MPN NA Issue 1

N AMERIC AN EDITION

MEDICAL PLASTICS news Making the world

a smaller place...

The finer detail behind Accumold’s big business

+ MEET THE POLYMER SUPERHEROES HOW DIGITAL INNOVATION IS BOOSTING EXTRUSION THE ROLE OF SILICONE IN MEDICAL DEVICES

ISSUE 1

Jan/Feb/Mar 2017

WWW.MEDICALPLASTICSNEWS.COM

ADVANCING MEDICAL PLASTICS

Get Your Device to Market Faster MD&M West, 3019

Our Customer Solution Centre is all about encouraging collaboration and innovation, reducing technical risk, developing a more market-ready product, and increasing speed to market

Work with our team. Share ideas. Refine concepts.

Examine each of the device’s elements with a focus on design for manufacturability.

Study demonstrative prototypes; refine design for optimal performance.

Achieve a well-defined device concept.

• Dedicated facility designed to foster innovation and maximize sharing of ideas and technologies

• In-house laboratory for testing and validation of device concepts

• Nine-step development process builds in your unique requirements early in the concept stage

• 3D modeling and printing services

• Decision making process utilizing our proprietary database of design elements and their contributions to the device’s design

• Quick turnaround of demonstrative prototypes • Fully-integrated, in-house capabilities can be customized to the requirements of your project

Phone: 1.800.474.0178 or 1.508.964.6021 E-mail: oeminfo@teleflex.com Web: www.teleflexmedicaloem.com ©2017 Teleflex Incorporated. All rights reserved. Teleflex is a registered trademark and “Work with the Experts” is a trademark of Teleflex Incorporated in the U.S. and/or other countries.

Work With The Experts™

CONTENTS MPN North America | Issue 1

Regulars 5 Comment Lu Rahman explains the thinking behind the launch of MPN North America 7 News focus 8 Digital spy 11 News focus Export markets: What can we learn from the rise of Chinese investment in the Israeli medical device industry?

12 News focus Mergers: focus on the increased business value 14 Cover Story Accumold outlines its micro molding expertise

34 Back to the future Whats the next big thing in medtech?

Features

23 Material gains Raumedic outlines how silicone has a crucial role to play in the manufacture of medication and feeding pumps

16 Meet the polymer superheroes Lucideon looks at high performance polymers with superhero properties

25 Let’s get digital Vention Medical, discusses how digital innovations in sourcing extrusions help get products to market faster

19 Keep it clean!

MasterControl discusses at the importance of cleanroom quality and planning and maintaining operations

26 Go West Why MDM West may just be the go-to event of the year

20 Developing news Clariant Plastics and Coatings on why plastic component design begins with a secure supply chain

32 Small fortune MTD Micro Molding examines micro molding bioabsorbable polymers

WWW.MEDICALPLASTICSNEWS.COM

1

EXPERIENCE AMERICA’S LARGEST MEDTECH EVENT Kick off 2017 with the medtech solutions, connections, and education that can take your products from concept to market, faster and cheaper.

SOURCE

Find over 2,000 advanced design and manufacturing suppliers on the expo floor.

NETWORK

Connect with over 20,000 professionals through a variety of networking activities.

LEARN

Gain exclusive medtech industry insights at the 32nd annual MD&M West conference.

DISCOVER

Join industry leaders at keynotes as well as expo floor presentations and product demos.

PRESENTED ALONGSIDE

33708_MDM_ANA17

EXHIBITION & CONFERENCE

FEBRUARY 7–9, 2017

Anaheim Convention Center | Anaheim, CA

MDMwest.com/MPN

CREDITS

EDITOR’S

comment

group editor | lu rahman deputy group editor | dave gray reporter | reece armstrong advertising | gaurav avasthi art | sam hamlyn 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 © 2016 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)

New Year, New MPN!

W

elcome to the first edition on MPN North America. We’re really excited about this new launch and latest addition to our life science group of magazines.

The medical plastics sector is vibrant and strong – market reports forecast its growth to reach $7.54 billion by 2022. Advances in healthcare, increased and ageing populations and a boost in consumer health awareness are contributing to the important role this sector has to play on a worldwide scale. According to Brisk Insights, “the global medical plastics market is majorly driven by factors like growing awareness regarding benefits of using medical polymers with biocide properties” and the “increasing popularity of lightweight, low cost, portable and small devices in healthcare industry is likely to propel further industry expansion”.

The rise in digital health devices and systems designed to be used in the home setting, giving patients more control over treatment is just one area helping secure the position of the medical plastics industry. Other factors such as the 21st Century Cures Act and even the election of Donald Trump are being held up by some as offering potential growth for the medical device sector. According to Qmed readers “nearly 46% to be exact—think US president-elect

Donald Trump will be good for the medical device industry.”

Since its launch in 2011 Medical Plastics News has captured the very best in medical plastics technology and design. Keeping its readers at the forefront of the sector – what the key players are offering, how technology is advancing – means the title is now a leader in its field. With that in mind and along with the fact that our US readership has rocketed during that time, 2017 is the right time to provide our North American audience with a title of its own.

The North American medical plastics industry is a major force on the global scene. Key players such as PhillipsMedisize, Freudenberg Medical and West Pharmaceutical Services push forward with advances in the market helping the region dominate – it reportedly account for over 43% of the global market. Companies such as Polymer Solutions and our very own cover star Accumold have a vital role to play in the manufacture of devices on a global level, highlighting just how much expertise this region has to offer.

“

So as we start the year with our own exciting news, we look forward to bringing you the best of North American news and knowledge in the year ahead.

So as we start the year with our own exciting news, we look forward to bringing you the best of North American news and knowledge in the year ahead.

WWW.MEDICALPLASTICSNEWS.COM

3

MORE THAN JUST A SILICONE PROVIDER. YOUR INNOVATIVE PARTNER IN SILICON-BASED MATERIALS FOR THE NEXT GENERATION OF MEDICAL DEVICES

Proven Performance. Trusted Expertise.

Visit us at MD&M West 2017 in Booth 1921 and discover how Dow Corning’s innovative silicone technology and regulatory expertise can help you select the right material the first time.

NEWS FOCUS

2017

WHAT’S IN STORE FOR THE US MEDTECH SECTOR?

I

t’s been an interesting time of late for US medtech. Recent legislation, the excitement of the election and even rumours that Trump may Lu Rahman looks at abolish the FDA, mean recent events in the US that there’s much to discuss about the future medical device sector of the medical device and what they mean industry.

for the year ahead

One of the most talked about topics as 2016 drew to a close was the 21st Century Cures Act. Said to hold significant implications for the medical device industry – such as faster approval – the act received substantial media attention, both for and against.

The Wall Street Journal (WSJ) described the bill as an attempt to ‘cut red tape’ at the agency” and that it was ‘expected to usher in a new, more industry-friendly era of drug and device regulation.’

The act was seen as significant.

Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), commented: “AdvaMed commends the Senate for passing this important piece of legislation. The 21st Century Cures Act is a win for patients and for medical innovation. When fully implemented, this legislation will help accelerate the discovery, development and delivery of medical advancements to ensure more timely access to new treatments and cures for patients in need.

“AdvaMed has been a strong proponent of the 21st Century Cures initiative from its earliest stages. We are pleased that this legislation – which will have such a positive impact for patients and the American innovation ecosystem – has passed one more hurdle to becoming a reality.”

It wasn’t all hearts and flowers for this bill though.

Some feared the

legislation could herald less stringent criteria being applied to new devices.

Public Citizen, a lobbying group, voiced its concern: “This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.”

The debate will continue and meanwhile we have Donald Trump’s relationship with the medtech sector to watch.

In the run up to Trump’s victory the plus and minus points of him scooping a win were well documented.

Discussions about the future of the medical device tax were rife with claims a Trump adminstration would repeal the tax.

AdvaMed has long argued that the tax – which was created as a funding measure for Obama’s Affordable Care Act – harms job creation, deters medical innovation and increases the cost of healthcare. It had put forward an argument that the tax should be scrapped.

At the time of writing it looks likely that Trump will do just that. Last month Nick Carey and Susan Cornwell, Reuters, described how Mark Throdahl, chief executive of OrthoPediatrics, Indiana, had been able to employ more workers since the medical device tax was suspended last January and that he hopes Trump will scrap the tax on a permanent basis.

According to Carey and Cornwell: “Trump and US lawmakers are l i k e l y to do that, according to lawmakers, lobbyists and industry executives, in a step that also would help larger medical device

WWW.MEDICALPLASTICSNEWS.COM

makers such as Medtronic Inc, Boston Scientific, St. Jude Medical Inc and Johnson & Johnson.”

Whitaker, AdvaMed is also watching the future for the medical device tax with interest.

“In the coming year, policymakers will be dealing with a number of important policy issues, including authorisation of the latest Medical Device User Fee agreement to continue improving the FDA regulatory process, repeal of the medical device tax, and ensuring that the coverage process allows patient access to the latest innovations.

These have been and will always be bipartisan issues. The medical technology community stands ready to work with president Trump, his administration and the new congress on pro-innovation policy solutions to address the health care challenges facing the country and to ensure all Americans have timely access to the latest medical technologies, devices and diagnostics.”

And the rumours about the FDA? Nancy Bradish Myers, Catalyst Healthcare Consulting, writes in Clinical Leader: “In its most official position taken on FDA to date, the Trump team has prioritised FDA reform and putting a ‘greater focus on the need of patients for new and innovative medical products.’

“This can be read several ways: For instance, it could simply reflect the many FDA reform initiatives included in the congressional 21st Century Cures reform efforts. On the other hand, it could be signalling a deeper desire to focus on significant FDA change.

It could reflect a more conservative agenda that is in line with Trump’s antiregulation, pro-innovation outlook, and could mean the new administration may have some initial areas of focus in mind for reform.”

Watch this space.

5

DIGITAL

MATERIAL UPDATE

spy

www.solvay.com

Solvay polymer INSTRUMENTAL IN DESIGN OF TONSIL REMOVAL TOOL

DIGITAL UPDATE

www.harvard.edu HOW A PLANT HAS INSPIRED A SLIPPERY SLOPE ON THE SURFACE OF IMPLANTS TO PROTECT AGAINST INFECTION

I

mplanted medical devices such as left ventricularassist devices for patients with heart failure or other support systems for patients with respiratory, liver or other end organ disease save lives every day.

However, bacteria that form infectious biofilms on those devices, called deviceassociated infections, not only often sabotage their success but also contribute to the rampant increase in antibiotic resistance currently seen in hospitals.

