MPN EU Issue 21

MPN issue 20.QXD_Layout 1 09/10/2014 11:22 Page 1

MPN

MEDICAL PLASTICS NEWS

ALBIS Manages Risk: Competent Supply of Medical Plastics Plus: Minimally invasives Extrusion - tubing Sterilisation The latest industry opinion

ISSUE 20 September-October 2014 WWW.MEdIcalPlaStIcSnEWS.cOM

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 2

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 3

17

Contents SEPtEMbEr-OctObEr 2014, ISSUE 20

18

Features 18. Minimally invasives Expertise from Raumedic, Teleflex and Eucatech

Regulars

26. Engineering polymers This issue - RTP and Topas

5. comment let’s get digital Lu Rahman discusses the growing need for us to consider the importance of all things digital 7. news analysis ibra coalition brings clarity to polymer mesh for breast surgery procedure 8. digital spy Stay in touch with the digital happenings of the industry

28. Innovation in the medical device industry Aleksandra Jones looks at the processes driving innovation in the medical marketplace.

12 38

34. cover story Albis explains why medical devices made form its medcial plastics are compliant and safe to use

10. news profile This issue a Star Trek medical device competition and anti-microbial technology for medical plastics

40. Extrusion – tubing Featuring Davis-Standard, Conair, Styrolution

15. Speech therapy Including a spotlight on digital health 54. beady eye The CEO of Endocontrol explains the innovation of using robotassisted systems for endoscopic surgery

33. Metrology Schneider Messtechnik present software to deal with rising metrological demands

15

46. designed for life How an Eastman collaboration led to the development of a BPA-free syringe 48. Sterilisation Techsil, Novartis and Noxilizer in focus

Disclosure: Medical Plastics News charges an undisclosed fee to place a contibutor’s image and headline on the front cover.

SEPTEMBER - OCTOBER 2014 / MPn /3

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 4

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 5

EdItOr’S cOMMEnt

crEdItS

Let’s get digital

editor | lu rahman

L

ast month I talked about the growing importance of social media in the industry.

More recently, the significance of this burgeoning area of technology has come to the fore.

Once upon a time, anyone undergoing plastic surgery, kept the procedure under wraps. Now, possibly in part due to the proliferation of celebrities having cosmetic work carried out on a regular basis, a certain status has become attached to this type of surgery.

Figures from the British Association of Aesthetic Plastic Surgeons (Baaps) say there was a 41% rise in liposuction procedures last year. Breast augmentation remains as popular as ever with 2013 figures showing a 13% increase on the previous year. According to a review of cosmetic interventions by the Department of Health last year, the value of UK cosmetic procedures was worth £2.3billion in 2010 – this is estimated to rise to £3.6 billion by 2015.

This highlights opportunities for the medical plastics sector and what is also interesting is that despite the breast implant scandal, the popularity of this procedure hasn’t waned – in fact quite the opposite – and it’s all down to social media. Figures from the US show similar trends as the UK with the American Society for Aesthetic Plastic Surgery reporting a 6.5% increase in the total number of procedures carried out. And believe it or not, the reason for this growth is being put down to that recent photographic phenomenon, the selfie.

According to New York plastic surgeon, Dr Ariel Ostad, speaking to ABC News: “I’ve noticed over the last six months that patients actually bring a selfie in the examining room.” Another surgeon says that he is seeing around eight patients a month for hand treatments alone, the rise being due to recently engaged women wanting their hands to look as nice as possible on social media engagement ring hand selfies.

One US plastic surgeon is also making use of social media for his own purposes. Dr Payam Jarrah-Nejad (also known as Dr J) is making use of Facebook to post volunteered before and after shots of patients and also has an Instagram account so that potential patients can view his work.

Medical device manufacturers’ Instagram accounts may not prove as popular as those highlighting surgical improvements but we are witnessing new ways in which technology is affecting the sector and having a positive impact on its growth. As an industry we need to look seriously at the ways in which we promote ourselves and use this technology to ensure we are not missing out on opportunities, and ultimately business.

Looking beyond social media at the growth of technology itself, it is clear that the digital health market is beginning to gain ground. From apps that track our health to systems that keep patients, doctors and healthcare providers informed of our well-being and need for care, the market is currently varied and extensive.

Amid this variety is a place for the medical device sector as early adopters of this area of health to begin to seek partnerships and collaborations to help grow the market. Pressures on the NHS in the UK mean ways of lightening the load where possible through digital interactions will become increasingly attractive.

Industry forecasts say the digital market could be worth $12 billion by 2016 and $53.2 billion by 2019. And with major players such as Apple, Samsung, LG and Sony currently on board, the healthcare market is being cited as one of the key drivers of this sector.

On the face of it, selfies seemed an insignificant, possibly highly annoying trend that has become ingrained in our vocabulary. Who would have thought they could now be helping boost the cosmetic surgery market? We are well aware of the power of social media and technology and it becomes even stronger when it begins to affect the business we carry out on a daily basis.

Technology holds myriad opportunities and just as social media is part of this wealth, so too is digital health. With this in mind the industry needs to be looking at digital access to information on products, the way we market digitally and the ways in which we can all work together to ensure we don’t miss out on the digital revolution.

contributing editor | aleksandra jones advertising | mandy o’brien 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: £80 Europe and rest of the world: £115 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

© 2014 Rapid Life Sciences Ltd While every attempt has been made to ensure that the information contained within this publication is accurate the publisher accepts no liability for information published in error, or for views expressed. All rights for Medical Plastics News are reserved. Reproduction in whole or in part without prior written permission from the publisher is strictly prohibited.

BPA Worldwide Membership ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital) SEPTEMBER - OCTOBER 2014 / MPn /5

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 6

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 7

NEWS ANALYSIS

www.cimedtech.com

ibra coalition brings clarity to polymer mesh for breast surgery procedure WORDS | Mike Smith A groundbreaking UK study of medical devices used in breast surgery called iBRA (www.ibrastudy.com) was recently established. This intensive analysis of both aesthetic and reconstructive surgeries, led in part by Dr Sigi Refsum of Belfast City Hospital, compared and contrasted patient outcomes. The study has proved to be particularly timely as media attention on Angelina Jolie has proved to have patient impact on risk-reducing genetic cancer prevention. and a second layer which lasts about six months before being eliminated.

It is only possible because of polymer chemistry. Novus Scientific settled on a fibre from the lactide polymer family blended with trimethylene carbonate to increase the elasticity of the fibre and resorption.

Lactide and glycol polymers have been in clinical use since the early 1970s. They are simply polyesters degrading with the help of water into simple metabolites already present in our body.

Stefan Sowa is director of operations for Novus Scientific which has developed the latest innovation in polymer-based surgical mesh.

“TIGR Matrix surgical mesh is made from a fast-degrading material, the same material found in Vicryl, Dexon and Maxon,” said Sowa. The polymer has been used for 40 years for suturing, and is comprised of a slow degrading material base on a higher content of poly-lactide.

A

t the London Breast Meeting in September, a group of UK oncology and breast surgeons, as well as plastic surgeons who reconstruct the breast, formed a coalition of nine hospital centres to compare best practices. Known as iBRA (http://ibrastudy.com/) the collaboration will also “evaluate clinical and patient outcomes of implant-based reconstruction.” For the first time, this clinical study will include both acellular dermal (animal skin) matrix and polymer-based resorbable mesh.

One important factor will be examining infection rates in breast surgery and how polymer-based synthetic suturing or mesh products can reduce, or eliminate, the incidence.

A major trend also impacting medical plastics demand and breast remodelling surgeries comes from Angelina Jolie’s decision to have a preventative mastectomy. There has been a huge influx of patient inquiries about risk-reducing surgery for those with the BRCA 1 genetic marker for cancer as well as family history. Using surgical matrix mesh to scaffold, support and offer natural tissue regeneration can make the reconstruction easier to select.

“Implant-based reconstruction is now the standard,” said Dr Sigi Refsum, surgical team leader at Belfast (Ireland) City Hospital and one of the first medical centres to engage in the iBRA study. “Implants are quick, allow a shorter recovery period, have a better shape and allow us to do surgical scaffolding using both synthetic and biologic materials to close.”

A new matrix mesh which resorbs based on natural tissue regeneration called TIGR will now be included in the iBRA metrics. “We find TIGR has a lower instance of redness, a lower cost advantage for the patient and has an added benefit of letting surgeons like me add to tissue coverage in unexpected situations,” said Dr Refsum. new technologies support breast surgeons TIGR Matrix is a polymer-based mesh that is knitted into a fabric-like material and is softer, more flexible and has two layers of absorption. This includes an ability to resorb over three months for breast surgery patients

“The knitted mesh consist of more than 15 fibre strands and each fibre alone has more than 80 individual filaments of the two different materials knitted into the unique design,” he added. There is high porosity to allow for good integration of new tissue and thus healing. The fast-degrading fibre disappears quickly to allow Mother Nature to take over,” said Sowa, and are therefore backed-up by the more slow degrading fibre providing support until the collagen tissues are ready to fully take over the load.”

Surgical mesh like TIGR can be “overlaid over the entire breast area so I don’t have to cut as much or as accurately, so initial results are promising,” Dr Refsum added. “We want to study this so-called ‘biosynthetic’ plastic mesh with the permanent synthetics, human cadaver or animal products out there.”

According to leading breast and oncology surgeons, bilateral mastectomy or prophylactic work with implants can permit reconstruction in about 90% of women with breast cancer. While implants cannot cure cancer, in over 50% of those cases where surgery is completed for those with genetic markers, it does prevent women from contracting breast cancer.

Still, it’s encouraging that these mastectomies bring the risk down to levels of the general population.

Dr. Refsum, who is the clinical team leader of Belfast City, said Jolie had, “brought breast cancer prevention to the forefront and raised awareness.”

She said many patients across the UK are seeking the genetic testing.

Mike Smith (twitter smittypa) is a Washingtonbased journalist. He reports for Huffington Post, Topix and many trade industry journals. He began his career in communications at Dow Chemical Company in Midland, Michigan.

SEPTEMBER - OCTOBER 2014 / MPn /7

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 8

DIGITAL SPY aPPY talKInG

InnOVatIOn

nathan doyle, business development manager Compounding Solutions Google Maps: Great for driving directions while on the road and for finding alternate routes around busy areas.

Yelp: Great for business and personal use. This app can be used to easily find restaurants or for bringing customers to us or while making sales trips or hosting customers at our own facility. Also great for personal use to find other types of businesses, like dentists or car mechanics. The reviews allow me to make informed decisions.

Kayak: All in one travel app. Great app for finding and booking flights or hotels, as well as, tracking flights.

Worldcard: This app is a great way to store contact information and build your contact list because it allows easy scanning of business cards. Great way to keep the information organized and accessible.

Weather channel: It is always important to know the weather while planning a trip, whether it is for business or personal. This allows me to plan accordingly and pack appropriately, as well as, anticipate possible travel delays ahead of time.

www.teknorapex.com A crystal clear medical elastomer from Teknor Apex has enabled a contract manufacturer of medical devices to replace PVC in a critical anesthesia component without sacrificing the assembly and handling advantages for which PVC tubing is well known.

Vincent Medical selected Medalist MD-585 thermoplastic elastomer (TPE) compound in response to the decision of an OEM customer to find an alternative to PVC for a gas sampling tube. This extruded item is a component of an anaesthesia delivery and monitoring assembly through which the desired ratio of gases are sampled, measured, and delivered to the patient. The challenge in making the switch was to match or exceed PVC performance in extrusion, assembly and clinical handling.

At the Vincent Medical facility, the Medalist MD-585 compound processed efficiently, exhibiting easy startups, tight tolerances, and high

speeds with minimal downtime, according to Otto To, general manager.

“The consistency of the material supplied to us made it possible to finetune our extrusion process and assembly operation,” he said.

“The surface feel and lubricity of the Medalist-based tube was similar to that of PVC—a benefit for our own operators and the healthcare professionals who will ultimately use the product. Its kink-resistance was also similar to that of PVC, and superior to that of other PVC alternatives.”

The Medalist MD-585 compound is part of the Medalist MD-500 series of elastomers, which Teknor Apex developed to be the first fully practical alternatives to PVC in medical tubing.

SEctOr SPY

www.idataresearch.com Regional growth for enteral feeding devices identified

SHOW SPY For those of you paying a visit to Fakuma, heading to the Netstal stand would be worthwhile. As one example of its expertise, the company will present the production of ultra light petri dishes in an 8+8 cavity mould highlighting its expertise in the production of medical parts.

“We offer solutions from the granulate to packaging, regardless of whether a corona treatment must be integrated, the stacking height must vary or a tubular bag must be labelled. Everything is possible and does not influence the speed,” explained Dr Patrick Blessing, head of business unit MED at Netstal.

At this year’s Fakuma, Netstal will present its high performance solutions using an 8+8 cavity production system as an example.

Hall a7, Stand 7304 With a cycle time of less than 3.7 seconds, petri dishes with a diameter of 90mm will be manufactured on an ELION 32001000 with a mould supplied by the Swiss firm Schöttli. The material will be a polystyrene with a mould flow rate of less than 3.5 g/10 min that has been FDA-approved. The process will be automated using a handling device supplied by the German company Geku. German firm Motan will be responsible for material preparation, while the cooling device will be supplied by Single (Germany).

8/ MPn / SEPTEMBER - OCTOBER 2014

According to a report by iData Research, the market for enteral feeding devices is expected to reach over $750 million (£462 million) in the US and Europe combined. The market is comprised of initial PEG placement kits, PEG replacement tubes, DPEJ tubes, PEG/J tubes. The enteral feeding replacement device market is segmented into low-profile balloon tubes, lowprofile non-balloon tubes, nasogastric and nasojejunal tubes, enteral feeding pumps and G-tubes.

Over 17 million enteral feeding device placement procedures are expected to occur in the US and Europe in 2020. Key players in the sector include Covidien and Kimberly Clark.

“The number of paediatric enteral feeding procedures being performed has been steadily increasing over the past several years,” said Dr Kamran Zamanian, CEO of iData. “This may be attributed to the reimbursement rate for paediatric enteral feeding procedures is approximately three times greater than for adult procedures.”

Markets for replacement devices such as low-profile balloon buttons and non-balloon buttons are growing the fastest in the enteral feeding market.

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 9

OnE MOrE tHInG nEWS

What’s your view on the European Union proposal for a nanomaterials register?

Schreiner MediPharm named as best supplier Schreiner MediPharm has scooped best supplier award from pharmaceutical company, Leo. It was Schreiner’s Needle-Trap, which can be applied to heparin syringes to protect for needle-stick injuries, which stood out for Leo. Needle-Trap combines a label with an integrated plastic trap.

Working closely with Leo Pharma, Schreiner MediPharm considerably improved performance with regard to quality and on-time delivery.

“We are happy that the co-operative partnership is reinforced by the award.

This prize honours us and motivates us to continue optimising our processes in the future,” said Rainer Alberth, senior sales director at Schreiner MediPharm.

The Chemical Industries Association (CIA) has questioned this proposal, saying it doesn’t recognise a need for a register for nanomaterials, as they are similar to other chemical/substance forms for which Europe is already heavily regulated.

A new register does not guarantee better safety, nor increase consumer trust and confidence, it says. Asking for notification to a register for nanomaterials would create a burden on that specific industry producing, importing or using such substances when competing with other non-nanomaterial substances. In addition, the cost of such a register would most probably be borne by consumers thereby entailing increased prices for value chains in the EU vs non-EU markets.

What do you think?

SOcIal SPY

My top tweets This issue, 3D Systems shared its favourite tweets with MPN Formerly conjoined twins celebrate 10 yrs since separation surgery, possible thru #3dprinting ow.ly/zYNB6 ow.ly/i/6syEe Medical modeling with 3D printing for advance surgical planning and improved outcomes.

tWIttEr WatcH

MPN’s top Twitter picks

Find out how Natasha got personal with #3dprinting and functional design ow.ly/zvaro 3D printed prosthetics that match your personality and form for a more comfortable you.

@MvanderJagt Co-founder Parx Plastics We liked . . .

Medical device maker confirms antibacterial property after their internal tests of Parx Plastics

Coffee-maker-sized, the ProJet 1200 micro-SLA machine will give your workflow a mega pick-me-up. ow.ly/yyuYW ow.ly/i/63Jri Desktop micro-SLA printing for high quality and affordable dental and jewellery applications.

@InterplasUK The UK flagship show for the British plastics sector We liked . . .

A great day 2 at @InterplasUK comes to an end... Now for the exhibitor party at the Rapid News stand!

