MPN EU Issue 24 by MPN Magazine

All Medical, All Plastics

MEDICAL PLASTICS news

Catheter finishing Elastomerics Med-Tech Innovation Medtec Europe

The Innovation Issue -

PHILLIPS-MEDISIZE IN THE SPOTLIGHT ISSUE 23

March-April 2015

WWW.MEDICALPLASTICSNEWS.COM

218252 Y Connector

140221 Roller Clamp Body

25659 Pinch Clamp

140222 Roller Clamp Wheel

90400 TexiumÂŽ Valve FLL Luer Activated Closed MLL with Female Cap 52222 Adapter

81460 Plastisol Reinforced Y Connector

Texium is a registered trademark of CareFusion 303, Inc.

11031 Slide Clamp 16107 Forceps

11400 MLL to Barb Connector

11045 Slide Clamp 26100 Cap/End Sealer for Step Adapters Non-Vented

11392 FLL to Barb Connector

34000 Sheet Clip

12524 4 Channel Multi-Cavity Clip

99771 3-Way Stopcock, 2 FLL, Rotating MLL

15003 Flat Pointed Tips Forceps

56014 Parallel Wye Connector

13106 Oxygen Bushing

All trademarks and registered trademarks are the property of their respective owners

Visit Qosina at MEDTEC Europe Booth 5C16, Stuttgart, Germany, April 21 - 23

Reduce Time To Market With Stock Components From Qosina

Visit Qosina.com to see over 5000 stock components, place orders and request a catalog. +1 631-242-3000

qosina.com

info@qosina.com

150-Q Executive Drive, Edgewood, NY 11717

CONTENTS March-April 2015, Issue 23

Regulars 5 Comment Heart of the matter Going back to basics with Lu Rahman

14 Cover story The human touch: Phillips-Medisize shows us its innovative approach

7 News analysis Jury still out on DEHP and medical devices

50 Beady eye Seeing eye to eye with Blink Medical

8 Digital spy Bite-size info from the medical device sector

Features

10 News profile The Innovation Leaders Forum outlines its life science event which aims to unite industry, government and academia 12 Speech therapy TVA Medical in the Q&A hotseat

17 Another dimension Innovation in the device sector including the role of 4D printing 25 Born Slippy Catheter finishing in the spotlight including DIA Technologies’expertise

35 Flexible working Elastomerics in focus 38 Making the connection With Greiner Bio-One’s welding and joining 42 Take the tube South West Polymers outlines its work in extrusion tubing 44 Centre of attention What’s happening at this year’s Med-Tech Innovation 48 Walk the walk How MyGait is impacting the world of orthopaedics

WWW.MEDICALPLASTICSNEWS.COM

Nordson EFD improves

Your manufacturing process

Comprehensive dispensing solutions for lubricating syringes and joining plastic components with greater process control.  For silicone oils, solvents, lubricants, etc.  Fast, precise, consistent deposits  Higher yields and lower costs  Products available - 24H delivery

Scan the QR code to get more details!

EFD International Tel. +44 (0) 1582 666334 europe@nordsonefd.com www.nordsonefd.com

MPN

All Medical, All Plastics

CREDITS

EDITOR’S

editor | lu rahman

comment

online editor | dave gray 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

© 2015 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)

Heart of the matter

n my other guise overseeing European Pharmaceutical Manufacturer, I recently wrote about the way in which new drug formulations can sometimes be found from substances we have had around us for years. A case in point was a study from Edinburgh University that highlighted how discoveries about what helps bacteria thrive in soil could aid the search for new drugs to fight infections. Another was the revelation that the hormone oxytocin could be used to treat alcoholism. It was interesting then to read that similar happenings are taking place in the medical device sector. Given the ongoing advances in devices and materials, Apple’s ResearchKit launch –which has the potential to revolutionise the life science world – and new drug formulations demanding new drug delivery methods, going back to basics is something of a twist on the way the industry is progressing. Women in Bolivia are putting traditional knitting and weaving skills to a different use – for a medical device that seals up holes babies’ hearts. It takes around two hours for each woman to produce the Nit Occlud device in a cleanroom. It has been designed by cardiologist Franz Freudenthal who treats babies from his La Paz clinic. He uses the device to block the hole in the patient’s heart.

“The most important thing is that we try to get really really simple solutions for complex problems,” Dr Freudenthal told the BBC and it’s this statement that’s key. As we continue to move forward with science and technology, sometimes it pays off to look to more traditional methods to help us make progress. It’s a bit like trying to reinvent the wheel. Why bother? Of course we need to make scientific and technological advances in the life science sector but sometimes using methods that have been with us for years, can be just as much of a breakthrough.

“

Going back to basics is something of a twist on the way the industry is progressing

As pressures increase upon medical device manufacturers – costs and skills for example – looking to more diverse methods of manufacture is interesting and shows that as we seek to improve and innovate we need also to examine tried and tested methods, adapting them to what we need today. It also highlights the need for us to retain old skills. In the healthcare environment, stitching is commonplace but now knitting? As more and more of us lose the ability to do anything other than via our computers, it’s almost refreshing to hear of what are considered to be traditional skills staking their claim in the bid to advance the medical device world.

What’s really interesting about this device is that most devices like this – occluders – are produced on an industrial scale but due to the small and intricate design of this one, traditional craft knitters were a better fit.

WWW.MEDICALPLASTICSNEWS.COM

Brilliant performance | ENGEL medical

ENGEL medical Fully-electric machines impress with great performance. The ENGEL e-motion medical series combines best-of-class performance with maximum cleanliness. Optimised for clean room applications, the machine has an encapsulated barrel to minimize particle and heat load, along with encapsulated injection unit drives and an oil return unit on the toggle lever as standard features. The ENGEL e-motion medical is available as a continuous series with up to 500 tonnes clamping force.

Clean and precise. With ENGEL medical. Because it is about life.

www.cimedtech.com

NEWS ANALYSIS

Jury still out

ON DEHP AND MEDICAL DEVICES In 2008, the SCENIHR assessed alternative plasticisers and new data on toxicity in animal and human studies. The verdict: “So far, there is no conclusive evidence that DEHP exposure via medical treatments has harmful effects in humans.” However, “the new information indicates that there is still a reason for some concern for prematurely born male neonates,” because of the high human exposure during certain medical procedures. Again, further studies were recommended. The authors advised a case-by-case approach for alternative plasticizers. Some could be suitable to replace DEHP, while others do not have the same functionalities. A risk assessment of the alternatives could not be performed due to lack of data.

The controversy and the 2014 update In 2012, an LCA by consultant agency eco2win asserted that DEHP-PVC blood bags “pose a significant risk to human health, due to both PVC and DEHP.” The PVC industry was surprised by these conclusions. The European Council of Vinyl Manufacturers commissioned the University of Manchester to review the eco2win LCA, which was found to be inadequate because it failed to follow key criteria normally expected from LCA studies. It also appeared to be motivated by a desire to phase out PVC blood bags regardless of the actual results.

EHP is one of the several plasticisers used in PVC medical devices. Scientists agree that DEHP can leach into the body from tubes, blood bags and other essential medical devices. A number of animal studies posit that DEHP can potentially harm By Ole Grøndahl reproduction among other adverse effects. Hansen, project Paradoxically, the main concern is whether manager at PVCMed, patients are at risk from using life-saving an alliance of medical devices.

the PVC medical industry value chain.

The European Commission’s Scientific Committees have published opinions on DEHP in 2002, 2008 and 2014 (under review). These European Committees must give “sound and timely scientific advice” to the Commission based on “the principles of excellence, independence, impartiality [and] transparency.” As such, their work forms the knowledge base of the legislative process regarding public health, consumer safety and the environment in the European Union. The Committee on Emerging and Newly-Identified Health Risks (SCENIHR)—under whose wings the review of DEHP currently belongs—is composed of fifteen independent scientists from public research institutions appointed by the Commission for a three-year period.

The 2002 and 2008 opinions According to the 2002 opinion, “there are no reports concerning any adverse effects in humans following exposure to DEHP-PVC, even in neonates or other groups of relatively high exposure.” Further, the Committee stressed that DEHPPVC medical devices had contributed tremendously to health care. However, the lack of data did not rule out adverse effects on humans, and the authors called for further research.

Unfortunately, the 2014 update of the 2008 opinion didn’t provide a clearer picture. Male neonates, especially those in ICUs, are considered at high risk of DEHP exposure during medical procedures “due to their physical conditions, the immaturity of many systems and organs as well as their small size.” However, the 2014 opinion states that “DEHPcontaining plasticised PVC devices are important for many treatments and justified because of the benefits of these procedures.” The 2014 draft opinion largely follows the previous opinion on alternative plasticizers. Some plasticizers’ toxicity and carcinogenicity were evaluated but human exposure data or information on leaching is “sparse” according to the draft opinion. For others, data on the toxicological profile is insufficient. The approval of the final SCENIHR opinion is expected by the end of April 2015.

An inconclusive conclusion and the road ahead Authors of the 2014 update reject the asserted links between DEHP and diabetes, obesity and other illnesses in their review of epidemiological and clinical studies. Moreover, the SCENIHR emphasizes the importance of taking a cautious approach to life-saving medical devices. The industry is actively working with relevant governmental bodies to find safe and suitable alternatives to DEHP in medical devices. Alternatives have been developed DEHP can and are increasingly being used in a wide variety of medical applications allowing potentially harm medical equipment purchasers to continue reproduction to benefit from PVC’s unique properties for patient comfort, economic affordability and hospital hygiene. A 2014 report by the Danish health and environment authorities and the PVCMed Alliance identified ten, already-in-use alternatives to DEHP and other phthalates in medical devices. Though more research is needed, most showed a better toxicological profile than DEHP.

WWW.MEDICALPLASTICSNEWS.COM

“

DIGITAL

spy

Breakthrough TECHNOLOGY

APPY TALKING

THIS ISSUE THE MPN TEAM SHARES ITS FAVOURITE APPS Lu Rahman Flipboard – I love this app and use it every day to keep on top of news and trends. The way you can organize and personalize it is great. It’s easy to use and make into something highly useful for both work and leisure. BBC News – can’t beat the tried and tested. It’s a must-go for current affairs. What more can I say? Hootesuite – with three titles to keep on top of, this app helps me manage tweets on the go. WordBrain – addicted to this great little word game that gets unbelievably hard the higher you progress. For someone that spends all day looking at words it’s a bit of a busman’s holiday winding down with this app but this one is a must.

Dave Gray Wunderlist – this app is a great way for me to organise my work. I started using it about a year ago and it’s been invaluable. Made a real difference. Dropbox – this is a must-have for me allowing me to share files quickly and easily. With so many people working remotely these days, Dropbox is perfect for ensuring we all have access to what we need. Spotify – I’m a bit of a music fan so this app is ideal, letting me listen to old favourites as well as more current releases too.