A team led by Joanna Aizenberg and Elliot Chaikof, at the Wyss Institute for Biologically Inspired Engineering has created self-healing slippery surface coatings with medical-grade teflon materials and liquids that prevent biofilm formation on medical implants while preserving normal innate immune responses against pathogenic bacteria.

The technology is based on the concept of ‘slippery liquid-infused porous surfaces’ (SLIPS) developed by Aizenberg.

Inspired by the carnivorous Nepenthes pitcher plant,

which uses the porous surface of its leaves to immobilise a layer of liquid water, creating a slippery surface for capturing insects, Aizenberg engineered industrial and medical surface coatings that can repel unwanted substances.

“We are developing SLIPS recipes for a variety of medical applications by working with different medical-grade materials, tuning the chemical and physical features of these solids and the infused lubricants to ensure the stability of the coating, and carefully pairing the nonfouling properties of the integrated SLIPS materials to specific disturbing factors, contaminating environments and performance requirements,” said Aizenberg.

“Here we have extended our repertoire of materials classes and applied the SLIPS concept very convincingly to medicalgrade teflon, demonstrating its enormous potential in implanted devices prone to bacterial fouling and infection.”

A

Solvay medical grade polymer has been used by Elasso Surgical Instruments to create a new tool for the removal of adenoids and tonsils.

The company’s Ixef GS-1022 polyarylamide (PARA) resin was used in the development of Elasso Surgical Instruments’ Elasso Tissue Removal Device, a singleuse electrocautery instrument for adenoid and tonsil surgeries.

According to Solvay, the material’s high flexural strength and high flow provided a viable alternative to metal, allowing the medical device company to optimise the ergonomics, precision and surgical efficacy of its instrument without compromising the rigidity of key components.

Elasso Surgical Instruments’ new tool received its 510(k) clearance from the US Food & Drug Administration (FDA) earlier this year and is commercially available in the United States.

DIGITAL UPDATE

www.compounding solutions.net Compounding Solutions picks up certification

C

ompounding Solutions, an expert in medical plastics compounding for use in class I, II, & III medical devices, has received certification that its quality management system complies with the requirements of ISO 13485:2003 from the National Quality Assurance.

The ISO 13485:2003 standard is specifically designed to meet the strict quality and regulatory requirements of the medical device industry. It includes requirements for quality management, risk management, process validation, and traceability systems.

Compounding Solutions had previously been certified to the ISO 9001:2008 standard.

6

“We pursued a very ambitious design for our single-use Elasso instrument, which relies on very long, thin forcep-like arms fabricated from Solvay’s high-performance polymer rather than metal to ensure better leverage, reach and control,” said Olivier Lecerf, chief operating officer, Elasso Surgical Instruments.

“We tested several very high-end polymers, but only Ixef GS-1022 PARA resin delivered the necessary combination of high flow in the mold and outstanding strength and stiffness in the finished part to give the forceps the leverage that our design targeted.”

WWW.MEDICALPLASTICSNEWS.COM

DIGITAL SPY

DIGITAL NEWS

www.medtronicdiabetes.com

Medtronic launches Android MiniMed Connect

M

edtronic is now offering an Android version of its MiniMed Connect mobile accessory, which allows people with diabetes to see their real-time glucose level on mobile devices.

The MiniMed Connect app, which was originally launched on iOS last year, helps people with diabetes see how they’re doing right on their phone by providing convenient access to their insulin pump and CGM (continuous glucose monitoring) data in a smartphone application. The app also allows care partners to better

participate in diabetes care with real-time access to glucose and insulin data on any internet-connected mobile device or PC and sends alerts via text message.

The app allows healthcare providers to more efficiently access data for therapy optimisation through daily uploads of insulin and CGM information into CareLink therapy management software.

“In addition to greater convenience, our recent data shows that with easier and better access to their data, the MiniMed Connect app helps patients reduce high and low sugar events, and keep their sugar within range more often,” said Annette Brüls, president, Diabetes Service and Solutions business at Medtronic. “Making the MiniMed Connect app available for Android users, their loved ones and their care partners propels us forward in our goal to meet both the diabetes management and lifestyle needs of people with diabetes so they can live with greater freedom and better health.”

NEWS

Injuries from medical devices – FDA WANTS TO IMPROVE REPORTING

F

ollowing inspections at 17 hospitals in the US, the FDA has found under-reporting of injuries and deaths that occur as a result of medical devices and is keen to improve this.

POINT

SKIN DEEP:

POLYMER HELPS MAKES OLD SKIN YOUNG AGAIN Scientists in the US have been developing a silicone-based material that might just prove to be the secret to eternal youth as well having potential as a drug delivery system Tell us more It’s a wearable, silicone-based material, developed by scientists at MIT, Massachusetts General Hospital, biomaterial research group, Olivo Labs and biotech company Living Proof. It can be applied on the skin to smooth out wrinkles and tighten skin to give the impression of healthy and youthful skin.

How does it work?

The material is applied on the skin It’s said to boost skin hydration and provide ultraviolet protection. It’s possible that the material could be used to deliver drugs to treat skin diseases.

What’s the thinking behind it?

As we get older, our skin ages, becoming less firm and elastic. Exposure to sun can make this worse and impair the skin’s ability to protect against things such as high temperatures, radiation and injury. Researchers developed over 100 possible polymers all containing siloxane, a chemical structure alternating between atoms of silicon and oxygen. These polymers can be assembled into an arrangement known as cross-linker polymer layer (XPL). They then tested the polymers to see which one would best mimic the properties of healthy skin.

The move follows a range of cases involving morcellators and duodenoscopes which were cited as causing injury and contamination to patients.

According to Toni Clarke, Reuters, Dr Jeffrey Shuren, head of the FDA’s device division, wrote in a blog post: “Many events uncovered at the 17 hospitals should have been reported and were not, in violation of the agency’s reporting requirements. The FDA believes such under-reporting is a nationwide problem.”

talking

Shuren added that the FDA believes these hospitals are not alone in this situation and that there is “limited to no reporting to FDA or manufacturers.”

The FDA is looking at ways to improve the reporting of issues and the ways that medical devices perform in a hospital setting.

WWW.MEDICALPLASTICSNEWS.COM

What did they find?

They found that the novel XPL had better elasticity than natural skin and could stretch it more than 250% before it returned to its original state. Studies on the material’s safety and efficacy included one where the XPL was applied to the area underneath the eyes. The researchers found that the material tightened the skin for around 24 hours and helped skin retain more water than certain moisturisers. “I think it has great potential for both cosmetic and non-cosmetic applications, especially if you could incorporate antimicrobial agents or medications,” said a researcher.

7

Launching and introducing to North America

Advancing Medical Plastics

The essential information source for anyone involved in design, manufacture and supply of medical plastics devices ⊲

Drug Delivery Devices

⊲

Micomoulding

⊲

Extrusion

⊲

Catheters & Stents

⊲

Injection Moulding

⊲

Sterilisation, testing and inspection

⊲

Polymers

Join the community and subscribe for your FREE magazine copy www.medicalplasticsnews.com

@MPN_Magazine

NEWS FOCUS

TRADING PLACES The Israeli medical device sector offers opportunities for companies across the globe. Daniel Green partner at Israeli law firm Yigal Arnon & Co, examines the rise of Chinese investment in the Israeli medical device industry and the lessons that would-be investors can learn from this experience

A

s China continues to transition from the centre of global manufacturing to an innovation-based economy, Israel’s technology sector has attracted its attention. Israel’s life sciences and medtech industry has experienced growth and development in recent years and is playing a pivotal role in the world healthcare market, underpinned by innovation and excellence in academic research, government support and increasing funding options.

These factors are leading to ever more success and record investments, especially from China.

Sources of innovation The primary sources of innovation in the Israel’s life sciences and medtech industry include world-class academic and medical institutions, enhanced government support and the active presence of global life sciences and medtech companies in Israel.

A number of leading academic and medical institutions within Israel’s small geographic area have led to the crossfertilisation of knowledge.

This has fuelled innovation in medical technology. Medical institutions such as Jerusalem’s Hadassah Hospital, Haifa’s Rambam Hospital and Tel Aviv’s Ichilov Hospital, plus academic centres such as Tel Aviv University, the Weizmann Institute of Science, the Technion and the Hebrew University continue to publish scientific papers.

These institutions have developed technology transfer offices (TTOs) for the commercialisation and licensing of technology developed by employees. This serves as a primary foundation of the life sciences and medtech industry in Israel.

Government support Decades ago, Israel recognised the importance of government support to assist the R&D sector. With the establishment of the Office of the Chief Scientist in the mid-1980s (now the Israel Innovation Authority), it was possible for early-stage technology life science and medical technology ventures to apply for and, if they qualify, obtain financial support for R&D. Government support is also provided through incubator schemes, many of which aim to attract global expertise to support local start-ups. In this way, government funding reduces the risks involved in investing in medical technology start-ups.

Presence of global medtech companies Global companies such as Johnson & Johnson, GE Healthcare and Covidien, have R&D centres in Israel to access local engineering and medical talent. These are a source of innovation. Teva Pharmaceuticals, the generic drug company, is heavily involved in R&D activities in the life sciences area. All of the above produce a steady flow of new life sciences and medtech start-ups and technologies.

One of the first challenges they face is obtaining financing (beyond grants that may be available).

Financing opportunities In terms of financing opportunities for early-stage Israeli life sciences and medtech companies, there are many options. While not every venture is able to benefit from ‘angel’ funding, there has been growth in support provided by accelerators,

incubators and more recently, accredited investor clubs. The leading source is Our Crowd, which operates an on-line accredited investor portal. It allows investors accredited in their jurisdiction of residence to invest in early-stage companies that have been screened by Our Crowd’s professional team.

Venture capital also plays a significant role in financing life sciences and medtech ventures in Israel, with some of the leading VCs having established funds focused on investing in Israeli start-ups and more mature companies in this sector. There has also been a significant increase in activity in the Israeli medtech and life sciences sectors by Chinese VCs. Going public is only an option for the most promising and profitable life sciences and medtech companies.

A more likely ‘exit’ strategy for promising life sciences and medtech companies in Israel is acquisition by global pharma and medtech companies.

Challenges for companies and investors Investors often face challenges when investing in or partnering

WWW.MEDICALPLASTICSNEWS.COM

with Israeli companies. Aside from language challenges, differences in business culture can impede negotiations. For example, Israel’s business culture places an emphasis on quick action and at times, complex contractual arrangements; the Chinese approach is more measured and straightforward contractual arrangements are often preferred. Chinese companies are often interested in the outright acquisition of IP rights and technology while Israeli medtech and life sciences companies typically prefer to grant licenses to such IP and technology. Bridging gaps can take time.