Olaf Diegel’s #3dprinted band gained a new member with the first ever 3D printed #saxophone. Have a listen: ow.ly/A23Xs The first fully functional 3D printed saxophone made to meet challenge of 3DS CEO Avi Reichental.

@UCLanInnovate UCLan Innovation & Enterprise provides support to university staff, student and external companies to developing their ideas and share university knowledge.

We liked . . .

Having a micro machining base line is essential for a manufacturing company

Check out these exciting @ProjectAra updates for news on what’s in the mix for the future of phones and #3dprinting ow.ly/y6cJ3 High speed 3D printing for accelerated and customised mass production for Google’s Project Ara.

MOVInG

story...

talKInG POInt Mark Hass is the new liquisol product manager at Plastic color corporation (Pcc) This new role will provide additional support to the company’s customers looking to find solutions with liquid colour and is one of a range of investments PCC continues to make with liquid colour.

Hass has over 20 years of experience working in both technical and business development roles with a focus on key accounts and will manage the sales and development of the LiquiSol product line.

What attracted you to your new role?

I have always enjoyed working in the plastics industry and the timing was right for me personally to take on the challenge. I believe I can make a difference in growing the Liquisol product line now and in the long term.

What areas do you plan to focus on?

We will initially focus on process improvement and implementation of new equipment for higher product performance. As we utilise the latest technology in pigment development, we will see additional pricing advantages for our customers.

What’s the company’s USP? PCC is unique in that it can support and build long-term relationships with its customers based on the availability to offer several product delivery options from pre-coloured, masterbatch, and liquid, or combinations of all to establish the best results for our customers’ needs.

Where do you see the business in five years time?

PCC continues to gain momentum and name recognition in the industry. I anticipate strong growth and continued investments in the business to support the market. I believe PCC will be a major player in the colourants and additives business for the plastics industry in the next five years. www.plasticscolor.com

SEPTEMBER - OCTOBER 2014 / MPn /9

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 10

NEWS PROFILE

Beam me up . . .

COMPETITION SEEKS STAR TREK-STYLE MEDICAL DEVICE With a $10 million prize, the Qualcomm Tricorder competition to design a StarTrek style medical device that sits in the palm of a hand, has attracted much media attention. corrine lawrence spoke to three of the ten finalists about their motivation, inspiration and technology

The pressures on healthcare providers and the popularity of portable wireless devices have come together, bringing the stuff of science fiction to fruition. The Qualcomm Tricorder XPRIZE, worth a cool $10 million to the winning company, aims to encourage radical innovation in healthcare by inviting companies to design and produce a palm-size device that can monitor and diagnose health conditions.

As if this isn’t challenging enough, the device must be capable of diagnosing 16 health conditions and capturing five real-time health vital signs. The heat is now on for the 10 finalists, which have been selected from the 34 entrants — they have until the middle of 2015 to produce their prototypes.

Pennsylvania-based Final Frontier Medical Devices (FFMD) is a company specifically formed for the competition. Basil Leaf Technologies founder, Basil Harris — an ER physician at Lankenau Medical Centre, with a background in engineering — and his brother George Harris — a network engineer with a history in computer science — were brought up on healthy doses of science fiction and computers, which fuelled their common purpose — to make the Star Trek tricorder a reality.

“The failures of our healthcare system are staggering. Once you strip away the emergency part of an ER you are left with the other 90% of patients who simply want a diagnosis and advice. Many people just have nowhere else to get this help,” explains Basil Harris. “When I read about this competition, I was immediately intrigued. We did our research and realised we could actually win this,” said Harris.

FFMD’s device — DxtER — reaches a diagnosis the same way as is done in the emergency department. It is capable of collecting and 10/ MPn / SEPTEMBER - OCTOBER 2014

interpreting large amounts of data to accurately diagnose specific medical conditions, provide real-time insight regarding a user’s health, and guide them to appropriate action. The design team has deconstructed the diagnostic process to its base components and replicated it to build their device’s brain. Their diagnostic tool combines elements from vital signs, patient history, physical exam, labs and special studies, when and where needed, to make an accurate assessment.

“Entering the competition gives us great public exposure and access to FDA. To win it would help us to build and market our device. This global competition is accelerating the development of a completely new class of medical device. This is part of the new revolution of medical informatics,” concludes Harris.

SCANurse — a UK team — was also set up to specifically enter the competition, with the aim to transform personal health diagnostics. Anil Vaidya, company founder, has a vision of how healthcare needs to change to deliver healthcare to a growing and ageing population.

This vision is based on his many years’ experience working with pharma, biotech, healthcare and diagnostic companies worldwide. Vaidya believes the device can be particularly beneficial in the Far East and Asia Pacific.

The digital healthcare company uses existing technology and modifies it to meet healthcare and tricorder competition requirements.

SCANurse’s device avoids using blood as a biological sample. “The competition appealed to my interests and background in medical engineering. It also appealed to my belief that this competition will kickstart a change in how healthcare and diagnostics are delivered to the consumer,” said Vaidya.

“The competition is an opportunity to compete globally with some of the best engineering minds in the world,” explained Vaidya. “Receiving one of the three cash prizes will help to off set the development of the device. More significantly, the publicity will help with us positioning the device in the market.”

Intelesens has a wealth of expertise combining medical electronics and body sensors producing wearable, wireless, noninvasive, intelligent health monitors. Zensor is one of a family of products designed and manufactured

by Northern Ireland-based Intelesens. “The Qualcomm competition challenges competitors to accelerate their development programmes and to compress their technology roadmaps.

The cash prize could be very significant in driving life sciences products forward,” explained Michael Caulfield, CEO of Intelesens.

The company’s existing Zensor product measures, analyses and transmits, to the cloud, data about a patient’s cardiac and respiratory health. It also measures levels of patient activity and movement. “The product we have entered into the competition is an enhanced version of this with extended capabilities enabling it to diagnose and interpret a set of 15 medical conditions and capture five vital health metrics, said Caulfield.

“Entering the competition has provided us with the opportunity to review our strategy, product progression and development roadmap. It has also provided us with a superb platform to promote and advertise Intelesens’ products, expertise and capabilities,” explained Caulfield.

“Winning the competition would position us firmly at the forefront of the development and production of consumer-based health diagnostic solutions. This type of product has the propensity to transform healthcare.”

MPN issue 20.QXD_Layout 1 09/10/2014 11:23 Page 11

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 12

NEWS PROFILE

anti-microbial technology offers OPPORTUNITIES FOR MEDICAL PLASTICS Michael Van der Jagt, Parx Plastics and Additives, is at the forefront of an exciting development which sees biocompatible and non-leaching antimicrobial technology offer new possibilities in medical plastics

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 13

www.cimedtech.com

NEWS PROFILE

Dr Eric Belt, gastrointestinal surgeon at the Erasmus Medical Centre in Rotterdam, The Netherlands occasionally needs to operate on a patient twice. With some patients the implanted hernia mesh gets infected after it has been implanted to resolve an inguinal or abdominal hernia. These meshes are commonly produced out of polypropylene materials and bacteria are its worst enemy.

Dr Belt and the academic hospital are eagerly awaiting the moment to try out and test hernia meshes with the Parx Plastics technology integrated. Parx Plastics has developed the world’s first non-leaching and biocompatible technology to make plastics antibacterial. Contrary to the existing technologies Sanipolymers do not make use of chemicals, heavy metals, nanomaterials or other harmful substances to kill bacteria. This solution derived from biomimetics cleverly makes use of an essential trace element that is present in food and necessary in our daily diet for a healthy immune system and for building up cells, skin, hair and nails.

“Parx is looking for partners to do more research and efficacy tests with” Absolute safety is guaranteed not only by the biocompatibility but also because the technology does not leach out. The antibacterial property is the result of an intrinsic change and not of leaching/migrating substances. The surface of a product becomes hostile to bacteria by means of a mere physical and mechanical action and TÜV laboratories prove it kills up to 99% of the bacteria within 24 hours (measured according to ISO22196).

<< No limit: According to Michael Van der Jagt, Parx Plastics, there are no limitations for this non-migrating and biocompatible solution which is suitable for any kind of product, device or touch surface >> “We are exploring the efficiency of our solutions using it on implants, but there are many applications in the medical and healthcare field that can come to mind.” says Michael Van der Jagt, one of the founders of Parx Plastics. “The fact that we have a non-migrating and biocompatible solution makes it suitable for any kind of product, device or touch surface. There are practically no limitations.”

A lively discussion is going on about the fact that today’s leaching solutions contribute to antibiotic resistance. “This is a topic that is being put on the agenda more and more these days, as it will impact on our future wellbeing and disease fighting strategies,” says Van der Jagt. The Parx technology ruptures the bacteria’s cell membrane and causes it to lyse and die by means of a pure mechanical/physical property. This natural behavior cannot lead to resistance and highlights one of the long-term benefits of the innovation. And as no active substances are leaching out, there is no degrading of the antibacterial property. It will last the lifetime of the product.

Currently Parx Plastics has begun the mass production of two Saniconcentrates. One can be used with ABS materials and the other is based on Eastman’s Tritan copolymer. The technology can be applied to roughly any plastic. An existing plastic is used as the carrier of the technology to create a Saniconcentrate that blends in at 3% with untreated material of the same kind. The technology does not impact the original characteristics of the material, so no difference is noticed in colour, clarity, strength, aging etc.

The company will work on more off-the-shelf solutions but is also open for custom projects to develop a Saniconcentrate of a specific polymer or for a specific application. Especially for medical applications Parx is looking for partners to do more research and efficacy tests with and who can be the launching customers of the tech in their market segment. Van der Jagt: “As mentioned we have an excited team ready in the Erasmus Medical Centre to perform in-vivo test with mesh made from Saniconcentrate. So we welcome companies that can team up with us for this research.”

Since the introduction a year ago the innovation has not gone unnoticed. Parx Plastics has been announced by the European Commission as one of the top tech start-ups in Europe and was recently nominated as finalist in the materials category in the World Technology Awards in association with Fortune and Time.

SEPTEMBER - OCTOBER 2014 / MPn /13

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 14

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 15

SPEECH THERAPY

digital revolution

R

eported investment into US digital health companies reached $2.3 billion (£1.42 billion) in the first half of 2014 representing 170% year on year growth. The firm Research and Markets predicts an annual growth rate of 18.5% in the global digital health market through to a value of $5.7 billion (£3.51) by 2018. As such, the likes of Microsoft, IBM, Samsung, Panasonic, Orange, tHE dIGItal HEaltH Deutsche Telekom, Philips, Google and Apple are some SEctOr IS bEcOMInG of the giants that have IncrEaSInGlY PrOMInEnt developed interests in this aS MOrE and MOrE field. An army of small companies have launched cOMPanIES lOOK tO GEt into this promising market InVOlVEd. bUt WHat IS It too but why all the and WHat MIGHt ItS excitement?

IMPact bE On tHE MEdIcal SEctOr? StEVEn dOdSWOrtH, d HEaltH, SHEdS SOME lIGHt

Global healthcare systems are coming under increasing pressure from an ageing population, the continued rise in life-style associated disease and constraints on healthcare budgets. In the face of record levels of mental and physical ill health, coupled with increasing incidence of obesity, infirmity and loneliness, our healthcare systems are commonly deemed to be unsustainable. Digital technology is opening up new possibilities to deliver more efficient ways to deliver services and this has given rise to the field of digital healthcare. Telemedicine, e-Health, m-health and telehealthcare contribute to a confusing lexicon for digital health(care) which is as broad as healthcare itself.

The digital health market segments in two main ways. The things that we used to do with pens and paper that we now do in clever electronic ways is typically labelled as health IT. While this is proving to be a relatively slow and often painful transition, this is an established industry. Perhaps the more challenging aspect of digital health is the necessity to deliver health and care services such that they are more efficient, effective and convenient for all involved and this is where significant growth is forecast.

Digitally enabled products and services are already here. Wearable fitness trackers are available on Amazon and in the aisles of supermarkets whilst the remote monitoring of patients by established service providers has

seen the likes of the company Tunstall grow to become a telecare giant.

The next-generation of products and services will become more intelligent and more tightly wrapped around the wants and needs of their end users.

But digital health is as tall as it is wide. Data from transmitting pills and wearable technology will feed medical and lifestyle data into personalised electronic health records that are owned by the citizen and accessed by their doctor such that both citizen and healthcare professional work in conjunction to deliver the best healthcare package possible for the individual. Buying a digital health product or service will become as easy and familiar as buying a microwave or satellite TV. From wrist worn health monitors to self-install systems to remotely monitor the elderly and infirm, digital health is on its way and it is becoming big business but there is challenge.

Device manufacturers take note. Whilst those responsible for developing and delivering devices in this market face a fluid and complex regulatory environment, there is an increasing need to embrace attributes from the retail markets where the end user’s needs and wants are paramount fashion, aesthetics, convenience and utility sit alongside value and affordability. The provision of new services through existing devices (the so-called bring your own device phenomenon) may actually reduce the need for bespoke devices in some areas of the market. Why offer a bespoke device when the powerful digital devices we already carry in the form of phones and tablets can act as “digital conduits”?

A move to unobtrusive systems that are incorporated into people’s clothing, jewellery or their own homes presents different kinds of challenge. The miniaturisation of sensors and power sources is an established trend and price sensitivity of the target markets will become an increasing factor as consumer digital health becomes a reality. Inherent in this process will be careful design, based around insight into the lives of the end user which may demand invisibility or aesthetic value depending on the nature of the opportunity.

Digital health is a novel, complex and rapidly evolving market and significant investment is being made into this sector, as is particularly evident in the US. The sector has yet to see the revenue to match this level of investment and yet the truth is, the challenges to our global healthcare systems are so large and so imminent, and digital health offers such potential in mitigating a potential crisis, that the money is flowing freely.

Commercial success lies ahead for those who can bring the diverse disciplines together to offer novel, affordable and effective packages.

SEPTEMBER - OCTOBER 2014 / MPn /15

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 16

16/ MPn / SEPTEMBER - OCTOBER 2014

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 17

SPEECH THERAPY

VOCAL Exercise Q. Who are you and what do you do?

Doctor’s appointment Who are you and where do you work?

Mr Robin Seagger, consultant orthopaedic surgeon, (shoulders, elbow, trauma) Pennine Acute NHS Trust, Manchester

Tell us about the medical devices that you fit I constantly use plastic implants in my practice - bone anchors used to ‘fix’ soft tissues eg tendon and cartilage to bone and I’ve used them in my practice since my specialist training started in 2004. In shoulder surgery I probably use more than my colleagues with other interests.

Over the last decade there has been a trend away from metal anchors towards bio-absorbable anchors eg polylactic acid (PLA) and polyether ether ketone (PEEK) - a nonabsorbable plastic that has the benefit of high chemical and structural stability under load. It’s ideal when trying to repair tendons and ligaments to bone.

Stéphane Regnault, chairman of the board of directors, Vygon Group.

Vygon designs, manufactures and markets single-use medical devices for healthcare professionals in hospitals and for use by private or independent practitioners.

Q. How would you sum up your company?

Vygon was established in France in 1962. Today, it sells over 200 million products a year and operates in over 100 countries through its network of 25 subsidiaries and 79 distribution partners. As a leading supplier in a number of clinical specialisms Vygon operates within a range of demanding clinical environments: neonatology, adult and paediatric critical care, anaesthesia, oncology, surgery and emergency medicine, and home care service providers.

Q. name a business achievement you are most proud of We are very proud of our subsidiary in India. It opened in the mid-90s and reflects our success in emerging markets with real growth potential. The site has a very well trained workforce of 100 and has sustained double-digit growth for several years.

Q. What excites you about this industry?

Everything - it is always evolving.

Where do you see innovation coming from in the medical device sector?

First medical experiments were trialled in the 1980s with the first successful clinical studies undertaken in the 1990s.

Widespread clinical acceptance followed quickly. The modern anchors allow surgeons to repair these structures arthroscopically or ‘key hole surgery’. Stabilising a dislocating shoulder requires about three anchors while a tendon repair will require three to four anchors.

Large multi-centre trials are about to be published supporting the patient-derived benefits and cost-efficiency these procedures can offer the modern NHS. I foresee stem cells and tissue engineering starting to play an increased role in surgery. Patients may have individual patient-specific anchors implanted, reloaded with their ‘stem cells or tendon cells’ to stimulate healing.

How could device manufacturers improve orthopaedic devices?

In shoulder surgery I feel the industry works very closely and well with surgeons. There are ‘well known surgical faces’ internationally behind most of the commonly used companies systems today.