INNOVATION

Researchers at the University of Hertfordshire and a team of European partners have developed a prototype of a robotic glove which stroke sufferers can use in their own home to support rehabilitation and personal independence in receiving therapies. At the chronic stages of stroke, patients are not likely to be receiving treatment but they continue to live with some impairments - the glove’s goal is to provide therapies to target these impairments. Over the past three years the team developed two prototype robotic gloves, which facilitate repetitive movement and exercise of the hand and wrist. The device also records the patient’s performance and sends this to a therapist for tailoring treatment remotely and arranging follow-up. Dr Farshid Amirabdollahian, coordinated the project called SCRIPT (Supervised Care and Rehabilitation Involving Personal Tele-robotics). He said: “This project focused on therapies for stroke patients at home. Our goal was to make motivating therapies available to

people to practice at home using this system, hoping that they have a vested interest to practice and will do so. We tried this system with 30 patients and found that patients indeed practiced at home, on average around 100 minutes each week, and some showed clinical improvements in their hand and arm function.” The overall aim of the project was to provide an educational, motivational and engaging interaction, making a more positive therapy session for the patient, while providing feedback to them and their health care professionals. Given the results achieved, the team is now considering a follow-up project to improve recovery outcomes, while also searching for funding to turn this prototype into a product for home rehabilitation. The team have passed the proofof-concept stage and are now looking at getting the glove into production. See the device in action on YouTube and visit the project’s website to find out more - http:// scriptproject.eu/

LEARNING SPY

Pharmaceutical Training International (PTI) Supplier of online and public, eventbased training courses for the pharma, biotech and medical device sectors, has launched a range of game-based e-learning courses. PTI’s game-based modules offer interactive approaches using both 2D and 3D interactive environments. Users will benefit from an engaging, entertaining and cost-saving method of acquiring skills through role-play in real world scenarios.

WWW.MEDICALPLASTICSNEWS.COM

Speaking about this new approach, PTI’s managing director, Rosie Bernard said: “At PTI, we want to bring the very best learning experience to our customers, whether they are looking for distance learning, event based or tailored on-site training. Game-based learning is a new approach for our customers that will help them develop new skills in a much more engaging and entertaining way.”

www.cimedtech.com

DIGITAL SPY

talking

POINT

MAIN STORY

www.prisymid.com

40% of medical device companies unsure about current labeling process

survey into the key labeling challenges for the medical device and life sciences industries in 2015, has identified regulatory compliance and supply chain efficiency as the key drivers for organisations needing to change or adapt their packaging and labeling operations. The survey, carried out by PrisymID, provider of turnkey labeling solutions for the medical device and life sciences industries, identified regulatory compliance, global standardisation of labeling processes and managing label changes as the three most important challenges for the coming 12 months. With Class II UDI regulations requiring compliance in 2015 and 2016, it’s no surprise that this continues to be a priority for many companies. More than 60% of those companies surveyed cited the labeling of products as ‘business critical’ to the supply chain and their organisation. Maintaining an efficient supply chain is widely acknowledged as a key strategic imperative for businesses across the global medical and life science

TWITTER WATCH MPN’S TOP TWITTER PICKS @digihealthnews News & discussion for digital healthcare We liked. . . Big week for Apple - Apple ResearchKit took hold overnight - but will it last? #ResearchKit @FosterCompounds Development & manufacture of polymer compounds We liked . . . Foster has been specifying, sourcing and processing medical #polymers for over 2 decades @SouthWestpolym1 Material development & polymer processing equipment We liked . . . Wanted to know a little more about plastics but were scared to ask?

sectors. Companies are under intense pressure to reduce costs, curb wastage and increase productivity – and to develop more agile operations that can respond to changes in the global marketplace. Around 70% of companies suggested that they would need to make changes to existing operations in order to meet the regulatory demands. Perhaps more concerning however is that around 40% of those organizations surveyed were either not confident or unsure as to whether their existing labeling process were sufficient, which suggests there is still some work to be done in order to control these issues. Warren Ward-Stacey, sales director at Prisym ID commented: “With the recent changes in regulatory compliance – particularly UDI – it is not surprising that this is still high on the agenda for many organisations. However, organisations should feel more confident in their systems and processes, and with increased market changes and a competitive landscape, this is something that must be addressed now.”

INNOVATION

www.liquiglide.com Smooth customer It’s had a lots of press for its potential as a ketchup-bottle coating that will see the end to residue left inside the bottle but LiquiGlide, the transparent non-stick coating is also being billed as the ‘first and only permanently wet, slippery surface technology’ that could be used for medical applications such as stents and tubes. It could also be used to coat catheters and endoscopes to make them easier to insert.

@medicamatch Linking healthcare businesses We liked . . . Interesting article on “Health care startups booming” #healthcare #medical #medicaldevices WWW.MEDICALPLASTICSNEWS.COM

VANISHING ACT Wireless device prevents infection then dissolves How does it work? Researchers at Tufts University, in collaboration with a team at the University of Illinois at Champaign-Urbana, have come up with an electronic implant that eliminated bacterial infection in mice by delivering heat to infected tissue when triggered by a remote wireless signal. The silk and magnesium devices then harmlessly dissolved in the test animals. The technique had previously been demonstrated only in vitro. Why is it so significant? According to Tufts School of Engineering, this is an important step forward for the development of on-demand medical devices that can be turned on remotely to perform a therapeutic function in a patient and then safely disappear after their use, requiring no retrieval. These wireless strategies could help manage postsurgical infection, for example, or pave the way for eventual ‘wi-fi’ drug delivery. Implantable medical devices typically use nondegradable materials that have limited operational lifetimes and must eventually be removed or replaced. The new wireless therapy devices are robust enough to survive mechanical handling during surgery but designed to harmlessly dissolve within minutes or weeks depending on how the silk protein was processed. The research Devices were implanted in vivo in S. aureus infected tissue and activated by a wireless transmitter for two sets of 10-minute heat treatments. Tissue collected from the mice 24 hours after treatment showed no sign of infection, and surrounding tissues were found to be normal. Devices completely dissolved after 15 days, and magnesium levels at the implant site and surrounding areas were comparable to levels typically found in the body. The researchers also conducted in vitro experiments in which similar remotely controlled devices released the antibiotic ampicillin to kill E. coli and S. aureus bacteria. The wireless activation of the devices was found to enhance antibiotic release without reducing antibiotic activity.

www.cimedtech.com

NEWS PROFILE

Taking the lead T

he Innovation Leaders Conference, run by the Innovation Forum – an international network of companies, researchers, Taking place in e ntr e p r e ne ur s a nd Cambridge, the pioneers – is an annual Innovation Leaders event that aims to bridge the gap between Forum outlines academia, industry and its life science government. Its latest event which aims event at the Cambridge to unite industry, Judge Business School on 16-17 April, promotes government and innovation across life academia science, pharmaceutical, healthcare, engineering and clean tech sectors. Over the last decade, Cambridge has fast become the hub of innovation and enterprise. Dr Marek Tyl, cofounder and chief executive of the Innovation Forum, set up the Leaders Conference to support the next generation of industry innovators and experts, and focuses on university student and academic participation. Tyl has a strong interest in knowledge exchange and education and is a member of an advisory committee for careers development of postdoctoral research at the Medical Research Council (MRC). He said: “The Innovation Leaders Conference looks to facilitate communication, introduce partnering opportunities across

Win win: Last year’s winner, SensorHut, collecting its cheque. L-R Bob Pettigrew, angel investor, Dr Andy Richards, angel investor, Dr Hakan Goker, director, Dr Kevin Johnson, partner at Index Ventures and Matthew Foy, partner, SR One

disciplines and act as a channel for the next generation of technological innovation. “The event is the perfect environment for up-and-coming innovators to be exposed to invaluable opportunities, from networking to collaboration and investment.” There is also the opportunity for entrepreneurs to pitch business ideas to a panel of judges in a Dragons’ Den style, in the hope of creating new business connections and potential partnerships. The event boasts a line-up of speakers from all sectors and occupations including: Kieran Murphy, CEO and president, GE Healthcare, Dr Jonathan Milner, cofounder of Abcam and angel investor and Dr Hermann Hauser, co-founder, Amadeus Capital. Chris Hancock, a consultant at George James, a recruitment consultancy in the science and technology sector and gold sponsor of the event, commented: “The Innovation Forum’s enthusiasm and passion to form better communication between industry, academics and investors is contagious. The conference provides the perfect opportunity for budding entrepreneurs to gain hands on experience networking and pitching business ideas to key, industry figures.” The event, now in its second year, has been extremely successful and has had over 100 companies from around the world pitch their ideas to compete in the Business Idea competition. The winner of 2014’s Business Idea competition, Tanya Hutter, cofounder of SensorHut, an innovative

business that has developed a chemical sensing technology that can be used in applications ranging from chemical process monitoring to medical diagnostics, explains the benefit of attending the event: “I was impressed by the quality of the speakers. There was a good mix of academic speakers, as well as a broad mix of high profile professionals from industry. I felt very inspired by the talks and came away from the event on a real high. It was also useful to be able to talk to people from different disciplines, who were both interested in academic research but also technology commercialisation. “The judges offered up some very interesting feedback and also pointed out a few problems we might have communalising our technology.” The £10,000 competition prize, which includes cash and services by leading law, accountancy and consulting companies, opens up an array of opportunities for companies. From publicity to seedfunding investment from the government, the Innovation Forum The event, now in hopes to accelerate local its second year, business and eventually has been extremely extend the conference successful and network to other areas of the country.

“

Tyl commented: “Due to the large success of the Innovation Leaders Conference, our aim is to help entrepreneurs and promote innovation all over the country. It is an exciting time for The Innovation Forum and its members and we look forward to the future and evolution of today’s technology.”

WWW.MEDICALPLASTICSNEWS.COM

When it comes to moulding, we’re ﬂexible. Introducing liquid silicone rubber moulding at Proto Labs

Proto Labs has recently added Liquid Silicone Rubber (LSR) to its expanding list of injection-moulding capabilities, providing designers and engineers with quick-turn LSR parts in a matter of days! LSR parts can withstand sterilization, are biocompatible, and have excellent thermal, chemical and electrical resistance — all of which makes them ideal for products and devices used within the medical industry. Whether you need 25 prototypes or a production run of 5,000+ parts in plastic or liquid silicon rubber, we’ll have them shipped in less than three weeks. Call us on +44 (0) 1952 683047 or visit us at www.protolabs.co.uk.

LSR Takes the Heat

Request your free technical brief at

protolabs.co.uk/parts Enter code EUMP215

ISO 9001:2008 Certiﬁ ed © Proto Labs 2014 | protolabs.co.uk | +44 (0) 1952 683047

SPEECH THERAPY

VOCAL

exercise very exciting to map out our business strategy with our team as we strive to commercialize the everlinQ system for the benefit of potentially millions of patients worldwide.

Q. Who are you and what do you do?

Adam Berman, CEO and co-founder of TVA Medical. I’ve worked in minimallyinvasive medical devices for 17 years, mostly cardiovascular and I really enjoy bringing new technologies from concept into commercialisation.

Q. What excites you about this industry?

I love the engagement across engineering, clinical research, finance, sales and marketing, regulatory, and reimbursement that is necessary for success in the medical device industry today. The need is stronger than ever for entrepreneurs to identify unmet clinical needs, partner with teams and clinicians on a strategy, and successfully execute to bring lifesaving technologies to patients in need.

Q. How would you sum up your company?

TVA Medical is developing a minimally invasive technology for kidney failure patients called the everlinQ system. It’s an investigational endovascular technology designed to create an arteriovenous fistula (AV fistula) for patient access to a haemodialysis machine without traditional open surgery. This endoAVF approach has the potential to offer patients on hemodialysis a less-invasive alternative to current procedures.

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

I’m excited about the promise of several cardiovascular, neurovascular and of course renal therapies that are poised for substantial growth.

Q. Name a business achievement you are most proud of.

I’m very proud of our everlinQ clinical studies to date, involving our first 100 patients, which demonstrate the positive clinical impact that a disruptive technology can have on kidney disease patients and their families. It’s also been

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

WWW.MEDICALPLASTICSNEWS.COM

I’d have to say PEEK or Pebax – very cool stuff.

