MPN NA Issue 5

N AMERIC AN EDITION

MEDICAL PLASTICS news

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From wearables to respiratory care

Dow Medical Solutions explains why LSRs are ideal for medical devices

DRUG DELIVERY DEVICES IN FOCUS TOP TIPS FOR SELLING MEDICAL DEVICES WHAT’S NEW IN PACKAGING?

ISSUE 5

Jan/Feb/Mar 2018

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ADVANCING MEDICAL PLASTICS

CONTENTS MPN North America | Issue 5

Regulars

Features

3 Comment

17 Trading places Lu Rahman looks at some of the ways businesses can facilitate growth overseas

5 News focus 8 Digital spy 12 Cover story Dow Corning in the spotlight 15 All in a day’s work Aaron Johnson, Accumold, kicks off the New Year with his regular column 32 Back to the future

18 Nail the sale Huthwaite International gives expert advice on how to secure a deal 20 Proof of delivery Where does the growth and opportunity lie within the drug delivery sector?

23 What lies ahead Invibio outlines augmented biomaterial for the next generation of spinal implants 27 California dreaming What’s on offer at this year’s MD&M West?

28 Making a connection Spectrum Plastics Group explains how to create trusted partnerships with original equipment manufacturers 30 Circle of life Lu Rahman has a look at some of the issues the sector faces in a bid to join the circular economy and Nelipak explains how more accurate packaging can aid the validation process 33 Centre ground Graham Engineering Corporation explains why the next generation of automatic die centering technologycould help to minimize die drool 37 The vanishing MTD Micromoldingdescribes how to ensure you take the right approach when micromolding bioabsorbable polymers

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5 THINGS TO CONSIDER

WHEN MANUFACTURING CONNECTED DRUG DELIVERY DEVICES The estimated number of connected drug delivery devices continues to increase and the impact of this trend could be significant, explains Phillips-Medisize.

While digital connectivity, or connected health, can improve the coordination and delivery of patient care, original equipment managers need to keep these five things in mind when creating connected drug delivery devices: 1 2 3 4 5

Development strategy and design consideration Situation analysis and patient compliance Connectivity ecosystem Wireless subsystem Security of device and information

As the Internet of Things continues to become an integral part of people’s lives, the opportunity to use it within drug delivery device applications remains promising. The manufacturers and device designers must identify, investigate and overcome these challenges so that the implementation of wireless and other related smart technologies can be achieved. When done successfully, connected systems enable the patient and caregivers a 360° view of both the patient and the disease – not only to manage adherence, but to improve results by understanding the effect of the regimen.

www.phillipsmedisize.com

CREDITS

EDITOR’S

comment

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

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

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

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

ISSN No:

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

Why my money’s on medtech

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e all know that this time of year prompts many of us to make resolutions.

It also causes us to look ahead, particularly in business, and assess where new opportunities lie across the course of the next year.

I have to admit, I love looking at what’s going to big. Often it’s no surprise – we see the emergence of a technology or types of products and their usefulness is overwhelming apparent. When technology emerges that creates discussion within the MPN team, it’s an odds-on bet that the rest of the population will find it just as interesting.

With this new tech in mind, I was really interested to read about Cleveland Clinic’s top ten breakthrough technologies for 2018. One of these is the hybrid closed-loop insulin delivery system. This type of product allows the patient to self-adjust and keep sugar levels safe. Medtronic brought our attention to these devices with the MinMed 670G which was hailed by the Wall Street Daily as a “medical device with the potential to change the lives of more than 1 million Americans who sufferfrom Type 1 diabetes.”

This FDA-approved device has unsurprisingly attracted substantial media interest. It’s not hard to see why. According to WHO, the number or people with diabetes rose from 108 million in 1980 to 422 million in 2014. In 2015 1.6

million deaths were attributed to the condition. With diabetes cases growing, technology that can improve the lives of the patient and allow them to live a normal, will be in high demand. We know that innovation that allows us to access care in a remote setting became a target market for businesses several years ago. This is showing no signs of decline with companies still keen to take advantage of the opportunities available.

“

Technology is fascinating and combining that with the healthcare sector has always created massive interest

Linking into this, another technology on Cleveland Clinic’s list is distance health. I have to admit I find this term a bit problematic and I’m struggling to work out what the difference is between distance health and telehealth/mhealth.

My main interest in it however, is that we’re clearly looking at the connected devices market. If big names such as Cleveland Clinic are highlighting the ongoing effect these products will have on the medical device sector, I find that exciting. It shows the extent of opportunity still available. Michael Roizin, Cleveland Clinic, spoke about these devices last year: “Due to

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an increase in connectivity through mobile technology and consumer demand, hospitals are getting ready for widespread adoption in 2018. 90 percent of healthcare executives reported to have or are currently building a telehealth program. Reports also predict seven million patient users in 2018, a 19-fold increase from 2013.

“These technologies are also expanding beyond the simple twoway video platform. More patients are now equipped with attachable devices that record and report medical information to doctors to monitor their condition. Over 19 million patients are projected to use these remote monitoring devices in 2018. With momentum building, the clinic believes that the emergence and acceleration of distance health technologies and services are assured in 2018.”

While this type of technology isn’t entirely new, its adoption is set rise, creating widespread business opportunities for device manufacturers. Technology is fascinating and combining that with the healthcare sector has always created massive interest. As we head into 2018 it appears that this partnership is showing no signs of slowing down. Given that life span is rising, we’re getting more illnesses, and we have advances in technology taking place at a rate of knots, who wouldn’t put their money on healthcare having a profitable 2018?

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NEWS FOCUS

What’s the industry take on US medical device tax?

The Advanced Medical Technology Association (AdvaMed) and the Medical Imaging & Technology Alliance (MITA) have been strong advocates for the tax’s suspension

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he tax, which manufacturers have to pay on all sales and imports of certain medical devices, was originally introduced as a funding measure for the Affordable Care Act in 2013. The tax was suspended in 2015 two years after opposition from medical device on for manufacturers and politicians.

A 2.3% tax medical device sales has resumed after a two year suspension.

Groups have argued that the tax negatively impacts job creation, device innovation and increases the cost of healthcare.

The Advanced Medical Technology Association (AdvaMed) and the Medical Imaging & Technology Alliance (MITA) have been strong advocates for the tax’s suspension.

Last year, CEO of AdvaMed, Scott Whitaker, wrote to president Trump asking him to overturn the tax. Whitaker wrote: “In 11 days, the medical device excise tax is set to be reinstated, meaning a massive tax increase is on its way. I am writing to you to underscore the devastating impact this tax has and will have on our industry. I know you have long supported repealing this onerous tax. I want to emphasise why, unlike other business taxes, retroactive relief from the device tax is not feasible and why action this year is essential”.

Whitaker argued that when previously active, the tax resulted in the loss or deferred creating of jobs, reduced R&D and also slowed capital expansion. He also wrote that the tax previously resulted in a loss of around 29,000 jobs.

The tax is expected to badly hit small companies that have developed innovative medical devices but have not potentially made much revenue from sales.

MITA has voiced its opinion on the tax and hopes it will be repealed once again in 2018. In a statement Patrick Hope, executive director of MITA, said: “Ultimately, we hope that Congress will continue to work toward full repeal of the medical device tax to safeguard high-paying, high-quality industry jobs and ensure that patients have access to the latest medical imaging technology.”

The Gloucester Times has reported that 500 companies and 21,000 jobs are involved in the sector in the Massachusetts region. One of these is Boston Scientific which the newspaper says expects to pay $75 million this year in tax alone to cover the excise tax. According to The Gloucester Times ‘those payments inhibit the growth and productivity of businesses that not only employ half a million or so people nationally but make equipment that improves the quality of life, even saving it, for untold numbers of others’.

It believes that start-ups will feel the pinch inparticular and reports that Congressman Seth Moulton has been vocal about the tax saying: “the medical device tax poses an unnecessary burden on the industry, but especially small businesses, and repealing it is simply the right thing to do.”

At the time of writing the spending bill due on 19 January could provide those in support of a repeal with an opportunity to get the tax suspended.

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NEWS FOCUS

Healthtech and open source – what should manufacturers do to keep medical devices safe??

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esting for security vulnerabilities in medical devices rarely happens, according to a 2017 report by the Ponemon Institute, sponsored by software security firm Synopsys. The report found that over half of healthcare delivery organisations do not test for security issues or are unsure whether testing occurs. 36% Mike Pittenger, of device makers do not test already-released Black Duck Software, medical devices to find new or previously advises device unidentified vulnerabilities.

manufacturers on how medical device security can be extended to open source

Over two million patients in the United States have implanted devices, including pacemakers and implantable cardioverter-defibrillators (ICD). More than seven million patients benefit from remote monitoring and connected medical devices part of their care. In the United Kingdom, as many as 39,000 people are fitted with pacemakers annually.