Q. Where do you predict industry growth will come from over the next 12 months?

Regulatory issues continue to shape the medical technologies landscape in terms of product development, access to market and patients care. Emerging markets overseas are a terrific challenge, with huge unmet needs. Vygon is currently investing in Asia and South America through its subsidiaries and local partnerships.

Q. Which medical plastic device do you wish you had invented and why?

The development of an artificial heart is a major innovation in the medtech industry both for patients and practitioners.

Vygon shares a similar passion to improve the quality of patient care. For example, Premicath is the smallest catheter on the market that is designed for use in babies that weigh less than 1kg. Vygon plans to develop further game-changing headline products every three years. Other key products include Bionecto, a closed needleless connector; Leadercath, venous and arterial catheters; Nutrisafe 2, the first safety enteral nutrition range for newborns and children and CPAP Boussignac, a non-invasive ventilation device.

SEPTEMBER - OCTOBER 2014 / MPn /17

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 18

MINIMALLY INVASIVES

DESIGNED FOR LIFE Mak Joshi, Teleflex Medical OEM, discusses designing a high performance interventional catheter for stent delivery Growing demand: Demand for minimally invasive procedures has increased the need for specialised catheters to deliver stents, stent grafts, and other medical devices in the body

D

emand for minimally invasive procedures has increased the need for specialised catheters to deliver stents, stent grafts, and other medical devices in the body. These catheters are technological wonders that are complex, multifunctional, and have small profiles. Engineering nextgeneration stent delivery systems requires a deep understanding of materials and advanced manufacturing processes to develop devices with even smaller profiles and, seemingly conflicting, performance characteristics of strength, pushability, flexibility and maneuverability.

Stents are typically used in the treatment of: coronary heart disease; carotid artery disease; peripheral artery disease; aortic tears; blockage or obstruction in the bile ducts and intracranial aneurysms.

Stent delivery procedures start in arteries in the thigh, arm, or neck as the clinician winds catheter through tortuous pathways of the human vasculature, twisting and moving the proximal end to position the catheter tip at the targeted organ. Following deployment of device or therapy, the clinician removes the catheter while minimising harm to the vascular pathway.

In design: A plethora of decisions go into producing high-performance catheters for stent delivery design considerations Vascular health is a key catheter design consideration. Tortuosity and rigidity of the vasculature, minimal tissue trauma, anatomical location, and size of vessels are major factors impacting design, material selection, and choice of manufacturing processes.

To function at its optimal level, a catheter must possess several desirable features and attributes: l High lubricity of the inner liner for smooth stent delivery l Reinforcement for strength, rigidity, and torque control along the length of the catheter while balancing the need for flexibility and kink resistance to navigate tortuous vascular pathways l High lubricity of the outer sheath for low insertion force and minimal vascular trauma l Soft tip and multi-durometer segments along the length of the catheter for excellent pushability and maneuverability l Radiographic contrast of tip and key segments for visibility of insertion and anatomical placement on radiographic imaging apparatus l Steerability and deflection for navigation of vasculature

18/ MPn / SEPTEMBER - OCTOBER 2014

Dimensions of the catheter shaft depend on the anatomy of the vasculature and the dimensions of the stent, for example: l CHD, CAD, and PAD applications generally require diameters between 5F and 8F (0.066 in. and 0.105 in.), and are typically 40 to 50 inches in length. l Catheters used for deployment of biliary stents are between 6F and 9F (0.079 in. and 0.118 in.), and are typically 30 to 60 inches in length.

Catheters used for stent delivery in neurovascular conditions such as intracranial aneurysms generally require extremely small diameters (1.1F or 0.014in.) but may go as high as 6F (0.079 in.) and are typically 70 to 90 inches in length. choosing the right materials and manufacturing processes An important first step in achieving optimal catheter performance is to choose the right materials for the inner liner and the outer sheath. Fluoropolymers, such as PTFE and FEP, excel in medical device applications because of their desirable properties of lubricity, chemical inertness, and biocompatibility.

PTFE is the most lubricious polymer available today, followed closely by FEP. Both polymers can be extruded in an extensive array of diameters and shapes with single- and multi-lumens, and readily accept secondary processing such as etching, cutting, and printing, as well as post-extrusion expansion to make heat-shrink tubing.

Once materials have been selected, production of the liner is the next step. The liner is constructed from PTFE and typically consists of ultra-thin walls and is produced in small diameters.

The next layer typically consists of some type of reinforcement.

Interventional catheters are frequently constructed with braiding or coiling to have a relatively rigid proximal section and a more flexible distal section. Materials commonly used for reinforcement are metals such as stainless steel and nitinol, or nonmetallic materials such as polyester and PEEK. Reinforced PTFE-lined catheters are made with flat or round wire braid, and/or coiled configurations. Flat wire is generally used for thin walled applications where â&#x20AC;&#x153;anti-kinkâ&#x20AC;? performance is critical.

Coiled shafts are more flexible and kink resistant, but they do not have the same torque capabilities as a braided shaft. In addition, coiling reinforces the catheter against crushing, kinking, and radial

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 19

expansion from internal pressure, while adding negligible bending stiffness to the body. A braided support layer also provides resistance to crushing, kinking, or radial expansion from internal pressure, while providing exceptional torsional stiffness. Several braid patterns can be utilised based on desired torque control features: regular braid pattern common pattern that uses 16 wires in a ‘one under two, over two’ pattern. diamond braid pattern is a pattern that uses 16 wires, but in a ‘two wire under two, over two” pattern. This pattern tends to provide better torque and more kink resistance than the regular braid pattern, but at a slightly higher cost. diamond braid pattern, half load utilises half the number of wires. The diamond pattern can be produced in a ‘one wire under one, over one’ pattern which provides more torque than the regular diamond pattern but incurs a much higher cost.

Designers are not limited to these patterns. Several original equipment manufacturers can create custom-engineered braid and coiling variations. Now it is even possible to utilise variable pitch, continuous reinforcement that can vary performance characteristics along the three to four foot length of the shaft.

Also, there are novel technologies for connecting dissimilar sections of the shaft without sacrificing shaft flexibility or performance. Designers can create precise catheter characteristics by combining any number of diameters, reinforcements, and hardnesses.

The outer sheath is the final layer. High-performance materials such as PTFE, FEP, ETFE, PE, Polyurethane, Pebax, and nylon are typically preferred. a coating can enhance performance Hydrophilic coating is used to enhance lubricity of the inner liner and outer sheath. The coating, usually negatively charged, exhibits ‘water loving’ properties, meaning it performs hydrogen bonding with surrounding water. This lowers the coefficient of friction of the material and wets the surface more evenly, reducing the insertion force, allowing the catheter to move through the vasculature more easily.

Unique catheter features By incorporating a variety of construction elements, manufacturers can create catheter shafts with unique features.

One such feature, a deflectable or steerable sheath, can be used in several different applications, including AAA stent graft delivery, transcatheter heart-valve delivery, and renal denervation. A steerable catheter shaft can be produced with as many as eight steerable wires, enabling clinicians to maneuver the tip precisely in multiple directions. Clinicians

must be able to position the tip in the right place so that they can deploy the device properly.

Another important feature is multi-durometer segments along the shaft and tip — in other words, different extrusion segments with varying degrees of softness or hardness which enable the manufacturer to alter the catheter’s flexibility, bend radius, and deflection angles. Multi-durometer shafts are typically terminated with a soft radiopaque tip, which prevents vascular trauma while allowing good contrast under radiographic imaging.

A third feature is use of metal marker bands to provide clinicians with visibility under radiographic imaging. Bands of high density precious metals — typically tantalum, gold, or platinum — are positioned along the shaft and used as a guide to distinguish key areas along the length of the catheter.

Flexible radiopaque markers are sometimes used in lieu of metal marker bands. Encapsulated with tungsten-filled Pebax, these markers provide similar radiographic visibility, while being soft and pliable.

Finishing operations Interventional catheters can be further enhanced with such finishing features as punched holes, shaping, tipping, and printing. For example, circular or irregular-shaped apertures can be formed along the catheter shaft using a suctioning process that results in consistent and repeatable openings.

Finishing operations also include custom-shaped shafts and tips, mating hubs, and tip attachments. Shafts and tips can be shaped to accommodate the target anatomy. Standard or custom mating hubs can be insert-moulded to the catheter. In all finishing operations, it is important to terminate the coil or braid precisely and ensure that the catheter does not contain exposed construction elements that can cause functional defects or vascular trauma during procedures.

Finally, the manufacturer can print useful information on the shaft to provide gradations or instructions for the clinician.

Printing also allows the manufacturer to brand the device. the long haul A plethora of decisions go into producing high-performance catheters for stent delivery. At each step of the process, these decisions can positively or negatively impact the overall function of the device. In addition, taking a concept from a functional prototype to a marketable catheter requires inhouse expertise, and superior design and manufacturing capabilities. Finding the right partner that can deliver along those attributes can go a long way toward a successful product launch.

SEPTEMBER - OCTOBER 2014 / MPn /19

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 20

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 21

MINIMALLY INVASIVES

INSIDE story...

PTCA balloon dilation catheters are made by the company Eucatech in Rheinfelden from a special polyamide mixture and used to expand coronary blood vessels. Frank brunnecker, LPKF Laser & Electronics writes

P

ercutaneous transluminal coronary angioplasty (PTCA) is the medical term for the expansion of a constricted coronary blood vessel from the inside without having to undertake open-heart surgery. PTCA is a standard procedure to improve the symptoms of chronic coronary disease, as well as a life-saving emergency measure after an acute heart attack. A balloon catheter is pushed into position along a special guide catheter inserted via the groin artery or the under arm artery. The balloon catheter has a balloon at the end which is expanded at approximately 8 – 12 bar and positioned inside the constricted blood vessel.

This reopens the blood vessel to allow the blood to flow freely again. This technique primarily makes use of the elasticity of blood vessels.

The key component of the PTCA catheter is the balloon, which has to be welded so that it is completely tight. Welding these components is highly complex because of the very delicate structure of the parts and because, in addition to achieving the specified degree of tightness, another critical aspect is complying with the stringent component tolerances of a few hundredths of a millimetre. Potential joining methods include gluing, hot air or hot element welding and laser welding.

Various processes are available for welding plastics using lasers. The most frequently used industrial method is transmission laser welding.

This method involves combining one material transparent to the wavelength of the laser beam – usually between 808 nm and 1064 nm – with another material which absorbs the specific wavelength. The laser beam is focused through the laser-transparent moulded component on to the absorbing joining component. This melts its surface. The transparent component is also plastified by heat transfer, and the accompanying pressure from the application of a specific amount of force creates the material bond joining the two materials. One of the preconditions for the success of this method is that one of the two components being joined can be made to absorb the laser light by mixing it with additives. Because this was not possible in the case presented here, a different solution had to be found.

It is possible to use laser light with longer wavelengths to join together two colourless polymers. Use is made here of a property of thermoplastic polymers: The absorption in colourless polymers rises successively starting from a wavelength of approximately 1.3µm, and is almost completely absorbed by the polymer above wavelengths of approximately 2.7µm. A

standard method for welding two transparent polymers uses a laser with a wavelength of 1.5µm.

When very thin materials are used, such as in a PTCA catheter, it is also possible to weld using inexpensive CO2 laser systems (wavelength 10.6µm). Laser light of this wavelength is directly absorbed by the upper film. The melting of the lower film and welding exclusively depend on heat transfer.

After a detailed evaluation of all the alternative methods, laser welding with a CO2 laser was selected as the optimum solution. Laser-based joining was chosen instead of heating element or hot air welding for a large number of reasons: in addition to much shorter cycle times, the main benefits include higher controllability and the high process security and stability. Laser welding can demonstrably boost the quality of the finished product. And the reject risk associated with the use of excess energy can be reduced to a minimum because the energy footprint can be restricted to a very small area. Another favourable aspect is the absence of any contamination of the component.

Since the advent of laser welding technology, gluing is only used as an alternative in the medical technology sector under very exceptional circumstances: in addition to the much lower process reliability, the amount of space required for a glued bond would be completely unacceptable in the assembly presented here.

A suitable system for producing the component was then elaborated in co-operation between eucatech AG and LPKF Laser & Electronics AG. The system uses a customised laser plasticwelding plant based on standard modules from the laser plastic-welding manufacturer’s product line. The machine is very compact even though all of the components such as the laser, cooler and controls are integrated within the equipment housing. Because of the production logistics, manual assembly of the welding plant was selected as the best solution.

<< Fig. 1: PTCA balloon dilation catheter, laser welded >> SEPTEMBER - OCTOBER 2014 / MPn /21

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 22

22/ MPn / SEPTEMBER - OCTOBER 2014

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 23

MINIMALLY INVASIVES

Choice words Raumedic offer expertise on material selection in catheter production

T

he multi-component technology under cleanroom conditions offers the ideal requirements for the development of new, innovative medical and pharmaceutical products. As well as improved economic aspects, the primarily aim is to improved functionality of new tubing products, with the aid of co-extrusion technology.

However, it is really the resulting advantages, such as the freedom of design and configuration through the combination of several polymer materials and the integration of additional functions through to the reduction of post-production and assembly stages, which make these technologies so interesting.

Other requirements in terms of miniaturisation of tubing products arise from the general trends in medical technology to use smaller products in procedures that are gentle on the patient. So-called minimally invasive surgery naturally demands smaller and more intricate catheter products but miniaturised hoses are also increasingly used in diagnostics because of the smaller sample quantities.

Multi-layer extrusion Where multi-layer extrusion in the area of foil production, eg for food packaging, no longer represents a particular challenge for machine and tool technology today, the co-extrusion of several polymer layers in the production of the smallest dimensions of tubing in medical technology is still new ground for process engineering in many cases. On special microextrusion systems, it is now possible to produce multi-layer tubing with up to three different polymer materials for various applications, with the smallest internal tubing diameters being around 0.1mm (100m) and wall thicknesses being possible in the order of 0.05mm (50m). The microextruders required for this can work with very low material flows, ie with a flow rate of around only 50g/h.

The range of polymers that can be used in co-extrusion is theoretically unlimited. Of particular interest, however, are those thermoplastics which have long since been tried and tested in medical technology and pharmaceutical applications, such as polyurethanes, polyamides, polyolefins, thermoplastic elastomers and, in some cases, soft PVC. High temperature thermoplastics such as PEI or PEEK can, of course, also be processed in micro-extrusion. These materials are seen as a substitute for metallic materials, because of their exceptionally good mechanical characteristic values. It is also possible to print high temperature materials with scaling should this be required. catheters for microdialysis In the development of catheters, a number of aspects must be taken into account in order to design the product optimally with respect to the requirements resulting from use on the patient as well as qualitative and economic considerations. Even in the early phases of the product design, the last two of these points in particular are significantly affected by the consideration of the subsequent manufacturing process and the coordinated selection of suitable materials for the individual components of the catheter.

Considering the multi-stage processes in series production, it is recommended that the design of individual components when in the development phase by optimised subject to the volume requirements in order to manufacture in the most economical manner whether this be manual assembly, semi-automation or fully automated. This also leads to an increase in process reliability. The selection of materials for the

<< Material world: Polyamide lumen catheter for microdialysis. The selection of materials for the catheter components must initially be made with respect to chemical and mechanical properties, biocompatibility and blood compatibility >> catheter components must initially be made with respect to aspects such as chemical and mechanical properties as well as biocompatibility and if applicable, blood compatibility. Additional fabrication stages such as the joining of the individual components, with numerous gluing technologies, and the selection of the sterilisation process must also be considered in the context of the compilation of the materials.

Microdialysis opens up entirely new possibilities in the continuous, quantitative analysis of substances in blood. In this, it is no longer necessary to take blood samples from the patient; rather, the substances to be investigated can diffuse out of the blood through a very thin, semipermeable membrane and are then identified with conventional analysis.

A physiological saline solution is generally used as the rinsing solution.

The diffusion of blood elements takes place in the same way as in dialysis, on the basis of osmotic pressure, until a concentration balance is reached between the blood and the rinsing solution.

The technical implementation takes place with the creation of a 2-lumen catheter in polyamide or polyurethane â&#x20AC;&#x201C; two materials that stand out for their good biotoxicological properties, blood compatibility and excellent processability. In the lumens, each at 0.3 mm, small segments of the dialysis membrane are used to form windows. Delicate and precise perforations at the end of the catheter guarantee contact with the blood.