COVER STORY

The human touch D

uring the development phases, pharma or medical device companies can encounter obstacles complying with the FDAâ&#x20AC;&#x2122;s drug and medical device regulations, as well as other global regulations that determine which current good manufacturing practices (cGMPs) and quality system regulations Bill Welch, CTO and apply for product manufacturing. There is also the need to manage complicated Jeremy Odegard, supply chain logistics from design, testing Design & Development and development to low-volume clinical Centre (DDC), trial manufacturing as well as the scale-up Phillips-Medisize, to higher-volume commercial production. The most minor detail can derail the explain how a human- development of a successful product, centred design resulting in lost time and resources and philosphy is key for deadlines missed. This could cause successfully integrated product development or regulatory submission to stall before it ever reaches product development the market. Tapping into the expertise of device companies also helps pharma/ biotech or medical companies pitch their product project for success.

The key benefits of this are product adoption and compliance; predictable processing; overall product quality improvement; cycle time reduction and stakeholder satisfaction. The human-centered approach is not limited to a single phase nor is it a stand-alone module that can simply be attached to the front end of a program. It needs to be embedded into the cultural fabric of an organisation in order to be effective.

Human-centered design principles:

Integrated product development

DESIGN RESEARCH Design research activities are typically conducted at the front end of a development cycle in order to establish a firm foundation for future design work. This is required to determine the needs of end users, uncovering attributes that will resonate with them on an emotional level. Common design research methods include targeted interviews, contextual observation (ie, witnessing a surgical procedure in an operating room or shadowing a diabetic patient through their daily testing and insulin injection routine in the home), participatory workshops, analogous product benchmarking, and trend tracking. These processes allow a cross-functional development team to appreciate circumstances, environmental conditions, and user expectations in an effort to identify design opportunities. Discoveries made through design research inform the development process, improving the likelihood of success upon market introduction.

Phillips-Medisizeâ&#x20AC;&#x2122;s integrated product development process combines human-centred design principles with a solid design for manufacturing (DFM) and design for assembly (DFA) philosophy. It addresses design research, industrial design and human factors engineering

INDUSTRIAL DESIGN Industrial designers build upon the foundation of design research, translating discoveries, product performance goals and marketing objectives into tangible concept directions. Product form, user interface, ergonomics,

Project complications and delays can arise as a result of collaboration among disparate organisations. For example, a design firm might not understand what can be achieved in injection moulding processes. Further, designs may not be optimised for manufacturing or assembly. By applying adequate due diligence in choosing the right partner, pharmaceutical or biotechnology and medical companies can improve the odds of launching a successful new drug product into the marketplace â&#x20AC;&#x201C; on time, and on budget.

focusing on product usefulness, usability, desirability, and manufacturability (see fig. 1).

WWW.MEDICALPLASTICSNEWS.COM

MAIN IMAGE

COVER STORY

Team effort: Industrial designers build upon the foundation of design research, translating discoveries and marketing objectives into concept directions

ABOVE The write stuff: Tapping into the expertise of device companies also helps pharma/biotech or medical companies pitch their product project for success. LEFT Part of the process: Design for manufacturing (DFM) and design for assembly (DFA) are elements of robust product development

aesthetic detail treatment, material selection, and manufacturing approaches are all considered during this phase which typically begins with collaborative brainstorming from multiple professional disciplines. Industrial designers then narrow their focus to a manageable set of concepts that may be evaluated through illustrations, preliminary CAD models, and physical prototypes. HUMAN FACTORS ENGINEERING (HFE) The objective of human factors engineering is to minimise use-related risks and ultimately to ensure safe and effective use. HFE activities may include product handling studies, usability testing with representative users, and final verification/validation studies to satisfy regulatory expectations. HFE methods are applied throughout the development cycle to mitigate product related safety risks and justify design decisions. HFE starts early in a design cycle and should be an integral part of the development process. Design inputs such as user profiles, use environment, and other contextual influences must be considered as early as possible. Proper planning, execution and documentation of HFE activities throughout the development process should streamline the submission process for regulatory approval. “Almost all of the extremely diverse medical sectors use and benefit from our HCD approach, among them diabetes, ophthalmology, oncology, gynaecology, cardio-vascular surgical intervention. In the field of medical devices, we are involved in the development of ‘knock-your-socks-off’ technologies and applications – developed all the time – for ever more complex Class III devices, those still requiring pre-market approval. Class III devices are usually those that support or sustain human life,” says Bill Welch, CTO Phillips-Medisize. DESIGN FOR MANUFACTURING AND ASSEMBLY Design for manufacturing (DFM) and design for assembly (DFA) are also foundational elements of a robust product development process. Much like human-centred design principles, a sound DFM/DFA philosophy should be a cultural mindset, becoming ingrained in all phases of development. While HFE evaluation throughout the process is typically focused on the user’s experience, DFM and DFA are focused on manufacturing quality, cost and risk. Certain aspects of DFM, such as design guidelines for moulded plastic or metal parts, have proven manufacturing process principles behind them and applying just a handful of established DFM guidelines for moulded parts can prevent a majority of design issues. The same can be said for DFA, in which planning for manual, semi-automated, or automated assembly from the early stages can prevent issues that would otherwise be found during clinical, pilot,

or manufacturing launch builds when mitigation of issues becomes much more costly. Designers, engineers and manufacturing representatives must collaborate early and often to develop designs that meet targeted quality and cost objectives, and other established program goals. DFM AS A GUIDING PHILOSOPHY Successful DFM requires a culture that unites product development and manufacturing and appreciates early manufacturing involvement from the concept phase. Since most of the product cost (as well as quality and risk) are driven by decisions early in the design cycle, the product development team must include expertise in DFM for the intended manufacturing processes. In the spirit of innovation and creating improved patient outcomes at a lower cost, it is recognised that DFM guidelines must sometimes be challenged. In these cases, the product development team must be committed to risk mitigation by applying computer aided engineering (CAE) tools such as mouldflow, finite element analysis (FEA), and tolerance analysis to an unfinished design, and subsequent prototyping to verify the CAE output. In the case of injection moulded plastic components, the design team understands that part design dictates mould design and can envision how steel is wrapped around part geometry to create tooling capable of meeting the required volumes and quality requirements when in production. From a development standpoint, both the mould geometry and injection moulding process must align with the part requirements, mould construction, and moulding process. Finally, the culture must support the belief that DFM must be applied across the product development process by a fully engaged multidisciplinary team including manufacturing representatives. DFM cannot be viewed simply as a checklist to be completed or a task in the development cycle. Early manufacturing involvement not only brings DFM expertise to the product development team, it also promotes concurrent early learning and buy-in by the manufacturing team, reducing lead time and risk downstream.

Cost-driven solutions Many customers are interested in getting their ideas transformed into a functional product, relying on the expertise of the Phillips-Medisize Design Development Center (DDC) to handle all the industry-critical factors in the shortest possible time. The company has developed an own-product development process to provide time and cost optimised procedures, allowing it to develop the simplest devices to highly complex systems.

WWW.MEDICALPLASTICSNEWS.COM

The Global Market Leader in Contract Sterilization Services

Sterilization Technologies: Gamma Irradiation Pure safe sterilization: we ExCellÂŽ in that.

Electron Beam High-speed, shorter exposure time: discover the power of the stream.

Ethylene Oxide Providing integrity and compatibility as unique as your productâ&#x20AC;&#x2122;s requirements.

Medtech Europe 21-23 April Hall 7, Booth F48

www.sterigenics.com

INNOVATION

Another dimension 4D

printing is selfreconfiguration or selftransformation – its printed elements in a strand, sheet or 3D object that While we are now well- transform into another shape versed in the capabilities of through the use 3D printing, 4D printing is of energy. The increasingly coming to the materials we fore. What is it and what are developing are capable of potential does it hold for t r a n s f o r m i n g the medical device sector? t h e m s e l v e s Stratasys sheds some light without human on this new approach to i n t e r v e n t i o n . These ‘smart’ product manufacture materials have properties which allow them to transform from one state into their programmed state through the use of water as an activation energy. Of course the development of 4D printing has been dependant on 3D printing. 4D printing is fundamentally 3D printing with the added capability of materials transforming over time. With Stratasys’ Connex technology, a single print, with multi-material features, can transform from any 1D strand into 3D shape, 2D surface into 3D shape or morph from one 3D shape into another. Using Stratasys’ Connex multi-material technology, researchers can programme different material properties into specific areas of the geometry and harness the different water-absorbing properties of the materials to activate the selfassembly process. With water as its activation energy, this technique promises new possibilities for embedding programmability and simple decision making into nonelectronic based materials. (Imagine robotics-like behaviour without the reliance on complex electromechanical devices). Self-assembly is addressing the development of smart, multi-functional, responsive materials. In a research collaboration between Stratasys’ Education, R&D departments and the Massachusetts Institute of Technology’s (MIT) SelfAssembly Lab, Skylar Tibbits, Self Assembly lab director, is focussing on developing self assembly technologies for large-scale structures in our physical environment. Tibbits’ 4D printing project is enabled by Stratasys’ Connex 3D printing technology with the added capability

of embedded transformation from one shape to another, directly off the 3D printer.

in this sector – smart materials would be ideal for products such as stents and orthodontics.

With a dedicated education department within Stratasys, the company is working in collaboration with educational establishments worldwide, while looking to push the boundaries of 3D printing in search of new possibilities. In fact, this is how the 4D printing project came about.

“We have an opportunity to make every material a smart material that will respond to any energy source – the medical space right for this,” he says.

Discussing the project with Skylar, not only is the overall concept of self-assembly intriguing but so is the challenge that producing the programmed smart materials pose. The aim here is to combine innovation with academia and push Stratasys technology to new possibilities. In collaboration with Autodesk, Stratasys was able to use Connex multi-material technology to combine two different materials simultaneously in one part, each programmed with a different reaction to water. The goal of the project is create materials that respond to different activation energies and can repeatedly transform state. Think sportswear and sports equipment that adapts to the user and how they’re performing when the body temperature or environment changes around them. For example, their sweat levels, heart rate and body temperature, the environment around them - how hot or cold it is – we’re looking at biomedical applications and many more.

“There are a range of sectors showing interest in 4D printing and medical is one of them,” says Tibbits and believes that the only barriers to the uptake of 4D printing in the medical sector will be the industry itself and regulations. Although not commercially available, self-assembly is just a beginning of a whole innovative world of manufacturing with minimum energy. As environmental, economic, human and other constraints continue to fluctuate, we will eventually need This is what the dynamic systems that DIY and maker can respond with ease and agility. 4D printing movements look is the first of its kind to offer this exciting capability. This is truly a radical shift in our understanding of structures, which have up to this point, remained static and rigid and will soon be dynamic, adaptable and tuneable for on-demand performance.

“

According to Skylar Tibbits 4D printing is what the DIY and maker movements look like. He highlights that the change taking place within the micro and nanoscale level is the ability to make materials change shape and properties. Speaking at the TED 2013, Tibbits mentioned the “ability to programme physical and biological materials to change shape, change properties and even compute outside of siliconebased matter,” revealing that, “there’s even a software called cadnano that allows us to design three-dimensional shapes like nano robots or drug delivery systems and use DNA to selfassemble those functional structures.” So how does this fit into medical device design and manufacture? Tibbits says that the requirements of materials, geometry and energy source to make 4D printing a success, mean it has a definite future

WWW.MEDICALPLASTICSNEWS.COM

Custom Solutions in Polymer Engineering

O EidMual

In d iv

R&D

Design & Tooling

Greiner Bio-One Ltd.

Tel: 01453 825255

Proto-type email: oem@uk.gbo.com

Global Production

Treatments/Sterilisation

@GreinerBioOneUK

WWW.MEDICALPLASTICSNEWS.COM

Â®

Greiner Bio-One Ltd

Packaging www.gbo.com

INNOVATION

On the surface

he risk of deadly hospital infections could be reduced by coating medical instruments and implants with newly discovered materials that repel bacteria, a study suggests.

