, if you are planning to bring your medical devices to the European market, you need to implement a “systematic and planned process to continuously generate, analyze and assess the clinical data pertaining to your devices (not an equivalent device) in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer”.

But what does clinical data mean? It is data that concerns the safety or performance of the device and may be sourced from published clinical literature, inhouse (unpublished) clinical reports and data, clinical trials, post-market feedback and clinical experience, external post-market data such as registries, or postmarket databases (i.e. the FDA’s MAUDE).

Nevertheless, be cautious when basing your clinical evaluation on literature data only. The rules have become more precise and stricter. The times of cherrypicking the favorable literature only without pre-defined search strategies are over. The literature review plan (eg. as part of the mandatory clinical evaluation plan) for your device needs at least to outline and justify the choice of search databases, search terms, as well as inclusion and exclusion criteria. In addition to that, the evaluation strategy for literature identified within this process should be described and duly justified.

Following the literature search and the appraisal of clinical data from any source, all information on your device needs to be analyzed in order to demonstrate compliance with all of the essential requirements pertaining to the safety and performance of your device when used as intended. This analysis of literature and clinical data also describes the benefits and risk of the device and explains the acceptability of the risk/benefit ratio taking into account the latest treatment.

Within this process, the expertise of the author(s) plays an important role. It is not only the product knowledge OR the clinical expertise that counts. The notified bodies put special emphasis on the combination of knowledge of the product, the regulatory requirements, biostatistics, medical writing, diagnosis and management of the disease to be treated (including treatment options), and research methodology. This might not be found in one person only, but in terms of the clinical evaluation a joint project could be set up. That way you have your internal (or external) key players on board to guarantee consistency between your clinical data, the instructions for use, and the risk management documentation in order to identify gaps and discrepancies, residual risks and uncertainties, or unanswered questions that should be addressed within your post-market surveillance plan.

The initial clinical evaluation report is just the beginning of the story. Since it is to be seen as a continuous process during the lifecycle of your device, you had better make it a living process in order to meet the noble goal of the European Commission: “Safe devices of high quality”.

Interestingly, similar changes can also be observed in other legislative and regulatory environments. Looking at the improved requirements for clinical evaluations and clinical data in China, comparable requirements in terms of data quality and regarding the choice of an adequate equivalent device are described. Therefore, the challenges associated with the implementation of the MDR requirements in regards to clinical safety may also be a chance to explore new markets.

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THERMOFORMING

The shape of things to come P

recision and safety are paramount in every facet of the medical industry; medical device manufacturers are always looking for processes that help them produce safe, durable and effective products at a reasonable cost – and thermoforming is at the top of the list.

Thermoforming is an excellent method for manufacturing production quantities from the low hundreds to the high thousands; and the process ensures that no matter the quantity, the quality (and specifications) are the same in the first piece as in the last.

Thermoforming 101 At its simplest, thermoforming is the process of heating a sheet of plastic until it becomes pliable, then using an aluminum temperature-controlled male or female mold to shape the material into a three-dimensional part.

There are two different methods of thermoforming: vacuum forming and pressure forming. In vacuum forming, the plastic sheet is stretched over a male mold and then the air inside the mold is vacuumed out, with the plastic retaining the shape of the mold.

The pressure-forming process adds 80–100 psi of air pressure to push the plastic sheet into the female cavity mold surface, providing very high detail and cosmetics on the outside surfaces of the molded part.

In both methods of thermoforming, the plastic is allowed to cool after being molded, which allows for a finished part with zero residual stress. Then, any excess plastic is removed with a six-axis, fully robotic trimming machine.

After trimming, further customizations can be incorporated – from aesthetic touches like silk screening and EMI / RFI shielding to the addition of functional hinges, handles and other hardware.

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THERMOFORMING

Jason Middleton, Ray Products examines thermoforming and the future of medical device manufacturing

A cut above So what does thermoformed plastic offer that other plastic manufacturing processes, like injection molding, don’t?