At the tip of the catheter, the flow of rinsing solution is simply â&#x20AC;&#x2DC;shortcircuitedâ&#x20AC;&#x2122;, so the saline solution can be fed back into the analysis device after absorption of the substances to be analysed. As such, continuous measuring is possible without the need to take larger quantities of blood from the patient. Here, the micro-catheter is applied with an indwelling venous cannula, as available commercially. The catheter system is completed with moulded components and a final fabrication, which holds the fine structure of the catheter tubing and creates the connection to the analysis device.

SEPTEMBER - OCTOBER 2014 / MPn /23

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 24

24/ MPn / SEPTEMBER - OCTOBER 2014

MPN issue 20.QXD_Layout 1 09/10/2014 11:24 Page 25

POLYMERS & PLASTICS

PrESEntatIOnS lInEd UP InclUdE: critical Knowledge for Mastering Polymers; a Class of Materials so Different from Metals Plastics in Medical applications; Orientation 101, Dr. Yash Khanna, InnoPlast Solutions, USA regulatory & Engineering considerations For Selecting the right Plastic for the Specific Medical device biostable Polymers in Medical devices, Dr. Mark Boden, senior fellow-corp. Research, Boston Scientific, USA trends in Polymeric Materials for cardiovascular applications, Dr. Ajay Padsalgikar, chief scientist-materials tech, St. Jude Medical, USA

Speakers announced for FOR MEDICAL DEVICE EVENT a SElEctIOn OF HIGH PrOFIlE SPEaKErS HaVE bEEn lInEd UP FOr nExt YEarâ&#x20AC;&#x2122;S POlYMErS & PlaStIcS In MEdIcal dEVIcES EVEnt taKInG PlacE In OrlandO nExt YEar

Medical Plastics News and InnoPlast Solutions have announced some of the speakers for the Polymers & Plastics in Medical Devices conference, being held in Orlando, Florida, USA, April 21-23, 2015.

The aim of this conference is to bring participants up to speed with the newest trends and technical advances in the field of medical devices as it relates to polymeric materials. The target audience is medical device producers, moulders of sub-assemblies, plastic and additive suppliers, equipment & prototype designers, regulatory professionals, sales, marketing, and business development leaders throughout the entire supply chain of the healthcare industry. The conference has been structured to provide ample opportunity for networking to encourage the sharing of new ideas and concepts throughout the value chain.

bioabsorbable, High-Modulus Polyester based Materials for Orthopedic applications, Dr. Scott Taylor, chief technology officer, Poly-Med, USA Plastic catheters today: an Interventional radiologistâ&#x20AC;&#x2122;s Perspective, Dr. Regina Khanna, assistant professor - interventional radiology, Queens Hospital Centre, USA Flexible tubing development & applications with Styrene-butadiene copolymer (Sbc) resins, Joe Zhou, K-Resin Technology, Chevron Phillips R&T Centre, USA High Performance Plastics for Hip-retractor application (vs Metals), Nathaniel Van Vliet, technical marketing engineer, Solvay Specialty Polymers, USA nEU View: translucent radiopaque Polymer Formulations for Specialty Medical devices, Dr. Jack Frautschi, senior biomaterials scientist, PolyOne/NEU, USA Fiberlive: a High-Strength, Fully absorbable composite Material for Implants Dr. Shawn Peniston, principal engineer, Corbion Purac, USA

www.mediplastconference.com

MPN

Selection and Evaluation of Plastics for cardiovascular applications, Dr. Ajay Padsalgikar, chief scientist-materials tech, St. Jude Medical, USA

A

choices in Medical device coatings Keith Edwards, president & ceo, BioCoat, USA

natural Fibers & composites in Fabricating body Parts Dahar Mujavar, senior technical manager business development, Autocluster SEPTEMBER - OCTOBER 2014 / MPn /25

MPN issue 20.QXD_Layout 1 09/10/2014 11:25 Page 26

ENGINEERING POLYMERS

Smooth operator Friction in single-use medical devices – new test data helps ease material selection process, reduces production costs and accelerates time-to-market, say Josh blackmore and ben Gerjets, RTP Company Chart 1

I

magine experiencing a severe allergic reaction – you reach for your epinephrine auto injector, inject it into your thigh and instantly receive a measured dose, averting potentially life-threatening anaphylaxis. With medical devices such as auto-injectors, injection pens, stop cocks, and safety syringes designed for single-use, there is only one chance at proper functionality.

Because of their extreme importance, it is critical that single-use medical devices move easily and have low break-away force. Various external factors, such as long periods of inactivity, shipping, and cold storage conditions can all have an effect on the friction behavior of plastic-on-plastic moving parts. These factors increase the chances of stick-slip phenomena or ‘stiction’, resulting in poor performance of a drug delivery device.

External lubrication such as silicone can reduce friction, but quality control, contamination and clean-up in manufacturing settings become issues. Specifying internally lubricated polymer compounds during the design phase can address stiction, but designers of single-use applications must choose carefully when seeking high performance materials. Until recently, there were no established industry tests that accurately predicted friction behavior in single-use devices, making precise material selection difficult. Existing standardised tribology tests look at predictive conditions of long-term wear performance, but do not address single-use device concerns.

Responding to this critical need, RTP Company, a global compounder of customer engineered thermoplastics, has developed an innovative friction test that allows designers to select the best possible material for single-use applications. The data collected from the test can prove invaluable, eliminating the need for trial and error when choosing polymers. With proper material selection, external lubrication and additional processing steps are unnecessary, thereby decreasing manufacturing costs and time-to-market. advances in testing When it comes to measuring the effects of friction on materials used in single-use medical devices, existing industry tests and standards are lacking. Finding the right material is challenging, with many polymers to choose from, but no data to allow for confident 26/ MPn / SEPTEMBER - OCTOBER 2014

decision making. Standards such as the ASTM D3702 thrust washer test looks at wear over an extended period under high pressure and speed, while ASTM D1894 tests for friction, but requires very specific conditions in order to achieve accurate results. Neither test is ideal for predicting performance of single-use applications.

The materials science and tribology experts at RTP Company have modified the thrust washer test for wear to measure friction. The new test utilises a small sweep angle that operates in both directions, measuring static and dynamic coefficient of friction (COF), and looking for low friction and low delta between the two.

The test has been modified for short duration and uses reduced speed and pressure that closely mimics the friction conditions of human actuated single-use applications.

Material matters When selecting materials for single-use medical devices, designers are looking for specific performance properties. The materials must be safe, have reliable performance, and pass biocompatibility testing. They must provide the right function for the intended application, and in some cases, must withstand harsh sterilisation methods.

Start-up coefficient of friction and stick-slip elimination play a vital role in the performance of single-use drug delivery devices, directly influencing material selection. Designers are looking for low COF for smooth and easy movement. However, friction is a complex issue with many variables affecting numerous moving

parts. For example, with an auto-injector, external factors during usage can cause dramatic changes in the amount of force needed to effectively operate the device.

Tests show that internal lubrication reduces friction. Take, for example, a typical single-use medical device requiring a 10 pound load or 50 pounds of pressure per-square-inch (psi) to operate (see Chart 1). Lubrication on one part reduces start-up and stiction, while lubrication on both parts enables low start up force and smooth operation of the system.

Additionally, RTP Company has created proprietary additives that further reduce stiction as indicated by the green line in Chart 1. Using the new test method, RTP Company explored base resins in a variety of combinations with friction reducing additives and a variety of silicones, along with its own All Polymeric Wear alloy. Data gathered from these tests is available from RTP Company. conclusion The data collected from the new material testing enables designers to make informed choices, rather than spend valuable resources on a conventional trial and error approach to medical device design and manufacturing.

Accurate up-front data lowers the cost-per-part and accelerates time-to-market. In addition, the data shows that costly external lubrication and processing steps can be reduced or eliminated.

Most importantly, concrete material data helps ensure optimal medical device performance and safety.

MPN issue 20.QXD_Layout 1 09/10/2014 11:25 Page 27

ADVANCED performance

<< Make the grade: Topas Advanced Polymers has developed Topas COC grades offering excellent transmission in the near UV region plus glass-like transparency in the visible region >>

ENGINEERING POLYMERS

Cyclic olefin copolymers (COC) make strong in-roads in diagnostic applications, by Topas Advanced Polymers Diagnostic technologies for the healthcare industry must deliver precise and reliable results. To ensure accuracy, makers of diagnostic products need high-purity materials, repeatable moulding of ultrafine details, chemical and moisture resistance and compatibility with advanced analytical techniques. With a history of excellent performance, cyclic olefin copolymers (COC) are becoming the standard in medical diagnostic applications. These devices include high-purity and high well count microtiter plates for high-throughput screening, complex microfluidic devices, microstructured cuvettes and test tubes for clinical analysis and glass-like containers for spectroscopic monitoring of biochemical reactions. To ensure purity, COC films are also used as lidding for many such devices.

Topas Advanced Polymers has developed Topas COC grades specifically for these diagnostic applications. They offer excellent transmission in the near ultraviolet (UV) region as well as glass-like transparency in the visible region. These advanced grades also provide excellent resistance to aqueous and polar organic media, outstanding biocompatibility, and the ability to reproduce extremely fine structures. Injection moulding is the typical manufacturing process for these diagnostic articles.

Microfluidics is key target market Microfluidics are the next frontier in analytics and diagnostics. The highly detailed replication and chemical resistance of Topas COC are perfect for mass-produced microfluidic devices.

Microfluidic chips and devices rely on the fine detail replication possible with these polymers.

Submicron features are possible and the high dimensional stability of COC ensures products

will consistently perform as designed. The materials have excellent chemical resistance to common microfluidic solvents including alcohols, DMSO, acids, bases and of course, water. Exceptionally transparent to light (92% clarity) and more UV transparent than other polymers, COC resins enable integration of advanced analytical capabilities into a highperformance design.

With an inherently high surface-to-volume ratio, microfluidic assemblies require an extremely pure substrate to minimise contamination and maximise accuracy. Topas COC answers the call with far lower leachables and extractables than most other polymers. The inert, nonreactive nature of COC medical polymers also contributes to the perfect environment for microchemistry. Topas COC resins are formulated without controversial ingredients like bisphenol A (BPA), plasticisers, halogens, or CONEG heavy metals, and have broad regulatory compliance for medical and food applications.

For advanced microplates, Topas COC is regarded as the purest polymer available, with superior flow than high-flow polycarbonate and polymethyl methacrylate (PMMA), enabling higher well counts and increased productivity.

Its ultra-high clarity and outstanding UV transmission make it a highly viable alternative for demanding analytical components including microtiter plates, cuvettes, and other products.

Grades are available with UV transmission at wavelengths as low as 220nm, which is superior to all other polymers and enables a broader range of analyses.

In terms of sterilisation, COC withstands high-energy radiation (gamma or electron beam) and ethylene oxide (EtO). With a broad product line, Topas Advanced Polymers offers

multiple grades that withstand standard medical steam sterilisation protocols. new grade elevates processability Recently, Topas has expanded its line of Topas 5013 cyclic olefin copolymer (COC) resins for injection moulding of high-performance components for the optical, diagnostic, and microfluidic markets. The new grade, Topas 5013L-10, has won strong acceptance because it features an internal mould release which delivers an exceptional balance of properties and easy processing.

The boost in processability from the internal mould release has made this new grade the ‘goto’ choice for components with high aspect ratios, precision details, and other molding challenges.

The new product features exceptional clarity, high flow, and a heat deflection temperature of 127°C (261°F). It is characterised by the highest level of flowability among transparent resins without loss of material strength and optical characteristics.

Topas 5013L-10 also delivers low birefringence and high moulding accuracy (including submicron detail replication) suitable for advanced optical parts, as well as for medical and diagnostic applications. The heat resistance and purity are ideal for DNA analysis, including typical 95°C (203°F) PCR protocols.

Productivity is enhanced with the reduction of runners and the use of multi-cavity moulds, along with easier demoulding. Other key advantages over competitive materials include high light transmission, low water absorption resulting in reduced warpage, and significantly less discolouration with age.

Topas 5013L-10 resin is available globally and has found commercial use in diagnostic applications.

SEPTEMBER - OCTOBER 2014 / MPn /27

MPN issue 20.QXD_Layout 1 09/10/2014 11:25 Page 28

INSIGHT

Think tank Innovation in the medical device industry is vital to the ongoing development of the sector. aleksandra Jones speaks to rowan Grant, Medical Technologies Innovation and Knowledge Centre and Steve roberts, Fripp Design and Research to find out who’s behind innovation and who is leading its progress All industries depend on innovative thinking, and the medical device industry is no different. There are new inventions entering the market every year, both sustaining — improving on an already existing product and its qualities — and disruptive — bringing a completely new value to the market and changing the already known paradigms. Both concepts were first mentioned by Clayton M. Christensen in his 1995 article Disruptive Technologies: Catching the Wave and further described in Christensen’s The Innovator’s Dilemma, in 1997.

Who leads innovation in the medical industry?

Within the medical industry, the innovative thought often comes directly from the consultant, according to Steve Roberts of Fripp Design and Research. He says: “The patient’s consultant might see a particular problem and come up with a solution. An example of this process can be JRI Orthopaedics — this is how the business started in the first place.

“As an industrial design business specialising in medical device design, Fripp Design and Research is always desperate to talk to consultants as they are the ones who bring us the ‘design problems’ to fix. For example, with our soft tissue prostheses project it was a maxillofacial consultant who asked us if it is possible to 3D print prostheses because he wanted to shorten the time between a patient undergoing an operation and receiving their prostheses. The consultant was also concerned about the quality of handmade prostheses.”

Rowan Grant, national outreach manager from the Medical Technologies Innovation and Knowledge Centre explains how these days innovation in the medical device industry is very often driven by the ageing population, clinical challenges and a changing regulatory environment: “In England and Wales there are approximately 160,000 total hip and knee replacement procedures performed each year — one in ten are revisions following failure. The total cost of hospital and social care for patients with a hip fracture amounts to more than £2.3 billion per annum in the UK — approximately £6 million a day.

28/ MPn / SEPTEMBER - OCTOBER 2014

“One in 11 people are still in work at the age of 65, and over the last 30 years the number of centenarians (people aged 100 years or more) in the UK has increased five-fold.

“New developments in regulation and compliance have created a need for enhanced pre-clinical simulation and testing, more robust designs and fuller evaluation under the conditions the devices have to perform. These factors have created a need for more robust designs, products and procedures in a more efficient and cost-effective manner.”

Grant continues: “MeDe Innovation (The EPSRC Centre for Innovative Manufacturing in Medical Devices) aims to answer these global demands, underpinning the development of musculoskeletal medical device manufacture to provide methods of producing cost-effective, reliable and effective devices; supporting the development of the sector and satisfying the health service’s requirement for new, innovative and costeffective treatment options. These devices — and manufacturing processes — will ensure that the patients of the future are provided with devices that offer enhanced standards of reliability and performance.” are there usually specific people within a company in charge of leading innovation?

According to Roberts, as innovative thought often begins directly with the consultant, there aren’t necessarily specific people within medical companies responsible for driving the innovation. He says: “Most medical device manufacturers have the in-house skills to develop a new product, but the ideas normally come from the profession who is the customer advocate: the patient’s consultant.”

MPN issue 20.QXD_Layout 1 09/10/2014 11:25 Page 29

As Grant outlines, the UK medical technology sector is comprised of more than 3,000 companies (99% of which are SMEs), which employ close to 77,000 people and have a combined annual turnover of £17.6 bn. These companies are keen to innovate to access opportunities worldwide (the global medical technology market is estimated to be worth £223 billion worldwide with growth rates forecast at 7% per annum over the 4.5 years and a market size approaching £291 billion by 2018).

Grant comments: “We work with many companies who are keen to access our expertise and these include large corporates and SMEs. Our experience has shown that whilst global companies have their own R&D divisions they still want to access worldleading research developments to expand their product portfolio.

Furthermore, the majority of the companies in the medical devices market in the UK are SMEs, and therefore often require additional support to their own team to innovate.”

What are typical lead times within the industry and what do they depend on?

The time it takes for a product to get to market is crucial for a company.

However, the medical device industry is heavily regulated, which often makes the lead times longer, and the whole procedure more complicated than in the case of other market sectors.

Roberts comments: “If the device is invasive, it could take years because of the need to undertake field trials and obtain regulatory approval. If the device is non-invasive, the process is much simpler. The MHRA in the UK and the FDA in the US have very similar methodologies for classifying medical devices and how this impacts how you obtain approval to market your device.”

Grant says a significant change is about to take place: “The global harmonisation of the medical devices directive has increased the essential requirements from 13 to 19. This is creating a significant pressure on companies to be able to progress new technologies through the regulatory approval process prior to the launch of the new directive in 2017, when the cost and timescale for approval are likely to increase considerably.”