• Identification and detection vulnerabilities and risk

of

cybersecurity

• Understanding, assessing and detecting presence and impact of a vulnerability

the

• Plans to eliminate the vulnerability and respond to regulatory or market requirements • Compensating controls, such as Web Application Firewall or Intrusion Protection System rule, to mitigate the risk of those vulnerabilities

Visibility of security of devices is critical

A major driver of the technological revolution in medical devices is software, and that is built on a core of open source. A study conducted by Black Duck’s Center for Open Source Research & Innovation (COSRI) found that the average commercial application included almost 150 discrete open source components, and that 67% of the 1000-plus commercial applications scanned for the research included vulnerable open source components.

Security threats to medical devices present a risk to safety. If a device has open, unused communication ports, an attacker could upload unauthorised malware which could compromise the device’s clinical performance. A vulnerability discovered in a pacemaker could result in its being reprogrammed by an unauthorised user. The end result could be a life-threatening injury or death.

Healthcare and life sciences software use a large amount of open source. The COSRI study cited found the average application in this market was comprised of 46% open source – almost half the code base. Healthcare, healthtech, and life sciences applications had the highest concentration of open source of any industry!

For example, a research team found it could reprogram a patient’s ICD. The researchers were able to instruct the device not to respond to a cardiac event, such as an abnormal heart rhythm or a heart attack. They also found a way to instruct the ICD to initiate its test sequence – delivering 700 volts to the heart – whenever they wanted.

While there has yet to be a documented incident in which the code of a medical device was breached to conduct an attack against an individual, medical devices in hospitals are often riddled with malware, which can disrupt patient-monitoring equipment, sometimes rendering the devices inoperable or becoming a entry point for the theft of private healthcare information.

In May 2017 a global cyberattack put lives at risk by paralysing computers at National Health Service (NHS) facilities across the UK. Thousands of operations and appointments had to be cancelled as the WannaCry malware threatened to delete files unless ransoms were paid.

Visibility into the security of the components used in medical devices is critical, as is security testing. Just as important is continuous monitoring of those components for new vulnerabilities, including establishing a process for:

With this level of open source, added to the fact that over 2,000 new vulnerabilities are disclosed in open source components every year, these applications warrant security scrutiny. To defend against open source security risks, medical device OEMS and suppliers should: Fully inventory open source components. A full and accurate bill of materials of the open source used in applications is essential.

Map open source against security vulnerabilities.

Manufacturers must determine if the open source components they use are vulnerable to security exploits.

Establish processes to receive timely alerts on new security threats. Given the number of new open source vulnerabilities discovered and disclosed every year, medical device manufacturers need to continuously monitor for new threats as long as their devices remain in service.

Open source lowers development costs, speeds time to market, and accelerates innovation. However, visibility and control over open source are essential to maintain security and code quality of medical device software and platforms.

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DIGITAL

DIGITAL UPDATE

spy

Global medical plastics market on course to hit $24.81 billion by 2022

TECHNOLOGY UPDATE

www.childrenshospital.org

Child’s play:

THE SURGICAL IMPLANT THAT GROWS WITH A CHILD

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edical implants can save lives by correcting structural defects in the heart and other organs. But until now, the use of medical implants in children has been complicated by the fact that fixed-size implants cannot expand in tune with a child’s natural growth.

To address this unmet surgical need, a team of researchers from Boston Children’s Hospital and Brigham and Women’s Hospital have developed a growth-accommodating implant designed for use in a cardiac surgical procedure called a valve annuloplasty, which repairs leaking mitral and tricuspid valves in the heart.

Currently, children who undergo life-saving cardiac surgeries, such as mitral and tricuspid valve repairs, may require several additional surgeries over the course of their childhood to re-repair or replace leaking heart valves. The novel growthaccommodating implant is meant to enhance the durability of pediatric heart valve repairs while also accommodating a child’s growth, decreasing the number of heart surgeries a child must endure.

Beyond cardiac repair, the research team says the tubular, expanding implant design used in their proofof-concept could also be adapted for a variety of other growth-accommodating implants throughout the body.

“Medical implants and devices are rarely designed with children in mind, and as a result, they almost never accommodate growth,” says Pedro del Nido, co-

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senior author on the study, who is chief of cardiac surgery at Boston Children’s and the William E. Ladd Professor of Child Surgery at Harvard Medical School (HMS). “So, we’ve created an environment here where individuals with expertise and interest in medical devices can come together and collaborate towards developing materials for pediatric surgery.”

By partnering with Jeff Karp, PhD, a bioengineer and principal investigator at Brigham and Women’s Hospital (BWH) and an associate professor of medicine at HMS, his laboratory’s expertise in chemical engineering and biopolymer materials was brought into the mix for this research.

After vetting many different concepts for a growthaccommodating implant, the team took its inspiration from the braided, expanding design of a Chinese finger trap, selecting its first proofof-concept to be a tricuspid valve annuloplasty ring implant.

This concept could be adapted for many different clinical applications, with exciting potential to be converted into an actively — rather than a passively — elongating structure that could act as a tissue scaffold encouraging growth.

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ccording to a new report, Medical Plastics: Global Markets to 2022, BCC Research estimates the global medical plastics market will grow at a compound annual growth rate (CAGR) of 6.2% to reach $18.44 billion (£13.6 billion) and $24.81 billion (£18.3 billion) in 2017 and 2022, respectively.

This report analyses the evolving medical plastics space. Long-term trends in the global healthcare industry will continue to push market growth. The movement of healthcare activities to less-costly locations, such as outpatient clinics and homes, has increased the need for lighter materials, especially for housings.

The growth of minimally invasive medical devices to minimize trauma, operating and recovery times also has

DIGITAL UPDATE

increased the need for housings for medical devices, as well as for lighter, easily designed and non-corrosive materials such as plastics.

Highlights • The US accounted for nearly 40% of global consumption of medical plastics in 2016.

• This report analyzes major resins such as polyvinyl chloride (PVC), high density polyethylene (HDPE), low density polyethylene, linear low-density polyethylene (LDPPE/ LLDPE), high impact polystyrene (HIPS), acrylonitrile butadiene styrene (ABS), polyesters, polycarbonates, acrylics, and TPEs. • Commodity thermoplastics dominate the global market with about 60% of total volume.

www.dupont.com

Some candy talking: Could plastic made from sugar be round the corner?

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t seems that DowDuPont Specialty Products Division might be about to bring us plastic with a difference – it’s derived from sugar.

According to Delawareonline, scientists at the company have come up with a process to create a ‘spaghetti-like molecular chain’ that can be formed into plastic products.

One of the scientists involved Paul J. Fagan, was recently named as a DowDuPont Specialty Products Names 2017 Pedersen Award Medalist.

Fagan has been recognised for his

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technical leadership in the application of chemistry to the development of renewably sourced materials.

He has made significant technical contributions, leading numerous important projects such as the production of sustainable polymers and the conversion of sugars to biobased products.

Speaking to Delawareonline, Fagan said: “A lot of our customers and, we ourselves, would like to get away from using oil to make things. We’re not only trying to make things sustainable but also... recyclable at the same time, that’s the advantage of the particular class of polymers I’m working on now.”

The newspaper says Fagan’s aim for a “100 percent sugar-based plastic puts the company in direct competition with several startups and mid-size firms – all wanting to be first to disrupt the half-trillion dollar global plastics business.”

NEWS ANALYSIS

DIGITAL SPY

talking

www.4spe.org/plastivan

POINT

Model answer: Pupils learn about engineering plastics

S

tudents at Westerly and Stonington High Schools have been exploring plastics applications and engineering thanks to presentations by the Society of Plastics Engineers (SPE) Plastivan Program. Sponsored by DavisStandard, high school students delve into the chemistry, history and sustainability issues of polymers and plastics and their distinct properties. Students also received exposure to career opportunities and college programs focused on plastics engineering..

“The PlastiVan Program is a great way to excite young people about the science of plastics, and the vast opportunities the industry has to offer,” said Eve Vitale, SPE foundation director. “We travel to schools and companies throughout North America, educating people of all ages about plastics chemistry, history, processing, manufacturing, sustainability and applications. For students in the Westerly-Pawcatuck area this is especially beneficial because they have a global leader in the industry, Davis-Standard, just down the road.

The PlastiVan Program, in its 21st year, educates students of all ages by ‘changing the perception of plastics one classroom at a time.’ Its goal is to increase student knowledge of the contributions of plastics in modern life and promote careers in

Web of intrigue: HOW A SPIDER’S WEB HAS INSPIRED AN IMPLANTABLE DIABETES DEVICE

Model students: Pupils at Westerly High School enjoying learning about engineering and plastics

engineering. Specific material covered with high school students includes how plastics are processed and manufactured; information on designer polymers; applications using super absorbing polymers; cross-linking of polymers; how history has impacted engineering and more.

According to Jim Murphy, Davis-Standard president and CEO: “The majority of our workforce in Pawcatuck is from the local area, so we want to make sure students realize the many opportunities available to them. This ranges from building machines that process polymers to the engineering and testing that makes it all possible.”