For one, thermoforming can produce very large pieces like MRI or CT enclosures, storage bins or other equipment like chairs and hospital beds. And while injection molding is excellent for small complex parts with very high volumes, similar details can often be achieved with thermoforming.

Thermoforming also has lower tooling costs and a faster turnaround than injection molding, plus equal (or sometimes better) aesthetics – unlike some injection molded parts,

thermoformed plastic doesn’t need to be painted, although it certainly can be. That said, there are some scenarios in which injection molding is the best option.

When compared with other materials, like sheet metal or fiberglass, thermoformed plastic outperforms the competition on nearly every level.

Fiberglass, which can be very labor-intensive and expensive, is up to 35% heavier than thermoformed plastic, is not recyclable and is more susceptible to damage from UV and impact. Notably, fiberglass does not support the complex geometries and repeatability that thermoforming offers.

Sheet metal is still used in medical devices, but in many cases, thermoformed plastic is a better alternative. Sheet metal is heavier and more prone to scratching and denting. Unlike sheet metal, thermoformed plastic can be formed into complex shapes, does not amplify noise and is incredibly durable.

With a range of materials, finishes and textures, there is endless room for detailed customization in thermoforming – especially in the medical industry.

Thermoforming & medical devices Sturdy, scratch-resistant and lightweight, thermoformed plastic is ideal for medical devices that see heavy use, like medical electronics, imaging enclosures, surgical device housings and sterile packaging.

One of the benefits of thermoformed plastic is its ability to contribute to the health and safety of healthcare environments, says Ray Products’ Jason Middleton

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But one of the key benefits of thermoformed plastic is its ability to contribute to the health and safety of healthcare environments. In addition to being easy to clean, thermoformed plastic can be constructed with antimicrobialresistant properties built into the plastic, helping to increase hygiene and protect patients and health care workers.

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DIGITAL HEALTH

Tony Kaufman, and Del R Lawson, 3M’s Critical and Chronic Care Solutions Division, outline the role that adhesives play in digital wearable medical devices HOW ADHESIVES MAY IMPACT THE FUTURE OF WEARABLE MEDICAL DEVICES May people habitually wear a device to track fitness or daily steps, nightly sleep and what they’re eating.

Some people also wear devices to help manage chronic illness, such as diabetes. Consumers and patients alike are now able to take more control of their health by using real-time data collected by wearable devices to help make health-related decisions. They want to proactively manage and improve their health without a device getting in their way. As a result, the wearable medical device market has seen rapid growth in recent years.

The wearable medical device market will further evolve as researchers determine ways to improve current non-pharmaceutical therapies and digital monitoring. Manufacturers will need to put those findings into practice and build products that enable more effective, personalised monitoring to keep pace with market need.

One way device manufacturers are already addressing this growing need is by making devices that easily integrate into everyday life. Devices are getting smaller, lighter and less invasive. How? From adhering a device together to sticking a device to a user’s skin, adhesives are a critical component in a device’s success. They also provide solutions to complex design challenges for manufacturers and help protect the end user from potential harm caused by their device.

THE IMPACT OF WEARABLE DEVICES PSYCHOSOCIAL IMPACT People who use wearable devices to track fitness goals are trying to lose weight, monitor calories burned or get to the next level in their training. In other words, they’re choosing to use a wearable device to aid them in reaching their goals. These users tend to be more open to sporting their devices as a proud testament to what they’re trying to achieve.

For others, wearing a device isn’t necessarily a choice and might be worn for a much more critical reason – they’re trying to manage a chronic illness.

These users may not want to draw attention to their

Wear time is a key consideration with adhesive selection says 3M

condition, meaning the device should be small in size and unobtrusive in design. The use of thin, clear, breathable films may provide the additional benefit of discreteness, while maintaining the wear duration benefits of an adhesive border, or skirt, around the device’s perimeter. Design engineers should consider the appearance of the design when selecting the materials.