The personal touch

D printing could become a powerful tool in customizing interventional radiology treatments to individual patient needs, with clinicians having the ability to construct devices to a specific size and shape. That’s according to a study presented at the Interventional Society of Interventional Radiology’s Annual Scientific Meeting. Researchers and engineers radiologists use 3D collaborated to print catheters, stents and printers to develop filaments that were bioactive, giving these personalised medical devices the ability to deliver antibiotics and devices that can chemotherapeutic medications to a targeted area in cell cultures.

deliver antibiotics and chemotherapy in targeted manner

“3D printing allows for tailor-made materials for personalised medicine,” said Horacio D’Agostino, lead researcher and interventional radiologist at Louisiana State University Health Sciences Center (LSUH). “It gives us the ability to construct devices that meet patients’ needs, from their unique anatomy to specific medicine requirements. And as tools in interventional radiology, these devices are part of treatment options that are less invasive than traditional surgery,” he added. Using 3D printing technology and resorbable bioplastics, D’Agostino and his team of biomedical engineers and nanosystem engineers at LSUH and Louisiana Tech University developed bioactive filaments, chemotherapy beads, and catheters and stents containing antibiotics or chemotherapeutic agents. The team then tested these devices in cell cultures to see if they could inhibit growth of bacteria and cancer cells. When testing antibiotic-containing catheters that could slowly release the drug, D’Agostino’s team found that the devices inhibited bacterial growth. Researchers also saw that filaments carrying chemotherapeutic agents were able to inhibit the growth of cancer cells. “We treat a wide variety of patients and, with some patients, the current one-size-fits-all devices are not an option,” added D’Agostino. “3D printing gives us the ability to craft devices that are better suited for certain patient populations that are traditionally tough to treat, such as children and the obese, who have different anatomy. There’s limitless potential to be explored with this technology,” he noted.

How infection risk could be cut with new coatings for surgical devices

Adding a new type of protective layer to medical equipment reduced the numbers of bacteria found on the surface by up to 96%, compared with existing uncoated devices, researchers say.

Preventing bacteria from attaching to medical instruments – such as catheters, breathing tubes and artificial implants – could significantly reduce the risk of infections and disease spread. The cost to the UK economy is more than €1 billion annually. One in 10 hospital patients in the UK is hit by a bacterial infection, and in the US, hospital-acquired infections are estimated to result in more than 90,000 deaths each year. Once bacteria attach to a surface, they create a protective biological layer around themselves – known as a biofilm. It acts as a physical barrier that makes the organisms highly resistant to antibiotics used to combat infections. Coating medical devices with substances that stop bacteria attaching to instruments can prevent the infectious organisms from forming biofilms. However, existing materials are often expensive, are only partially effective, and some risk triggering allergic reactions in patients. A team of researchers and clinicians at the University of Edinburgh used an advanced screening method to identify inexpensive synthetic materials that could be used as coatings to reduce infections. They tested hundreds of man-made materials and found that two significantly reduced the risk posed by various types of dangerous bacteria. Seshasailam Venkateswaran, of the University of Edinburgh’s College of Science and Engineering, who led the study, said: “Bacterial infections on medical devices are a serious and global issue. With the continued emergence of highly antibiotic-resistant bacteria, antibiotic-free polymer coatings which prevent a wide range of dangerous organisms from binding to such devices have tremendous potential to reduce infections.” The study, published in Journal of Materials Chemistry B, was supported by the East of Scotland BioScience Doctoral Training Partnership, and funded by the Biotechnology and Biological Sciences Research Council.

The research team is also able to print biodegradable filaments, catheters and stents that contain antibiotics and chemotherapeutic agents. These types of devices may help patients avoid the need to undergo a second procedure or treatment when conventional materials are used. D’Agostino believes that this early success with 3D-printed instruments in the lab warrants further studies, with the goal of receiving approval to use these devices in humans. D’Agostino also sees an opportunity to collaborate with other medical specialties to deliver higherquality, personalized care to all types of patients. WWW.MEDICALPLASTICSNEWS.COM

P3 medical advert 2015_Layout 1 30/01/2015 11:02 Page 1

P3 Medical Ltd Contract Manufacturing Services

Made in the UK The new DESMA E-Training platform provides you with optimal knowledge transfer, in your own time, at your own pace. www.desma.biz/en/e-training

Our Manufacturing Capabilities in ISO Class 8 cleanrooms • Injection Moulding • Plastic and Tubing Extrusion • Assembly • Bonding • Tipping • Sealing Contact our experienced team to discuss your project today! Tel. +44 (0) 117 972 8888 sales@p3-medical.com www.p3medical.com 20

Soul & Solutions for Global Success

FULL SERVICE FROM DESMA

ALWAYS RIGHT AT OUR CUSTOMERS’ SIDE WORLDWIDE Before, during and after the purchase. DESMA stands by its customers, providing full service and technical support. The dense network of international DESMA production and service locations guarantees knowledgeable consulting worldwide and prompt help. The DESMA team of experts provides advice and support from project engineering to run-off tests. DESMA service technicians can be on site fast in order to ensure secure and on-going production. • • • • • • • •

Consulting and project management from A–Z Assembly, engineering and support Remote consulting and remote diagnosis Reconditioning and upgrades Retrofitting Spare Parts Your experts in rubber Inspection and silicone injection moulding. Training www.desma.biz

WWW.MEDICALPLASTICSNEWS.COM

24/7

INNOVATION

Staying power: Neil Oliver says consumers expect lightweight and thin devices that last up to 12 hours

TAKING CHARGE T

he last few years have seen considerable efforts by consumer electronics companies to enter the wearable and portable medical technology sector, including the launch of development platforms such as Apple’s HealthKit and Neil Oliver, Samsung’s S Health. Many experts are Accutronics looks at concerned about the result of mixing commercial short-termism with traditional the Apple expectation long-term medical device development.

– exploring the use of portable medical devices in home healthcare and patient’s expectations

Think of a medical device and you’ll immediately think of a large, AC mainspowered machine like a ventilator, anaesthesia machine or medical imaging equipment such as an MRI, PET or CT scanner. However, dig a little deeper and you’ll realise you’re probably carrying one in your pocket. A typical smartphone now carries the computing power historically limited to process intensive industries such as space exploration missions. It is this ambiguity which is blurring the line between a consumer electronic device, such as a smartphone or smartwatch, and a fully-fledged professional medical device. Designed for portable use to monitor, diagnose and inform long term treatment plans, the functions performed by professional medical devices, such as pulse oximetry, blood pressure monitoring, kidney diagnosis and glucose meters, have opened the market to consumer manufacturers and third-party app developers, putting patient health at risk.

Design traits typical of consumer devices are defining the normally expected characteristics of portable medical devices. As consumers we have come to expect lightweight and thin devices with often embedded batteries that last up to 12 hours and products that are replaced with new versions every 12 months. Because product development lifecycles (PDLCs) for medical devices are typically longer, around ten years, removable rather than embedded batteries are the norm. This allows backup batteries to be used in the field, effectively extending battery life on the fly as well as meaning that users can easily replace batteries at the end of their life. It’s normal for Lithium-ion (Li-ion) batteries to provide 300-500 charge cycles before the battery life drops to an unacceptable level. Excessively reducing weight and thickness for aesthetic purposes can also have a knock on impact on battery life and quality. Less space means the battery’s volumetric and gravimetric density will be limited, affecting its total lifespan.

Home healthcare The innovation in portable and wearable devices has largely been the result of an ageing population all over the world. As more and more developing countries reach a median stage in their demographic transition model, life expectancies continue to rise at the same time that birth rates decline.

WWW.MEDICALPLASTICSNEWS.COM

www.cimedtech.com

INNOVATION

This trend has led to the rise in age-related, long term health conditions. The most common chronic conditions are high blood pressure, Alzheimer’s, heart disease, depression, arthritis, osteoporosis, diabetes, cancer and stroke. It’s no surprise then that this trend is proving challenging for an already over burdened hospital and inpatient infrastructure.

“

Medical devices designed for use in hospitals were never intended for use in the home

Research by the US Food and Drug Administration (FDA) has shown that, ‘as patients move to the use of home health care services for recuperation or long-term care, the medical devices necessary for their care have followed them. In fact, according to results of the 2000 National Home and Hospice Care Survey approximately 1,355,300 patients were receiving home health care services from 7,200 agencies. In 2004, the National Association for Home Care & Hospice reported that more than 7 million people in the United States receive home health care annually.’ However, the medical devices designed for use in hospitals by trained professionals were never intended for use by patients in the home. As a result, many patients, especially those who do not have the regular assistance of a dedicated home healthcare professional, struggle to operate, understand, maintain and troubleshoot devices. This has spurred third-party manufacturers to cater for patients looking to fill the void with pseudo-medical devices that feature familiar ergonomics and heuristics.

Industry collaboration Being part of a company that has over 40 years’ experience in the design, development and manufacture of batteries for medical devices, I’ve seen my fair share of trends come and go over the years. To embrace this latest innovation in wearable and portable devices used predominantly in a home healthcare environment, Accutronics’ innovation philosophy embodies an ethos of a holistic product development process. Although it’s important to take a holistic approach when designing batteries for hospital based medical devices, it’s absolutely vital when designing portable products for use in home healthcare. The smaller size and lower mechanical tolerances mean that if battery design is left as an afterthought, as it so often is, it could lead to the commercial failure of the product. At Accutronics we advocate a widespread industry collaboration between numerous stakeholders, including design engineers, manufacturers, healthcare professionals and healthcare organisations as well as regulatory and

Smart effort: Accutronic’s range of batteries incorporate a powerful Lithium-ion battery with smart protection circuits that prevent overcharging, over discharging and overheating

accreditation bodies. Reducing the fragmentation so prevalent in the industry currently, will create a culture of sustainable product development, one that’s required to face the challenges posed by the paradigm shift towards home healthcare. Our range of credit-card batteries have been designed to overcome these problems by incorporating a powerful Lithium-ion battery with smart protection circuits that prevent overcharging, over discharging and overheating, all packaged in a credit-card sized unit. As well as this, algorithmic software security prevents fake batteries being used in these health-sensitive portable and handheld devices. The yellow card system used by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is used in the medical industry to allow patients to report the adverse effects of medicines and incidents occurring from the use of medical devices. Raising awareness of methods like these will ensure that the right feedback is given to manufacturers to improve their products, undergoing any clinical testing where necessary.

A holistic approach is vital when designing portable products

So, as companies like Samsung and Apple enter into the wearable medical space, a concerted effort by all stakeholders will ensure that commercial short-termism can be turned into sustainable long term improvements in our health and, more importantly, in our quality of life.

Grand design: Innovation in battery design

“

WWW.MEDICALPLASTICSNEWS.COM

ADVERTORIAL

Nolato Medical offers tight tolerances with high process capability.

Nolato Medical’s catheter balloons are known for their extremely high quality Nolato Medical is a world leading supplier of high quality latex catheter balloons. The balloons are used worldwide by major medical device manufacturers. Sales have grown strongly in recent years because of Nolato Medical’s high level of service and outstanding quality. The balloons are known for their superior material properties in purity, symmetry and resilience. These properties are crucial for several catheter applications such as Embolectomy, bipolar pacing, stone extraction and thermodilution. Applications where the balloon is often the most critical component. “A validated process and an excellent raw material compound are keys to manufacture catheter balloons efficiently with high quality,” explains Kristian Sandberg, product manager at Nolato Medical.

New product development projects During recent years, Nolato has been part of several successful NPD projects. “We can offer a dedicated and experienced project team assisting in balloon design. Additionally, we have very short lead times for balloon samples,” Kristian Sandberg adds.