DIGITAL BREAKTHROUGH

Get your coat: New hydrophilic coating tech launched

T

eleflex Medical OEM has launched a proprietary, hydrophilic surface coating for polymer-based devices that are navigated through the vascular system. The company says the coating performs favorably in terms of lubricity and extended durability when compared with other coatings on the market. It’s also said to have proven biocompatibility and shelflife stability and exhibits low particulate count in testing, plus outstanding adhesion to the substrate material. The coating can be customized to optimize certain performance characteristics based on specific user needs.

Similar to other hydrophilic coatings, Teleflex Medical OEM says its coating may reduce the required insertion force which may result in improved control, placement, and tracking of a device. Applications for this surface technology include introducers, diagnostic catheters, balloon catheters, and components.

Where and who has made this discovery?

A Cornell-led research team is behind the development to create a removable implant that could control type 1 diabetes. In Type 1 diabetes, insulin-producing pancreatic cell clusters (islets) are destroyed by the body’s immune system.

The group, led by professor Minglin Ma, from the Department of Biological and Environmental Engineering in the College of Agricultre and Life Sciences, came up with a method for implanting islet cells into a patient. The work also featured contributions from other departments including the College of Veterinary Medicine.

These are protected by a thin hydrogel coating and the coated cells are attached to a polymer thread that can be removed or replaced once they no longer have a use.

Can you explain the science behind it?

According to Tom Fleischman, Cornell Chronicle, the transplantation of stem cell-derived, insulin-producing islet cells is an alternative to insulin therapy. However, it does require longterm immunosuppressive drugs. “One well researched approach to avoid the immune system’s response is to coat and protect the cells in tiny hydrogel capsules…However, these capsules cannot be taken out of the body easily, since they’re not connected to each other, and there are hundreds and thousands of them,” writes Fleischman.

One of the main considerations with transplants is the ability to remove the device as tumours can form on stem cell-derived insulin-producing cells. Should the transplant die or need to be removed, this could cause a problem.

Does the Cornell device get round this?

Ma says that the team looked at the way water beads on a spider’s web but is going one better because unlike a spider’s web, it involves using a hydrogel layer that covers a string uniformly.

The string is an ionized calcium-releasing nanoporous polymer thread. It has been named TRAFFIC – Thread-Reinforced Alginate Fiber For Islets EnCapsulation – and it’s this element that has taken its inspiration from a spider’s web although its difference is that it covers the thread uniformly.

Ma told the Cornell Chronicle: “With a spider’s silk, you still have gaps between the water beads. In our case, gaps would be bad in terms of scar tissue.” Also, TRAFFIC’s large surface area is also said to promote better mass transfer.

What exactly would the treatment involve?

It’s a minimally invasive laparoscopic surgery where around six feet of hydrogel coated thread is implanted into the patient’s peritoneal cavity.

www.teleflexmedicaloem.com

And the future?

Apparently this could be a game-changing medical device.

According to Dr James Flanders who contributed to the work: “There have been other devices sort of like this but this one seems to have so much promise. It’s minimally reactive, it protects the islet cells, it allows them to sense glucose, they don’t attach to anything and it can be easily removed. To me is sounds like a win-win.”

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Gut Reaction:

NEWS FOCUS

HOW WIRELESS POWER CAN DRIVE TINY ELECTRONIC DEVICES IN THE GI TRACT

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magers, gastric pacemakers and other diagnostic and therapeutic tools could someday transform the way diseases of the gastrointestinal tract are measured and treated. For these electronic devices to work, they need a power source but traditional power sources, such as batteries, can be incompatible with the mucosal lining of the gastrointestinal tract and have a limited lifespan within the body. A more promising possibility is to power electronic devices from outside the body.

the potential to transform how we evaluate and treat patients. This work describes the first example of remote, wireless transfer of power to a system in the stomach in a large preclinical animal model – a critical step toward bringing these devices into the clinic,” said cocorresponding author Carlo Traverso, a gastroenterologist and biomedical engineer at BWH.

In a new study published in Scientific Reports, investigators from Brigham and Women’s Hospital, Massachusetts Institute of Technology and The Charles Stark Draper Laboratory report that an ingestible electronic capsule, complete with a capsule-sized antenna capable of receiving a radio signal wirelessly, can safely power a device in the gastrointestinal tract in preclinical models. The new work makes wireless medical electronics for treating the gastrointestinal tract one step closer to reality.

Other medical devices – such as cochlear implants or neural probes – use a well-established technique known as near-field coupling to deliver power wirelessly. But ingestible devices must be small enough to be swallowed and, moreover, lie a significant distance from the surface of the body, making this technique unattainable for most gastrointestinal electronics. A new technique known as mid-field coupling provides an alternative way to deliver power to deeply implanted devices. Mid-field coupling operates at higher frequencies to deliver power two to three times more efficiently.

“Electronic devices that can be placed in the gastrointestinal tract for prolonged periods of time have

To test whether mid-field coupling could help deliver power from outside the body into the gastrointestinal

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tract, the research team designed antennas capable of operating efficiently in tissue. They then placed one antenna outside of the body and the other in the esophagus, stomach and colon of a swine model.

They were able to transmit power levels of 37.5 uW, 123 uW and 173 uW, respectively, all of which are sufficient to wirelessly power a range of medical devices from outside of the body.

“We are very excited about this work which we feel can someday offer many new opportunities for oral drug delivery of different molecules,” said co-corresponding author Robert Langer, institute professor from the Harvard-MIT Division of Health Sciences and Technology.

“In further work, we would like to expand on these measurements by characterizing the effects of animal size, antenna depth, orientation and more on transmission efficiency, and focus on propagating fields – or the way power travels – to make transmission even more efficient,” said Traverso.

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COVER STORY

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

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COVER STORY

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

Accepted for a variety of medical uses since the early 1950s, silicone materials have two properties that are critical for driving industry innovation: biocompatibility and biodurability. Silicone elastomers are the material of choice for long-term medical implants since they can last for more than 30 years – far longer than any other material. Because silicones are inert, they are biocompatible with the human body, with no adverse effects on human health.

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

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

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

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

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

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

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

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

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

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

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

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

WWW.MEDICALPLASTICSNEWS.COM

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ALL IN A DAY’S WORK

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nother year has come and gone and 2018 is well on its way. If you’re like me, you’ve probably made a few New Year’s resolutions like, eat better, exercise more or finally get on that budget. If you’re also like me, you’ve probably already slipped a bit. Regardless of how we’re doing so far, the point each year is a reflection on how we might improve ourselves. We recognize where we may need improvement or want to be challenged to grow.

While we are easy to point to diet or exercise, how quickly do we bring these thoughts to our work life?

Accumold is a regular contributor to MPN thanks to its micromolding expertise. In a new regular slot for the magazine, the company’s Aaron Johnson provides some words of wisdom as we head into the new business year

Again, if you’re like me, you’ve probably already had an annual review where you’ve had opportunities to make goals and evaluate your performance for the year. Perhaps you even get that feedback on a regular basis. That’s even better. What I am suggesting is by chance one step further.

What I am suggesting is taking a step outside the day-to-day, mechanical objectives and adding something a bit more reaching. I have three suggestions for you to ponder and possibly add to your resolutions for 2018.

Staying RESOLUTE

1. GET CLOSER TO YOUR CUSTOMER It’s very easy to get lost in the moment of our work and forget why we’re doing what we’re doing.

Some medical device companies do a really good job of keeping their end customers in front of their teams, but how well do you know your customers? Make it a priority this year to get to know the end customer in a deeper way than you have before. Go beyond the marketing materials.

Find someone real to connect with. Renewing our purpose for the work can lead to great things, even if it’s just capturing our drive to do good work.

2.RESEARCH A NEW PROCESS/ TECHNOLOGY Take the time this year to pick at least one technology or process that you don’t know much about.

It doesn’t have to be something that’s new to the market, maybe you just don’t know much about it. We hear all the time at Accumold, “I didn’t know you could do that with plastic?!” Diving into a technology might reveal opportunities for innovations you didn’t even know you were looking for. Walk a trade show floor, attend a conference, thumb though this very publication and pick something new to research.

3. READ SOMETHING DIFFERENT Vince Poscente in his book, The Age of Speed, made the observation that you can’t separate what you learn in your personal life from what you learn in your corporate life. It’s a simple, and somewhat obvious claim.

However, I think we sometimes compartmentalize what we view as “work”and rule out subject matters that may not be directly related to our everyday tasks. I love reading Daniel Pink and Malcomb Gladwell. Neither of these authors directly help me make more tiny plastic parts, but they do challenge my way of thinking, and in turn, help me grow as a person and employee.

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What I am suggesting is taking a step outside the day-to-day, mechanical objectives and adding something a bit more reaching, says Aaron Johnson, Accumold 15

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EXPORT MARKET SUCCESS

Trading places

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wonder if we don’t give enough thought to the graft and strategy that goes into achieving business success in overseas markets. When MPN visits international trade fairs we encounter a host of companies that make trading in export markets look like a walk in the park. It’s easy to overlook the fact that immense planning makes a and effort has gone into attending these events.