How much collaboration exists between different companies, academia and other institutions?

Grant describes how industry collaboration works at MeDe Innovation: “Here at Leeds, and amongst our partners at MeDe Innovation, we have a strong track record of collaboration. We have 14 co-investing industry and clinical partners and a core research group across five universities

Rowan Gra nt

nationally, plus feasibility projects with three other research groups developing new research ideas driven by demand from industry. Our external advisory board is made up of global leaders in medical device innovation with representation across academia, industry, clinic, and regulation and standards. It’s essential that we all work together to develop innovations that are fit for purpose and driven by needs from industry, clinic and patients.”

On the other hand, Roberts thinks that there is very little collaboration between different companies in the industry, due to the competitive nature of the markets they serve. He comments on academia, which is usually perceived as having a monopoly on innovation. In his experience, this is often not the case: For the soft tissue prostheses project, it was the University of Sheffield asking Fripp Design and Research to share its expertise on the subject, rather than the other way round. Sometimes universities and other academic institutions buy the IP developed by companies, as in the case of the Ocular Prostheses project by Fripp Design and Research, where Manchester Metropolitan University invested in the IP. Roberts comments further: “The Technology Strategy Board (or Innovate UK as it is now known) has a role to play in ‘pump priming’ medical device manufacturers to take on new product development risk (where, in isolation, it is too risky for the company to take it on themselves).” He thinks that research councils should extend their support more broadly to SMEs, rather than just focusing on universities, which are not always the quickest at adopting innovation and creating commercial advantage from available knowledge. He also points out that with institutions there is always danger of decision processes taking too long — companies might be more willing to take risks, make decisions faster and therefore drive innovation forward.

Rowan Grant, national outreach manager from the Medical Technologies Innovation and Knowledge Centre/MeDe Innovation — The EPSRC Centre for Innovative Manufacturing in Medical Devices and Steve Roberts, Fripp Design and Research SEPTEMBER - OCTOBER 2014 / MPn /29

MPN issue 20.QXD_Layout 1 09/10/2014 11:25 Page 30

IN PROFILE

HaVInG ScOOPEd an ErnSt & YOUnG aWard EarlIEr tHIS YEar, StEPHEn tHOrPE PUt cME MEdIcal In tHE SPOtlIGHt. HE dIScUSSES tHE cOMPanY’S rEcEnt InItIatIVES and EtHOS bEHInd tHIS aWardWInnInG lancaSHIrE FIrM

Northern light C

ME Medical hit the headlines recently when chairman Stephen Thorpe was named North of England Entrepreneur of the Year by Ernst & Young.

Founded in 2001, the company distributes portable infusion products to over 300 NHS trusts as well as private hospitals, homecare providers and GP surgeries. Thorpe’s background is from within the pharmaceutical industry where he gained knowledge of medicines and healthcare.

“I moved in to the medical equipment sector when I set up CME Medical, as it’s now known, in 2001. Our business is fundamentally a medical products distribution business in the UK and Ireland, but we have always fostered deeper engagement with our principles, getting involved in product development which led to us partnering with Caesarea Medical Electronics in 2007. Specialist infusion has been our core business to date and we are now adding new sectors to our business, taking our considerable support and operational expertise to new customers,” he says.

Recent developments at the Blackpool-based company have centred around the development of specialist medical infusion pumps to grow CME’s core business.

“We recently partnered with Italian Manufacturer, Canox, to distribute Myfuser – a pre-assembled, elastomeric, disposable infusion pump which achieves efficiency, safety and ease of use through innovative design,” says Thorpe.

Innovation is key to the company. Thorpe outlines one of CME’s latest initiatives.

“We are working with a group of NHS physicians on a patient-controlled sedation system using our volumetric infusion pump, new software, based on tried and tested sedation algorithms, and an innovative feedback mechanism that enables the pump to assess the patients’ level of sedation. Being able to tailor the amount of sedative given to patients undergoing endoscopy or colonoscopy for example, to achieve the optimum level of sedation is ultimately significantly safer, aids enhanced patient recovery and saves on drug cost too,” he reveals.

30/ MPn / SEPTEMBER - OCTOBER 2014

<< Team spirit: CME Medical recently partnered with Italian Manufacturer, Canox, to distribute Myfuser – a pre-assembled, elastomeric, disposable infusion pump >> Thorpe admits that most of the company’s innovations are more evolutionary than revolutionary. “We listen to healthcare professionals to understand their practice and use the technology at our fingertips to solve safety and utility problems with them.

There are many safety and utility issues that face physicians, so dealing with these one at a time and improving clinical practice step by step is our ultimate objective,” he says.

Other developments at the company have also included a joint investment by CME Holding with Spark Impact, into Touchstone Medical, specialist supplier of gynaecology and women’s health solutions.

It is hoped that this investment will help drive business growth in the expanding medical technology market, alongside Spark Impact, managers of the North West Fund for Biomedical.

This partnership places CME Holdings as a majority shareholder of Touchstone Medical. Its subsidiary, CME Medical now has a new sister company.

John Carrington, managing director of CME Medical says: “This latest development is part of a longer term strategy to invest in like-minded, ambitious businesses that are a good fit with CME Medical in terms of their outlook, people, products and markets. We’re excited to be working alongside the Touchstone Medical team to offer expert input into the success of the business via our expertise in financial, customer service and supply-chain support.”

Looking ahead, CME has further plans in the pipeline.

Thorpe explains: “We continue to develop the scope of specialist medical infusion products and develop strategic partnerships with more companies to offer complimentary innovative products into our existing markets, so our customers can access the best technology and support from one partner.”

MPN issue 20.QXD_Layout 1 09/10/2014 11:25 Page 31

SEPTEMBER - OCTOBER 2014 / MPn /31

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 32

3

P

Medical Ltd

Contract Manufacturing Services

Our Manufacturing Capabilities in ISO Class 8 cleanrooms • Injection Moulding • Plastic and Tubing Extrusion • Assembly • Bonding • Tipping • Sealing Come and see us at Medica in Hall 5, Stand D11 to learn more about our wide range of contract manufacturing and OEM services!

Tel. +44 (0) 117 972 8888 sales@p3-medical.com www.p3-medical.com 32/ MPn / SEPTEMBER - OCTOBER 2014

Made in the UK

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 33

<< New age: According to Schneider Messtechnik, Saphir QD belongs to the age of Metrology 4.0 – as inspired by Industry 4.0 >>

METROLOGY

Rising to the challenge Quality standards in industrial production are constantly rising and only manufacturers of high-quality products will be able to ensure their long-term success in global markets. In light of this development, corporate metrology has come to play an ever more important role. To cater to the needs of an increasing number MEtrOlOGIcal of users, easy-to-learn procedures dEMandS arE On and intuitive user interfaces are a priority in the creation of new tHE rISE. ScHnEIdEr key measurement methods and MESStEcHnIK HaS devices.

rESPOndEd tO tHIS cHallEnGE bY PrESEntInG ItS nEW MEaSUrEMEnt SOFtWarE SaPHIr Qd and a nEW SErIES OF PrOJEctOrS

Dr Heinrich Schneider Messtechnik, production metrology specialist, presents its new measurement and analysis software Saphir QD and a new series of projectors.

“Saphir QD clearly belongs to the age of Metrology 4.0 – as inspired

by Industry 4.0,” explains Dr Wolfram Kleuver, managing director of Dr Heinrich Schneider Messtechnik. “This is because the workpiece automatically integrates itself into the measurement process as an information carrier, without an RFID chip being required!”

The new series of projectors is a new development designed as a modular system. Clients can enlarge and upgrade the entry-level model (which, by the way, is ready for use without any further accessories) into a high-precision measuring projector, depending on their requirements and budget. Measurement with the Saphir QD software is easy to complete: after the device has been switched on, it will only take a couple of clicks until the software is ready to measure and analyse the workpiece placed on the measuring table – no previous manual alignment is required. As soon as the user’s hand has disappeared from the field of view, the workpiece recognition process will be triggered and measurement will be performed. In the next step, the measurement report including a graphical log of the measured elements will be displayed in the live image of the workpiece in the form of an overlay with colour coding (green=good; red=bad). The workpieces to be measured can even be placed on the measurement table in a mirror-inverted way – the part will nevertheless be recognised so that measurement can be performed without a problem.

In the development of Saphir QD, the design engineers at Schneider Messtechnik have not only provided for the measurement of individual parts, but have also integrated functionalities for the measurement of several identical parts

(MMi=Multiple Measurement identical) and several different parts (MMd=Multiple Measurement different). The user is not even required to inform the control unit about the number of parts to be measured; this number can now freely vary from one measurement to the next. The software will reliably capture all parts positioned within the measurement coverage area.

Apart from the crucial aspect of fast measurement, the Schneider Messtechnik experts have also attended to the programming feature: whenever a workpiece without a dedicated measurement programme is placed on the measurement table, the contour of the part will nonetheless be recognised immediately.

The software will automatically identify the centroid of the workpiece and then perform an alignment operation. By placing arrow heads in the locations to be measured on the workpiece, the user can trigger an automatic transfer of measurement locations to the measurement programme. Alternatively, this task can also be entirely delegated to the software itself because the software is capable of capturing all measurable elements and integrating them into the measurement programme as required.

The list of options available for the new series of vertical projectors is as extensive. For example, users can choose from: 2 screen diameters (300 or 360 mm) 4 telecentric objective lenses (10x/20x/50x/100x) Manual acquisition of measurement points, automatic edge detector or camera Analysis units: 2-axis digital display, measurement software M2 (edge detector) or measurement software M3 (camera) Measurement table with fastening threads or T-slots Measurement table with or without quick adjustment mechanism Rotation mechanism for the ground-glass screen – with or without digitisation Measurement table with a measurement path ranging from 200 x 100 mm to 500 x 200 mm.

“One of the key aspects in the development of the new series of projectors was the changeover to a modern and efficient workpiece illumination system. Thanks to the use of highperformance LEDs in both incident and transmitted lighting, we have been able to achieve an unprecedented illumination quality and a significant reduction in energy consumption”, emphasises Dr Kleuver. “The wishes and expectations of our clients were the most relevant criteria in the development of our new products.

We are, therefore, confident that the new series of projectors and the Saphir QD software will spark strong interest in the metrological community.”

SEPTEMBER - OCTOBER 2014 / MPn /33

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 34

COVER STORY

Material gains Mike Freudenstein and Ian rogers from Albis — a thermoplastic polymer distributor and manufacturer — explain how the company’s risk management strategy ensures that medical devices made from Albis’ portfolio of medical plastics are safe to use and compliant in the marketplace Q: tell MPn about albis’ portfolio of plastics for medical and healthcare applications. a: ALBIS offers a range of medically compliant polymers as part of its distribution programme. We distribute on behalf of a number of world class medical polymer producers such as Bayer MaterialScience, Styrolution, BASF, LyondellBasell, Eastman, Solvay and AlphaGary. In addition Albis is able to manufacture and colour compounds under official licence agreements from Bayer MaterialScience, Styrolution and LyondellBasell. Application developments benefit from the comprehensive range of products available with regulatory accreditation.

Q: name some of the most popular products and potential applications. a: Albis is able to offer dedicated healthcare materials across the full range of polymers. Among others, the most common brands are: Purell polyolefins, which are typically used in applications from pharmaceutical packaging to medical devices and in vitro diagnostics (IVD); Makrolon polycarbonate and Tritan copolyester materials for applications requiring a high degree of clarity combined with chemical resistance; and Novodur HD ABS grades, which are used in the context of fluid or drug administration systems like injector pens or inhalers.

Q: How does albIS approach the supply of medical plastics to OEMs and moulders? a: Albis is a responsible supplier to the healthcare sector and takes every care in assessing the application and suitability of materials through a highly specialised risk management strategy and dedicated healthcare marketing team. This overarching policy is supported by Albis’ technical and commercial support package, available to all customers from initial design to ramp up and full scale product launch.

Support services offered include help with product design, material selection, tool modifications, process troubleshooting and commercial and market insight. The approach provides customers with significant added value during their materials selection process while ensuring polymers used are compliant with regulatory requirements.

Albis’ market leading global manufacturing and distribution network provides a strong foundation for local and global medical device design and production operations alike.

<< Expert offering: Albis says it offers a strong distribution product portfolio combined with a comprehensive risk management process and globally renowned technical expertise >>

34/ MPn / SEPTEMBER - OCTOBER 2014

Q: tell us more about the risk management process. a: Albis has put in place a robust medical protocol, administered by a dedicated team, to manage the risk associated with using polymers at every stage of the development.

At the start of a project, before any material can be supplied Albis insists on the completion and sign-off of a comprehensive questionnaire to collect important information about the device to be developed. The information collected — under secrecy agreement , if required by the customer — includes the type of application (for example medical device, pharmaceutical packaging or IVD), requirements regarding biocompatibility testing, as well as specifications in regards to resistance to sterilisation. For medical devices, customers share the risk class according to the medical device directive (MDD). It’s not intended to extract proprietary or secret information per se, it’s only intended for providing an impression on the function of an article.

Once completed, the case is presented to the Albis Risk Management Council for a final decision on suitability. The procedure is consistent across the ALBIS group, whose markets include Europe, the USA and the Far East. Albis registers and retains all records in a central database.

Q: traceability is one of the critical aspects for medical devices, something with emphasis in the upcoming revision to the Medical device directive (Mdd). How do you ensure traceability of ingredients for your compounds and how can you ensure full traceability of batches for distribution products?

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 35

a: For every compound we intend to sell into the healthcare market we ensure that our suppliers are fully committed to having implemented a system for tracking their batches and ingredients. Moreover we ensure that for every ingredient we source, commitments regarding notification of change are in place. Regarding distribution products, our systems and processes in combination with our suppliers’ systems ensure full traceability of every batch back to when and where it was produced with which ingredients.

Q: How does albis ensure that customers are notified of changes to formulations in a timely manner? a: We work closely with our suppliers of medical grade polymers and as such, have an in-depth understanding of the products in our portfolio and how they can be best put to use in medical applications. In that context change management is one of the highest priorities for medical device manufacturers and this is why they prefer to work with ‘medical grades’. Typically this term refers to biocompatibility testing of a polymer. It is however often neglected that such biocompatibility testing only reflects the condition of a polymer at the time of testing. The value of

ISO10993-compliant colour compounds deliver results for Lotus ultrasonic scalpel Albis UK added significant value in the design and development process for an ultrasonic scalpel by supplying ISO10993-compliant colour compounds and important corrections to mould design to SRA developments, a UKbased designer and manufacturer of medical devices. Albis UK supplied colour compounds into six components of the device.

Colour coded plastic parts are a crucial part of the device’s appeal — including a pioneering ergonomic ‘palm fit’ design with spring-loaded trigger as well as easy-to-use functional features like finger activation buttons and a rotational wheel for curved rotating shears.

At the design stage, SRA approached Albis UK for assistance in material selection. The team undertook a full assessment of the device, an essential part of working with the medical industry, to fully understand regulatory requirements.

The scalpel was to be recognised as a Class IIb device under the Medical Device Directive, needing to undergo sterilisation by ethylene oxide (ETO) and be certified biocompatible under ISO10993. The colour coded parts made from materials to be developed by Albis under licence from Bayer Material Science would help the surgical team quickly and accurately select the correct version of the device according to the nature of the planned operation.

SRA was looking for colours which were already ISO10993 certified as well as advice on the best polymers to use from an engineering perspective.

As the project involved a particularly complex design with a number of polymer engineering challenges, Albis was involved at every stage — from design concept, material recommendation, mould tool design, tool trials, product launch and process optimisation.

<< Lotus position: Albis provided technical design, mould flow support as well as ISO10993-compliant colour compounds for the Lotus ultrasonic scalpel >>

such testing remains limited if the manufacturer of a polymer cannot ensure that the polymer as well as fundamental parameters of the production process will not change. Now there might be important reasons for changing a product, for example the replacement of an additive due to a change of legislation. In such cases it is essential to work with suppliers who understand the criticality of change and are ready to communicate changes to their customers.

The polymer manufacturers we cooperate with in healthcare applications are aware of this requirement and have implemented processes to ensure a timely communication on product changes. Most of them also commit to a pre-warning period before changes will be implemented. This period may vary from 12 to 36 months depending on manufacturer and product.

Q: What benefits does this strategy bring to the marketplace? a: Customers benefit from a combination of strengths. The healthcare team’s regulatory expertise ensures a comprehensive risk management process, providing peace of mind for designers and structural and administrative support once a project is in the commercial production phase. Albis’ long history in the distribution and licenced compounding of a wide range of medical grade polymers from leading suppliers provides customers with a supply of unrivalled technical and commercial knowhow in developing new projects and supporting projects to market clearance and beyond.