Opportunities There is no doubt that life sciences and medtech ventures are a major part of the Israeli high-tech industry and will continue to contribute to the incredible growth of Israel, the ‘Start-up Nation’ while bringing improvements to the lives of millions of people around the world. While there are certainly challenges for investors such as the Chinese seeking to invest in or partner with Israeli companies, there are many opportunities to be had.

9

NEWS ANALYSIS

Combined forces M&A activity is rife in the medtech sector. Deborah Douglas, is managing director of the Douglas Group, a merger and acquisition firm focused on the sale of middle market companies.

She explains how the union of two companies can often lead to increased business value

T

he range of buyers for companies with plastic product expertise in medical markets of today continues to grow exponentially, as medical uses expand. Mergers and acquisitions (M&A) advisors commonly talk of the potential for great business combinations where the sum of the parts becomes greater, with the combination (1+1=3). This article will highlight a handful of such expansion directions possible and will talk about value-building exercises to create enhanced opportunities for the growth-oriented plastics manufacturer to significantly boost business value in the years to come.

Markets for medical plastics in 2017 and beyond are broader than ever. One of the first highlyvisible fronts for plastics in the world of medicine was the use of disposable products. Products from bandages to disposable containers to more sophisticated metal-replacement devices, have flourished and expanded steadily for the past half-decade. Also, sophisticated enhancements in recent years to add impact resistance or nano-reinforcements, which create added strength, allow for widening specialty uses.

Companies of today grow naturally as expanded uses are identified – just as medical catheters have expanded from a dozen suppliers back in 1960 to hundreds today. However, there are even more expansive changes coming for the future as companies combine medical plastics

10

expertise with other production capabilities. For example, plastic manufacturers sometimes find it effective to combine with material producers, particularly in the high tech world of medical products.

Berry Plastics combined with Avintiv late in 2015. The company’s capabilities together with Avintiv’s expertise in specialty materials may prove to be a significant game-changer for the future. This combination, in its first year of operations, is exceeding its past EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortisation) already – which was already in excess of 17% of sales! And positioning for the future is strengthened by possibilities of continued product expansion, as a result.

Growth through acquisitions in the medical sector happens at all levels – not just the billiondollar-plus size ranges. In March of 2016, Johnson Precision was acquired by MRPC. Johnson made custom injection molded products for medical use. MRPC produces silicon-based medical devices and supplies.

The enhanced range of product builds strength for the future, with higher barriers to entry for competitors, and longer life cycles for product.

Geographic diversity also lends power in this second-tier size range of acquisitions.

Even more far-ranging combinations are occurring, like the acquisition of PhillipsWWW.MEDICALPLASTICSNEWS.COM

Medisize by electronic and interconnect giant Molex. The combination was rather startling but as company executives explained: “Molex’s global scale in electronics, coupled with Phillips-Medisize’s strength in designing and manufacturing innovative products for medical device customers, will help us become a global leader in connected health solutions.”

Often the truly spectacular M&A coups are born of the more creative combinations of resources. This is probably truer in the medical sector than almost any other industry today. As solutions are developed they often integrate wider ranges of technology. In today’s healthcare environment, solutions may involve complex biocompatible materials or elaborate antimicrobial components in the design.

Medical devices may utilise complex electronic elements or other sophisticated mechanical devices integral to product function.

As developing medical product manufacturers evolve what can they do to build potentially saleable value for the future?

Those companies that add new technical capabilities may be building extraordinarily valuable foundations for the future. When customers wish to explore solutions to evolving problems, opportunities result. While it may require some diversion of resources and some

NEWS ANALYSIS

time commitments from top engineering talent, the broadened base of expertise will often pay for itself many times over, with passage of even just a few years’ time for new capabilities to become recognised and appreciated. Also, talented technical people love the challenge and appreciate the potential for their personal development.

and thus of growth potential. Be it listings of evolving providers of niche products, data on material consumed by segment, or forecasts of growth to come, such information adds power to plans for the future. Collection and analysis of strategic potential information is valuable both for sales and management staff today, and for value analysis for the future.

New sales channels can often be enhanced by connections made at trade shows and industry events. Although participation may be somewhat costly, contacts by attendees who talk of their specific problems and developmental opportunities can be precious as introductions for next phase products to come.

One of the healthiest exercises we have seen commonly used by growing and changing companies, involves classic SWOT analysis.

This examination of strengths, weaknesses, opportunities, and threats is a healthy and wholesome exercise and of particular value in a fast-moving and changing environment, like medical plastics.

Measurement of profitability by product segment can be precious when seeking new capital or contemplating sale. Gross margin data by product, by customer, by geographic region, and/ or by technology can add substantive value to contemplated transactions.

Later, when value is solid and it is time to court potential buyers or investors, a good chunk of ‘how to’ in order to be successful, lies in considering potential partners in a full circle – with a 360 degree look at who might fit. The best buyers are seldom the obvious.

The best usually come from companies who do something UNLIKE what you do. The company that will benefit the most from the addition of yours, is the company which doesn’t have what you bring to the table. Hence the acquisition of the medical product company by the interconnect giant or the addition of the plastics manufacturer by a resin developer.

It pays to nurture and develop management talent. As companies grow, their speed of development and their potential for competitive advantage is influenced more powerfully by the calibre of management and technical talent than by probably any other single factor. Investment in strong talent always pays dividends in value of the employing company.

Within the world of medical products, reputation within the industry is precious. It pays to build a reputation for niche expertise. Articles in trade publications, recognition at technical events and any published recognition of technical coups have significant value.

Identification of opportunities, where new technical capabilities may be evolving, can be a valuable source of new customer potential,

In scoping out who ideal prospects may be, there are several possible directions in order to try to get that full 360 degree view that will prove valuable.

Makers of healthcare products which are used with plastic packaging or which formulated with plastic component pieces are an obvious and often nice fit for the plastics medical supplier.

In order to be an ideal buyer, potential buyers WWW.MEDICALPLASTICSNEWS.COM

probably need to have some spread in products likely to fit within the capabilities of the seller.

(That is often possible in a surprising breadth of situations!)

Suppliers of specialty resins or other medically-oriented material components or enhancements, can sometimes benefit disproportionally from an added capability to make the plastic products their materials may enhance.

Mold-makers with good medical connections and relationships may have a ready ‘in’ to great new medical customers and may benefit from adding the capability for the next phase of production process to their range of product possibilities.

Sometimes the sheet product manufacturer or the injection molder or the thermoformer with strong customer penetration may find themselves with unusually solid access to customers who need other services that they may add through acquisition.

Companies with strong medical product focus or concentration are often highly desired by companies that do similar types of production but don’t have (although they do want) medical customers. Sometimes such suitors are willing to pay disproportionately for the potential for access to medical markets.

The astute manager of a business will keep his eyes peeled, looking at who might benefit most from investment in his company’s future. Great acquisitions come from visionary combinations.

Owner wealth and management growth are nurtured by the resulting combinations. There are many possibilities in the world of medical plastics, and the prognosis continues to be strong for the future.

11

COVER STORY

What kind of growth has Accumold seen of late?

We’ve been fortunate to have had significant growth over the years. With that we have made investments in infrastructure to ensure we have the scalability and sustainability to meet our customer’s coming needs.

Recently we cut the ribbon on a special 40,000 sq ft addition. It’s the second expansion in the last few years and we now have a total of 134,000 sq ft. of manufacturing space dedicated to micro molding.

The space is being filled with new machines and equipment. In the last year, we’ve also added over 100 new team members and we expect to reach 450 employees in the next 12-18 months.

We like to say, ‘we’re huge in micro!’

What makes this addition so special?

We built ‘Building Three’ as a hardened structure designed to withstand EF-5 rated winds. It was constructed with its own independent operational plant with back-ups and redundancies for continuous operations.

This structure is unique to our dedicated industry.

For many of our customers we are the sole source for their critical components. To provide

an assurance of supply we built this superstructure to offer this capability. We can run redundant presses in multiple locations in our factory without having to lose the main efficiencies of the vertical integration of our tool build and manufacturing processes.

The structure was also built as cleanroom manufacturing space. This gives us a total of eight clean manufacturing spaces adding flexibility and capacity. We offer ISO Class-7 and Class-8 options depending upon the customer’s requests.

There’s a lot of interest in micro, what exactly is it?

Micro molding is the art and science of injection molding small or micro-sized plastic parts or components. The main delineators between micro molding and standard molding, besides the size, are the complexity and tolerances often associated with these projects. It’s not uncommon for micro molded parts to have features or tolerances well under 25μm (.001”).

To date, Accumold’s smallest commercial part roughly measures 800μm x 380μm x 300μm.

The easiest way to tell if you’ve designed a part for micro molding is when your current suppliers no quote the project claiming it’s too small, too difficult, or not moldable at all. In some cases, that may be true but for more than

three decades Accumold has produced parts that were once called impossible.

Is micro molding limited to plastic-only parts?

No. At Accumold we provide all-plastics parts but also a variety of value-added processes.

Operations like lead-frame, insert-molding or overmolding are common. We have overmolded metals, fabrics, glass, ceramics, other plastics and other customer requested media. In addition to these we also have experience with two-shot micro molding, automated subassemblies and packaging.

What advantages does micro molding have for medical manufacturing?

The obvious advantage is centered on design.

Just like consumer microelectronics, smaller, lighter, higher-functionality, more features, cost-reductions, etc, are all valid ways medical manufacturing can take advantage of micro molding. Less-invasive surgical tools, more complex catheter deployment/delivery systems or more sophisticated personal care/diagnostic devices are just a few examples where micro technology, micro molding and medical manufacturing intersect. The smaller the better is often the desired design outcome.

The more important advantage is quality. The engine that is necessary to build tools and

Making the world Ankeny, Iowa based Accumold has been very busy the last twelve months with expansion, growth, and innovation. vice president of marketing and customer strategy, Aaron Johnson, sits down with us to share Accumold’s thoughts on micro molding, medical manufacturing, and the future of the industry.

12

WWW.MEDICALPLASTICSNEWS.COM

COVER STORY

produce quality micro molded parts requires an attention to detail that is second to none. The precision needed to cut steel to microns, and process and measure the molded parts to that same level of accuracy is the best platform for high-quality manufacturing. Be wary of suppliers that claim high-quality output but don’t have the infrastructure to drive it fully. There are no short cuts for high-precision output.

What other solutions does micro molding bring for medical manufacturers?

Medical manufacturing seems to be facing increasing pressures that many consumer industries have faced for a long time. The demands to reduce cost and/or add more functionality are increasing. Medical device manufacturers are looking for ways to add competitive advantage that often end up being difficult to produce. These challenges are putting pressure on some industry suppliers that are out of their reach, stifling creativity and perhaps leaving potential behind.