What company achieve success in an export market? Lu Rahman looks at some of the ways businesses can facilitate growth overseas

According to the Observatory of Economic Complexity (OEC), the US is the second largest export market in the world. In 2016 the country exported goods worth $1.42 trillion and while during the five years between 2011 and 2016 exports from the US decreased at an annualized rate of -3.494% – according to the OEC – there are still exports opportunities to be had. Canada and Mexico top the list of companies that US businesses look to trade with. The is followed by China, Japan and the UK. Canada also has a strong export market, coming in at twelfth globally, and listing the United States, China and the UK as its biggest export markets. In 2016 Canada’s export market was worth $387 billion. Just behind it is Mexico which exported $373 billion in the same year. The medical instrument export market in both the US($26.2 billion) and Mexico was worth 1.8% ($6.87 billion).

Know your markets To achieve growth in overseas markets, it is important to know where to target and if there is a need for your products.

For both Mexico and Canada, China has become a key export market for medical equipment. According to Export. gov which helps US companies plan global trade strategy, the medical device sector is one of the fastest growing markets andhas held on to double digit growth for over a decade.

The organization highlights that given that globally the medical device market is 42% the size of the pharmaceutical market, however in China it is around 14%, there is significant opportunity for growth.

Export.gov outlines the way in which the Chinese medical device market is split into two – domestic manufacturers supplying low to mid-range products and foreign-sourced, high-end products supplied by big industry players such as GE and Siemens.

With certain markets, of which China can be one, it’s worth determining if certain regions are open or closed to foreign business. Competition from state-owned organizations that benefit from strong financial and technological resources can be high. Are you prepared?

Target your audience Advertising in niche business-2-business publications is a good way of reaching potential new customers. The combination of print magazines and social media access offered by b2B titles allows huge potential to reach a new audience.

Trade fairs can be a great way to meet new overseas customers as well as engage in meaningful conversations to discover what they are looking for from a new business partner. The financial outlay needs to offset any potential new business. There are the stand and associated travel costs but it’s also worth thinking about the costs of having staff out of the office for the event duration and the impact this will have on workflow.

Regulations and approvals A key consideration when looking at export markets, are regulations, administration and approvals of that country and region. It’s crucial that you get to grips with the legal and regulatory environment of the country you are exporting to. Contacting the embassy of the country in which you plan to do business is a good place to understand the admin requirements of a particular place. Keeping a solid documentation trail is also vital as is understanding the legislation and legal requirements attached to the movement of goods across borders.

The simple things The power of language shouldn’t be underestimated. Having visited more trade fairs than I can count, it can be frustrating when there’s no one on the stand that can communicate with you. If you’re travelling to a country where there may be a language barrier is it worth hiring a translator? And finally, one company I know that operates successfully in overseas markets explained to me that patience is a virtue. It takes time to build up longstanding business partners and create a network of customers in a particular field. Don’t write off an event if it doesn’t yield massive results instantly. It takes a while for your face and your business to become known.

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NAIL THE SALE:

Expert advice on how to secure a deal

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

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

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

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

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from the purchase, what level of influence do they have and then address each accordingly.

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

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

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

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

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

The problem is, the medical device sector is now selling to, amongst others, negotiation professionals – a notoriously tough bunch to crack.

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

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

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

OPINION

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

01

Ask questions and apply your research By asking questions that open discussion around the challenges the client is facing, you can position yourself as a helpful adviser and problem solver. In this case it’s important to understand the brief the procurement team has been given. Are they looking to buy in bulk, what are the key features, how can you communicate this in a straightforward way?

This also helps you to steer the conversation – meaning you can apply your research findings and start to build a valuable rapport with the client, in turn this will help to differentiate you from those still adopting the more oldschool approach to sales in the sector.

02

03

04

Find the answers you need

Listen to your customer

Agree a meaningful next step

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

Situation questions are used to uncover the facts and background of the customer’s existing situation, for example, the type of patients a device needs to serve, or what locations they are based in.

Problem questions are about customer’s problems, difficulties and dissatisfactions.

They identify whether or not something is a problem and should also be used to clarify that problem, for example, how satisfied are they with their present equipment? Or where does the problem happen?

Our YouGov research found 85% of business decision makers believe a good buying experience involves a salesperson listening carefully to their requirements. This shows a desire on the customer’s behalf to be heard by the salesperson.

And if salespeople aren’t listening, it means they’re talking; usually about the equipment or device they are looking to sell. This is a real danger as it’s a missed opportunity to discover how you could help your customer. Sellers must be careful not to be caught up in the excitement of talking about the bells and whistles of their device.

In a major sale, clients are seldom likely to order something or decide ‘no sale’ immediately; next steps are likely to be what we call Advances or Continuations. An Advance is when a customer commits to take action that moves the sale forward by providing access to a new, meaningful resource.

A continuation, on the other hand, is when the customer doesn’t commit to doing anything, but the seller may have to do a lot. We consider Advances to be successful, but Continuations not to be.

Successful sellers look for the highest realistic commitment they can get from each interaction to continue in the sales cycle.

05

Don’t immediately make a counterproposal Negotiating terms is standard in any sale, but it can be a potential minefield.

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

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

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

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DRUG DELIVERY

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

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

According to Persistence Market Research, North America leads the ways in this sector, followed

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

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

Thanks to the recent boom in mobile and digital health technologies, the connected drug delivery device market shows significant potential, providing interest to the sector.

Opportunities are strong. According

to Statista, the global digital health market is set to hit $2016 billion by 2020, with the mobile health market on track to reach $21 billion globally.

With devices available that allow the patient to administer drugs in their own home, that also remind them to dose while recording and sending their results to a physician, it’s clear to see why such devices have gained ground. Freeing up time for both the patient and the healthcare professional, connected drug delivery devices always had a strong chance of being a success. At the moment diabetes, cardiovascular and auto immune diseases top the list of conditions where connected drug delivery devices are stealing a march.

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

Manufacturing expertise Phillips-Medisize is an expert on the connected drug delivery device

markets and the critical considerations device manufacturers need to bear in mind when producing high viscosity/ high volume drug delivery devices.

With the increased use of biologics, the industry has explored ways of creating devices that can cope with these viscous substances. In an article written for MPN last year, the company explained: “There has been a rise in popularity of wearable self-injection systems for biologics. Instead of scheduling a doctor’s appointment for certain treatments, a wearable device allows patients to self-administer injectable medication. By 2020, biologics are expected to make up more than half of the world’s top 100 selling drugs. To keep pace with these trends, device designers are tasked with overcoming various challenges associated with delivering these drugs.”

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

Cilcare a leading clinical research organization specializing in ear disorders, and CBSET, a non-profit research institute specializing in the

The intracochlear drug delivery device is revolutionizing the treatment of inner ear diseases by circumventing the tissue permeation barriers that have long hampered the development of pharmacotherapies for hearing disorders

advancement of novel therapies, recently announced a collaboration with Draper, a company that focusses on the design, development and deployment of advanced engineering solutions.

The company has developed a novel intracochlear drug delivery (ICDD) device for hearing loss and related indications. With the ability to maintain a precise and constant volume of the inner ear fluid and with its small size, the ICDD is being said to highlight an innovative technological solution to treat patients with congenital and degenerative hearing loss.

“The alliance between Cilcare, the world’s leading services company in ear disorders, and Draper’s expertise in biomedical solutions, will allow us to develop a new generation of treatments to cure hearing loss. With 360 million people suffering from hearing loss in the world the stakes are high, and this collaboration provides a fast track for the development of safe, direct and effective treatments for patients.

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

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DRUG DELIVERY

Making it better Graham Reynolds, West Pharmaceutical Services, explains how patient-centric drug delivery is having a marked effect on device manufacture

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he biopharmaceutical industry is experiencing a rapid shift toward greater patient engagement. The voice of the patient is beginning to permeate every facet of the industry – from drug discovery to clinical trials, to regulatory approval and beyond.

This increased focus on patient centricity is spurring significant advances in injectable drug administration.

Biopharmaceutical manufacturers are working to engineer better patient experiences into their treatments by focusing on an injectable drug’s delivery system earlier in the drug development process and working with delivery system manufacturers to create administration systems that are easy and convenient for patients to use.

The rise of self-administration Increasing healthcare costs are driving care for many conditions out of the doctor’s office and into the home. In particular, treatments for many chronic conditions such as diabetes, multiple sclerosis and rheumatoid arthritis often require patients or caregivers to deliver regular injections of medication themselves. It is, therefore, important that drug delivery systems evolve to ensure that injectable medications can be easily, safely and effectively delivered in the home environment.

To create easy-to-use self-administration systems that aid in compliance with care plans biopharmaceutical companies and their drug delivery system partners must consider user needs along all stages of the patient journey.

For an arthritis patient, for instance, they may transition through a variety of injection systems, from a syringe to an auto-injector to a wearable injector. Manufacturers stand a better chance of satisfying the needs of the

patient throughout the course of treatment if they put the patient experience at the center of delivery system development.