Outsourcing of in-house manufacturing Through efficient outsourcing programs, some customers have completely shut down in-house balloon manufacturing and outsourced the operations to Nolato Medical. Outsourcing to Nolato ensures improved quality at a lower overall cost. “One of our customers, a major US based medical device company, lowered their market complaint rate by 40 percent using Nolato Medical’s latex catheter balloons,” says Kristian Sandberg as an example of a successful program. “An improved balloon quality opens up possibilities for increased sales for your balloon devices,” he ends.

Nolato Medical is a long-term, global partner within the development and production of polymer products for market-leading medical technology and pharmaceuticals customers. Fifty years of experience in advanced medical technology operations has given us a firm foundation of cutting-edge expertise and quality awareness, which feature strongly in everything we do today. For more information about catheter balloons, please contact Kristian Sandberg, product manager at Nolato Medical. Phone +46768 880061 or e-mail kristian.sandberg@nolato.com.

www.nolato.com/medical Visit us in our stand at Medtec Europe STAND No. 5D10

G ET

Y O U R

EXTRUSION PROJECT

DONE Medtec Europe, Booth 5C40

([WHQVLYH YHUWLFDOO\ LQWHJUDWHG FDSDELOLWLHV 'HHS H[SHUWLVH LQ 37)( 3((. )(3 DQG RWKHU KLJK SHUIRUPDQFH PDWHULDOV KHDW VKULQN WXELQJ DQG PXOWL OXPHQ 'HFDGHV RI H[SHULHQFH :H DUH WKH H[SHUWV ZKHQ LW FRPHV WR DOO WKLQJV H[WUXVLRQ 2XU WHDP KDV ZKDW LW WDNHV WR LQVSLUH LQQRYDWLRQ IROORZ WKURXJK RQ HYHU\ GHWDLO DQG XOWLPDWHO\ JHW \RXU SURGXFW LQWR WKH PDUNHW

Work with the Extrusion Experts™ /LPHULFN ,UHODQG | 3KRQH (PDLO RHPLQIR#WHOHÁ H[ FRP :HE ZZZ WHOHÁ H[PHGLFDORHP FRP 6RFLDO PHGLD )DFHERRN /LQNHG,Q DQG *RRJOH

/HW·V ZRUN WRJHWKHU WR FUHDWH VRPHWKLQJ DPD]LQJ 7HOHÁ H[ ,QFRUSRUDWHG $OO ULJKWV UHVHUYHG ´:RUN ZLWK WKH ([WUXVLRQ ([SHUWVµ LV D WUDGHPDUN RI 7HOHÁ H[ ,QFRUSRUDWHG

extrusions

catheters

components

medical devices

CATHETER FINISHING

www.cimedtech.com

BORN SLIPPY D

emographics are playing a major part in the increased demand for today’s medical devices. This is due DiaNia Technologies is to an ageing population, solving many catheter rising health problems by harassing p r o b l e m s advanced polymer in younger chemistry through generations eg obesity, materials science and d i a b e t e s , engineering h e a r t disease etc and an increase in home healthcare with the transition of acute illnesses into chronic diseases. Increasing healthcare costs are a constant topic on the agenda of all world leaders. Consequently, cost containment and austerity has forced many device manufacturers to rethink their long term product strategies through innovation. One of the major issues encountered by users of catheter-based devices is the difficulty in delivering the device to the desired location in the anatomy, with a range of associated clinical risks from artery perforation and emboli formation to stroke and possible death. Extruded tubing is the core on which most catheters are built, with low friction being a key characteristic in reaching the correct location. However this low friction attribute within the system is the leading cause of problems like delamination, bond failures, leaks and detachment, buckling and crimping as illustrated in Figure 1. Current methods to reduce friction include Teflon/PTFE liners and/or hydrophilic coatings. These products are applied to the extrusion surface which

adds numerous process steps and associated costs to the manufacturing cycle. Furthermore, the strength of the bond between all these components is dependent on the extrusions’ surface and is critical in facilitating function and safeguarding patient safety. Essentially the clinician’s demand for lubricity conflicts with the manufacturers need to secure device features such as soft tips, balloon bonds and stent retention. Through the provision of in-built lubricous surfaces on the inner and outer diameter of an extrusion, ExtruLub technology not only has the ability to reduce both product and organisational costs but also facilitates reduced device profile enabling entry into smaller vessels. X-ray photo spectroscopy (XPS), an analysis technique used to obtain chemical information about the surfaces of solid materials, was used to show that the properties at the surface of the ID and OD of an extrusion could be modified compared to a control group. The coefficient of friction (COF) of pure Teflon liners is stated at close to 0.1, which became our first friction target. Subsequently, the COF was measured using the ASTM D1894 standard with a polymer on polymer test set up. The target COF was achieved with a hydrophilic ExtruLub surface in the PEBAX 7233 bulk resin. A second feature of the ExtruLub technology is in the significant reduction in manufacturing cycle and complexity. Here it is compared in two sample devices, an intermittent catheter and a cardiology

Figure 1 While positioning a catheter into the heart, there is a potential for buckling and/or crimping between catheter devices due to an excess of friction

introducer. Higher value and margin opportunities are possible for the OEM at both the product and organisational level through reduction in process cycles, as is clearly evident from Figure 2. In the case of an intermittent catheter, manufacturing costs of €1.00 are generally broken out into 40% materials, 40% Packaging and 20% Overheads, with an average Actual Selling Price (ASP) estimated at €1.66. Cost containment could realise an increase in gross margin of 13% per device. This increase multiplied by annual volumes, commonly for this type of device in the order of 100 mn units, could equate to savings in the region of tens of millions. In the second example, the containment of costs for an introducer is attainable through yield improvement, estimated at 17%, reduction in related costs and overheads at 50%, with further savings through shorter validation and production timelines. Hydrophilic coatings purport to enhance surface

WWW.MEDICALPLASTICSNEWS.COM

friction below values of 0.05, however, as the human body cannot differentiate friction below 0.05, our next friction target is to achieve 0.05, on which work is progressing well. The goal of DiaNia Technologies is to license ExtruLub technology to the OEM, enabling them to maintain control over their product lifecycle. So far innovation in catheters has relied mainly on novelty in engineering with surface modification achieved through coatings and polymer liners. DiaNia Technologies is solving many catheter problems by harassing advanced polymer chemistry through materials science and engineering. This type of solution is the key to advancing the next generation of medical devices globally, reducing clinical risk and facilitating new therapies whilst increasing the capability of current diagnostic and therapeutic treatments.

Figure 2 Impact of ExtruLub technology on the manufacturing cycle of (A) an urinary intermittent catheter and (B) a cardiology introducer

CATHETER FINISHING

Put to the test I

ncreasing regulatory pressure is challenging medical equipment manufacturers to meet strict requirements in design, testing, and production. This trend is reflected in catheter systems that are used for vascular surgery along with coronary stents. Alan Thomas, Zwick There are many types of catheters Roell, advises on including those used to transport small addressing catheter instruments or repair devices to a particular testing challenges site in the body. Some catheters have small built-in tools so that a surgeon can repair a problem in the patient’s body without having to perform open heart surgery, while some can deploy a stent that will keep an artery open. For surgeons, challenges associated with such procedures include feeding catheters into femoral arteries, navigating sharp turns, and advancing the device without damaging tissue. Manufacturers of catheter systems work closely with surgeons to develop standard and custom catheters, stents, and guide-wires to meet these challenges.

Track force, push efficiency, insertion force measurement, guide-wire movement, flexibility, guide-wire and catheter lubricity track measurement.

FIGURE 2

FIGURE 1

Catheter manufacturers continually monitor their product by physically testing the complete units, as well as individually testing the component parts. To properly test such devices, catheter manufacturers need to replicate the condition of a patient lying on an operating table and a surgeon inserting a catheter. ‘Pull-off’ testing is important because joined parts should not fail when the catheter is inside the patient. Stents are tested, both in compression and flexure modes, and the frictional behaviour of the complete catheter is measured as it is pushed through a simulated artery known as a ‘tortuous path’. To facilitate this action, Zwick Roell has developed a system that controls the test machine crosshead and special automated pneumatic grips. The horizontal machine is essentially a test bed that incorporates space above and below the main test axis to accommodate 3D models and water baths. In a typical test, the testing machine pushes the catheter into the tortuous path for a designated distance before the pneumatic grip then releases the catheter and the crosshead moves back to the original start point. The pneumatic grips close onto the catheter, moving the crosshead forward once again. This sequence is repeated until the catheter has been fully inserted into the simulated artery. This test procedure, which is fully automated, can easily accommodate different sizes of tortuous paths and the machine software enables the following results to be calculated:

The results can be calculated with high precision. The extremely stiff load frame with digital control and drive systems ensures that forces measured during the test originate from the sample under test and not from within the machine itself. The machine control system has such a high degree of accuracy and resolution that it can position the crosshead of the machine to less than 1 €m, and read forces to an accuracy of better than 0.5% down to values of less than 0.1 mN/0.02 lbf The machine software platform can control all of the test parameters including the safety features of the testing machine. At the same time, it can acquire and process the raw test data in real-time and store this data, as individual data points and as calculated result data. Stringent regulatory environments require the ability to maintain accurate records of the testing procedures and results. Record keeping requirements are described under FDA 21 CFR Part 11. Part 11 requires drug makers and medical device manufacturers, biotech companies and other FDAregulated industries to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are required to be maintained by FDA predicate rules or used to demonstrate compliance to a predicate rule. Record keeping to satisfy Part 11 standards, can be integrated as an option into software. Medical device companies can take full advantage of this feature and save the costs of third party accreditation. The software includes the functions; “Electronic Records and Signatures” for complete digital documentation of all safety critical tests. Test results can be automatically stored in the customer’s database. Operator and environment safety concerns are also critical. The testing equipment can be supplied with splash-proof electrical connectors and a supplementary emergency stop button for additional safety. A software plug-in is available that enables a standard video camera to be connected to the system to record the test sequence. The incoming video signal is automatically synchronised with the force and displacement data. It allows a more complete record of the test to be saved or transmitted to interested third parties.

WWW.MEDICALPLASTICSNEWS.COM

-0. /CTOBER!D PDF

-9

#-9

$!%##

The perfect fit for all your minimally invasive device solutions

+ Design and Development + Complex Extrusion and Moulding + Catheter Balloons + Braiding and Coiling + Advanced Delivery Solutions + Catheter Assembly and Packaging

www.vistamed.net Visit us at Medtec Europe Hall 5, Booth 5E24

WWW.MEDICALPLASTICSNEWS.COM

CRITICAL CARE. That’s what we put into every package.

Barger’s Elkhart, IN facility is now

ISO 13485

At Barger, our 100% medical focused team will work with you to create protective packaging that’s intuitive, functional, and cost-effective. Whether you need a simple non-sterile thermoformed tray, or a complex double sterile barrier system – we have the people, process and precision you’ve been searching for.

certified.