Good design for micro molding offers opportunities for more complex, featuredriven, smaller and smaller parts. These capabilities can lead to design advantages like part consolidation, reduced manufacturing processes, or better yet, adding new features that lead to faster diagnostics, healing, or recovery.

What besides the molded parts should medical manufactures consider?

In the throes of asking, ‘can this even be made?’ the most often overlooked aspect of micro molding for medical components is the time, cost and process of pre-production qualification runs. Micro molded components are often complex parts with multiple critical dimensions that must be measured, validated and proven repeatable. Consideration for the design and implementation of a solid IQ, OP, PQ (Installation Qualification, Operational Qualification, Performance Qualification) process for these challenging parts should not be overlooked. From the beginning, in the Design for Manufacturability stage, discussions should begin for this often-required aspect of production.

What innovations has Accumold focused on recently?

Recently our innovation team has been expanding our micro-molder capabilities by enhancing our insert/overmolding molding expertise. The ability to overmold very delicate media like glass, fabrics or other very-expensive inserts is in high demand.

Our team is asked regularly for something like, pick up a fragile, little 2mm speck, introduce it to the molding process, add a bit of complex

a smaller place will Accumold at g in it ib h be ex TRIPLE WHAMMY: The Accumold Building Three, its 40,000 sq ft hardened structure addition Credit: Dan Cross

est MD&M W44 Stand 28

plastic, inspect and package it, and do it all in one closed system – then do it a million times a month or more. Our innovation team collaborates closely with our automation & robotics team to integrate these custom micro manufacturing cells to be successful.

What does the future of medical manufacturing look like?

The blurring of the lines between the Internet of Things (IoT) and medical device is the future.

The convergence of these technologies will ask even more of the supply chain to produce increasingly complex and difficult devices.

This demand will force greater reliance on strategic partnerships with key experts in micro manufacturing fields to accomplish these desired outcomes.

We look for these partnerships. Our goal isn’t to be a job shop. The efforts required to build and produce high quality micro molded components takes too much commitment to take lightly.

As the pressures mount to do more with less space, we hope to be a trusted extension of our customers’ engineering team. This intimacy can lead to quicker development time and a partnership to a more robust production process.

Where’s the best place to begin?

Start early in the design stage and with your ideal design. There can be many roadblocks pushing back on your idea. What might be possible, might get designed away, potentially losing competitive value in a design effort. Work this out with your expert supplier.

I like to call our process, ‘conversation-based micro molding’. Each project is different.

There is no easy-button when it comes to evaluating and working through the design for manufacturability stage – especially when pushing the limits of size, geometry or tolerances.

Accumold has spent the last 30 years pushing the limits of micro-injection molding and we’re not about to stop innovating now. Together we can make the world a smaller place. What can you challenge us with?

SELECTION BOX: Examples of micro molding DESIGN NEWS: Delicate media overmolding. This flex-circuit and connector required careful tool design and processing so the expensive flex wasn’t damaged

WWW.MEDICALPLASTICSNEWS.COM

13

r

e m y l o p e h t t Mee

S E O R E SUPERH formance s at high per ok lo n eo d ci u ’s bury, L erties – what Richard Pad perhero prop su h it w s re er tu e fu polym ay and for th available tod

A

s the aging population rises and healthcare costs spiral, the healthcare industry is under pressure to develop new devices that address increased incidence of chronic diseases and injuries while sustaining exceptional standards and properties – all at a reasonable cost. It used to be that materials conforming to the human body capable of withstanding extreme conditions were a thing of comic book superheroes. However, with the development of high performance polymers, materials that can withstand large impacts, radiation, harsh chemicals, extreme temperatures, stretch well beyond their original length and magically disappear, are a reality.

Conventional polymers have been used in medical devices for decades such as ultra high molecular weight polyethylene (UHMWPE) frequently used in hip and knee repair, polymethyl methacrylate (PMMA) for bone cements and polyethylene terephthalate (PET) widely used in vascular prostheses and sutures.1,2 A high-performance polymer is a material whose properties such as strength, heat, and chemical resistance exceed those of conventional polymers. Of the different families and generations of polymers, polyether ether ketone (PEEK) certainly ticks every box due to its incredible properties such as high tensile strength (90 to 110 MPa) and melting temperature (>334°C (633 °F)) – over two and a half times higher than UHMWPE.1 Therefore, PEEK will stand up to the most demanding applications, repeated sterilisations and exposure to chemicals or drug formulations.

Furthermore, PEEK’s biocompatibility, high lubricity and comparable properties to bone make it a candidate for long-term implants that require high resistance to wear. Subsequently,

14

PEEK is a superhero material that performs incredibly well in almost every application, if cost is not a problem.

While PEEK is a well-known replacement for metals in a variety of engineering applications due to its light weight and attractive mechanical properties, it is easy to overlook other beneficial properties of polymers such as flexibility. Therefore, another class of polymer with superhero characteristics is thermoplastic elastomer (TPE) that provides exceptional toughness and extensibility. TPEs are copolymers of two or more monomers providing both thermally stable crystalline segments interspersed with flexible amorphous regions creating an elastomeric or rubbery characteristic.2 They can be easily melt processed in standard equipment and their physical or chemical properties can be tailored by varying the ratio of monomers or molecular linkages such as amide, ester, olefinic, styrenic or urethane building blocks. Therefore, TPEs can be used for applications from catheters and surgical instruments to medical bags and tubing.

So far, we have introduced high strength polymers with exceptional extensibility which can fulfill a range of medical device applications.

However, perhaps one of the most inspiring developments branches from the arrival of synthetic bioresorbable polymers. These provide support to damaged or blocked tissues while slowly degrading over time allowing the body to restore normal function. Common bioresorbable polymers include poly(l -lactide), poly(glycolide), polycaprolactone and their respective blends or copolymers which are all well known for their biocompatibility. Subsequently, these materials degrade via hydrolysis upon contact with water in surrounding tissues.3 Commercially available biodegradable polymers are used for medical devices such as sutures, tissue staples, stents and drug-delivery devices as well as being candidate materials for scaffolds in the exciting, expanding field of tissue engineering.

These materials signify an evolutionary trend in the use of polymers for medical devices.

While the first generation of medical polymers such as UHMWPE, PMMA and PET were designed to be inert and minimise the threat of an immune response, the second generation of medical polymers, such as PLA, PGA, PCL were designed to be biocompatible or bioresorbable. There is growing interest in materials that stimulate a specific cellular response namely, third generation biomedical materials.4 It is important to note that first and second generation materials can support the development of third generation biomaterials by promoting cell adhesion and growth through immobilisation of proteins or incorporation of bioactive compounds. For example, to improve the biological activity of PEEK, researchers are exploring the incorporation of bioactive particles such as hydroxyapatite (HA) onto the surface of implants to accelerate bone regrowth and improve attachment between the implant and surrounding bone tissue.5 Furthermore, HA has been incorporated into super elastic polycaprolactone or poly(lactic-co-glycolic acid) bioresorbable polymers for tissue scaffolds that support cell viability and proliferation.6 This next generation of biomaterials has superhero properties due to their ability to enhance human health and wellbeing.

As a polymer scientist, I am fascinated by the diverse range of polymers that can be produced Figure 1.

Chemical structure of PEEK

WWW.MEDICALPLASTICSNEWS.COM

HIGH PERFORMANCE POLYMERS

from blends, copolymers or synthesised from entirely new chemistries. It is reasonable that material selection for a specific application can be one of the most daunting tasks encountered by medical device designers and engineers.

There are seemingly limitless options to choose from as each polymer is part of a large ancestry of subtle changes in molecular make-up that creates notable variations to their macroscopic properties. So where should I start?

Material selection requires an understanding of polymer characteristics and how chemistries and morphologies influence their inherent properties. Polymers are characteristically different from their ceramic and metallic alternatives because of the long polymer chains that make up their unique structures. These long polymer chains are typically arranged in an entwined, random order similar to the state in which you find your Christmas lights at the start of the holiday season. However, domains of ordered, adjacent chains packed tightly together in a repeating pattern may also form resulting in polymers with semi-crystalline morphologies.

As such, polymers are viscoelastic materials with distinct time dependencies, melting points and transition points which determine whether the polymer acts like a flexible, rubbery material or a brittle glass. It is a polymer’s unique chemistry that separates it from the diverse range of alternative polymers. So, which polymer should you use?

The choice of material is closely connected to the properties required for the given application. Therefore, it is essential to create a comprehensive list of requirements for the medical device that underpin key constraints such as regulatory restrictions, operational use and mechanical properties as highlighted in Figure 2. Perhaps one of the most crucial considerations for a medical device is whether the polymer needs to be biocompatible. Clearly, if the polymer is going to be in contact with tissue or fluids inside the body for long periods of time, exposure to potential process contaminants, residues, leachables and degradation products must be evaluated. Finally, the mechanical properties, dimensions and lifetime requirements of the device will have a substantial influence on the range of polymers suitable to achieve the required specifications.

Selecting a polymer material based on these factors will be determined by traditional characteristics such as strength, stiffness or impact resistance as well as sorption, temperature deflection properties and chemical resistance which are required for a variety of climate conditions, including during transportation and storage.

polymers such as injection molding, blow molding and fibre formation. However, polymer structure and process conditions are intimately connected – polymer structure influences the process parameters needed to construct the material into a useful form, and process conditions can alter polymer structure to either enhance their properties or less conveniently, adversely affect them. Polymer processing is an art form, with an array of controls that need to be tuned to the inherent properties of the polymer material and the final requirements of the medical device.

Cost determines which materials and processes will be selected for a given application. Cost is largely driven by volumes and whether the device is single-use or implantable.

In summary, the classical definition of a highperformance polymer is a material that has a high service temperature, resistance to chemicals and mechanical strength. However, we have a range of polymers with distinctly unique characteristics from high strength to exceptional extensibility or the ability to bioresorb. Therefore, the definition of high performance is perhaps more subjective than initially presented and strongly related to a polymer’s performance for a specific application. We encourage developers to consider the factors described above and the range of materials that will provide the necessary regulatory, mechanical and biological properties for the specific use. In the long run, selecting the right material for the right application will permit its optimal performance during use at the lowest overall cost.

Figure 2 Rational material selection process

References: Sastri, V. R. Plastics in medical devices: Properties, requirements, and applications. Amsterdam, Elsevier/William Andrew, 2010 Domb, A. J and Khan, W. Focal Controlled Drug Delivery. Springer US, 2014 Zhang, X. C. (2016). Science and Principles of Biodegradable and Bioresorbable Medical Polymers: Materials and Properties. Woodhead Publishing, 2016 Hench, L. L. Third-Generation Biomedical Materials. Science. 2002, 295 (5557), 1014–1017.