Human factors research and analysis can be greatly beneficial in this process. This systematic, data-driven approach can facilitate a deeper view of patients’ needs, desires and behaviors. This research can yield valuable insight into patients’ preferences and emotional requirements, which can be translated into the design of the drug delivery system.

Drug/component compatibility Equally important to understanding how a patient will use a delivery system is a consideration of how the components of a drug delivery system function together.

Delivery systems that effectively manage the interrelationship of a drug, its primary container and its administration system can help ensure that it functions effectively, accurately and reliably.

Compatibility is a top concern for all injectable drugs and particularly with biologics. Many modern biologic formulations may be sensitive to silicone oil – used as a lubricant in glass syringes – or tungsten and therefore, may require alternative packaging. Cyclic olefin polymers can be attractive alternatives that help enable effective drug containment and delivery as they offer benefits including break resistance, consistent gliding forces, reduced extractables and leachables, and minimized risk of drug/container/component incompatibility due to the impact of silicone oil and tungsten on drug stability and protein aggregation. Additionally, polymer-based syringes can provide dimensional precision and strength, which can be significant factors when combining a syringe with a springbased auto injector.

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Connected health With the rise of self-administration, it is increasingly important for patients to be fully engaged and invested in their treatment regimens. However, as patients take administration into their own hands, there is greater potential for adherence levels to drop, particularly when they are asymptomatic.

Connected health shows great promise for improving the patient experience and help better adherence. One way to achieve this is by integrating the self-administration process with technologies patients use in their everyday lives: smart devices. West’s collaboration with HealthPrize Technologies is an example of how this challenge is being addressed. The collaboration allows patients to use electronically-connected drug delivery systems to track in real-time when they take their medication and uses gamification to reward patients for compliance. The platform is accessed through a mobile app or web portal and can also gather information such as dosage and device history use for trends and analytics.

By tapping into the ubiquitous nature of smart devices, self-administration can be a personalized experience that more easily dovetails into a patient’s lifestyle.

Conclusion The shift toward patient centricity is a step toward improving the patient experience and health outcomes. Yet it requires a novel approach to drug delivery that considers the relationship between the patient, the drug and the delivery system at all stages.

Biopharmaceutical companies who partner early on with drug delivery partners to design innovative systems with the patient in mind stand the best chance of providing demonstrable benefit for patients.

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HIGH PERFORMANCE POLYMERS

Invibio looks at augmented biomaterial for the next generation of spinal implants. This includes regulatory clearances for PEEK- Optima HA Enhanced in the US and CE mark approval in Europe, plus encouraging pre-clinical study results and early clinical experience

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wealth of research and clinical experience is confirming that the use of PEEK-Optima polymer-based spinal implants confers advantages that can, potentially, enhance the efficacy of spinal implants and improve patient outcomes.

Combined data from three clinical studies that directly compared PEEK-Optima with titanium devices for cervical fusion showed fusion rates between 88-100% for PEEK-Optima versus 47-93% for titanium devices.1-3 The highperforming polymer was the first implantable PEEK and introduced by Invibio Biomaterial Solutions (Invibio) in 1999. Since that time the company has pioneered further innovations and supported its partner companies with preclinical study results and clinical outcome data to achieve regulatory clearances and to help educate the medical community.

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

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

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

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

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

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

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

A previous study had evaluated and compared the bone ongrowth that resulted from the use of the two implantable polymers in a bone defect model in sheep, and revealed that PEEK- Optima HA Enhanced resulted in approximately 75% direct bone

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

Provided courtesy of Invibio Biomaterial Solutions ©2018 Invibio.

SOLID FUSION: Solid lumbar fusion at six months with CT scan

apposition as early as four weeks following implantation compared with PEEK- Optima Natural.5

Early clinical experience with the novel material combination A nine-patient case series was presented at the North American Spine Society (NASS) Annual Meeting in October 2016. These patients, male and female, were aged 39-76 and had varying levels of health, including pre-existing diseases or conditions, and experience of previous surgery.6 Patients also had various combinations of leg pain, cramping and weakness, and back pain necessitating lumbar fusion. All patients underwent a one- or two-level lumbar fusion utilising the same EVOS-HA Interbody device from Cutting Edge Spine, cage setup and pure iliac crest bone graft. The interbody fusion device used was made with PEEK- Optima HA Enhanced polymer. Anteroposterior and lateral X-rays were taken at six and twelve weeks postop and CT scans at six months post-op.

At six months, post-op CT scans revealed solid fusion for eight of nine patients, with solid fusion at one year for a patient with a history of heart problems and smoking. One-year radiographs indicated solid fusion in all patients. There were no neurologic sequelae.

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Trinseo_MPN Ad_NA page.indd 1

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HIGH PERFORMANCE POLYMERS

4 WEEK HISTOLOGY: More consistent and continuous degree of direct bone contact was observed.

Provided courtesy of Invibio Biomaterial Solutions Copyright ©2018 Invibio.

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

Brad Prybis, MD, Carrollton Orthopaedic Clinic, Carrollton, reported on an eight-patient case series that tested whether PEEK- Optima HA Enhanced provides better bony on-growth and fusion: “I observed pain and neurologic function and took anteroposterior, lateral and flexion extension radiographs at six months post-op.”7 Patients included males and females aged 43-66 with chronic neck, arm, hand and finger pain, numbness and weakness. Some patients also reported loss of control, coordination and balance in the affected areas. Diagnoses included various levels and combinations of cervical radiculopathy, cervical myelopathy, myeloradiculopathy, central stenosis with spinal cord impingement, foramenal stenosis, and chronic pain.

All patients underwent a two-level Anterior Cervical Discectomy and Fusion (ACDF) with a device made with PEEK- Optima HA Enhanced.

As part of this procedure, Dr. Prybis utilized a high-speed burr to maintain good bonecage contact and some endplate bleed, when preparing the endplates for a PEEK- Optima HA Enhanced spacer.

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

Neurologic Function Results: • Improved neurologic function in all 8 patients • Residual numbness in 3 of 8 patients • Residual weakness in 1 of 8 patients Clinical Results: • Arm pain resolved in all 8 patients • Neck pain resolved in 5 of 8 patients • Neck pain improved in 7 of 8 patients • Neck pain unresolved in 1 patient

Dr. Prybis concluded: “All eight cases utilizing the HA enhanced devices provided as good or better clinical and radiographic results than traditional PEEK Interbody Fusion Devices.

Patients healed quicker and could return to normal activity after only two weeks. I’m convinced that HA integration does make a big difference in clinical outcomes.”

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

In 2017, the potential advantages of PEEKOPTIMA HA Enhanced devices were highlighted when Innovasis was the first company to receive FDA 510(k) clearance for a standalone ALIF (anterior lumbar interbody fusion) system made from the polymer. This system is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). Used to facilitate fusion in the lumbar spine and inserted using an anterior lumbar interbody fusion (ALIF) procedure, the device meets all the surgical requirements of implant stability (anti-migration), ease of implantation, and straightforward assessment of the fusion process.

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

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

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

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

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

These results indicate a potential for improved patient outcomes, with all that implies for an improved quality of life. An increased number of regulatory clearances in the US and CE mark approvals in Europe will help to ensure that innovative devices made from PEEK- Optima HA Enhanced achieve quick and effective market up-take.

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

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MD&M WEST

California dreaming M

edical Design & Manufacturing (MD&M) West, the medical design and manufacturing event, has announced its newest features for the 2018 event including attendee-to-exhibitor matchmaking, a 3D printing focus and product showcases from leading exhibitors in the field.

Taking place on February 6-8, 2018 at the Anaheim Convention Center, MD&M West will feature a new matchmaking networking activity and 3D printing focus

The event provides the opportunity to source from the world’s largest collection of medtech suppliers and connect with over 20,000 design and manufacturing professionals who attend the event.

“The primary goals of MD&M West are to display the most groundbreaking innovations from the industries we support and to nurture business and networking opportunities for our attendees and exhibitors,” said Nina Brown, vice president of events, UBM.

“This year’s attendee-to-exhibitor matchmaking and 3D printing focus strongly align with this emphasis, and both features truly complement our already robust slate of education and activities at the show.”

Matchmaking platform New for 2018 is the attendee-to-exhibitor matchmaking platform, which will aid attendees and exhibitors in making successful business and networking connections during the event.

Attendees will have the opportunity to meet with over 100 participating companies across the three-day event for focused, one-on-one meetings tailored to specific areas of interest and products offered. Registration for the attendee-to-exhibitor matchmaking will open one month before the event and will take place in the Connection Corner, located in Hall E of the Anaheim Convention Center.

3D printing zone MD&M West will also highlight 3D printing during the 2018 event.

According to a Global Market Insights report, the healthcare 3D printing market will be worth $2.2 billion by 2024. To help industry professionals keep up with this exponential growth, there will be numerous 3D printing focuses at MD&M West, including:

• 3D Printing Exhibitors — many 3D printing focused exhibitors will be exhibiting on the show floor in 2018, including 3D Systems, Forecast 3D, OnShape, Protolabs, Purple Platypus and Stratasys.