VISIT BARGERPACKAGING.COM TO LEARN MORE

WWW.MEDICALPLASTICSNEWS.COM

CATHETER FINISHING

www.cimedtech.com

CONTROLLING

behaviour T

he extrusion process and catheter finishing processes are inextricably linked and balancing them can be complex. There are a number of variables that can affect the performance of the According to finished product; these Vistamed, tightly include the properties of the raw material controlled inputs and the extrusion deliver optimal process itself. Careful performance consideration of the when dealing with process is essential to ensure consistency and extrusion and repeatability. catheter finishing The manufacture of high quality extrusions used in sophisticated catheter systems is affected by tight control of the ‘inputs’ – the greater the control of the inputs, the higher the probability of achieving the desired ‘outputs’ necessary to develop and manufacture high quality extrusions. INPUTS: Extrusion environment; raw material; storage conditions; resin drying; extrusion equipment; auxiliary equipment; tooling; personnel. OUTPUTS: Process stability in order to consistently meet the agreed upon customer specifications, such as dimensional; visual; mechanical properties; physical properties; functional specifications The tolerance expectations from customers are challenging the boundaries of extrusion capability. It has become more significant for tubing manufacturers to maintain close control of their inputs and close control of the extrusion process. An understanding of polymer science and material behaviour is crucial for producing highquality catheters and balloons. The morphological structure of the thermoplastic material can change with varying thermal conditions which determines key physical properties such as strength and flexibility. The polymer exits the die head of an extruder in an amorphous state and the rate and length of the cooling

downstream from an extruder controls the degree of crystallinity of the final product. In some medical applications such as balloon forming, it is critical that the extruded tubing is amorphous prior to the balloon forming process. Therefore, the cooling parameters and cooling method used are critical to ensure that crystallisation does not occur in the tubing during the extrusion process. In other applications, such as the extrusion of PEEK tubing, it is critical that the PEEK tubing achieves a relatively high level of crystallinity during extrusion to ensure that the tubing utilises the outstanding properties that PEEK possesses. To produce high quality balloons and catheter systems it is fundamental to have all the extrusion inputs under control. Extremely tight dimensional tolerances for tubing must be maintained for consistent balloon quality and desired performance. A sophisticated extrusion process with precise in-line monitoring and control is crucial to achieving high quality balloon tubing. Small process variations can hinder the quality and performance of the final product. These variations potentially impact melt homogeneity and can result in variability in balloon tubing performance. Polymers can degrade due to excessive temperatures or high shear stress causing deterioration in the material molecular weight which compromises the material’s performance. An important first step in achieving optimal catheter performance is to choose the right materials for the catheter delivery system. Leading-edge polymers have begun to replace traditional materials and these new polymers are being integrated into the design of next-generation catheters. For optimal performance, engineers need to consider the biological, physical, and chemical characteristics of polymers and the growth of new break-through manufacturing processes.

In order to optimise catheter performance and achieve optimal results several features should be incorporated: Braid/coil 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 pathways. Use of hydrophilic coatings delivers high lubricity for low insertion force or a reduction in friction for a specific delivery application. Soft tip and multi-durometer segments along the length of the catheter provide excellent atraumatic entry and manoeuvrability. Radiopaque contrast at the tip and key segments offers better visibility for the physician to visualise accurate anatomical placement. Steerability and deflection for optimal navigation. To achieve some of these attributes, a number of design aspects can affect performance and design: Varying material durometer along the outer jacket length will provide a number of flexibility options. Different levels of flexibility and kink resistance can be achieved by varying the pitch of the braid on the shaft. Braid patterns will affect flexibility and torque response. Wire options can also effect catheter performance; round wire will provide a more flexible shaft while flat wire will deliver a lower profile and less flexibility. Hybrid coil-braid designs can also offer the best balance between torque, flexibility, and a thin wall solution. Requests are on the rise for braided shafts with the lowest possible wall thickness while maintaining adequate levels of track and kink resistance. Controlled extrusion inputs combined with a robust extrusion process play a key role in achieving these nextgeneration catheters.

Fig 1: Braid to Coil delivery system

WWW.MEDICALPLASTICSNEWS.COM

CATHETER FINISHING

Figure 3. Holes laser cut into a polyimide catheter

Figure 1 laser marked catheter

Figure 4 Holes laser drilled in braided catheter with PTFE liner and nylon outer layer Figure 2 End of catheter that has been stripped and cut by laser

BRIGHT

ideas

number of factors have to be taken into acount when laser micromachining of polymer catheters. Compared with metals, polymers are more flexible and tend to move during processing. This problem becomes more significant when machining small features (<50Âľm) on thin-walled tubes. The ability utilise machine vision track the tube position in realtime, allows for high cutting speeds David Moore and while holding tight tolerances of +/-5um David Gillen, Blueacre over long parts.

Technology, offer their expertise when it comes to the laser processing of catheters

In the past pad printing of inks onto catheters has been the main process whereby marks are added as indicators of position or for part traceability. However with advances in how laser beam delivery have been integrated with part handling systems, it is now possible to laser mark over the full length of a catheter device. Blueacre Technology has developed equipment capable of marking over catheters over a metre in length. As the marks are part of the catheter material, they do not suffer from bio-compatibility and fading issues associated with traditional pad printing techniques.

Catheter finishing One of the issues with cutting the end from a braided catheter it that there is no longer a restraining force on the braid, which can un-coil. Figure 2 shows a catheter that has been cut using a laser process developed by Blueacre Technology. This cutting process prevents the braid from un-coiling and allows a distal tip to be overmolded without an increase in profile diameter. As medical technology develops so does the demand to cut holes in the side walls of catheters. There are a number of applications for catheters with such side holes, from drug infusion to arterial flushing. The core requirement for side holes is to produce a feature that has a clean edge without any burr or raised portions. An example of catheter holes in a polyimide catheter are shown in Figure 3. Laser machining allows holes down to 10um in diameter to be drilled with both high precision and tolerance. It is also possible to machine very clean features in multi-layer materials that include PTFE/Nylon combinations. The drilling of side holes in braided catheters has a number of issues, as the inclusion of a metal layer adds increased process requirements on the laser. If the hole is not machined with minimal heat input, the outer layer can soften, the braids can push outwards and the profile increases. In the worst case scenario the braids can protrude through the outer layer leading to the possibility of trauma. Figure 4 shows images of holes drilled into the sidewall of braided catheters and with careful choice of laser parameters it is possible to cut clean holes with no damage to the braid.

WWW.MEDICALPLASTICSNEWS.COM

See us at Medtec Europe, Booth 7E10

PRODUCT FOCUS

THE JET SET

ith the ability to apply consistent shots as small as 2 nanoliters at speeds ranging from 150 Hz (cycles per second) up to an industry-leading continuous 500 Hz, the Pico system is ideal for high-speed, high volume applications that require many precise fluid deposits. The narrow Nordson EFD says small, design of the valves, with a width of its jet dispensing approximately half an inch, makes them system improves particularly well suited for installations process control where space is tight or valves need to be mounted close to each other.

and reduces costs in medical product manufacturing through fluid deposit repeatability at high production speeds

Because the valve nozzle does not contact the substrate, the Pico system is also a good choice for applications where controlled amounts of fluid must be applied on surfaces that are not perfectly flat or when contamination or damage may occur to fragile substrates through contact with the needle. In the case of medical electronics, with so many components tightly spaced on a small board or device, it is difficult to place the needle in many areas or get close to components. By eliminating contact with the substrate, the Pico system solves this issue and also allows to eliminate the need for vertical Z-axis movement and precise height positioning, which can significantly increase production speeds.

Pico valves are available in several different configurations to handle fluids with a wide range of viscosities. Nozzles are available with 150€m, 200€m, 300€m and 400€m orifice diameters to accommodate a wide range of dot sizes. Most Pico valves, except those used exclusively for lowvicosity fluids, incorporate a heater near the fluid channel in order to thin the fluid to its optimum jetting viscosity. Depending on the rate of consumption, fluid can be supplied to Pico valves from syringe barrels, tanks or drum unloader systems. Valve controller. The Pico valve controller is available in 2- and 4-channel configurations. Both versions feature a graphical digital display and a user-friendly menu system that makes it easy to set the fluid application parameters for each valve. Complex jetting processes can be easily created on a PC and downloaded via the integrated SD card slot. A password protection feature ensures that standard The range of possible procedures are not changed accidentally, applications is huge helping to achieve repeatable results.

“

The new generation of valves have a modular design and offer the flexibility to swap out only the parts that might be worn out while keeping the valve body in place. Replacing just the worn out part instead of the entire valve saves both money and time. When only the faulty part of a valve needs replacing, it only takes minutes to change, rather than hours or days. Price point: According to Nordson, its jet dispensing system improves process control and reduces costs

The range of possible applications is huge. Sample uses include electronics (bonding cell phone speakers with UV-cure adhesives), life sciences (attaching needles to medical syringes), and precision mechanical applications (jetting small amounts of grease on micro gears). Jet valve. The Pico jet valve contains two piezoelectric actuators composed of stacked ceramic coins that expand and contract in response to changes in voltage supplied through the valve driver. The extremely fast action of the piezoelectric actuators makes it possible to dispense fluid continuously at speeds of up to 150 cycles per second. Depending on the fluid being dispensed, the system can produce consistent shot volumes as small as 2 nanoliters, and the high resolution of the Pico valve controller (0.01 milliseconds) makes it possible to adjust deposit size with exceptional precision. WWW.MEDICALPLASTICSNEWS.COM

ELASTOMERS

Bend it shape it: Medical device manufacturers are turning to thermoplastic elastomers (TPEs) for applications that require flexibility

Flexible working

edical device manufacturers increasingly turn to thermoplastic elastomers (TPEs) for applications How TPEs are that require flexibility emerging as or rubber-like elasticity. materials of choice These compounds ave replaced for medical devices, halternative materials by Ross Van like thermoset rubber Royen, Teknor and PVC in standard Apex Company applications like tubing, bags, pouches, drip chambers, masks, cushions, syringe tips, ventilator bags, luers, stoppers, gaskets, seals, and dropper bulbs. And as designers have come to appreciate the value of TPEs, more and more are using these elastomers for new applications. Versatility is one reason for the growth of TPEs in medical devices. TPE compounds now on the market meet a range of end-use requirements and for any given application, there may be two or more chemically different TPE types on offer by suppliers. The Medalist range of medical-grade TPEs from Teknor Apex, for example, includes compounds based on styrenic, olefinic, and vulcanizate polymers, and within each of these broad polymer families there are differing chemistries. Within this selection of TPEs, hardnesses can range from ultra-soft or gel-like to semi-rigid; optical properties can range from water clear to opaque; and there are grades available to meet most requirements for strength, lowtemperature toughness, heat stability, and chemical and UV resistance. TPEs can be injection or blow moulded, multi-material- or insert-moulded, and extruded or co-extruded into film, sheet, profiles, or tubing. TPEs are excellent candidates for medical applications due to their chemical inertness or ‘clean’ ingredients. Medical grade TPEs are made with FDA compliant raw materials and are free

of phthalates and latex proteins. In addition, TPEs are inherently designed to have extremely low extractables or leachables, even when in contact with aqueous based systems (like bodily fluids). Medalist TPEs are considered biocompatible per ISO 10993 testing protocols for cytotoxicity, irritation, and sensitisation. Products made from TPEs can be sterilised by e-beam, gamma, ethylene oxide, or autoclave methods. Besides versatility, a second reason for TPE growth in medical devices involves their advantages over alternative materials. The most obvious advantages stem from the fact that TPEs are thermoplastics. They process more efficiently and economically than thermoset rubber, provide greater design freedom, exhibit a wider range of color options, and, unlike rubber, can be recycled. At the same time, TPEs provide device manufacturers with a means of obtaining comparable or even superior properties while avoiding problems associated with certain alternative materials. This has been particularly apparent in replacement of the following: PVC. In the medical device industry, there is movement away from PVC compounds due to the phthalate plasticizers they contain. Although phthalate-free PVC compounds are available for medical applications, many medical device manufacturers are still concerned with the life cycle management of PVC and are looking for alternatives. Teknor Apex offers Medalist TPEs that can be used as alternatives to PVC in films and bags, face masks, and tubing. These TPEs exhibit the same crystal clarity and processability as flexible PVC compounds but are phthalateand oil-free. In addition, TPEs remain flexible even at low temperatures, unlike PVC and olefinic materials, which generally stiffen and can become brittle. This becomes important for bag

applications where fluids are stored at low temperatures. TPEs would better preserve the integrity of the bag, making it less susceptible to rupture. LATEX. Medical manufacturers seek alternatives to latex due to protein allergies, concerns with the level of extractables or leachables from the cure system, and odour. Another factor is economics: Processing rubber is more laborious than processing TPEs, and TPE processing scrap is recyclable. Typical applications include extruded film and dipped anaesthesia bags. SILICONE RUBBER. Often silicone is over-engineered for applications which don’t require high heat resistance or low compression set at elevated temperatures. Silicone surely has its benefits, including being able to withstand multiple sterilization cycles, but for certain applications, Medalist TPEs are a more cost-effective alternative. In many cases, they offer improvements over silicone. Typical applications where TPEs can be used instead of silicone are drainage tubing, bottles, and bags; peristaltic pump tubing; face mask cushions; resuscitation bags; and seals, gaskets, and diaphragms. The move to alternative materials is also taking place among TPEs themselves. For example, the device industry is seeing a shift from thermoplastic vulcanizate (TPV) elastomers to other TPEs, in particular those based on styrene block copolymers. TPVs were first to market as a replacement for rubber and became well established in many medical applications. They exhibit superior compression set at high temperatures in comparison with other TPEs. In most medical devices, however, the product is not exposed to high temperatures and TPVs are over-engineered for the application. Furthermore, at 70€C and lower, styrenic TPEs often have a better compression set than TPVs.