Durham, J. W. et al. Hydroxyapatite Coating On PEEK Implants: Biomechanical And Histological Study In A Rabbit Model. Mat. Sci. Eng. C. 2016, 68, 723-731.

Jakus, A. E. et al. Hyperelastic Bone: A Highly Versatile, Growth Factor-Free, Osteoregenerative, Scalable, And Surgically Friendly Biomaterial. Science Translational Medicine. 2016, 8, 358, 358ra127

While polymer structure and chemistry impact their material properties, it is also important to consider how manufacturing processes influence stability. There is a range of manufacturing techniques available for medical WWW.MEDICALPLASTICSNEWS.COM

15

TESTING

KEEP IT CLEAN! Alex Butler, MasterControl, looks at the importance of cleanroom quality and planning and maintaining operations in the manufacture of medical devices

D

uring the manufacturing process of medical devices it is important that contaminants are absent from the process – which is why cleanrooms are used. In addition to reducing the safety and effectiveness of the medical devices, contamination in a cleanroom could lead to a shutdown, resulting in the loss of significant amounts of money and time.

Cleanrooms are especially important in the manufacturing process of plastic products that are becoming more prominent in medical devices. Impurities can cause defects in the products, which in turn can cause problems in the medical devices.

Therefore, it is imperative that organisations have policies and procedures in place to maintain the environmental integrity of a cleanroom.

In order to have a pristine cleanroom, organisations must first understand the threats that could cause contamination of a cleanroom.

Micro-organisms, dust/smoke, unapproved equipment, inadequate environmental controls and human error are among the leading causes of contamination in cleanrooms. In general, some research has shown that cleanroom personnel contribute to approximately 80% of all contamination that is found within the cleanroom.

In regards to plastics manufacturing for medical devices, injection molds are a source of contaminants, especially if the molds are not properly maintained.

Other cleanroom contamination sources specific to plastics are dust that is released during production and contaminated raw materials.

There are some steps that companies can take to significantly reduce the risk of contamination, with a number of these preventative measures taking place outside of cleanrooms. Two good sources to look at before developing cleanroom policies and procedures are the Institute of Environmental Science and Technology recommended practices for contamination control and the ISO 14644 series of international standards for cleanrooms and associated controlled environments.

A quick overview of some of the best basic cleanroom practices includes:  Developing a thorough cleanroom gowning requirements and procedures, such as what is to be donned and in what sequence.

 Ensuring the correct cleanroom supplies

are present and they are used properly.

This is important for not producing quality products but to protecting cleanroom personnel.  Instituting cleanroom housekeeping procedures and schedules. This is common sense for not only cleanrooms, but for many different aspects many industries. Preventative maintenance is a good idea, especially for plastic mold injection equipment to reduce contaminants that are produced during the process.  Training personnel on behavioural standards within the cleanroom environment.

Carelessness and ignorance can lead to disaster.  Continuously auditing and assessing cleanroom procedures and making improvements as needed. As technology advances with new types of materials and new types of devices, cleanroom procedures need to keep pace with the contamination threats and sources that may arise.

For organisations that need to build a cleanroom, they can get a headstart on contamination prevention with a sound facility design and floor-plan. One good tip from the Johns Hopkins Applied Physics Laboratory is to have a centralised air system that has air filters and fans to keep a predictable, clean airflow. A centralised air system also is important in regulating the conditions needed from drying the plastics.

According to Controlled Environments, facility design evaluation is the first phase

WWW.MEDICALPLASTICSNEWS.COM

of the five-phase cleanroom validation process, which is performed to ‘ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications (URS)’.

The other four phases are installation qualification, operation qualification, performance qualification, and the postqualification monitor and control phase.

The best cleanroom practices outlined earlier in this article play a key role in the cleanroom validation process.

Of course, in addition to having a good cleanroom program, medical device manufacturers must provide documentation of their efforts, such as information of sterility in 510(k) submissions. In the spring of 2016, the Food and Drug Administration issued the Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile which has updated recommendations regarding sterilisation processes that should be in 510(k)s for devices labelled as sterile.

As with all government regulations, it is strongly advised that medical device manufactures have a full understanding to of the new regulations, especially as it pertains to novel sterilising methods. An organisation using a novel sterilisation method will likely have to undergo a facility inspection by the FDA. Maintaining efficient cleanroom operations requires careful planning that begins before the cleanroom is built and implementing proactive policies and procedures.

17

Colour show: A variety of drug delivery devices using colour to make them more appealing

Developing news Stephen Duckworth, Clariant Plastics and Coatings, uses his expertise in healthcare polymer solutions to explain why plastic component design options begin with a secure supply chain

A

s the medical device industry continues to grow, device developers face a double challenge. Develop products that are functional, compliant and easy to manage for medical professionals in clinical settings, but they also need to keep consumers/patients in mind. These users select and rely on these products to monitor health status, manage chronic conditions, and dispense medications at home, in the workplace, or on the go, and they want devices that are attractive and easy to use.

Managing the materials and supply chains that are fundamental to meeting these two demands may be likened to threading a needle—or more appropriately—a series of needles.

First, there are regulatory challenges, where authorities such as the US FDA, the EU, and others, require detailed information on material composition, manufacturing processes, and extensive supporting data with respect to physical and mechanical properties of every proposed device. They become increasing vigilant on ‘changes’ between a new device and one already on the market, and it is here that materials used often are subject of regulatory challenges.

18

Next, plastics for medical devices must not only deliver critical performance properties – resistance to different types of sterilisation, chemicals and lipids, they also must meet strict standards for biocompatibility and toxicity.

Once these materials are properly documented, device manufacturers can use them in their designs and products with the confidence that they will meet regulatory and application requirements. However, the documentation is a point-of-time submission and is materialand formulation-specific. Any material or formulation change over the life-time of the product and at any point in a sometimes highly complex supply-chain, can invalidate previous approvals. So, beyond initial material selection, change control is also critical.

Colours signal differences, add appeal As people live longer with chronic diseases including asthma, COPD, and diabetes, devices to self-administer medication – whether through inhalers, auto injectors and the like – are becoming the norm. Yet, the success of these treatments is heavily reliant on patient compliance. US studies show as little as 28% patient-adherence to prescribed treatment WWW.MEDICALPLASTICSNEWS.COM

programs. Only high compliance can drive the kind of patient outcomes essential to justifying the perceived effectiveness and value of device brands among patients, prescribers, and insurance or payer entities.

Developers looking for ways to make their devices more attractive and easier to use are creating standard ‘device platforms’ that can be customised with new colours, visual effects, or components that can signal new formulations, dosing options, or patient-convenience features.

Any cues that trigger positive differences in user perception or response are important to reinforcing the value of a particular brand or helping patients feel comfortable about using it – a factor in increased compliance.

Just about any colour imaginable can be developed for medical devices and there is a huge palette of ‘standard’ colours with documented compliance to regulatory standards available and change control policies already in place. In terms of visual appeal, users may also respond to special effects, which have been used along with colour for many years to enhance the look and market appeal of personal-care and consumer goods. When added to plastics, special effect pigments can

MATERIALS

impart unique appearance effects, such as pearlescence, sparkle, or a metallic look. Whilst these types of effects have been widely used in consumer packaging (e.g. for shampoos), their use in healthcare has been restricted because of lack of regulatory information. It is only recently that testing has been completed to confirm that the ingredients in these new materials conform to medical and pharmaceutical norms.

Functional additives protect performance Colour and special-effect pigments are not the only materials being used to add medical value or consumer appeal to devices. A growing number of functional additives, preevaluated using biological evaluation standards ISO10993 and USP23 parts 87 and 88, are also becoming available to device designers and manufacturers. Among these are:  Lubricants











that reduce surface friction between plastic components, such as those used in dial-dosing gauges and auto-injection actuators. When incorporated into device materials, such lubricants make it easier for medical personnel or patients themselves, to select and administer proper dosages.

Stabilisers that protect certain polymers (such as polypropylene) against the loss of important mechanical properties when they are exposed to gamma or e-beam sterilisation. These same stabilisers can help reduce yellowing of devices caused by repeated sterilisation.

Nucleating agents, which counteract the dimensional changes that can result with the use of different colors in a product material mix. Nucleating agents affect how polymers harden during processing and can help to prevent product warping due to differential shrinkage. They can also help to speed up process cycles or reduce component weight, which reduces cost.

Clarifying agents are particular types of nucleating agents that enhance the clarity and optical properties of transparent plastic components.

Anti-static agents, which reduce or eliminate the buildup of static electricity on component surfaces.

Radiopaque fillers that make plastic diagnostic or surgical devices, such as catheters, more visible to X-rays.

Product identification and anti-counterfeiting Yet another class of additives is taking on increased importance with the phase-in of Unique Device Identification (UDI) serialisation programs in the United States and Europe.

These regulations will require that, by 2020, UDIs be placed on medical device labels, on packages and on all medical devices intended for reprocessing and multiple use. Permanent device labels must include the UDI in humanand machine-readable forms.

Today, laser-marking is ideal for implementing UDI part marking due to its speed, economy, and ability to support variable data essential for serialising even small parts and /or complex geometries. But many plastics are transparent to laser energy, making effective laser part marking very difficult. For this reason, demand for laser-friendly additives, additives that make plastics more receptive to laser marking, is rising rapidly. Fortunately, there is a growing number of laser-friendly additives becoming available with the biological evaluation and supporting regulatory documentation required for medical device and pharmaceutical packaging applications.

The device traceability provided by UDI requirements will enhance patient safety. But protection against counterfeiting, which affects both consumable medical devices (insulin pens, inhalers, diagnostic tools, syringes, etc.) and high-value drugs will require additional steps.

To date, the most effective means of combatting counterfeit products and protecting your own brand is to use multiple levels of security, typically involving both covert and visible coding on both devices and their outside.

Incorporating a taggant – a covert ingredient – in the production of plastic components can provide immediate, incontrovertible proof that a device is genuine. Introduction of such an ingredient, however, will raise the same supply chain and change-control concerns as apply to any other additive or colourant.

That is why Clariant recently teamed up with SICPA, a trusted provider of global security solutions. The two companies have launched the Plastiward system, which uses proprietary covert taggant additives (produced by SICPA) that are compounded into various polymers at one of Clariant’s ISO13485-certified plants. The taggants then become an integral part of the plastic product or packaging and are readily detectable using SICPA’s proven deployment and monitoring platform. Once the tagged product enters the supply stream, the SICPA monitoring system is able to identify them at any point from factory to pharmacy.