BAND VS. STICK-TO-SKIN APPLICATIONS There is a distinct difference between devices designed for consumers looking to improve their fitness and devices designed for patients who are working to manage chronic illness. In some cases, these differences result in two different design styles – a wrist band and a stick-to-skin application.

Devices as wrist bands may be more visually appealing and fashionable, but they don’t offer the level of accuracy and precision that’s required for critical medical diagnostics and delivery. In illustration, let’s take a look at fastening devices, like a band or wrap. They rely on a tight fit, but how ‘snug’ can and should the device be? If it is too loose, the sensor could slip, slide or rotate, leading

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DIGITAL HEALTH

to an inaccurate measurement. On the other hand, with stick to skin devices like adhesive patches, the sensor can be stuck where it is needed, minimising potential error associated with adjustable fasteners.

They also allow a ‘one-size fits most’ design.

THE DANGER OF INFORMATION FATIGUE With so much data at our fingertips, it’s normal to come to a point where you’re not processing it anymore. Users have the power to shut off some points of interaction by turning off a device’s volume or discontinuing alert updates. The challenge facing wearable medical device manufacturers then is coming up with creative ways to keep their devices’ data relevant to prevent users from reaching information fatigue and no longer interacting with the alerts. Keeping the data simple and manageable, along with an adhesive system and wearable design that allows the user to forget it is there, is the best way to keep users engaged.

Now that we’ve discussed the impact of wearable devices, let’s dig into the key areas in which adhesives will help progress them.

How adhesives help advance wearable devices DEVICE SIZE AND WEIGHT Mobile phones aren’t the only electronics getting sleeker. Consumers and patients alike want wearable medical devices that are smaller, lighter and less cumbersome. The design process can be challenging as the devices must maintain accurate sensing capabilities, but also reduce friction to ensure precise data collection. Options with flex electronics and adhesive selection, as well as addressing battery implications and electromagnetic interference may provide potential opportunities for future innovation.

RESILIENCE AND DURABILITY Users who enjoy activities such as hiking, rock climbing and swimming should be able to do so without their device getting in the way, figuratively Consumers and patients alike want wearable medical devices that are smaller, lighter and less cumbersome

or literally. The prospect of a device touching water and moisture often challenges the design process, and makes design engineers cringe but the level of wear and tear a device can handle is crucial to its success long term and overall marketability.

Adhesive solutions that provide durability and extended wear time exist to help devices stay intact and attached longer. For example, using a nonwoven, acrylic-based adhesive with a nonwoven, breathable backing can provide a solution. Adhesive manufacturers, like 3M, will need to continue improving breathable adhesive and backing options in order for devices to increase their durability, resilience and wear time.

It’s important to note that wear time is a key consideration with adhesive selection. It not only impacts how the device is designed and what it can handle, but also the user and how often they will have to change their device. Fourteen days appears to be the longest possible adhesion time because skin regenerates itself within that approximate timeframe. Since skin is continuously shedding, after about two weeks, the top layer of skin is well on its way to completely regenerating itself. Even if the adhesive is still sticking to skin, the skin may no longer be sticking to the user. This specific wear time length allows device manufacturers to work towards creating devices that can function for the same length of time. One way manufacturers measure their adhesives’ functionality and make improvements and refinements is by conducting human wear time studies. Researchers test adhesives in real-life situations to evaluate their performance so that when certain requirements are needed out of an adhesive, design engineers know what they’re getting.

COMFORT Regardless of how long a device is worn or how long an adhesive is stuck to skin, comfort of both the device and adhesive is important. But as the length of wear increases, comfort becomes more critical.

As mentioned, users don’t want their device to be a burden. Large, clunky devices get in the way and can be heavy and awkward.

Skin health also contributes to comfort levels. As a living organ, it needs to breathe, expel moisture and move. When something gets in the way of these needs, skin does everything it can to force the foreign object off. A common mistake is choosing an adhesive that sticks to skin but isn’t breathable. Moisture will get trapped underneath, which can cause maceration (whitened layer of skin caused by trapped moisture, essentially drowning the skin). Adhesives can also cause pain upon removal, if they’re too strong for the application.