Albis prides itself on being able to offer impartial advice on a range of polymers, ensuring the most suitable material both technically and commercially is suggested at the critical material selection stage. This is combined with in-depth awareness of sterilisation effectiveness.

Furthermore, the fact that ALBIS has such a comprehensive selection of medically accredited products, including medically accredited pre-developed colour compound options across a range of materials, can have the added benefits of a speedier decision making process, reduced development and validation times, and ultimately reduced time to market.

The latter point is particularly important as it supports OEMs through what is traditionally a lengthy development period.

Dealing with a central supplier who can cover all polymer material requirements provides multiple benefits, not least in speeding up design and development times, reducing the number of meetings required, ultimately resulting in customers getting products to market ahead of their competitors.

SEPTEMBER - OCTOBER 2014 / MPn /35

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 36

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 37

CASE STUDY

Who: contract technical moulder, carclo technical Plastics (ctP)

What: Has ventured into ISO class 8 manufacturing

How: With the installation of two activecell self-contained cleanroom moulding and packing cells from Sumitomo (SHI) demag

VEntUrE caPItal

C

TP provides injection moulding and contract manufacturing services for a range of industries including medical and operates from twelve locations across USA, UK, Czech Republic, China and India.

Following numerous customer requests for medical devices made to class 8 standards, CTP’s operation in Brno (Czech Republic) looked to integrate an onsite cleanroom at its 4730 sq m facility, yet it seemed to be cost exorbitant to build a facility. When the company discussed the dilemma with its injection moulding equipment supplier Sumitomo (SHI) Demag, the proposal of a self-contained activeCell cleanroom moulding and packing system, was described as a ‘eureka’ moment for Carclo Technical Plastics’s technical director, Lee Dodd.

He said: “Without specifying any application details, we challenged Sumitomo (SHI) Demag to build two systems to meet our customer’s proposed capacity requirements. We required a moulding and packing solution which had no restrictions, navigated numerous obstacles both technically and commercially, and could easily switch between several different modes of production.”

The six-axis robot is a value-add for manufacturers looking for future expansion options including pick and place, assembly or even palletising

The ActiveCell units were built within 20 weeks, met all CTP requirements and currently manufacture a range of complex single impression and multi-impression parts (including contact lens cases) to class 8 standards in volumes from 125,0009,000,000. With order values to date exceeding £500,000 per year, CTP will see a return on its investment in less than 24 months.

“The solution hit a sweet spot, in that it was affordable, flexible and transferable. Without Sumitomo (SHI) Demag’s ActiveCell solution, we would not be able to offer cleanroom moulding. We now have a cost effective and highly flexible machine blueprint which any CTP facility worldwide can use should they decide to expand into cleanroom manufacturing,” concluded Lee. “ActiveCell has been designed to address current market requirements for a low investment alternative with complete flexibility at a fraction of the cost of a full cleanroom,” added Flowers.

The all-electric system is installed fully compliant meeting GAMP and FDA requirements with DQ, IQ and OQ documentation and available in 100, 160, 220 and 280 tonne formats.

<< Eye spy: carclo technical Plastics manufactures contact lens cases on the activecell >>

Sumitomo (SHI) Demag had a number of bespoke challenges to overcome: the cell’s seal would be broken by cranes and other equipment regularly entering the machine, yet the system had to retain class 8 standards; the product portfolio was extensive requiring large and small parts of all geometries to be manufactured and then either bagged or boxed; the facility to track and trace bagged products; identical machines were required with inter-transferable mould and robot programmes.

The all-electric compact mini cleanroom system designed and installed by Sumitomo (SHI) Demag was fitted with laminar airflow cabinets for particle free air in the mould-space area, integral packaging equipment and a six-axis Yaskawa Motoman robot which removed parts from the mould ready for packing “Over and above its primary purpose, the six-axis robot is a value-add for manufacturers looking for future expansion options including pick and place, assembly or even palletising,” comments Sumitomo (SHI) Demag managing director, Nigel Flowers.

SEPTEMBER - OCTOBER 2014 / MPn /37

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 38

EXTRACTABLES

Quality first diane Paskiet, director, scientific affairs, West Pharmaceutical Services explains how to understand risk from extractables and leachables (E&L) and the key quality considerations when designing E&L studies Materials that have direct or indirect contact with a drug or biologic product can leach harmful substances into the final pharmaceutical product. Substances that leach can originate from various materials, at any point in the supply chain and throughout the productâ&#x20AC;&#x2122;s lifecycle.

Constituents that migrate from primary packaging into the final product when manufactured and stored under its normal conditions are referred as leachables. Typically, leachable compounds are found in trace amounts yet can have a negative impact on pharmaceutical quality with potential to compromise patient safety. Any component used during manufacture, storage, shipping and administration to the patient can be implicated as a source of leachables. compatibility issues There are multiple types of components to be considered throughout the manufacture, storage and delivery to patients. Primary classes of materials used to manufacture and store drugs and biologics include elastomers, plastics, glass, metal and paper board components. These components must be compatible with the final product and function properly for intended use as well as provide protection over the drugâ&#x20AC;&#x2122;s shelf life. A pharmaceutical product can be affected by chemical substances migrating from material into final product with distinct outcomes. The leached substance can be toxic, affect the product stability or react with active pharmaceutical ingredients or excipients to form a new chemical entity. Patient risk needs to be assessed and mitigated based on understanding potential for leaching. This is accomplished by designing systematic studies to identify and quantitate extractable substances.

Component profiles have many levels of complexity, which may become more varied once the component is formed, washed, sterilised and assembled. Common sources of extractables include residuals and by-products from the material. Processing aids and additives such as stabilisers, antioxidants, lubricants, curatives and their breakdown products are all examples of species contributing to the chemical profile. An extractable study will establish the chemical profile, which reflects risks relative to potential toxicity and incompatibility. Toxicity will depend on the leachable concentration in the final product and patient total daily intake; incompatibility is fundamentally dependent upon the pharmaceutical matrix and conditions of use. Often compatibility issues are manifested by different end points such as pH shift, degradation, oxidation,

aggregation, foreign particles and other impurities that can become evident over a period of time. All materials will leach to some degree under certain conditions. The goal of an extractable study is to provide evidence that materials are suitable for intended use by understanding how risk for leaching correlates to patient harm and eliminating or mitigating that risk.

Key considerations for E&l studies An extractable and leachable strategy consists of multiple steps in which voluminous information is acquired and builds until final drug product stability studies are completed. This can span a period of five years or more from discovery to confirmation. The objective of an E&L study is to identify and communicate risks by conducting controlled extractable studies, which can be correlated to drug/biologic safety and quality. Formal risk assessment tools such as flow diagrams, control charts, risk ranking/filtering or hazard analysis, and critical control points can add value in assessing components for intended use, although these tools are not required. The studies should be designed so the various components are evaluated commensurate with the level of risk to final product quality and safety. Criticality should be justified based on the likelihood of component interaction with the drug or biologic product during manufacture, storage or when in contact with a patient.

Once the components are deemed critical for evaluation, the chemical make-up of each material should be understood. This will feed into the component sampling, preparation of extracts and analysis techniques.

Multiple solvents that encompass organic as well as aqueous solutions should be employed to explore a comprehensive chemical profile.

Multiple analytical techniques and those that are orthogonal should detect a wide range of extractable species with various sensitivities.

Analytical methods should be robust and fit for purpose; that is, having a system capable of detecting certain predetermined targets at specified levels as well as detecting unexpected extractables.

<< Point of concern: any component used during manufacture, storage, shipping and administration to the patient can be implicated as a source of leachables >>

38/ MPn / SEPTEMBER - OCTOBER 2014

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 39

<< testing testing: Understanding a materialâ&#x20AC;&#x2122;s chemical profile is necessary to detect leachables, says West >>

Understanding a materialâ&#x20AC;&#x2122;s chemical profile is necessary to enable detection of leachables. The chemical characterisation of a component should include extraction solvents and conditions that are aggressive enough to indicate the basic chemical ingredients and by-products of the material; however, this is not often indicative of actual leachables. In certain applications, it can be an advantage to simulate or mimic final product under exaggerated conditions to define targets better. The purpose of an extractable study is to provide comprehensive data to indicate risk for leaching and guide a leachables assessment. Methods need to be optimised to measure trace leachables which are easily masked and difficult to detect in a complex matrix. Spiking and recovery studies are necessary to confirm the presence or absence of target compounds. Correlation of the component extractables with confirmed leachables under worst-case conditions will lead to the necessary control strategy.

Setting acceptance limits There are limits in various compendia for certain materials used in the pharmaceutical and medical device industries; however, these limits are considered a starting point to identify materials that might be acceptable. The final drug or biologic product will influence appropriate specifications and acceptance criteria. Acceptance criteria should be set based on the observed range of variation according to ICH guidance Specifications: Test Procedures and Acceptance Criteria for New Drug Substances, New Drug Products (Q6A); Biological Products (Q6B). The guidance establishes the criteria to which a drug and biologic product should conform to be considered acceptable for its intended use. There is a provision for control of extractables from container/closure systems in which parenteral products are considered significantly important. The guidance indicates that where development and stability data show evidence that extractables are consistently below levels demonstrated to be acceptable and safe, the elimination of this test can be accepted but should be reinvestigated if the container/closure system or formulation changes. The guidance also recommends collecting data for components as early in the development process as possible. This is consistent with quality guidelines on Pharmaceutical Development (ICHQ8 (r2), Risk Management (ICHQ9) and Pharmaceutical Quality Systems (ICH Q10).

Acquiring appropriate evidence to demonstrate suitability of materials is necessary for each pharmaceutical product. Extractables are a function of the material chemical make-up, physicochemical properties, configuration of the delivery systems, various environments and length of exposure. Risk variables include component proximity to the final product, area of direct contact, dosage form and conditions of use throughout material processing, manufacturing, filling and storing. Risk for leachables can be indicated based on identifying those extractable compounds with the highest propensity to leach into final product.

The extraction and analysis methods should be tailored to substantiate that leachable levels are below quality and safety concerns. This allows risk of toxicity or poor quality needs to be identified and mitigated. It is not practical to assume a standard method or even suite of methods can provide all the essential evidence. Nonetheless, a standard strategy has been conceived by the Product Quality Research Institute (PQRI). In 2006, Recommendations for Safety Thresholds and Best Demonstrated Practices for Leachables and Extractables in Orally Inhaled and Nasal Drug Products (OINDP) was published (www.pqri.org). This is currently being extrapolated for parenteral and ophthalmic drug products (PODP). Recent USP guidelines <1663> Assessment of Extractables Associated with Pharmaceutical Packaging and Delivery Systems; and <1664> Assessment of Leachables Associated with Pharmaceutical Packaging and Delivery Systems were also published in USP PF 39 in September 2013 and are consistent with PQRI approaches.

To set acceptance criteria for extractables and/or leachables, relevant data must be collected and assessed. It is important to justify specifications based on impact to final product and patient. Control points can be considered early on, but the nature of leaching often occurs over time. Variability will exist from component to component as well as the extractablesâ&#x20AC;&#x2122; propensity to leach. Control points are not easily derived until there are multiple lots of components representing full shelf-life stability studies. Once an analytical target profile (ATP) is established for leachables methods should be optimised and measurements fully validated. Statistically relevant data is necessary to establish acceptance criteria.

A range of sophisticated analytical technologies can be employed for extractable and leachable testing. While all-purpose methods can be a starting point, these will not address distinct applications. Pertinent information is acquired by understanding the materials and intended use to enable specific extraction and analytical methodology to be justified.

Upcoming advances may be a combination of improving technologies for identifying/qualifying leachables along with development of new materials that are engineered to fit a purpose in a quality by design (QbD) paradigm. Accurate and precise analytical measurements will be the means to enable the future of applying the right knowledge at the right time to materials used in the manufacture, containment and delivery of high-quality pharmaceutical products.

SEPTEMBER - OCTOBER 2014 / MPn /39

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 40

EXTRUSION TUBING

Take the tube Styrenics are attractive to healthcare and diagnostic providers due to their cleanliness, safety, lower density, balanced performance, superior processing as well as excellent aesthetics.

Styrolution looks at the way in which styrenics are enabling innovations in tubing

I

nnovating new, safer and more reliable ways to deliver medicine and enable the work of doctors is a key focus for medical product manufacturers. As healthcare technologies evolve, so must the materials that support these advancements.

Medical tubing is one product sector that continues to undergo advancements, as tubing provides a crucial vehicle for the delivery of medicine and care. However, to ensure new developments in tubing are safe, feasible, cost-effective and hygienic, some manufacturers have turned away from traditionally used materials and have sought new material solutions.

Styrolux can be extruded, thermoformed and injection moulded into a variety of high-quality products, especially high end medical tubing (multi-lumen).

Innovation through styrenics Understanding the importance of developing new material solutions, Styrolution, a global player in styrenics, has used its 15 years of experience in the healthcare industry to create materials that offer greater benefits when compared with other materials.

From its product portfolio applicable to medical applications, two materials have shown particular usefulness and value in the creation of complex and advanced medical tubing: Styroflex and Styrolux.

creating complex tubing with innovative materials The potential and promise of Styroflex and Styrolux were recently brought to fruition by Microspec, a specialist in medical tubing with a reputation for extruding the most complex tubes in the healthcare industry. Seeking to create highly flexible, transparent or self-coloured multi-lumen tubing which allowed for the administration of different medications from one access point, Microspec partnered with Styrolution to find the best material for the application.

Styroflex is a styrene-butadiene block copolymer (SBC) with the properties of a thermoplastic elastomer (S-TPE). Suitable for extrusion and injection moulding, it offers a combination of high resilience, toughness, optical clarity and processability. A costeffective alternative to other materials, the flexible plastic maintains extremely high tear and perforation resistance and incredible transparency. For medical tubing, it offers outstanding bonding performance to other polymers, like acrylics and polycarbonate, as well as lower drug absorption compared with other plastics, helping to ensure the safe delivery of medication without concerns of migration.

To enable its complex tubing, Microspec needed materials that offered a desired stiffness, low drug absorption, exceptional processability and brilliant clarity. Additionally, as the lumens in the tubes vary in shape, number, symmetry and diameter, Microspec required a material that offered the properties necessary to address the complexity of the application. Given the strict regulatory environment for the healthcare and diagnostics industry, it was also critical that the material provider of choice offered long-term recipes for its products and a deep expertise on medical standards and regulations.

Complementing the flexibility of Styroflex is the strength of Styrolux. Styrolux resins are a range of SBC copolymers that boast outstanding characteristics such as high transparency, brilliance and impact resistance. The good miscibility of Styrolux with Styroflex, in combination with polystyrene allows for adjustments to the desired softness or toughness, enabling customised grades.

Both materials are particularly useful to the development of medical tubing due to their excellent processability, which allows for the production of more complex tubing structures, and low drug absorption. Styroflex and Styrolux also deliver other advantages including a low yellowness index, better clarity than traditional materials and increased run rates.

After undergoing a collaborative innovation process with Styrolution aimed at ensuring that the most appropriate materials and grades were selected, and developed (if necessary), Microspec selected Styrolux and Styroflex for the development of their transparent multi-lumen tubes. Not only did these materials satisfy the property requirements of the application, but the high processibility of the materials provided optimal tube stabilisation These material solutions also delivered a density advantage of 20 to 30% when compared with other materials that Microspec had evaluated, resulting in material cost savings.

Future material innovations Microspec is just one example of how Styrolux and Styroflex have been employed in the development of medical tubing. Other companies have used Styroflex to replace previously used materials in different tubing applications. Additionally, these material innovations offer possibilities in other applications including IV bags, collection and blood bags, medical drip chambers and connectors â&#x20AC;&#x201C; all of which highlights the endless potential of Styrolutionâ&#x20AC;&#x2122;s SBC copolymers.

<< Flexible friend: Styroflex is a styrenebutadiene block copolymer (SBC) with the properties of a thermoplastic elastomer >> 40/ MPn / SEPTEMBER - OCTOBER 2014

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 41

EXTRUSION TUBING Medical Lab Line Equipped for Innovation and Profitability

THE RIGHT LINES Thanks to a new lab line at Davis-Standard, customers can test new resins, make parts for proof-of-concept, and conduct downstream R&D prior to making a large capital equipment investment

A

new lab line at Davis-Standard’s Technical Centre is enabling customers to turn innovative medical tubing concepts into reality. The line, installed last spring, is engineered for end product development of small, tight tolerance tubing used in medical applications. Customers are able to test new resins, make parts for proofof-concept, and conduct downstream R&D prior to making a large capital equipment investment. The line is also situated in a dedicated, climate-controlled area, offering a cleanroom environment for trials.