• 3D Printing Custom Solutions in MedTech—Steven Pollack of Carbon Inc. will discuss how 3D printing has opened new doors in medical treatment as it can provide customized care and parts for individual patients. Pollack will also cover medical implications of 3D printing and how it will impact the medical field in the future.

• Show Floor Tour: Leading New Materials in 3D Printing— Chris Wiltz from UBM will lead this guided tour of the most innovative 3D printing companies on the expo floor. This tour will cover the new materials and design techniques that are advancing 3D printing.

• 3D Printing Innovation Summit—This two day educational summit will include presentations about biomaterials, bioprinting and beyond prototyping.

To see all of the 3D printing-focused conference sessions at MD&M West, visit:mddionline.com/3d-printing MD&M West runs alongside four other events, including Automation Technology Expo (ATX) West, Pacific Design & Manufacturing, PLASTEC West and WestPACK. To learn more about the event, visit: mdmwest.mddionline.com

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MERGERS & ACQUISITIONS

Gaurav Kapoor, Spectrum Plastics Group explains how to create trusted partnerships with original equipment manufacturers

Making a Connection O

riginal equipment manufacturers (OEMs) in the medical device industry are faced with a complicated supply chain and an evolving set of regulatory compliance standards that can make it difficult to be successful in a competitive market. As a result, OEMs have created vast networks of contract manufacturing partnerships to help offset gaps in expertise. However, the sheer volume of partners can further complicate the process of continuous product development and pressure to bring next generation devices to market. This general trend has led to a sharp increase in medical manufacturing mergers and acquisitions, including the formation of a new manufacturer, Spectrum Plastics Group.

By merging Pexco with PPC Industries, which also includes Kelpac Medical, Spectrum Plastics Group is helping OEMs navigate challenges in a more efficient way. The combined expertise within one unified source allows OEMs to engage with one partner for a variety of needs.

In the case of Spectrum Plastics Group, those areas of expertise can be selected across three fundamental business platforms: a ‘legacy’ medical tubing operation; ‘specialty’ services for advanced manufacturing in medical implantable and performance plastics injection molding;

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and finishing services to support contract manufacturing and original design and manufacture operations.

Spectrum Plastics Group is now a single-source partner for the medical device industry. To get there, Spectrum Plastics Group focused on creating trust with OEMs. That meant adopting the OEM point of view and understanding that all products, parts or components manufactured by Spectrum are ultimately used by practitioners to drive patient outcome. That thought process permeates the culture at Spectrum and creates trusted OEM partnerships that go beyond the figurative manufacturing floor.

Other times those thought processes are quite literally part of the manufacturing environment, including visual reminders on the manufacturing floor that reads, ‘Remember the Patient’.

OEMs are looking at the trend of consolidation from a supplier base as well. As approved supplier lists (ASLs) continue to grow, medical device manufacturers are looking to diversify and simplify the supply chain, add to offerings and provide turnkey solutions.

The geographic locations offered by a supplier can hold significant value. The size and scale of the business is another reason why Spectrum Plastics Group

has experienced rapid success. Hubs of medical technology are forming in key areas around the world, including Ireland, Malaysia, Costa Rica and northwestern Mexico as well as key areas within the United States, such as southern California and the Northeast. Spectrum Plastics Group has facilities in all of these regions, and more, which means that products can be shipped to and warehoused at any facility. Customers can operate knowing that the components needed are only a few hours away. If more are needed, there is less, if any, downtime resulting in added efficiency.

Global regulators have also brought a focus to supply chains, and with that, comes evolving standards. Within the last few years, there has been a marked increase in warning letters from the US Food and Drug Administration driven by supply chain practices. Governing bodies in Europe, Canada and Australia, for example, are also issuing significant changes to the regulatory process. Since health care is managed differently in different regions of the world, so too are the regulations. While the timing of certain standards may be different for various parts of the global economy, all seem to have a sense of fluidity and are moving in the same direction. As OEMs are held to more stringent standards of

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MERGERS & ACQUISITIONS

responsibility, demands are increased throughout the supply chain as well.

Therefore, creating partnerships with suppliers that have differentiated capabilities become that much more attractive. OEMs need quality control and assurance that can withstand even the most aggressive regulatory standards.

Again, the size and scale of an operation like Spectrum Plastics Group is better equipped to deliver on the need for quality control. Spectrum has more than 100 people dedicated to quality control, spanning five countries and 20 facilities. While Spectrum’s footprint spans continents, the quality mission is the same everywhere: to design quality into the product. Rather than relying solely on end-of-line inspection to cull out the ‘bad’ product from the ‘good’, Spectrum inspectors confirm that the process is performed as expected and quality teams design quality into the product before the first unit is even manufactured. That key delineation, involving quality control before the units are manufactured, provides OEMs the confidence they need: that when the manufacturing lot is on, the products are efficacious and demonstrate the quality needed not only to pass regulatory standards, but that the devices can be trusted to better patient outcomes.

Spectrum Plastics Group says its can better deliver on the need for quality control because it also manufactures registered products of its own as private label solutions. Experienced members of the team regularly submit documentation to many different regulatory bodies. That bridge in knowledge base is becoming more and more relevant for OEMs as standards evolve more rapidly. From product validation to design protocol, it requires a careful and practiced level of understanding that many OEMs do not have internally—especially those that are startups and not likely to have a regulatory expert on staff.

Supply chain and regulatory challenges remain top considerations for OEMs on one hand, however, finding a partner to create a symbiotic relationship to drive innovative product development is in the other.

Supply chain and regulatory challenges remain top considerations for OEMs on one hand, however, finding a partner to create a symbiotic relationship to drive innovative product development is in the other.

The engineering team at Spectrum Plastics Group is as sizable as the quality team, employing more than 100 people.

Providing engineer-to-engineer support helps address the needs of OEMs in many different ways. A primary area of expertise that can accelerate innovation is material selection. If a device is designed with certain specified materials that cannot in fact be used during the manufacturing process, Spectrum’s engineers will address it before the process is started—preventing repetitive iterations to draw the same conclusion.

Even if the material can be used to manufacture the device, the regulatory implications can once again become a

burden. As OEMs expand and grow to support the manufacture of devices for different uses, the lack of knowledge can weigh the process down. Working with an experienced partner can help an OEM transition from devices that support fluid pathways to implantable and bioresorbables.

In today’s market, finding a partner that can bring size, scale and expertise from material selection to regulatory standards is what OEMs need to do to stay competitive. There is an imperative to choose wisely and find a partner that not only delivers supply chain and regulatory compliance expertise, but also one that understands the need of the OEM. What that ultimately boils down to is creating an environment that puts the patient first. That means supplying practitioners with the tools they need to improve outcomes.

JOINT EFFORT: By merging Pexco with PPC Industries, which also includes Kelpac Medical, Spectrum Plastics Group is helping OEMs navigate challenges in a more efficient way

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PACKAGING

C e l i r c

Being sustainable is a given. But how does it fit into the healthcare packaging industry?

Lu Rahman has a look at some of the issues the sector faces in a bid to join the circular econonmy

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e don’t need to be told how important it is to be sustainable. We are aware of the need to re-use and recycle and there can’t be many industries that haven’t explored how they can contribute to the circular economy. Some time ago we fell out of love with squeezing the life out of products, using something to its highest value and re-using where possible. In recent years however, society and business have increasingly started to look at the entire life cycle of a product and its impact on the environment from sourcing, to manufacture, to end use.

Medical devices however, and the packaging they are ensconced in, can often fall short of our desire to re-use and recycle. Single use devices are exactly that - single use – and as such the amount of packaging they create can be higher than many other sectors. With issues of contamination to consider, many medical devices don’t have the option of being recycled, hence higher healthcare waste.

The packaging market is big business.

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

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

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

One could argue that for certain industries – healthcare packaging being one of them – style and function can overtake sustainability. And why wouldn’t this happen? Where medical device manufacturers and pharmaceutical companies are concerned, the priority has to be patient safety and regulation compliance. If sustainability can follow, it’s a win-win situation.

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

For instance, says Future Market Insights: “Auto identification is one of the technologies that is used to help the machines identify objects or persons. This includes a number of individual technologies such as barcodes, biometrics, and Radio-Frequency Identification (RFID).

The advent of smart and intelligent packaging systems has enabled medical device packaging manufacturers to optimize their efficiency, thereby facilitating growth of the medical device packaging market.”

Last year HPRC Europe and Aarhus University Hospital hosted a workshop focused on enabling circular economy solutions related to healthcare plastics and packaging. With stakeholders representing plastic suppliers, medical device manufacturers, hospitals, and recyclers, the event tackled challenges in recycling healthcare plastics within the WWW.MEDICALPLASTICSNEWS.COM

European regulatory landscape and posed possible solutions based on value chain collaboration.