Future adhesive and device iterations will need to incorporate breathability and skin-friendliness into their designs in order to produce a comfortable product.

To enable further growth in the wearable medical device market, adhesives must continue to push the boundaries of what’s expected and what’s thought to be possible.

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Take the tube:

Tubing expertise used in liver transplant device

How tomatoes could help fight counterfeit breast implants

R

A

aumedic is producing a complex tubing set that simulates vital bodily functions for Metra, a new device for liver transplants from the British firm OrganOx. Within the system, the disposable set helps to keep donor livers perfused outside of the body for up to 24 hours.

Shortly after the liver is connected to the transplant device. Very quickly, the Raumedic tubing set is filled with the packed red blood cells. The pump head works like an artificial heart to circulate the blood through the tubing from the filter bag to the oxygenator. The latter functions as the lung would to enrich to blood with oxygen and maintain body temperature.

Syringes supply the donor organ with the necessary nutrient solutions.

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team of German researchers at the Fraunhofer Institute for Applied Polymer Research IAP, has devised a method to stop counterfeit materials being used to develop breast implants – using tomato DNA. Counterfeit medical products have become a major concern for manufacturers and consumers. Fake medical products tend to be inferior to the original and can put patients’ lives at risk.

The team has developed

a method which involves using tomato DNA as a way to positively identify implants.

“We isolated genomic DNA (gDNA) from tomato leaves and embedded it in the silicone matrix. We used approved siloxanes, which are building blocks for silicone products, to manufacture breast implants,” says Dr. Joachim Storsberg.

The team managed to prove that the extracted DNA’s temperature remained stable throughout pilot experiments.

The method should be

desirable to manufacturers: tomato DNA is inexpensive and is suitable as a counterfeitproof market for many polymer-based implants.

Is this the future for catheters?

M

edical device company CompactCath has increased its catheter line, with what it says are discreet new products.

CompactCath Coudé combines the compact design of CompactCath, is a smaller, easy to use, and discreet catheterisation experience unlike traditional catheters.

The device’s curved tip increases reach for patients to successfully drain their bladder. Also, CompactCath Coudé has been designed for

easier insertion and is the first of its kind to feature the “Case Up, Tip Up” design, which simplifies the catheterisation process by reducing the need for visual dependency.

CEO of CompactCath, Naama Stauber Breckler, said: “Since launching the CompactCath brand, we’ve received overwhelming positive feedback from both users and clinicians, citing the catheter’s non-touch insertion, discreetness, portability, and convenience as revolutionary

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in comparison to current catheters available in the marketplace.”

Currier Plastics employs the same standards of safety, quality and precision in healthcare applications as we do in our traditional markets.

Currier Plastics provides IVD, pharma, and other medical markets with a full range of value-added capabilities including design, blow molding and injection molding- all at one location. Our speciality in reagent packaging provides medical market customers with four critical competencies: Design We work closely with your team at the conceptual stage of your product to provide direction for the molded part design, material performance selection and best packaging method for the product.

Development We move into the prototype stage with single cavity molds to prove the concept functions as designed and enables design changes to be made quickly for faster results.

Manufacturing We source high precision/ tight tolerance production tooling to produce parts as designed without defect in a cleanroom environment.

QualiďŹ cation QualiďŹ cation Our quality assurance team is integrated into every step of the development process, collaborating with our process engineers on every molded component. Our Quality Management System is ISO Our Quality Management System is ISO 13485:2016.

13485:2016 certiďŹ ed.

You can rely on Currier Plastics and eliminate the need for multiple supply chain channels, a critical consideration for manufacture of diagnostics and pharma consumables that must be consistent without exception. Because we design and manufacture both closures, containers and other components we control the total package so you have a reduced risk of quality issues.

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