Supply chain management cuts risk exposure As noted, a range of new colour, performance and functional options are available to device developers who use plastic components as long as they understand the regulatory complexities and manage the risks involved.

For example, there is almost always a risk associated with even ‘routine’ changes in the supplier of product pigments or additives, even if the chemical type did not change. The key is in understanding where risk comes from and dealing with it early in the design process.

To help the medical device and pharmaceutical packaging industries minimise their exposure to supply chain risks, Clariant Masterbatches

reorganised its operations ten years ago, creating a network of three global manufacturing plants (one each in the USA, Europe, and Asia) and managing them under the ISO13485 quality system with change control protocols.

This is important because, firstly, production of a medical device may be required in different regions or be transferred and secondly, backup supply is normally a requirement.

Next, it standardised raw materials in terms of chemistry and supplier. This involved the technical, product stewardship and supply chain functions that assess each raw material not only on performance characteristics, but on regulatory criteria including RoHS, REACh, and BSE/TSE, and whether the supply was available in each of the three sites. Each plant uses the same defined raw material ingredients, the same formula, and the same key product quality parameters. The measurements not only include typical tests such as colour and physical properties, but also ISO 10993 part 18 extraction, biological evaluation (ISO10993 and USP parts 87, 88) and comparison to the chemical ‘fingerprint’ of a reference product.

Approaches like these, which Clariant applies to the production and supply of both masterbatches (colour or additive concentrates that are diluted with polymer in the processing machine) and fully compounded resins, help to eliminate uncertainty in the global material supply chain.

Medical device makers can therefore utilise the full range of colours, performance additives and functional ingredients in the form that best suits their product quality and manufacturing requirements. They are then able to deliver new, superior and fully compliant medical devices to market faster.

In hand: A simple handheld device can be used recognise covert taggants incorporated in plastic materials which helps in anti-counterfeiting

9, 2017 FEBRUARY 7CA er, Anaheim, nt Ce n tio nven 759 Anaheim Co #1 h: ot Bo Visit us at

DRUG DELIVERY DEVICES

MATERIAL GAINS T

hey are vitally important, make therapy possible, and they have become an integral part in hospitals or home-care settings: Markus Rössler, medication and feeding pumps supply patients Raumedic outlines with essential medication how silicone has a and nutrition. It is not only crucial role to play in the right electronic and the manufacture of mechanical components that are crucial factors, but medication and also the choice of materials feeding pumps for the pump segment. As in so many other areas of medical engineering, silicone plays a prominent role here.

What properties must a product have in order to find a lasting place in the healthcare sector? What are the specifications? It must be biocompatible, and in many cases skin- and bloodcompatible as well. Compatibility with common sterilisation processes is usually a key requirement. It should be resistant to heat and cold and display excellent storage stability while maintaining a consistent pump performance. It is also important that the product works reliably and provides precise pumping over long periods of time. For the use in hospitals and in the home-care domain this means always administering the right dose, whether with drugs or in feeding applications. Obviously, no substances should be released from the processed material.

So-called ‘extractables’ can have a negative impact on drug formulations.

It all adds up to quite a long list of product-specific requirements, which must in turn be met by the chosen material and its processing methods.

Single issue: According to Markus Rössler, Raumedic silicone injection molding allows a range of features to be integrated in a single part

Silicone – an exceptional material Silicone is a perfect fit for the requirements of precise dosing and integrity when in contact with medications. Its physical/ mechanical properties and the high degree of chemical purity in its formulation are decisive factors in this respect.

Among its mechanical properties, the exceptional resilience of silicone plays a significant role. It has a direct influence on the tubing segment’s pump performance over the entire period of use. The developer can be sure that his pump will always precisely dose and deliver the prescribed and programmed quantity of medication or nutritional solution. To ensure this functionality, the pump segments are subjected to a qualification and validation process as part of the development phase. Upon customer request, each lot or batch manufactured can also be tested during the production phase. The segments are tested for their adherence to pump performance specifications on a custom-built test stand that has the corresponding production pump built in.

To ensure that medications maintain the greatest possible purity, platinum-cured silicone is often preferred over the use of a peroxide catalyst, due to its excellent extractables profile.

Fit the bill: Silicone is a perfect fit for the requirements of precise dosing and integrity when in contact with medications, says Markus Rössler, Raumedic

material formulation, in terms of Shore hardness and the type and degree of crosslinking, extremely high dosing accuracies can be achieved for the pump system as a whole over the course of the product lifecycle.

Silicone injection molding provides added value The intelligent use of silicone injection molding technology allows for a range of features to be integrated in a single part. Previously these had to be provided by a more complex component. The advantages include:  no component-internal assembly

costs

Silicone injection molding vs extrusion

 finishing work such as cutting and

The pump segments available on today’s market are manufactured in two differently manufactured ways. In terms of ‘pure’ production costs for fixed lengths, extruded tubing is generally more economical. However, customer and product requirements with respect to improved precision in delivery rates are becoming ever more demanding.

Injection-molded variants are therefore beginning to draw increased attention.

The reason for this is that the diameter tolerance of tubing segments (for both inside and outside diameter) can be reduced by almost half, depending on dimensions and geometry. This fact has a direct positive influence on the dosing accuracy of individual pump segments in the range of 1%. Combined with the development of the appropriate silicone

WWW.MEDICALPLASTICSNEWS.COM

       

stamping processes are no longer necessary precision-shaped edges of the component - no sharp corners material is highly particle-free very narrow tolerances - very high dosing accuracy section for air bubble detection integrated connectors – poka-yoke principle high degree of design freedom improved anti-counterfeiting maximum patient safety

When it comes to pump segments, the extrusion and injection molding approaches each have their advantages and disadvantages.

21

OR F E T A D A !

Y R A I D R YOU Exhibit at Med-Tech Innovation Expo 2017 Now is the time to boost your share of the UK’s medical device manufacturing market.

The UK and Ireland’s medical device manufacturing sector is worth in excess of £27 billion and the show floor at Med-Tech Innovation Expo is your route to this market.

100% dedicated to the research, development, design and manufacture of medical devices

Prime locations booking fast, call us today on +44 (0)1293 710042 to secure your booth on a rapidly expanding floorplan.

www.mtiexpo-uk.com

EXTRUSION

LET’S GET DIGITAL The race to innovate and get medical devices to market faster has underscored the importance of sourcing high-quality, medical-grade Katie Karmelek, extrusions earlier in Vention Medical, the design process. engineers discusses how digital Design use extrusions in a innovations in range of applications, sourcing extrusions from simple IV lines have helped design to complex valve engineers get products replacement devices.

Regulatory bodies to market faster are increasingly scrutinising devices to ensure that manufacturers use medical-grade material resins, pigments, and processing techniques during the development process.

For decades, engineers iterating their devices had to order custom runs of extrusions early in the development process, often with long lead times and high minimum orders that were costly and wasteful. Alternatively designers had to resort to non-medical, industrial tubing without certifications or material traceability, which required retesting with medical-grade extrusions later in the process.

Three innovations have made it easier for medical device designers to source highquality extrusions earlier in the design and development process, which has improved the quality of early prototypes, reduced the need to retest materials later in the process, and accelerated product development overall:  Online access to medical-grade stock

tubing

 Rapid extrusion digital design tools  Quick-turn custom extrusions

Medical-grade stock tubing options Taking a page from the retail industry, several medical device suppliers now offer online stores with in-stock, medicalgrade products that ship quickly, bypassing the request for quotation (RFQ) process. Online stores often have low minimum order quantities, which save development costs and reduce waste.

Vention Medical broke new ground when it launched the industry’s first online store in 2012. Inventory has now grown to more

Fast worker: Several suppliers have dedicated extruders offering rapid or quick-turn extrusions

than 1700 components and technologies — including medical balloons, medical tubing, and the Versatility Universal Handle — ready to ship within 24 hours.

“What Vention has done with its online store is a game-changer,” said David Rezac, a development engineer and principal of Distal Solutions, a Bostonarea medical device consultancy. “It puts a huge number of right-sized options at my fingertips, enabling much faster frontend R&D. Knowing that each product can be scaled through a mature, qualified supply chain means you can develop with confidence. No more choosing between speed and quality.”

Rapid extrusion digital design tools Building on the success of online stores, several suppliers have leveraged digital technology to speed the design process, with online tools to design semicustom or custom tubing, balloons, sheaths, guidewires, and balloon catheters. These tools can dramatically reduce the time and cost of developing a catheter-based device.

Vention has developed several online design tools, including two specifically for engineers who need more customised extrusions than the stock products available in the online store. Online tools like these allow designers to access custom extrusions faster and more conveniently than ever before, with no need to pick up the phone or wait weeks for a lengthy RFQ process.

Rapid custom extrusion tool This online tool lets design engineers choose from a range of specifications (including ID, OD, wall thickness, length, and 20+ materials) to order custom,

WWW.MEDICALPLASTICSNEWS.COM

single-lumen extrusions.

Design your own extrusion Engineers who need full customisation beyond the standard specs can use this tool for even greater flexibility.

Designers can simply input their design specifications (including the option of uploading a design file) and receive a quote for a custom extrusion within 24 hours.

Quick-turn custom extrusions As more digital tools become available, it is also critical to support them with the proper extrusion equipment and resources to provide custom extrusions faster than ever before. Several suppliers have dedicated extruders offering rapid or quick-turn extrusions, putting complex extruded tubing into engineers’ hands in several days rather than several weeks or even months.

Experienced extrusion suppliers now make complex tubing available faster than ever before, including:  Single- and multilumen tubing  Coextruded tubing  Taper/ bump tubing  Braid- or coil-reinforced tubing

These three innovations have changed the way medical device engineers source extruded tubing. With these digital advances, startups as well as medtech giants have equal access to the components they need, which has helped to level the playing field. When designers get the components they need in their hands faster, they can iterate more quickly, get their prototypes built and ultimately, get their products to market faster.

23

Your community, your voice This is what the industry says about MD&M West…

“A major provider of solutions for the medical device industry. All the creativity and innovation is there to benefit from.” John Walker, principal manufacturing engineer, Breg.

“A great place to find suppliers and new technologies for our company!” Juan Miguel Manzano Tenorio, senior materials engineer, Medtronic.

“A rare opportunity to see a diverse range of the latest manufacturing technologies in action, all in one place.” Joe Uhlik, senior engineer, Roche “A whirlwind of companies and products sure to leave you feeling like a kid in a candy store.” Jonathan Mahan, process engineer, Applied Medical

T

GO WEST

his annual event allows visitors to source from one of the world’s largest collection of suppliers on one show floor.