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

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

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

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

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

IT’S A WRAP

PACKAGING

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

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

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

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

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

To do this successfully, it’s extremely beneficial for OEMs to choose a packaging thermoformer that understands DFMEAs and brings a thorough understanding of industry trends, end-user needs and challenges to every project.

It’s no longer enough to just have comprehensive manufacturing capabilities; a packaging partner must be able to deliver insight and innovation early in the design phase in order to create custom specifications by which to best validate a product.

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

Thermoformers need to understand how packaging influences the customers’ operations and supply chain.

In addition to reducing the overall amount of plastic used and footprint of the product, well-designed products have the ability to reduce labor and handling costs such as transportation, sterilization and storage through the supply chain.

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

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

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Save the Date!

Extractables & Leachables 2018 May 7-9, 2018 Bethesda, Maryland

www.eandl-conference.com

Smithers Rapra’s Extractables and Leachables USA (E&L USA) conference will once again provide the industry with a great chance to come together and discuss all of the current E&L issues facing the pharmaceutical industry. E&L USA will bring together the complete pharmaceutical supply chain to discuss the latest research in minimizing the risks associated with extractables and leachables.

Attending the conference will give you the opportunity to learn about the latest developments from industry practitioners and working groups to meet regulatory requirements and ensure compatibility in drug-package combinations, whilst networking face to face with 150 expected attendees.

EXTRUSION

Centre ground Graham Engineering Corporation explains why the next generation of automatic die centering technology could help to minimize die drool

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raham Engineering Corporation has completed testing of its American Kuhne Automatic Die Centering (ADC) technology with PA12 and Pebax polymers. Previously ADC has been used successfully in the field with high viscosity polymers such as polyolefins, thermoplastic elastomers and bioresorbables such as PLLA. In addition, ADC is now available on XC300 Navigator, the company’s new PC-based extrusion touchscreen control system.

Navigator leverages the multi-core PC computing power without the need for a PLC. This allows Graham Engineering to costeffectively retrofit ADC technology into existing tubing extrusion lines that include an ultrasonic wall thickness measurement system.

How it works ADC allows for touchscreen based manual or automatic adjustment of tubing concentricity as shown on Figure 1. The die head includes four low wattage pin heaters located in the rear mandrel of the die head where they can be heated in an uneven pattern to ‘flex’ the die pin position relative to the die bushing.

The integrated touchscreen system allows the operator the ability to graphically view the current centering positions, make manual adjustments and control automatic operation. Once the line is running the operator hits a button to bring the die to center.

The system reacts to adjust to the power levels of pin heaters in the mandrel to flex the mandrel and precisely adjust the pin location relative to the die. The system is integrated with an online ultrasonic gauge for full closed-loop control of concentricity (wall thickness variation). This involves capturing the data from the gauge controller into the PC to perform the process control. Concentricity levels of 97% and higher can be quickly reached, levels that cannot be achieved by the traditional and time-consuming method of manually adjusting four die bolts. The system also allows the operator the ability to make adjustments to compensate for the tubing twisting as it moves through the ultrasonic wall gauge.

The importance of uniform wall thickness ADC technology is ideal for stringent micro tubing applications where the physical properties of the polymers are being pushed to the limits such as thin-walled PA12 and PA12/Pebax blend tubing for angioplasty and stent delivery balloons, and

FIGURE 1: Navigator screen shot from touchscreen control of concentricity

FIGURE 2: TPU tubing with external and internal die drool

bioresorbable PLLA tubing for stent scaffold applications.

Thin wall PA12 balloon tubing with pressure requirements up to 30atm (450 psi) often require concentricity levels of > 95% across the length of the balloon tubing. Any thin spots in the wall thickness result in mechanical failure points. For bioresorbable stent applications ultra-uniform wall thickness control is critical because the tubing lumen accommodates fluid flow and any variations in wall thickness (particularly on the higher side) can cause increasingly turbulent flow that can lead to adverse clinical events such as thrombosis in vascular applications.

Long runs plagued by die drool ADC technology is also beneficial for long runs of singlelumen medical tubing from PE, TPE, and TPU for fluid transfer applications. In the production environment, lot-to-lot variations in the raw material do occur. Most modern extrusion lines compensate for drifts in the process by incorporating sophisticated inline gauging systems that include closed loop control of OD tolerances and in some cases wall thickness tolerances. Today’s gauging systems include high measurement rates (4000+/second) with up to 4 axis OD micrometers and up to 8 point wall measurement systems. ADC adds a new dimension to extrusion technology by enabling tight control of tubing concentricity. However, one of the limiting factors related to long tubing runs is an interruption in production from die drool.

Die drool occurs during the extrusion of polyolefins, polyamides, thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), and most radiopaque filled polymers resulting in an unwanted build-up of low molecular weight fragments on the exit face of the die. One of the compounds where die drool is recognized as a chronic problem is aromatic TPU with 20% barium sulfate in

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EXTRUSION the 85A to 55D durometer range. In some cases, a savvy extrusion technician can scrape the accumulated material from the die exit region. Die drool can also be found on the inside surface of the tubing as shown on Figure 2, which makes manually scrapping the drool mass from the die virtually impossible. The die deposit (internal or external) will eventually release from the die face and affect the quality and appearance of the extruded tubing.

Invariably the extrusion line has to be shut down to clean the die deposit, which is costly and time consuming. In order to fully take advantage of ADC for long run tubing applications, further work must be done to minimize the frequency of die drool.

FIGURE 3: Die drool caused by excessive die swell Image courtesy of Daniel Cykana, Extrusion Solutions

Die drool is a complex problem with many interrelated mechanisms, but there are a few extrusion parameters that can be studied in an attempt to minimize build up on the outer die surface. These include pressure fluctuations (surging) in the screw, moisture levels, die tooling coatings, and die exit angles.

Effect of die swell and screw surging For unfilled polymers, die swell has a large influence on die drool build-up. Both are proportional to extruder output rate or the velocity of the melted polymer through the die. Die swell is the release of normal stresses at the exit. Figure 3 shows where the swell of the polymer melt is excessive and impinges on the outer die face. With increasing output rates, there is a corresponding increase in shear stress at the die exit land as shown on Figure 4 that enhances die swell and die drool build-up. This problem is exacerbated if there are pressure fluctuations (surging) in the screw, as shown on Figure 3, which can originate from lot-to-lot variations in the raw material.

When a severe surge occurs the swell can make the extrudate expand so rapidly that it contacts the exterior of the die face leaving a buildup. The amount of die swell is largest with zero land length die tooling. Increasing the die land length as shown on Figure 5 reduces die swell and, as a result, die drool; however, the drawback is increased die head pressures.

Some experiments have been performed that show reduced die drool as the surface energy between the die-wall and the polymer decreases. The addition of fluoropolymer or silicone slip additives compounded with the base polymer can help by depositing a thin layer of the low friction additive to the internal die surfaces during processing, thereby reducing the surface energy between the additive and the polymer interface. However, this may not be a practical solution for many processors. Coating the die surfaces with fluoropolymers such as PTFE with low-friction properties has shown promise, but they do not last very long during tooling handling and cleaning.

Ongoing studies will include the use of low friction metallic coatings on the die land length that are wellknown in extrusion for their ability to eliminate stick-slip.

FIGURE 4: 2D FEM analysis Image courtesy of Compuplast

FIGURE 5: Long-land dies reduce die swell Image courtesy of Daniel Cykana, Extrusion Solutions

Modified die exit geometries Some experiments have been performed in academia to analyze the effect of die exit angles on die drool intensity during extrusion. This includes chamfering, flaring, and sharp edges. These designs in addition to increasing die land lengths will be studied as part of the comprehensive understand the role of die design on die drool phenomenon.

Video link: https://www.youtube.com/ watch?v=ysg56dz1zc0&t=1s WWW.MEDICALPLASTICSNEWS.COM

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R E G I S T E R B Y F E B R U A R Y 9 , 2 0 1 8 A N D S AV E $ 3 0 0 !

A division of UBM Americas

THE PREMIER VALIDATION EVENT FOR MEDICAL DEVICE AND DIAGNOSTICS MARCH 13-15, 2018 | COURTYARD MINNEAPOLIS DOWNTOWN | MINNEAPOLIS, MN

Expert Insights and Best Practices on Validation • Examine key considerations in the global regulatory landscape

Top FDA speakers present on current trends and hot topics in the industry.

• FDA Town Hall — Get your questions answered directly by the agency

CAPT Kimberly Lewandowski-Walker,

• Tackle the complexities of supplier partnerships in validation

Senior Regulatory Officer, Office of Compliance, Division of International Compliance Operations, Medical Device Single Audit Program, CDRH, U.S. FDA

• Overcome challenges in TMV for diagnostics • Build a strategic plan for facility validation

Adam E. Saltman, M.D., Ph.D., FACS; Medical Officer, CDRH Office of Compliance, U.S. FDA

• Delve into risk management in change control • Utilize risk to optimize V&V sampling plans • Delve into risk management in change control

Francisco (Cisco) Vicenty, Program Manager, Case for Quality, Office of Compliance, CDRH, U.S. FDA

BONUS MATERIAL FOR YOUR TOOLKIT • Summary of significant regulatory changes • Gap assessment template • Checklist for CSV testing • Multiple MVP templates • Supplier on-site audit template

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MICROMOLDING

The vanishing Lindsay Mann, MTD Micromolding, describes how to ensure you take the right approach when micromolding bioabsorbable polymers

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or micro medical components, there is a variety of materials to choose from.