WWW.MEDICALPLASTICSNEWS.COM

ELASTOMERICS

Breathe easy: Respiratory care masks can be made from TPEs moulded with an engineered polymer substrate in one step, producing an excellent end product in less time and at a lower cost

Flexi-time

s new technologies and materials become available, medical devices and components continue to evolve in the rapidly Josh Blackmore, changing healthcare RTP Company, market. Over the past discusses the decade, devices ranging from surgical tools to advantages of using respiratory masks, and thermoplastic even straightforward elastomers in components like tubing healthcare devices, and connectors, have experienced dramatic by Margaret Cox, transformations in their RTP Company look and functionality. Designers and manufacturers alike have experienced a great deal of success in improving functionality and appearance through the use of thermoplastic elastomer compounds (TPEs).

TPE form and function TPEs are specialised thermoplastic compounds that provide many functional capabilities, such as slip resistance for surgical tools even when the user wears gloves. When the material is overmoulded onto rigid thermoplastics, a non-slip grip and/or a ‘soft-touch’ feel is created, which significantly enhances the ergonomics of a device. According to Josh Blackmore, RTP Company’s global healthcare manager, the trend for medical device designers is to use softer TPEs in the Shore A4560 range, which allows the user to form a depression and improve the mechanical advantage, ergonomics, and tactical control. TPEs also offer a range of product differentiation possibilities. “TPEs can enhance perceived value and provide dramatic visual presence through the use of unique shapes and colours,” says Blackmore. “Furthermore, TPEs can be an excellent cost competitive alternative to other medical grade materials such as thermoset rubber and engineered polymers.”

Why TPEs are an excellent choice for medical devices There are many reasons why TPEs are an excellent choice for medical devices. Designers and manufacturers often use TPEs to capitalise on the non-slip grip and/or a ‘soft-touch’ feel they provide. This technique is particularly useful for surgical tools and electrocautery cutters, improving the instruments’ grip and comfort level for extended periods of use. TPEs can also be used as a replacement for other materials. For example, respiratory care masks, which are typically made from silicone rubber, can be made from TPEs moulded with an engineered polymer substrate, providing a high degree of clarity and low tack for contact with the patient’s skin. In addition, by utilising a two shot technique, a part can be produced in one step, which reduces assembly costs and cycle time. Another great example is that of extruded TPEs, which are used as replacements in tubing applications to replace PVC, thereby eliminating the use of phthalate plasticizers. If allergic reactions are of concern, TPEs are an excellent latex-free and PVC-free material option. In fact, the appearance and functionality of a device is more rugged and durable simply by overmoulding TPEs around edges and corners. This simple enhancement improves the actual and perceived life of the device itself, and ultimately, the marketability of the product.

Proper material selection eases path to approvals Of course, designers and manufacturers must also take great care to ensure the safety of the medical devices they produce. Material selection is crucial; not only are physical properties important, such as the hardness of the material

for good strength and flexibility (30 to 80 Shore A is recommended for most medical devices), it makes sense to select compounds that are pretested for biocompatibility. In response to this need, some compounders like RTP Company offer TPE compounds that have been pretested for cytotoxicity, irritation, and acute systemic toxicity in compliance with ISO 10993-5/10/11. Compounds such as biocompatible styrenic-based TPEs offer advantages such as gamma and EtO sterilisabiliy. “By selecting TPEs that are biocompatible, healthcare device designers and engineers have already taken a step toward a smoother regulatory approval process,” says Blackmore.

The advantages of colour Another consideration is the colour of the selected material. TPE compounds can be naturally translucent and neutral in colour, which is appropriate, and often preferred, for use in many Class l and Class II medical devices. However, TPEs are fully colourable using biocompatible pigments and colour masterbatches. Colour can be important for medical devices in healthcare settings, as it can be used for accurate tool identification and for safety indicators such as on/off switches. In retail settings, colour is often used for product differentiation and branding of medical devices, providing shelf appeal and increased visibility. “Biocompatible thermoplastic elastomer compounds have the unique combination of versatile physical properties, processing flexibility, and aesthetic possibilities that allow for greater innovation,” explains Blackmore. “And innovation ultimately leads to improved products and procedures that advance medical treatment.”

WWW.MEDICALPLASTICSNEWS.COM

www.sikora.net/purityscanner

»Absolute purity is the benchmark!« Holger Lieder Sales Director SIKORA AG

The PURITY SCANNER is a newly developed system for the 100% online inspection and sorting of plastic pellets as they are used for example for thermoplastic elastomers (TPE) in medical technology, but as well for other raw materials, masterbatches and compounds in all kinds of production processes. Contaminated pellets are separated and sorted out, assuring that only pure pellets get into the production process. The pellet inspection allows the detection of organic and metallic contamicontami nation inside the pellet as well as on the pellet surface, using a special combination of X-ray technology and an optical system.

PURITY SCANNER • Dual inspection: X-ray and optical cameras • Detection of metallic and organic contamination down to a size of 50 µm on the surface and inside the pellet • Automatic sorting • Sealed system • Innovative cleaning concept • Easy to integrate in new and existing production lines

See us at PLAST, Milan, Italy, May 5-9, 2015, Booth 11 B101

www.cimedtech.com

WELDING & JOINING

Make the connection Figure 1 Two wells filled with methyleneblue. The overmoulded well is tight (left), while the well on the right is leaking (see the blue colour under the rim)

ultiwell plates within cell culture applications are supplied with a variety of properties from coatings applied to the surface to the actual colour/transparency of the resin. Increasingly a transparent base is required which is Dr. Lutz Staemmler, independent of the main body to enable Greiner Bio-One, compatibility with complex microscopy. examines, For products designed for cell culture, joining technology for the technique to combine two separate components must meet the following cell culture labware conditions: • The bond must be stable/leak-proof > 14 days at 37 °C and at a rel. humidity of 95 % (incubator conditions). • The bond must withstand centrifugation at 4800 g. To follow is an overview of common techniques utilised to join plastics.

Overmoulding For applications that require enhanced optics, eg cell imaging, a film bottom is attached to the plate producing micro-plates whose wells have a very thin base. This process starts with the thin film being placed into the open injection moulding tool. The material for the body of the plate is then injected onto the film. The temperature of molten resin coupled with the pressure inside the tool melts the film and the plastic together. GreinerÖs µClear plates are produced by a patented overmoulding process to produce a coloured microplate with a transparent bottom [1]. This processes guaranties sealed wells.

relatively long time to flow from the needle. Equating to a rate of coverage achievable being 10 mm/s. In addition the gluing process must fulfil the following conditions: • To not be cytotoxic. • It should not fluoresce • Fluorescence dyes should not attach to the adhesive or interact with fluorescence measurements. • Be transparent. Efficient adhesives should: • be applied using an automated dispenser • have a short curing time. The main requirement is the ability to join two plastic components. Examples of unsuitable plastics are: • Polyoxymethylene (POM) • Polytetrafluorethylene (PTFE) • Polyethylene (PE). However, specific surface treatments may render a plastic suitable for adhesive bonding [2]. Gluing is the best method when joining two different materials; such as glass to plastic. Figure 2 Greiner Bio-One SensoPlate: 96 well polystyrene (PS) microplate with a glass bottom

Gluing Although many adhesives are available, the principle of the gluing remains constant: An adhesive forms the connection between two components. Hardening of the adhesive is either instantaneous or by a treatment eg UV light. For bonding in series production, adhesives cured by UV light are most commonly used because curing can be initiated at a predetermined point in time. Heat curing is less popular as most plastics are susceptible to heat. The entire area that will form the bond must be covered by adhesive. In the case of a microplate the adhesive is dispensed around each well; making gluing a serial and slow process. Furthermore, the viscous adhesive takes a 38

WWW.MEDICALPLASTICSNEWS.COM

WELDING & JOINING

Figure 4 Laser welded wells. The weld seam appears black around the wells.

Laser welding

Ultrasonic welding

In all welding technologies the bond is formed by the two components themselves where they are melted to form the bond. This process is identical for all welding applications. The difference is in the way the heat is applied. To succeed both welding components must have a similar melting temperature. If not, incompatible states will exist.

The disadvantages of serial welding can be circumvented by the use of ultrasonic welding, as it offers welding in parallel and is, by virtue, a faster process. Welding times of a fraction of a second are standard.

The laser beam is absorbed by at least one of the two components and is heated to its melting temperature. Where one component absorbs the energy, the other component is melted indirectly by the heat generated. [3] A mirror (galvohead) drives the laser beam along the weld line (Figure 3). Again a serial process, but faster than gluing at 500 mm/s. The limiting factor is bonding time Figure 3 shows the welding zone being between the two sheets of plastic. The laser only penetrates the upper sheet. Therefore the upper sheet has to be a material that is transparent to the incoming beam of light and the lower one opaque. Thus, heat is generated in the lower opaque sheet only.

Laser Plastic Welding

A piezo crystal oscillates between 20 and 50 kHz and drives a mechanical resonator (sonotrode) to oscillations with an amplitude of microns. The sonotrode is placed on top of the upper surface. It induces friction, creating a heating effect, between the two surfaces, which is sufficient to melt both components forming a welded seam. It is possible to make a weld seam as small as 100 €m wide. Thus, allowing very complex structures to be manufactured, a criterion that is a prerequisite when producing microfluidic structures. No colour restrictions like in laser welding exist for ultrasonic welding, as it is a mechanical process.

Comparison Advantages and disadvantages of the aforementioned techniques are shown in the table below:

References [1] Patent DE 197 12 484 C2: Mikroplatte mit transparentem Boden und Verfahren zu deren Herstellung (1999-07-08). Greiner GmbH

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

[2] HABENICHT, G.: Applied Adhesive Bonding, Weinheim: Wiley-VCH (2009)

Figure 3 A moving mirror drives the laser beam along the weld line.