“There continues to be significant growth and development in medical tubing applications. We want to ensure our customers have the resources for success,” said Wendell Whipple, vice president of DavisStandard’s pipe, profile and tubing group.

“This line provides a fully equipped option to develop new products and test equipment, which is aligned with our commitment to support customer profitability.”

The line features two direct drive interchangeable-barrel MEDD extruders in 25mm and 19mm 24:1 L/D sizes, enabling a full range of product development opportunities. The MEDD is Davis-Standard’s premier compact extruder optimised for clean room environments with efficient operation and a replaceable feed section liner. The line incorporates Davis-Standard’s patented alternate polymer process, with all components being monitored and controlled by our EPIC-III.

<< In line: A new lab line at DavisStandard’s Technical Centre is engineered for end product development of small, tight tolerance tubing used in medical applications >>

advantages and capabilities of the line include: Enclosed, ventilated and air-conditioned space EPIC-III control and process data collection Bump/taper tubing capabilities Able to process common thermoplastics (PE, PP, PA, TPU) as well as high temperature polymers (PEEK, PEKK and others) including fluoropolymers (FEP, PFE, ETFE, and others) Highly instrumented extruders and extensive screw inventory Desiccant drying capabilities, up to three resins simultaneously Melt pumps with servo drives Mono and coextrusion capabilities Multi-lumen capabilities Vacuum sizing capabilities Laser and ultrasonic gauging including trim control; two gauging systems Dual servo belt puller capable of 250 fpm Six-foot belt conveyor for sample collection Space for customer-supplied equipment (coiler, payoff) Product development including microbore, multi-lumen and catheter tubing

SEPTEMBER - OCTOBER 2014 / MPn /41

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 42

42/ MPn / SEPTEMBER - OCTOBER 2014

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 43

EXTRUSION TUBING

Development studies

T

he Conair Group makes downstream extrusion equipment for medical microbore tubing (less than 1.52 mm in diameter) and for larger commodity medical tubing. Microbore tubing is tHE cOnaIr used in products like heart and brain GrOUP OUtlInES catheters, and properties such as ovality, concentricity, and elongation/burst rEcEnt strength are key.

dEVElOPMEntS In EQUIPMEnt FOr MEdIcal tUbInG ExtrUSIOn

“For extrusion of microbore tubing speed isn’t an issue, but these specialty materials are expensive so manufacturers want to use the least material possible while maintaining precise properties,” says Bob Bessemer, Conair sales manager, Medical Extrusion.

Bessemer explains the benefits of using vacuum sizing, rather than free extrusion, to accomplish the high level of precision necessary for microbore tubing extrusion. “With free extrusion, if the draw down ratio is not correct then more air is needed to create the desired tube size,” he says. “Since air is compressible and variable, this creates more fluctuation in tolerance. At Conair, we teach the use of vacuum sizing as a process.”

Conair’s MedVac vacuum sizing/cooling tanks have chambers that can range in length from 0.9 to 5.5m long with temperaturecontrolled water. It uses differential pressure to expand the tube, and the vacuum is applied over a specific length for consistency.

“However, it is still essential to pick the right tooling to make the tube and to use the vacuum to accomplish roundness rather than to grow the tube,” Bessemer says. “Let the tube tell you what size it wants it to be because if you push the size, then you push the tolerances.”

Precision is also needed in maintaining the water temperature as heat-transfer rates directly affect material properties. At the end of the line, a MedLine puller/cutter servo-drive speed controller maintains consistent pulling. “We also work with blade manufacturers to get thin and sharp blades that cut tubes without particulates or collapsing,” he adds.

When the ultimate in particulate-free cutting is required and when the materials being extruded tend to shatter (like crystal polystyrene, high-density polyethylene, et. al.), Conair recommends a micro-scale planetary cutter. The knife assembly rotates and makes a lathe-like cut around the circumference of the tube. The unit can precision cut rigid and semi-rigid medical tubing as small as 2.03 mm in outside diameter (OD) automatically at line speeds of up to 30.5 m/minute. The new cutter can make distortion-free and particulate-free cuts at rates up to 50 per minute, depending on wall thickness and material, while holding cut-to-length tolerances of ±0.127 mm. Even tighter tolerances are possible with a dual-head model, which cuts both ends of the tubing at once, leaving only a short scrap piece.

At the other end of the spectrum, manufacturers of commodity tubing focus on making it at high speed without sacrificing precision. They are reducing wall tolerances to minimise material use. In addition, because the extrusion is performed in cleanrooms, space is a major issue. Conair has a multi-pass tank that includes a vacuum-sizing section and a conventional cooling section and horizontal rollers to guide the tubing back and forth through the tank. A servo-driven wheel in the tank serves as the primary puller to increase tubing precision. This configuration saves half to a third of the space compared with conventional sizing and cooling tanks and minimises stretching of the tubing during cooling. The system also has OD/ID wall gauging and monitoring, which is important for documenting process conditions for customers and the FDA. “It is key to make changes in a very controlled and automated manner,” Bessemer says.

He says that manufacturers are gradually moving away from using flexible PVC for commodity tubing because of consumer concerns about possible toxicity. However, alternative materials tend to be much more expensive, so it is even more important to keep production rates up and tolerances tight. “The goal is to accomplish high speed with tight precision while limiting the material used,” he says. “We are consistently pushing processing to tighter tolerances and faster speeds.”

SEPTEMBER - OCTOBER 2014 / MPn /43

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 44

FAKUMA

International affair This year’s Fakuma, promises to be a success. With a record number stands being sold, the event offers strong international expertise, providing a complete range of plastic technology to cover all plastics processing requirements With 1288 exhibitors, Fakuma 2014 has sold out. The international trade fair for plastics processing not only has record-breaking exhibitor levels but an even bigger mix of international companies than ever before, says its organiser.

“Fakuma provides us with an outstanding forum for presenting innovations to international experts, as well as for maintaining relations with existing customers and establishing contact with new customers. For us, it’s this year’s most significant trade fair in Europe.” said Dr. Christoph Schumacher, head of marketing and corporate communication 44/ MPn / SEPTEMBER - OCTOBER 2014

For the last 30 years, Fakuma has become a prominent meeting place for the industry. It provides a comprehensive overview of all plastics technologies - injection moulding, extrusion technology or thermoforming. The event organiser says visitors can find out about all processes machines and tools for the working and processing of plastics.

Participants come from 32 countries, occupying more floor space than ever at the Friedrichshafen Exhibition Centre on Lake Constance. Germany will be represented by 675 exhibitors, Italy 72 manufacturers and distributors and Switzerland, 66 companies. Austria, China and the Netherlands also have a strong presence at the event.

Fakuma boasts a range of suppliers covering the entire process sequence - from product development to rapid prototyping and toolmaking, up to series production. This year there has been no shortage of technological innovations in the field of plastics in 2014, says the organiser. Trends on display include energy and material-saving production and processing of plastics; expanding use of composite materials; improved precision injection moulding of components used in micro-technology and medical engineering; advancing functions integration despite miniaturisation and components/modules with ever thinner walls; new applications for rotation moulding technology like the thermoforming process, and 3D printing.

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 45

SEPTEMBER - OCTOBER 2014 / MPn /45

MPN issue 20.QXD_Layout 1 09/10/2014 11:26 Page 46

DESIGNED FOR LIFE

Team Spirit A

fter 16 years of manufacturing syringes, DMC Medical foresaw a trend in for options free of bisphenol A (BPA).

The manufacturer responded by collaborating with a specialty chemical company to develop a high-performance BPAfree syringe with increased chemical and lipid resistance and glass-like transparency.

WHEn dMc MEdIcal SPOttEd The relationship with an OVErall MOVE tOWardS Eastman Chemical bPa-FrEE PrOdUctS, tHE Company piloted product testing and eventually a cOMPanY WaS KEEn tO new product launch in dEVElOP a bPa-FrEE SYrInGE November 2013.

FOr tHE MarKEt. and bY cOllabOratInG WItH tHE EaStMan cHEMIcal cOMPanY, dMc WaS ablE tO MaKE tHIS VISIOn a rEalItY

An ongoing topic of conversation in the medical device industry, BPA and related legislation were on the manufacturer’s radar prior to seeing an industry need for a high-performance alternative to polycarbonate. Workable materials that serve as a polycarbonate substitute are scarce, especially when considering a BPA-free option. With this in mind, DMC Medical proactively ventured into testing materials and products, with a focus on quality.

“Providing options is a real advantage in our market. Customers have to take into account so many elements, including everchanging regulations, and we wanted to alleviate any hesitation by offering multiple high-quality options for syringes,” said Bryan Wixted, CEO of DMC Medical.

The list of considerations was long — toughness and clarity had to be equal or superior to the polycarbonate alternative, workability was a major factor, and retooling was not an option.

Beyond the basics, the material also needed to be suitable for ethylene oxide (EtO) and radiation sterilisation (gamma and electron beam) to address mounting healthcare-associated infection (HAI) concerns. Overall, choosing the right material — one that improves the final product, while also providing economic benefits for the supplier and customer — was the biggest consideration.

DMC Medical’s moulding expertise was coupled with Eastman Tritan copolyester. For the new syringes, Eastman provided technical expertise, along with sales and R&D managers, to help DMC Medical through the fabrication process and to bring the product to market.

“At Eastman, we’ve worked with OEMs to create new products for years. The challenge of being presented with an idea and having to help find or develop the appropriate solution is where our team excels,” said Anthony Sammut, specification sales and marketing manager, Eastman Chemical Company.

Generally, a project of this nature would take approximately two years from concept to end-user product. This particular collaboration resulted in a product launch after only nine months. This can be attributed to extensive conversations around material and process prior to testing.

46/ MPn / SEPTEMBER - OCTOBER 2014

First, the organisations met to identify a material that was suitable as an alternative to polycarbonate. Careful consideration went into chemical and lipid resistance in devices, which frequently come into contact with substances including aggressive disinfectants, specific drugs and carriers of therapeutic drugs.

The material had to also provide clarity, allowing healthcare practitioners to easily see the syringe’s contents. Ultimately, the team landed on Eastman Tritan copolyester. Suitable for EtO and radiation (gamma and electron beam) sterilisation, Tritan also allows devices made with the material to retain their color and functionality post-sterilisation.

When developing a new product like this, the expense and time required for major changes to DMC Medical’s current tooling would make the project too costly. To alleviate costs and maintain a tight timeline, DMC Medical worked with Eastman to customise current tooling to fit new product needs. The stable manufacturing process, similar to that of polycarbonate, made this transition possible.

After the tooling was in place, the teams collaborated on a thorough testing process. Knowing that testing would determine the project’s success, the teams spoke extensively about the materials and process to ensure every concern was addressed prior to trialing. Several trials were run with the material to ensure quality and functionality and this extensive planning worked — the material passed each test without issue.

“The amount of testing this product went through to make sure it was worthy of taking to market was extensive. Passing each trial without issue is a testament to the team’s collaboration and preparation,” said Wixted. “This is a premium syringe with many advantages and we’re proud to be the first to bring an option of this calibre to the market.”

After nine months of collaboration, NuGen Eastman Tritan Copolyester Syringes launched at the 2013 Compamed Trade Fair. This end product was made possible through extensive collaboration, early considerations for the quality of the materials used and the complementary expertise provided by both companies.

<< Fair point: After nine months of collaboration, NuGen Eastman Tritan Copolyester Syringes launched at the 2013 Compamed Trade Fair >>

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 47

MPN Medical Plastics News (MPN) and InnoPlast Solutions are Pleased to Announce a Conference on Emerging Trends in…..

Polymers & Plastics in Medical Devices The theme for this year’s 2-day conference on “Polymers & Plastics in Medical Devices” is to bring the participants up to speed on the newest trends and technical advances in the field of Medical Devices as it relates to Polymeric Materials. The target audience is Medical Device producers, Molders of Sub-Assemblies, Plastic & Additive suppliers, Equipment & Prototype Designers,

Regulatory professionals, Sales, Marketing, and Business Development leaders throughout the entire supply chain of the Health-Care industry. The conference has been structured to provide ample opportunity for networking to encourage the sharing of new ideas and concepts throughout the value chain.

April 21-23, 2015 DoubleTree - Hilton, Orlando, FL 32804, USA Call for presentations We are soliciting presentation(s) that represent a NEW development in any of the following areas: IMPLANTS: CardioVascular, Orthopedic & Vision Care DURABLE Applications: Housing & Components for Medical Devices DISPOSABLE Applications: Catheters, Tubings, Storage & Diagnostics NEW DEVELOPMENTS: Coatings, Additives & Processing for Higher Performance

What is Required ?

In order to make it easier for the speakers, we are asking only for the Presentation Title and the Speaker’s contact information by AUGUST 15, 2014; nothing else is required until April 1, 2015 when the PowerPoint slides will be due.

Presentation TITLES can be emailed to info@InnoplastSolutions.com; for further details, call Innoplast Solutions at (973) 446-9531 in USA or visit www.MediplastConference.com

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 48

STERILISATION

NovaSterilis commercialises supercritical carbon dioxide sterilisation technology to meet the needs of advanced biomaterials

M

edical devices are increasingly more complex and the materials that make up devices and regenerative products more specialised. These products require delicate sterilisation technologies to maintain properties essential to ensuring optimal therapeutic outcomes, yet must provide the level of sterility required of implantable devices by regulatory agencies. NovaSterilis has developed a green sterilisation technology harnessing the unique properties of supercritical CO2 in combination with a small quantity of a proprietary additive, to achieve a device industry Sterility Assurance Level of 10-6 (SAL6) while minimising impact to many highly specialised products1,2.

As the medical device industry develops and incorporates more specialised materials, the challenge of sterilising devices incorporating new materials grows. Sterilisation by nature is destructive; many current devices are simply constructed of metal or durable plastics that withstand current harsh sterilisation technologies. In addition, these products are not porous reducing the risk of retaining residual toxins used in chemical sterilisation processes. The incorporation of new polymers, materials and porous matrices with properties that can be specifically tuned to the desired application has presented the industry with sterilisation challenges due to tight material property tolerances3.

NovaSterilis is meeting the sterilisation needs of a growing number of these specialized products2.

As the medical device industry develops and incorporates more specialised materials, the challenge of sterilising devices incorporating new materials grows.

48/ MPn / SEPTEMBER - OCTOBER 2014

“Since today’s highly technical products require very specialised handling, the sterilisation of smaller batches and a desire to maintain custody of product is more important to many of our customers,” stated David Burns president and ceo, NovaSterilis.

“We are able to offer customers an in-house ‘green’ sterilisation solution that can be completed in minutes to hours, the customers can maintain custody of their products and prevent inventory delays.”

What is supercritical cO2?

The supercritical or fluid phase of carbon dioxide is achieved at low pressure (1099 PSI/73 ATM) and moderate temperature (31.1°C). As a supercritical fluid, CO2 maintains ideal properties of the liquid and gas phases; as a liquid, CO2 is an excellent organic nonpolar solvent, and the gas phase has no surface tension providing unsurpassed penetration.

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 49

Historically there has been a desire to utilise CO2 for sterilisation and a number of respected researchers attempted to achieve this with some promising results on viruses and vegetative bacteria.

But, the inactivation of bacterial spores, the hardest to kill, to a SAL6 was not possible until NovaSterilis combines a subtherapeutic quantity of a liquid sterilisation additives with supercritical CO2. It is this approach of using a combination of two sub therapeutic products, CO2 and sterilisation additive, that results in a very lethal yet gentle sterilisation process. In its supercritical state CO2 acts like a gas and penetrates Tyvek gas permeable medical packaging making it possible to terminally sterilise devices, ready for surgery.

It is important to highlight NovaSterilis’ use of very low levels of additive (25–100ppm) in combination with supercritical CO2 limiting the negative effects of a chemical sterilant for the process technician, device recipient, and product. Most of the chemical sterilant is removed from the product and unit during the depressurization cycle of the unit; this provides the user with a product ready for inventory. Testing on allograft products sterilised using the NovaSterilis process has exhibited no measurable chemical residuals reducing any potential side effect.

Mode of action There are numerous theories on mode of action of this technology, but it has been shown that a physical destruction of the microbe is not responsible. In the context of low pressure (1450psi) and temperature (35°C) supercritical CO2 process, two components are suggestive of a mode of action. These components include the presence of water and a method for enhancing mass transfer of CO2 and additives that affect cell viability4. Together, these factors point to the formation of carbonic acid inside of the microbe inactivating the microbe.