Most micromolding materials fall into two categories: thermoplastics and bioabsorbables.

Thermoplastics are polymers that become pliable and moldable above a specific temperature, and return to a rigid state upon cooling. They have long been used in the micromolding world.

Many new micro medical applications rely on bioabsorbable materials (also called resorbable, bioresorbable, or biodegradable) because the materials dissolve or absorb into the body, eliminating the need for additional surgeries and minimizing concerns about adverse effects.

Devices made from these materials metabolize over time so secondary invasive procedures are not needed to remove them.

Across the board with plastics, the rules are different when you mold it so small. But when it comes to bioabsorbable resins, some molders assume that a thermoplastic material shares the same molding properties, so it is treated the same way. Bioabsorbables, however, require a much more extensive and specialized approach.

Specializing in bioabsorbables If you have a complex bioabsorbable medical device design, you need a specialist to be successful.

Think of it this way. Who would you go to fix your complex medical issue, your general practitioner or a specialist?

The general practitioner can offer a broad spectrum of services, but cannot offer the same high-level expertise as a specialist. Because the specialist devotes all their effort on that one specialty, their level of expertise, specialized equipment, extensive knowledge and experience allows them to diagnose and fix your problem in the quickest and best way possible, whereas even a great general practitioner may not have the knowledge and tools needed to solve your problem at all.

For example, say you’re a runner and you have a recurring knee problem. Your general practitioner might tell you to take some pain medication and stop running. Since that’s likely not the right solution for you, you’d likely find a doctor who specializes in sports medicine.

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Having worked with numerous athletes and being equipped with specialized diagnostics tools, the sports medicine specialist could offer in-depth insight on how to manage your knee injury—and hopefully help you avoid surgery.

The same premise holds true for bioabsorbable micro molding. A molder who does not focus solely on medical micromolding and bioabsorbables will not have the necessary tools or knowledge to effectively find the optimal solutions for your bioabsorbable needs. Like the general practitioner who says ‘stop running,’ a non-specialized molder may tell you that your bioabsorbable design is impossible and can’t be done. By turning to a bioabsorbable specialist instead, you get access to the in-depth expertise and equipment to make your ideas possible.

Bioabsorbable materials Designing a bioabsorbable medical device is expensive. First, these materials often cost more than conventional polymers – typically $5,000/kg.

Adding to the expense is the fact that bioabsorbable materials are much more difficult to mold and process than other polymers, due to their sensitivity. It’s important to understand the

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MICROMOLDING FIGURE 1: This bioabsorbable fixation suture design required an unconventional tooling approach. Extremely tight tolerances throughout the design were required for part functionality

material capabilities—and limitations—to help avoid costly delays in the development process and material waste.

Working with a micro molder with an indepth knowledge and experience working with both standard and custom-compounded bioabsorbable materials will help you to produce a bioabsorbable component with better speedto-market and quality control.

Typical challenges faced with these novel materials include low glass transition temperatures (ie. distortion characteristics), ensuring the proper amount of crystallinity within the product post-molded is present, as well as maintaining a consistent and acceptable molecular weight loss (IV loss) over long-term larger production lots.

The beginning challenge to working with a bioabsorbable material is obtaining useful information for optimal processing of these types of resins. A detailed documented starting point for micro injection molding of bioabsorbable materials does not exist from any material manufacturer. With limited processing data to start from, a micro molder needs to employ a rigorous characterization process for any new materials to assess and determine material behavior on the micro scale—before, during, and after molding.

For example, consider the striking differences between the more exotic bioabsorbable RESOMER X (polydioxanone) and the more common PURASORB PLG 8218. PLG 8218 is less challenging to mold. The material flows easier

and can achieve crisp features and narrow geometries. RESOMER X is unique in that it is not stiff at room temperature, since that is below its glass transition. It never becomes a strong material and completely degrades in the body significantly faster than all other bioabsorbable polymers. It’s also extremely expensive (~$15,000/ kg). Despite its inherent molding difficulty, it opens some unique applications.

It’s critical to know what your component requires out of a material: strength, dimension, IV loss, and physical properties. It’s also important to select a material that will ensure premium quality and maximum cost-effectiveness.

Custom solution resorbable materials Boutique material suppliers are making specialrecipe materials to meet the exact needs of upand-coming next generation products. By adding pharmaceuticals, fillers, or lower molecular weight materials that dissolve quickly, the required material properties can be tailored to meet the specific needs of the application, both physically and chemically. For example, some medical applications require bioabsorbable materials with more flexibility, higher rigidity, or higher or lower rates of absorption. There are many possibilities and the various iterations of products that are available are wide-spectrum.

A successful bioabsorbable micromolding project will incorporate the criteria of premium part quality from a robust molding process window, less invasive devices with increased precision and capability, superior post-mold mechanical and functional properties, consistent and minimal

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post-mold IV loss, and highly capable critical dimensions. We help our strategic partners develop new solutions, exploring and producing tiny, delicate, and intricate components required for specialized surgeries, bioabsorbable devices, and implant devices.

MTD predicts that bioabsorbable applications will continue to grow with wider exposure and acceptance in marketplace. As exposure and interest continues to grow, novel and improved uses will follow suit. Resorbable materials have also become popular for products in the closure market and laparoscopic procedures and with the advent of new materials and engineers pioneering new solutions, the products have expanded into dynamic devices. Materials now need to bend and flex like an elastomer but provide high mechanical strengths, while also achieving the desired function and result.

It is also predicted that micromolding will also continue to be a solution for polymer-based drug delivery systems. Traditional molding practices would not allow a drug to be compounded into a material before molding, without severely degrading it through the injection molding process. But with specialized medical micromolding it is, in fact, very possible. Products like drug-eluting bioabsorbable implants are becoming more prevalent in the market. These products consist of an active drug that is compounded with a bioabsorbable material that gets injection molded and then implanted inside the body. The bioabsorbable carrier dissolves, delivering the drug into the surrounding tissue over a controlled period of time.

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REASONS TO HEAD TO MD&M WEST Medical Device Security Conference Anyone with a conference pass will also be allowed entry in to the Medical Device Security conference, organised by the Diabetes Technology Society.

Cyber security is a huge issue across the globe and the conference boasts representatives from Google, Samsung, the FBI and FDA as well as other organisations looking at security issues for connected healthcare devices.

3D printing focus Also new for 2018 is the 3D Printing Focus. Delivering faster prototyping and lower manufacturing costs, 3D printing is helping drive the medtech sector.

MD&M West is making this tech an event focus allowing visitors to explore 3D printing technologies, tours and activities throughout the three daysof the show

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Samsung stimulates the senses at CES

F

or anyone at this year’s CES, Samsung’s two new digital health products caught our eye.

Developed as part of the company’s Creative Lab programme, the two products include a breathing device for faster recovery and a pair of smart glasses for people with vision challenges. Samsung’s GoBreath was designed to help people with lung damage and who suffer from breathing problems after general anaesthesia. Patients often need to do deep breathing exercises to

help with recovery and commonly use an inspirometer. Those who have undergone surgery can often find this difficult however due to lung pain. The device was designed by a doctor at Samsung Medical who wanted to find a way to help his patients recover faster. GoBreath consists of a portable device and a mobile app that teaches patients breathing exercises.

Samsung also announced the Relúmĭno smart glasses to help visually impaired people see images clearer. The glasses work in conjunction with a

smartphone. They work by having the smartphone process images from videos projected through the camera of the glasses. The processed images then float into the display of the Relúmĭno glasses.

Smart Apple: Heart monitoring feature on the cards?

We’re excited to hear reports that Apple is working on an integrated heart-monitoring feature for the next model of its Watch Series, according to Bloomberg. Apparently users of the Apple Watch will be able to record an electrocardiogram (ECG) by squeezing the frame of the smartwatch. The feature would work by passing a current across the user’s chest to monitor electrical signals in the heart.

This would allow users to detect any changes in the rhythm of the heart and potentially be alerted to any serious heart problems. An attachable sensor that can capture ECGs was recently cleared for use with the Apple Watch by the FDA. KardiaBand attaches to the Apple

Watch’s strap and lets users record an ECG in around 30 seconds.

Apple also recently launched a heart study app alongside Stanford Medicine to gather

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data on irregular heart rhythms.

Reports suggest that while Apple is looking into the technology, it may not include the feature in future products. The move would definitely push the smartwatch into the territory of medical device regulation, something that the company’s CEO, Tim Cook has said he is reluctant to do. “We don’t want to put the watch through the FDA process. I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it — maybe an app, maybe something else,” Cook said.