It offers the ability to connect with over 20,000 engineers and executives looking to forge business Medtech moves fast. For partnerships and allows you to learn from 32 years, MD&M West industry luminaries. It’s three days of industry immersion medtech professionals has helped take medical can’t afford to miss.

devices from concept to market by uniting cutting- Find your solutions edge technology with the industry’s foremost minds MD&M West aims to

The MD&M West conference is a top resource for accessing the ever-shifting medtech marketplace. In its 32nd year, it will deliver three days and three tracks of product development strategy, design technique, and in-depth workshop learning.

With unlimited track hopping and access to the Smart Factory Innovation Summit taking place over all three days, this conference provides you with the tools you need to tackle your company’s next step.

provide answers from leading medtech suppliers, allowing you to be the first to witness demos of technology yet to hit the market as well as draw insight from keynotes and activities focused on business development, improving patient outcomes, value engineering, design thinking, speed to market, 3D printing and the IoT.

New in 2017: Explore the smart manufacturing revolution

Connect with your industry

The event lets visitors explore collaborative robots and robotics accessories on display from the world’s top suppliers. It’s also possible to attend free activities that connect you with the leading technologies and professionals building the factories of the future. The three-day, expert-led Smart Manufacturing Innovation Summit offers the opportunity to come face-to-face with your industry’s game-changer.

The event allows you to engage with over 20,000 industry professionals from leading companies such as Boston Scientific, St. Jude Medical, 3M, and Medtronic. In an increasingly digital world, face-to-face connections matter, and the networking activities help you build partnerships you simply can’t forge on the phone.

24

Deepen your knowledge

Smart manufacturing is redefining this industry — and it’s here to stay. Cobots are becoming smarter and complex systems are connecting to provide unprecedented flexibility, insight, and efficiency on the factory floor. It’s not an option of if to adopt, it’s when. And you can see it all in perspective at MD&M West.

WWW.MEDICALPLASTICSNEWS.COM

MD&M WEST

Explore the expo

The latest tech in action

The MD&M West expo gives you a huge collection of advanced design and manufacturing technology suppliers under one roof.

Whether your focus is new materials, intelligent sensors, testing solutions, components, contract manufacturing, packaging, or other industry solutions, you can source products and services for the development of life-saving medical innovations — all in a time-saving format and with more than 2,200 solution providers in one location.

The Tech Theater is where the most innovative exhibitors showcase the latest products and services serving the medical device industry. Ask questions, get answers, and discover new solutions you can engineer into your projects.

B. Braun, Burpee Materials Technology, Donatelle, DuPont Medical Packaging, Johnson & Johnson, Lubrizol, Nelson Laboratories, Nordson Medical, and Qosina are just some of the exhibitors on the floor this year. Connect face-to-face at their booths, or discover the opportunities you can’t find online — visit multiple theatres, networking spaces, happy hours and awards ceremonies.

Curated expo walks Join an expert guide on a one-hour tour of the show floor.

Each tour focuses on a key theme at the forefront of the industry, including disruptive design, new materials, packaging innovation, sensor technology, and robotics.

Your learning hub Center Stage will be the base for all of the show action, every day.

Free presentations, demonstrations, and industry spotlights will cover topics including industrial robotics, industrial IoT, virtual reality, mega trends, and DIY.

Networking Opportunities Matches in minutes

Speed networking hand-picks the professionals you need to meet and connects you for five-minute sessions.

From engineers and executives to suppliers and key decision makers, sit across the table from the faces that can help your business. Participation at last year’s speed networking was at full capacity, so get in early!

Create lasting connections

Connection Corner is your destination for peer-to-peer networking and problem solving in a relaxed environment.

Join other medtech professionals for roundtables and meet-ups. Whether you want topic-specific discussions or a quick chat with like-minded professionals in your field, this is your destination.

It’s the expo, VIP-style

Enjoy a premier experience at the industry’s premier event. Free gifts, relaxing seating, refreshments, snacks, and workstations will make your time at MD&M West as comfortable as it is effective. The perfect place to talk with other industry professionals or enjoy some downtime between booths, you

WWW.MEDICALPLASTICSNEWS.COM

can access Club Connect by invitation or with a conference pass upgrade.

Leading medtech conference

The 32nd Annual MD&M West Conferencee is back, delivering three tracks of education to industry professionals.

Discover how to better define your design techniques and development strategies, tackle barriers to market adoption through user-centric design, and leverage the latest breakthroughs in value-based product development — it’s knowledge that impacts your bottom line

25

MOLDING THE FUTURE OF PLASTICS INNOVATION Kick off 2017 with the plastics solutions, connections, and education that can take your products from concept to market, faster and cheaper.

SOURCE

Find cutting-edge plastics solutions from leading suppliers on the expo floor.

NETWORK

Connect with more than 20,000 advanced design and manufacturing professionals.

LEARN

Gain insights at the MD&M West conference and Smart Factory Innovation Summit.

DISCOVER

Join industry leaders at keynotes as well as expo floor presentations and product demos.

PRESENTED ALONGSIDE

33500_W_PL17

EXHIBITION & CONFERENCE

FEBRUARY 7–9, 2017

Anaheim Convention Center | Anaheim, CA

PLASTECwest.com/MPN

MD&M WEST

Why should you attend?

Industry-leading speakers

Smart manufacturing suppliers

Valuable, curated content

Smart manufacturing innovation summit

Hand-picked for their influence in today’s medtech landscape, MD&M West’s speakers know where the bar is set — and how to raise it. Representatives from the FDA, Biosense Webster, UCLA Technology Group, IBM Commerce Research, and other leading companies are taking the stage to share their first-hand experience and expertise in taking products from concept to market.

Attend their sessions, chat to them one-on-one, and take their insights back to the office.

Built for the industry by the industry, the conference features three tracks of up-to-the-minute thinking in medtech design, regulatory processes, R&D, sensor technology, and value-based care. Offering a variety of formats, including presentations, panels, workshops, and case studies, the program offers perspectives on the topics that matter most to your marketplace.

Get face-to-face time with specialists in collaborative robotics and accessories. Discover how leading companies are releasing next-gen robots from their cages while increasing productivity and safety on the factory floor. See cutting-edge smart technologies, including software, sensors, and the bots themselves, on display. You can find the who’s who of industry leaders — including ABB, FANUC, Rethink, and Universal Robots — highlighted on the show map upon arrival onsite.

This three-day summit is a can’t-miss for professionals relying on Industry 4.0 — as well as those yet to make the shift. Join expert speakers from top companies such as Omron Adept Technologies and IBM Waston Internet of Things as they delve into the latest thinking in data collection, machine learning, interoperability hurdles, 3D perception, IT vs. OT challenges, and many more considerations for manufacturing’s smarter future.

Exclusive conference networking

Join other delegates for a one-hour tour of the hottest innovations on the floor. Or meet with them, along with many of the speakers, for drinks and snacks at the exclusive conference drinks reception. Your pass also includes access to the event’s dedicated networking area, Connection Corner, where you can build relationships through your industry and topic of interest.

New for 2017: Smart manufacturing and the rise of the cobots

This is not a trend, this is the future. The smart manufacturing focus at MD&M West takes the current and future impacts of the fourth industrial revolution and puts them into perspective. Collaborative robots are leading the way, getting smarter and increasing productivity. Whether you’re an IoT novice or a smart factory guru, you can’t afford to miss this opportunity to experience the latest breakthroughs at supplier booths, interactive presentations, tours, and networking events across all three event days.

27

Accelerating 3D Technologies

MAG N.AMERICA EDITION Accelerating the adoption of 3D technologies for design, development and manufacture across all industries ⊲

CAD/CAE Software

⊲

3D Printing

⊲

Additive Manufacturing

⊲

Moulding & Tools

⊲

Machine tools

⊲

Metrology

⊲

Inspection

Part of the TCT group MAG EUROPE EDITION

MAG N.AMERICA EDITION

MAG

SHOW

ASIA

GERMAN EDITION

www.thetctgroup.com @TheTCTMagazine @TCTEvents

ASIA EVENT INSIGHT

MD&M WEST

s

expo hour

February 7–8, 5:00 p.m.

10:00 a.m. – 9, ry ua br Fe 4:00 p.m.

10:00 a.m. – a.m. early at 9:00 Hall E opens a.m.

30 8: at s en op Registration

Discover the factory of the future Smart manufacturing is here to stay. Explore a host of activities, specialist suppliers, and educational sessions that will bring you face-to-face with the collaborative robots and cyberphysical systems you need to understand to keep up with the shifting landscape.

Meet the robots!

Don’t miss the hottest robots on display at the show. Follow an expert guide on a one-hour innovation tour of the floor, focusing on the exhibitors whose bots lead the way in lifting factory IQ and creating faster, safer production environments.

Feed your hunger to learn Honouring design excellence Join the sponsored lunch-and-learn sessions, as well as the full- and half-day workshops, for extra insight and education you simply can’t find at the office. Last year’s sessions included an insightful look into MedAccred’s supply chain oversight scheme — details for 2017 will be announced in the coming weeks.

Celebrate the exceptional efforts in advanced design and manufacturing — by start-ups and giants alike — at the event’s industry awards. Don’t miss meeting 2017’s innovative winners, including the Rising Engineer Star and Gadget Freak of the Year

north america event calendar January 31-February 2, 2017 Santa Clara, CA I Santa Clara Convention Center, DesignCon February 7-9, 2017 Anaheim, CA I Anaheim Convention Center, ATX West Electronics, MD&M West, Pacific Design & Manufacturing, PLASTEC West, WestPack March 29-30, 2017 Cleveland, OH I Cleveland Convention Center, Advanced Design & Manufacturing Expo

May 3-4. 2017 Boston, MA I Boston Convention & Exhibition Center, BIOMEDevice Boston, Design & Manufacturing New England, PLASTEC New England, ESC May 16-18, 2017 Toronto, Ontario I Toronto Congress Centre, Advanced Design & Manufacturing Expo, ATX Canada, Design & Manufacturing Canada, PACKEX Toronto.

PLAST-EX Toronto Powder & Bulk Solids June 13-15, 2017 New York, NY I Jacob K Convention Center, Atlantic Design & Manufacturing, ATX East, EastPack, MD&M East, PLASTEC East

WWW.MEDICALPLASTICSNEWS.COM

October 24-26, 2017 Santa Clara, CA I Santa Clara Convention Center ARM TechCon November 8-9, 2017 Minneapolis, MN I Minneapolis Convention Center ATX Minneapolis, Design & Manufacturing Minneapolis, ESC, MD&M Minneapolis, MinnPack, PLASTEC Minneapolis December 6-7, 2017 San Jose, CA I S!l.ll Jose Convention Center, BIOMEDevice San Jose, ESC

29

Small fortune Lindsay Mann, MTD Micro Molding, examines micro molding bioabsorbable polymers. What impacts quality, performance, cost-effectiveness, and speed-to-market? And why aren’t they your average thermoplastic?