Carbonic acid is generated from the reaction of CO2 with water, this may be responsible for a portion of the inactivation of cells through the transient acidification of the interior of the microbial cell and/or inactivation of essential enzymes. NovaSterilis Peracetic acid (PAA) based additive is both an acid and peroxide.

As an acid, PAA may have transport properties in supercritical CO2 that contribute to overall intracellular acidification. The same mass transfer enhancement may also facilitate the delivery and/or action of PAA as a sporicidal agent. This hypothesis is consistent with the synergy observed between supercritical CO2 and PAA for inactivating bacterial endospores5.

NovaSterilis has a growing number of customers developing this process for their specific materials. The gentle nature of this process makes it a valuable tool for human and xenogenic allograft sterilisation, an unmet medical need since current good tissue practices are centred on donor screening and aseptic processes they leave the recipient of transplant tissue vulnerable for post transplant infections. Radiation and ethelyne oxide have effects on the tissue or recipient that restrict the effectiveness.

Other new technologies, for example H2O2 plasma simply do not penetrate the tissue and achieve sterilization in the deep layers of the tissue. In addition H2O2 plasma technology produces large quantities of free radicals to achieve sterilisation6.

These free radicals can react with materials being sterilised. The Tissue Banking Industry made great strides in reducing risk, but the addition of a sterilisation technology with minimal impact on tissue can further improve the safety of the tissue supply. A small company is developing this sterilisation technology for a new twist on an old material, one that needs a very sensitive approach

NovaSterilis has a growing number of customers developing this process for their specific materials.

that will not degrade the material. Supercritical CO2 was able to achieve SAL6 without any degradation to this valuable finished product. Additional established applications for SCCO2 include but are not limited to PLGA/PGA, PEEK, absorbable sutures, active pharmaceutical ingredients and drug delivery devices.

The NovaSterilis supercritical CO2 process is safe for many polymers, allograft tissues, plastics, and surgical metals.

NovaSterilis manufactures 20 litre and 80 litre fully automated, computerised, and network capable sterilisation units. Designed with a small footprint, these units are ideal for biomedical material companies that require high value and flexibility. NovaSterilis provides supportive technical services; assisting customers to determine if this process is appropriate for specific products, establishing cycle times, and developing validation and regulatory plans.

1

US patent 7108832 Sterilization Methods and Apparatus Which Employ Additive Containing Supercritical Carbon Dioxide Sterilant 2 Qiu et al. Inactivation of Bacterial Spores and Viruses in Biological Material Using Supercritical Carbon Dioxide With Sterilant. Published online 6 July 2009 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/jbm.b.31431 3 Holy et al. Optimizing the Sterilization of PLGA Scaffolds for Use In Tissue Engineering http://www.ecf.toronto.edu/~molly/Binder/optimizing%20the%20 sterilization%20of%20plga%20scaffolds.pdf 4 Dillow et al., 1999; Shimoda et al., 2001 5 Angela White, David Burns, Tim Christensen Effective Terminal Sterilization Using Supercritical Carbon Dioxide, Journal of Biotechnology accepted 15 December 2005 6 Clapp, P.A., Davies, M.J., et al., 1994. The bactericidal action of peroxides; an E.P.R. spin-trapping study. Free Radic. Res. 21 (3), 147–167 7 US patent 7108832 Sterilization Methods and Apparatus Which Employ Additive Containing Supercritical Carbon Dioxide Sterilant

SEPTEMBER - OCTOBER 2014 / MPn /49

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 50

<< Clean sheet: As devices become more complex and the medley of materials grows, so do the challenges to successfully and efficiently sterilise them, says Stephen Morley, Noxilizer >>

STERILISATION

Germ warfare Stephen Morley, Noxilizer looks at sterilisation tools for device designers and the way in which alternatives support innovation and improve manufacturing efficiency Like many industries, the medical device industry is innovating to meet the requirements of a changing world. New technologies, materials and processes are continuously being introduced. This is driven by the need to improve patient safety, reduce production costs and optimise supply chain efficiency, and with that, reduce the cost of healthcare.

Ethylene Oxide (EO) Despite acknowledged pitfalls, EO remains the most widely-used method of sterilisation. It is compatible with a variety of materials (indeed, manufacturers of polymers have historically screened their materials for traditional sterilisation methods, so this broad compatibility is not surprising).

A growing proportion of drugs are bio-pharmaceuticals, which impose new constraints on packaging and processing due to being heat labile. There is also an increasing use of prefilled syringes (PFS). This is driven by both quality and cost factors, including greater fill and dosing accuracy (less waste, greater safety) and higher safety in self-administration (reduced cost, greater convenience).

For drug-device combination products, there are concerns around toxic residuals, a relatively high temperature/humidity process and long â&#x20AC;&#x2DC;turnaroundâ&#x20AC;&#x2122; time (>20 days, including transportation). The main drawback to bringing EO sterilization in house is that it is flammable/explosive. Therefore, care must be taken when designing EO facilities, which generally require a dedicated building and systems to destroy the gas after use.

These considerations require substantial investment, which, coupled with growing regulatory requirements have driven growth in the Sterilisation Service Provider segment.

Other examples of increasingly complex medical devices include drug-device combination products and customised implants, which create additional manufacturing and processing challenges.

!"#$%&!

As devices become more complex (eg. dual chamber syringes, drug-device combinations), the medley of materials grows, so do the challenges to successfully and efficiently sterilise them.

Sterilisation methods available for manufacturers: Steam Despite high energy usage, steam sterilisation remains a simple and cost-effective method for materials that can withstand the temperature and pressure conditions. Steam/air autoclaves may be used in-house for a variety of medical and drug-delivery devices such as contact lenses and packaged prefilled syringes (heat-stable products). It is also non-toxic and leaves no residues.

-.//*012$(+)1

3(4+*+#+"5!

6"75%))"*1 -(8"#01

!(#"7+(*1 2%9/(#+:+*+#0!

;.7)(7%.)&11 ;"9/"7(#.7"1 ;+9"1

67"55.7"1

"#$$#! +)*('*,),-.! %#&'#(')*!

"/*/0#112!

3,(-),04/&! #-!#!5/06'4/!

7/02! ;/(<#1! ?0)@1/$-!A'(<!

58/4'#1'9/&! =)-'$/(/0-! -)$/!8)12$/0-! C!D!E!&#2-! :#4'1'(2! %/>,'0/&! #*&!=0,B!?0)&,4(-!

%))$!

F/$8/0#(,0/!

G$@'/*(!

HIJ/#$!

+)*('*,),-.!

K*IL),-/!)0!

3,(-),04/&! #-!#!5/06'4/!

7/02! ;/(<#1! ?0)@1/$-!A'(<!

58/4'#1'9/&! =)-'$/(/0-! -)$/!8)12$/0-! :#4'1'(2! %/>,'0/&!

M40)--!1'*N'*BO!

%))$!

F/$8/0#(,0/!

G$@'/*(!

H(<21/*/!

3R'&/!

J#(4<!

"/*/0#112!

3,(-),04/&!! #-!#!5/06'4/!

7/02!

35LG!?H;S! "/*/0#112!"))&U! 58/4'#1'9/&!

P??T! /R4/8(!&0,B! :#4'1'(2! +#04'*)B/*!

80)&,4(-!

L'B<!

7#4,,$! ?,1-'*B!

X'(0)B/*! =')R'&/!

J#(4<!

5(/#$!

J#(4<!

K*IL),-/!#*&! ?)A/0!

35LG!?H;S! 3,(-),04/&!!

5,8812!3*12!

E??T! #-!#!5/06'4/! "/*/0#112!

K*IL),-/!

5'B*'Z'4#*(!

G*4'11#02!

H>,'8$/*(!

J,0*!

L#9#0&!

C!D!PQ!&#2-!

V!D!WQ!&#2-!

M1/--!A'(<!! +)$@'*#(')*! ?0)4/--'*BO!

"/*/0#112! "))&!/R4/8(! +/11,1)-/!

Y!C!<),0-!

[*-,'(#@1/!Z)0! $#*2!T/&'4#1! =/6'4/-!\!=0,B-!

Y!C!<),0-!

G$@'/*(!! %))$! #*&!7#4,,$!

F/$8/0#(,0/! ?0)4/--/-!

L'B<!

7#4,,$! ?,1-'*B!

* X)(/S!!]</*!-(/0'1'9#(')*!'-!8/0Z)0$/&!0/$)(/12!Z0)$!(</!80)&,4(')*!-'(/U!'(!0/>,'0/-!&/I8#11/('9'*B!#*&!0/I8#11/('9'*B!)Z!(</!

80)&,4(!4#0()*-!^!$)0/!<#*&1'*B!#*&!/--/*('#112!#!@#(4<!80)4/--_! !

50/ MPn / SEPTEMBER - OCTOBER 2014

'()&*+),!

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 51

SEPTEMBER - OCTOBER 2014 / MPn /51

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 52

STERILISATION

Stick with it dr detlef Heindl, Panacol, provides expertise on UV curing adhesives compatible with common sterilisation processes

A

dhesive technology can be a cost-effective solution to connect components for single use medical products. When bonding transparent or translucent substrates, using a UV curing acrylate adhesive has several advantages: They are easy to handle, can be quickly dispensed and if necessary, can also cure in seconds. In addition cured acrylates are compatible with common sterilisation processes such as autoclaving, gamma and ETO. They maintain high adhesion after sterilisation. Interestingly, in several tests electron beam sterilisation (not in the diagram below) has even improved the adhesion. by sterilising and good preparation, acrylates can achieve significantly better bond strength After curing, uv curing acrylate adhesives are very resistant to autoclave sterilisation, gamma irradiation and ETO treatment. Usually there is no reduction in bond strength at all. E-beam Sterilisation has proved to be especially effective, and with some acrylates improvements can be achieved, because of an increase in the degree of polymerisation of the chemistry. This means that invisible bonding, transparent acrylates have high strength, long lasting adhesion and good sealing properties, even after several cycles of sterilisation.

Especially non-polar substrates, mostly plastics such as polyethylene or polypropylene, and also steel, after a surface pre-treatment such as Corona or Plasma will often achieve a better and lasting bond. With a few acrylate adhesives you can achieve improvements in bond strength through pre treating the substrates by up to 50% increase.

Typical examples for the use of UV curing acrylate adhesive are bonding catheters, and lancets; also suction tubes, blood sugar metering or medicine holders, bonding to larynx heads or blood pumps and breathing masks.

Fast curing increases productivity Acrylates are solvent-free, environmentally friendly and very well suited for manual and automatic production processes for high volume component manufacturing. As a single component system they are easy to handle. In many cases they are cured with LED light devices and wavelengths within visible light range - all within 10 seconds. The cold LED technology is especially important for bonding temperaturesensitive parts.

In principle, the curing time of an acrylate is between 0.5 and 60 seconds.

For example, during the bonding of needles in syringes, then curing is significantly less than a second.

Despite a short cure time, a very high/ high mechanical strength is achievable ; itâ&#x20AC;&#x2122;s worth noting the E-module. The E-module is a benchmark for the inner strength (cohesion) of a material, however it is dependent on the elasticity of the adhesive: the more elastic the adhesive and the higher the elasticity, the lower the module. That is why low modules do not necessarily mean poor mechanical properties.

Measuring the tensile bond strength under different climatic conditions The bond strength of the substrates was investigated by measuring the tensile strength. Two flat samples were bonded to each other under different climatic storage conditions and pulled apart to the point of failure. The value of the required force is a measure of the adhesion of the adhesive. After 24-hour storage of the specimen in isopropyl alcohol or water, as well as under the influence of elevated temperature for a long time and humidity, the results are compared with values of unpolluted samples. In all cases there was no fall in bond strength or a only very small decrease.

Acrylates are ideal for transparent or translucent substrates such as glass and plastic, and are also ideal when bonding these substrates to metals.

Techsil offers a range of Vitralit acrylate adhesives from manufacturer Panacol, for many different applications. They are all USP VI and/or ISO 10993 certified.

52/ MPn / SEPTEMBER - OCTOBER 2014

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 53

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 54

BEADY EYE Keeping an eye on the next big thing can be hard. Each issue MPn selects a company, service or technology that it thinks is one to watch...

I ROBOT MPn: Who are you and what do you do? cV: EndoControl is an innovator of robot-assisted systems for endoscopic surgery. Our mission is to enhance clinical progress by designing solutions for surgeons. The company markets a range of products including ViKY EP, a laparoscopic motorised endoscope holder, the ViKY UP, the first motorised uterus positioner, and JAiMY, the first 5mm motorised articulated laparoscopic instrument.

A ROBOT AS AN ACTOR WORKING ALONGSIDE THE SURGEON? CLéMENT VIDAL, CEO OF ENDOCONTROL, EXPLAINS HIS NEW APPROACH TO ROBOT-ASSISTED SYSTEMS

Over 10,000 surgical interventions have been carried out globally using ViKY. In Europe, the Middle East, Africa and South-East Asia, EndoControl markets its products via a distribution agreement with Trumpf Medical System (Germany) and we are also represented in the USA, Canada and Japan by a network of independent distributors.

<< Global player: there are currently 150 Endocontrol robots in use in medical establishments around the world >>

There are currently 150 EndoControl robotsin use in medical establishments around the world.

MPn: What projects / developments have you been been focussed on recently cV: Today, as tasks are becoming ever more robotised, medicine presents a particular challenge. The anatomical and pathological differences between patients mean that tasks cannot be reduced to perfectly reproducible actions. The solutions proposed so far seek to turn the robot into a mere ‘slave arm’, remotely controlled by the surgeon. With its products, EndoControl optimises the collaboration between the doctor and the robot in order to make the best use of human skills (pathological knowledge, ability to adapt, flexibility) and the benefits of robotics (precision, stability, reproducibility, computing power, databases,). With JAiMY, for example, we brought to market the smallest robotic surgical instrument, reducing pain and scarring

the assisting robot to become a co-worker – both guiding and being guided by the surgeon. Intelligent surgeon/robot interaction meets the need for surgical actions to be individualised, whilst still assuring a high degree of precision.

ARCC is truly advanced, both in terms of technology and the approach to surgical robotics, allowing the robot to become an actor in treatment strategy, working alongside the surgeon, rather than in series, as was the traditional remote-controlled approach.

MPn : What does it mean for the medical sector? cV: The challenge in surgery today is to be less invasive. Smaller skin incisions leave less scarring, are less painful and enable faster recovery, shorter hospital stays and less time off work. These all benefit both the patient and overall society. The role of the industry is to help surgeons achieve this, even for complex surgeries; by providing state-of-the-art instrumentation.

EndoControl innovations are a part of this global challenge.

MPn: describe your latest innovation?

MPn : Plans for the future ? cV: Our JAiMY instrument fits in a 5mm incision and maps the surgeon’s hand movements in the patient’s body. It enables the surgeon to perform complex surgical procedures through a smaller incision.

EndoControl’s latest project, ARCC, has been rewarded in the ‘worldwide innovation challenge’ 2014. It aims to take robotic assistance in surgery to the next level. The ARCC project allows

54/ MPn / SEPTEMBER - OCTOBER 2014

cV: The ARCC project is still at its early stage. The worldwide innovation challenge grant will allow us to develop those concepts with the objective of releasing a product in 2016. More than a product, ARCC will be an open platform for further innovations to be developed by EndoControl and its partners.

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 55

Real parts. Really fast. ................

product development team needs parts ........... A to meet its rapidly approaching deadline.

Upload 3D CAD file.

.

How Many Parts?

10–10,000+ parts

Receive a ProtoQuote® interactive quote.

Finalise quote and submit P.O.

Receive order confirmation with gate and ejector layout.

Approve.

1–10 parts

Receive FirstQuote® interactive quote.

From £995

From £50

Mould design and milling.

Parts ready for shipping.

Parts ready for shipping.

Part production.

Finalise options, order.

It’s easy to work with Proto Labs.

Just upload your

3D CAD model and choose the best process for your project:

Machining begins.

CNC machining in 1–3 days or injection moulding in 1–15 days.

Real parts in real materials, in days—not weeks. And that’s the real story. Call +44 (0) 1952 683047 or visit www.protolabs.co.uk

Rapid Prototyping Technologies Visit www.protolabs.co.uk/parts today to receive your FREE copy of our comprehensive comparison of rapid prototyping technologies. Enter source code EUMP13

Check out our video design tips!

© Proto Labs 2013

ISO 9001:2008 Certified

MPN issue 20.QXD_Layout 1 09/10/2014 11:27 Page 56