T

he market for less invasive micro medical devices continues to grow worldwide. In fact, the medical device industry leaps ahead almost daily, with constant demand for newer, smaller, never-before-seen micro medical devices. For the past 15 years, MTD Micro Molding has partnered with medical OEMs who came to MTD with an idea they weren’t sure could be made – looking for a solution. By refining its micro design for improved manufacturability and consulting on materials, its team of engineers helps brings these new products to market.

In addition to less invasive devices, novel uses of bioabsorbable technology are constantly evolving as well. And MTD has developed expertise in micro molding bioabsorbable, implantable applications.

While bioabsorbables seem like a new trend, MTD has been micro molding bioabsorbable medical components for 15 years and has worked with numerous types of bioabsorbable polymers.

Successful bioabsorbable micro molding projects will meet the following criteria:  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 post-mold IV loss, and  highly capable critical dimensions.

Here are just a few ways MTD helps medical device companies achieve bioabsorbable micro molding success:

Runner optimisation MTD’s MicroRunner tool has a ratcheting runner system that varies in diameter and aids in determining the minimum runner size required to fill the volume of your part with the goal of sizing a runner system to adequately mold a product without sacrificing material.

This is extremely important for bioabsorbable materials, given that they are so expensive. This important step can result in an annual savings of over $250K in material for the medical OEM.

Robust validation Validating a bioabsorbable part requires more steps than a non-bioabsorbable part, but with good planning and exact execution, the timeline to get to production is far from daunting. One MTD customer said it best: “We assumed that the smallest component in our device would be the hardest to validate, being that it was bioabsorbable, the most intricate, and criticalto-function. However, it turned out to be the smoothest validation process out of all the [larger, simpler] components in the device” With a collaborative approach, MTD fully documents and customises its validation processes for each client and project. It stores each part’s quality score with all the process data, providing a high level of traceability for all our micro medical device parts.

A competitor’s larger 4-cavity runner weighs around 1g, while the smaller, optimised 4-cavity runner by MTD weighs .09 grams. With annual production volumes of eg 250,000 parts, the optimised version in this example saves the customer over $280,000 a year in bioabsorbable material runner waste

30

WWW.MEDICALPLASTICSNEWS.COM

Validating a bioabsorbable part requires more steps than a non-bioabsorbable part, meticulous planning, and exact execution

In-house testing Many micro molders need to outsource their testing for Inherent Viscosity (IV) and Differential Scanning Calorimetry (DSC), which can add weeks or months to the project timeframe.

MTD has the in-house capability for real-time, continuous testing. This allows us to monitor, optimise, and report IV loss throughout the development and validation processes of a product as well as verify post-mold IV to release every production lot to the customer.

In-house testing capabilities saves weeks in a bioabsorbable parts’ development process.

Minimal and consistent IV loss What’s important to keep in mind is that postmold inherent viscosity (IV) loss is dependent on the micro molder and the material. Even if a micro molder has the equipment to work with

MICROMOLDING

a particular material, they may have trouble delivering consistent product with controlled IV loss for each molding run if they are not familiar with the complexities of the material. On-site IV and DSC testing capability enables the impact of process variables on these outputs to be determined and adjusted immediately, allowing for a better optimised molding process, minimal and consistent IV loss, and improved capability.

One of MTD’s high volume production lines, having zero product returns with over 15 million components produced, has a historical postmold IV variation of less than 2%.

micro molded parts, especially those that are bioabsorbable or made from other high dollar value materials. This may initially seem counterintuitive.

Material waste Figure 1 shows an example of optimised micro runner system designs that can be utilised for any material. You can see that the inherent material waste is in simple surface area. With expensive materials like bioabsorbable resins, which can cost $5-10 per gram, it’s easy to see how this amount of waste results in a non-cost savings situation. In micro molding, it’s estimated that a runner-to-part ratio for an optimised 1-cavity design is about 80:1. For an 8-cavity, it’s an estimated 800:1. An 80:1 ratio may seem like the runner is big and wasteful, but the reality is the majority of the material will always live in the sprue and runner, because the micro parts they are feeding are extremely small in comparison.

Increased cycle time When increasing from a 4-cavity to an 8-cavity runner system design, one may assume that you’d double the yield. But in reality it takes longer for the molding process to create an 8-cavity shot — about 10–15% longer cycle than a 4-cavity version.

This implantable bioabsorbable tack features sharp points that must be less than 0.0002 R.

Controlled handling and packaging Storage of bioabsorbable and sensitive materials and molded inventory in temperature controlled environments is critical. At MTD, temperature is monitored, logged, with alert limits if critical settings are exceeded. All manufacturing occurs in environmentally controlled ISO Class 8 cleanrooms and specialised shipping procedures for sensitive materials are in place.

Mold & automation issues Complex, tightly-toleranced micro designs lend themselves best to smaller cavitation tooling.

With hundreds of variables to control in micro molding, introducing higher cavitation can further expose the molding process to risk. And risk is expensive. Hidden costs of high cavitation micro molds are a result of significantly more time and resources being spent on hardto-avoid issues like more frequent repairs, maintenance and downtime. The automation complexity increases with more cavities as well.

remove a tiny, fragile part from a 1-cavity mold, present the part to multiple camera systems, and dispense the part into a custom packaging solution is a feat in itself in micro molding. That challenge gets compounded significantly with more cavities.

How to ramp up production while decreasing piece part price With high cavitation tooling not being an ideal cost-savings option for micro molding, and especially for bioabsorbable products, how can piece part pricing effectively be reduced with production volume ramp up? We recommend focusing on the following four areas to bring the piece part down for bioabsorbable products: RUNNER SIZING: Use runner optimisation to pinpoint the minimal amount of material required for the runner system to be successful.

PRODUCTION OPTIMISATION: Having a successful molding optimisation period during early production helps with planning and efficiency, which can result in cost savings down the line.

ACCURATE FORECASTING, STEADY ORDERING: Accurate forecasting, blanket purchase orders, and steady ordering can allow the molder and material provider to be more efficient with their processes, resulting in less manufacturing costs and piece part cost savings passed down to the customer.

(For example, MTD was able to reduce a bioabsorbable piece part price with steady ordering and accurate growth forecasts by 40% over a five-year span.)

RISK MITIGATION STRATEGY: Designing the validation protocol to validate the widest range of bioabsorbable material IV lots available is a risk mitigation approach that could result in cost savings for the product.

Customised, specialised equipment At MTD, specialised micro molding equipment is in place to control critical bioabsorbable processing factors like residence time, shear and degradation rate of material. MTD creates customised screws in-house, specialty drying media and procedures – not only is it investing in specialised equipment, it customises it completely once it arrives.

Figure 1

High volume bioabsorbable micro component production When OEMs prepare to increase production volume of a micro molded component, many focus on multi-cavitation tooling as a strategy to reduce piece part price. While increasing cavitation may be a cost-effective approach for higher volumes of simple thermoplastic parts, it is typically not the best approach for

Having a robot successfully and accurately WWW.MEDICALPLASTICSNEWS.COM

31

BACK TO THE FUTURE

<<

CK A B TO E R U T U THE F Making it big BACK TO THE FUTURE IS ALL ABOUT THE NEXT BIG THING – THE TECH WE LIKE AND YOU’LL BE TALKING ABOUT. DIDN’T MAKE IT TO CES? THIS ISSUE LU RAHMAN HANDPICKS THE SOME OF THE BEST NEW MEDTECH ON OFFER FROM THE LAS VEGAS SHOWFLOOR

BOX CLEVER

W

e’re a big fan of Cambridge Consultants here at MPN so we were really excited to hear about its new smart medical packaging that actually talks to you! This interactive packaging design aims to improve compliance and the patient experience.

Medical leaflets can be complicated but obviously are vital if you’ve been diagnosed with a chronic disease and need to learn how to inject yourself with medication.

Cambridge Consultants’ smart packaging lets the user trigger audio messages using touchsensitive paper packaging.

This gives patients guidance and support to help overcome any initial fears of starting a new treatment. The ‘talking’ packaging is designed to help them through those first few weeks and avoid any danger to their health.

32

S

cooping a CES 2017 Innovation Award, the Rapael smart glove is a high-tech device for stroke rehabilitation. What makes this little device exciting is that it connects to an app offering gamebased therapy for patients to use the product at home.

food or play a sport, the device ups the level of activity required to see how well the patient is doing.

The data is analysed via Bluetooth and an exercise plan created to suit.

It’s lightweight and made of elastomer so is easy to wear and clean. Sensors in this handy device measure wrist movements and a computer works out the amount of individual finger movement. By making the wearer pretend to chop

S

Listen up

T

hrough our sister title Digital Health Age we get to know about all sorts of connected devices. We really like the sound (haha) of ReSound hearing products which once again have been on show at CES. The company first introduced its iPhone friendly hearing aids at the event a few years ago and we’ve heard good things about these little wireless devices that offer boast excellent sound quality.

SLEEP EASY

leep apnea can be serious stuff – if left untreated it can impact on quality of life and may also increase the risk of high blood pressure, stroke, heart attack and type 2 diabetes.

A partnership between Kyomed, a French start-up specialising in personalised medicine, and Neogia, an expert in connected healthcare wearables, has created the Motio HW, a connected

WWW.MEDICALPLASTICSNEWS.COM

bracelet for patients suffering from sleep apnea.

Its makers say this is the first medical wearable that prevents, diagnoses and monitors the sleep apnea. It also collects data (such as heart rate and respiratory rate which are processed to get a better understand of the sleeping profile of each patient and improve the quality of life.

Brilliant performance | ENGEL medical

Medical technology is an industry apart. Maximum product safety, absolute cleanliness, precision in production, and complete documentation are essential requirements.

No compromises. After all, itâ&#x20AC;&#x2122;s a matter of health, quality of life and life itself.

At ENGEL, we provide precise solutions to meet these stringent requirements. Offering all-electric, hybrid or servo-hydraulic machine models, and a complete range of cleanroom and automation equipment, ENGEL provides the high performance package to suit your application.

With ENGEL medical. Itâ&#x20AC;&#x2122;s a matter of life.

www.engelglobal.com

Come visit us at MD&M West Booth #3851

© 2017 Husky Injection Molding Systems Ltd. All rights reserved.