[3] RUSSEK, U. A.: Laserschwei en von Kunststoffen, MŁnchen: SŁddeut- scher Verlag onpact (2009)

Hannover fair: April 13 – 17, 2015, Hanover, Germany, Hall 17, Booth E63 MEDTEC Europe: April 21 – 24, 2015, Stuttgart, Germany, Hall 5, Booth D41

BONDING TECHNOLOGY Gluing

Ultra- sonic

Laser

Fast process

Yes

Flexible geometry

Yes

Different materials

Yes

Colour limitations

Yes

Applicable to glass

Yes

Limitations

Adhesive

Particles

Smoke

WWW.MEDICALPLASTICSNEWS.COM

LPKF Laser & Electronics AG Phone +49 (911) 669859-0 www.lpkf-laserwelding.com

MEDTEC EUROPE

European UNION

edtec Europe takes place 21-23 April 2015 at Messe Stuttgart, Germany – the heart of Germany’s This month sees manufacturing industry. A key event for medical Medtec Stuttgart d e v i c e technology taking place on 21-23 professionals, Medtec April where some of Europe will provide access Europe’s industry’s to the latest technology, solutions, networking and key medical device education

players will be exhibiting their latest innovations

Medtec Europe is entering its 13th year and continues to provide an informative platform for those working within the medical device manufacturing industry. The event provides suppliers with the opportunity to meet with over 6,000

Join forces: LPKF’s PrecisionWeld can create weld seams with a thickness of 100 �m

industry specific professionals, it hosts cutting-edge conference quality education and displays dozens of interactive features. This year, Medtec brings a new Start-Up Academy where new businesses can showcase their latest innovation to potential partners from the medical device industry. Some key exhibits at the show will include: Mulitvac who will be presenting thermoforming packaging machines, traysealers, special chamber machines and labellers for packing small to medium-sized batches. All the models, which will be exhibited in the ‘medical packaging’ theme pavilion on Stand 7F10, will typify high levels of precision and flexibility. LPKF will presents a laser system that enables the creation of completely new product layouts for microfluidic parts (think ‘lab-on-a-chip’). The LPKF PrecisionWeld can create weld seams with a thickness of 100 €m and has positioning repeatability of 10 €m. Transparent components can be joined using the new LPKF ClearJoining technology. The focus of a 2€m laser beam lies exactly in the welding plane. An optimized clamping technology and an integrated camera system allow the detection of specially applied fiducial marks. This ensures a fast and secure production. STAND 5D41 Phillips-Medisize will present solutions for plastics products aimed at the medical device and diagnostics technologies to visitors during Medtec in Stuttgart. The exhibits will range from peristaltic pumps, titer plates and mixing injectors to complete MDD application sets, special drug delivery devices, dosing systems, disposable insulin pens, inhalers,

Pumped up: Peristaltic pump - complete systems solution from Phillips-Medisize

bottles and closures, as well as sterile multi-chamber bags and test tubes. From the concept right through to the complete solution, from design to the sterile packaged finished product, Phillips-Medisize offers customers a complete service chain. Production is controlled across processes driven by highly prioritised quality assurance measure according to ISO 13485 and the applicable FDA and GMP standards (Good Manufacturing Practice). STAND 5B40 Arburg will present an application for processing liquid silicone (LSR) at the exhibition. An electric Allrounder will produce bellows used as a valve in medical test devices. This application is designed to showcase Arburg’s expertise and demonstrate the potential of the LSR material in medical technology, as well as to demonstrate that the clean room connection to the machine via an encapsulated conveyor belt is a costeffective production solution. STAND 5B04.

WWW.MEDICALPLASTICSNEWS.COM

Medically compliant polymers from Distrupol Be expertly guided to your polymer solution with Distrupol. Visit us at MedTech stand 53 to discover more about our medical range. info@distrupol.com www.distrupol.com

7515 Distrupol Medical Plastic News - Q1 2015.indd 1

25/03/2015 10:18

Specialist in Elastomers and Polymers for Healthcare

MELITEK is dedicated to production of meliflex elastomer and polymer compounds specially designed and produced to meet rigorous requirements of medical applications and healthcare users. The meliflex elastomer and polymer compounds offers customized solutions based on wide range of prime polymers including PE, PP, COC, TPE, TPO, TPV, SBC, ABS, PS.

meliflex is produced at our state of the art high efficiency plant in Denmark and is based on over 30 years’ experience in servicing medical and pharmaceutical industry with advanced technologies. We add value by creating value!

The meliflex materials offer: -

Compliance to ISO 10993 and USP 88 (class VI) requirements No phthalate plasticizers, PVC, BPA, latex, animal based additives Wide range of shore hardness (Sh 10A – 75D) Extensive medical service concept; full traceability, change control, line clearance, segregated production, etc. - Customized materials on colour and functionality - Cost efficient alternative to soft PVC, TPU, Silicone

Hartvig Jensensvej 1 • DK-4840 Nr. Alslev • Denmark • www.melitek.com Tel: +45 70 250 255 • Fax: +45 70 250 277 • E-mail: sales@melitek.com

WWW.MEDICALPLASTICSNEWS.COM

EXTRUSION TUBING

Take the tube

ased in Torquay, Devon, Southwest Polymer Supplies (UK) specialises in the import of thermoplastic and rubber processing equipment from laboratory to fullscale manufacturing. The company also supplies a range of equipment from Mike Thompson, injection moulding machines to single and Southwest Polymer twin screw extruders.

Supplies outlines the company’s expertise in extrusion tubing

I’ve worked for various companies including Amcor Flexible’s, Alcan, Petlon Polymers, Lorient Polyproducts and Millmerran. Within these companies I fulfilled a variety of positions and roles from operator through to development manager and more lately polymer engineer for Millmerran. In this previous role as polymer engineer, I developed an extrudable, ceramifying intumescent which has certification for fire doors from 30 minute up to two hours. Extrusion is ideally suited to the production of continuous lengths of tubing. The successful manufacturing of tubing depends greatly on good die design and the correct setup of the extruder which should include the correct screw design to optimise output dependent upon the polymer being processed. Generally this is not as straightforward as it may appear since the interaction effects of post extrusion swelling (die swell) and the complex flow characteristics of viscoelastic fluids (rheology) need to be balanced. Much research has been written around the viscoelastic flow and its complexities. The majority of profile dies (including annular dies) are designed from the experience of the tool designer/maker. This experience is now being supplemented by computer aided design packages that take out into account the material’s rheological properties. By performing complex mathematics these packages that can help produce a die that negates the majority of guesswork from the design. Thus adding ‘value’ to the business by reducing the cost of die trialing and bringing the cost of the whole project down. Tubing is made from a die with an annular die exit. Dies for tubing products are predominately made from in-line dies (also called spider dies) shown opposite. Although it must be noted that other dies including cross-head and co-extrusion are available The key elements of an in-line die are: • Housing: Mounts onto the end of the extruder, providing a circular passage through which the melt flows; this supports the mandrel and retaining ring. • Mandrel (Torpedo): suspended in the centre of the circular passage in the die body with metal bridges called spiders (typically three are used). One spider allows for passage of air into the centre of the torpedo and is streamlined to avoid flow stagnation, and supports the die pin. • Die pin: mates with the torpedo to provide a streamlined sizing to the final inner diameter of the melt tube leaving the die. An air hole runs through it to allow the passage of air through the die body to the interior of the melt tube. A slight positive air pressure may be used to keep the inner diameter of the tubular extrudate from collapsing on exiting the die. • Die land: This forms the outer diameter of the tubular extrudate, held in place with a retaining ring and position adjusted with centering bolts. The die land can be changed to create a tube of a different diameter or wall thickness while keeping the original die pin. • Heater band: Closely fitted to the housing (and for larger pipes to the exposed portion of the die pin) to ensure that the die is held at a temperature close to the required temperature of the melt. • Flange for extruder attachment: Tapered flange to permit alignment and attachment to extruder with split locking collars.

WWW.MEDICALPLASTICSNEWS.COM

MEDTECH INNOVATION

Centre of attention Med-Tech Expo Innovation 2015 takes place at the Ricoh Arena Coventry April 29-30 and is set to feature more plastics-based medical technology suppliers than ever before

WWW.MEDICALPLASTICSNEWS.COM

art of the reason for the rising attraction is the fact that MTI Expo is exclusively focused on the UK and Ireland and the show itself includes the movers and shakers within these markets, organisations such as Medilink, STFC, Innovate UK, SBRI Healthcare (NHS) and others. These National groups are exhibiting at the Ricoh Arena alongside the med-tech manufacturing sector. The Medilink National Awards, Gala Dinner and Conference are being held alongside the exhibition - and all at the show are offered a growing community experience of networking and business opportunities within the growing med-tech industry. Another good reason for exhibiting here is simply the fact that plastics expertise is in demand. At the same time the med-tech sector’s appeal is rising, and offering a valueadded market for enterprising trade/contract moulders. First time exhibitor Pentagon Plastics, for example, is showing its wares at MTI Expo for that reason. The Horsham based company estimates that med-tech applications currently deliver some 35% of its repeat business and its Expo showing is designed to strengthen and boost that figure. Similar thinking applies in the case of Sirane, a Telfordbased innovator in polymer-based packaging products. Food and drink currently constitute the lion’s share of Sirane’s output but the firm’s medical division has been longstanding and it currently accounts for some 15% of turnover. Sirane has a new med-tech proprietary product line on the horizon and is set to expand its medical and healthcare marketing through this year. Expo 2015 will provide a ready boost. Another MTI Expo newcomer, Bristol-based P3 Medical, will use the exhibition to show its contract manufacturing services; making its cleanroom extrusion and moulding lines available to visiting buyers and specifiers. Meantime, show stalwarts such as Carville Plastics, Europlaz Technologies, Coda Plastics and Sovrin Plastics will all be showing their latest capabilities. All of these report recent growth and expansion. Europlaz, based in Southminster Essex, is in the middle of expansion and a recruitment drive. Coda has just launched its new website, Carville is adding awards and accolades to its track record and Sovrin Plastics is getting set to move its headquarters into a new bespoke €4.5 million facility adjacent to its existing site in Slough.

Small wonder: A component for use in microsurgery, moulded by TML

On show: Colin Martin, founder and director of Med-Tech Expo

Make It In Plastics, a new services and networking venture has picked its moment to exhibit at MTI Expo for the first time. The new company aims to help busy contract moulders with a number of services; including promotion and marketing into a variety of end-use sectors. MIIP founder and director Adrian Lunney says that, “We’re here to help plastics processors who simply don’t have the time for some functions such as marketing: MIIP can take that work on for businesses and can help profile and steer their capabilities into customer zones such as med-tech, automotive building products, packaging and others.” On the materials supply side MTI Expo exhibitor Distrupol is leading the way. Part of the unique Distrupol signature is its status as official distributor for the DuPont range of polymers, also Ineos, Lucite (Acrylic), Versalis and many others. Distrupol claims that it has ‘probably the largest range of plastics and expertise for the medical industry’ and visitors to the company stand at Expo will be able to find out for themselves. At Expo 2015 Distrupol will be showing a range of medical plastics that comply with USP Class VI, Drug Master File (FDA) and ISO 10993. Expo show director Colin Martin says that plastics based companies enjoy a number of facets and benefits at Expo 2015 like no other. “Firstly, Expo 2015 is more accurately four events in one – exhibitions, awards, conference, seminar programme – with the exhibition set to be some 15% larger than last year. There’s a lot to learn about the marketplace – and Expo gives plastics based companies a very efficient way of doing that,” he says. He adds: ”Just visiting with the Medilink network for example - which representing over 1500 med-tech manufacturers in the UK regions - gives businesses an unparalled way to get closer to all that is happening in the sector.” MTI Expo’s overarching aim is to create synergies, contacts and bridge building within med-tech; strengthen the UK and Irish supply chains, and thus help the creation of value-added and innovation – both for consumption in home markets and in export sales. The MTI Expo conference and seminars are all intended to support that aim and to provide helpful topics and resources to manufacturers on the subjects of; internationalisation and exporting, NHS adoption, supply chain management, raising finance, skills and training; working with AHSNs, research, development, design and manufacturing. All the major industry sectors will be covered at Expo 2015 including cardiovascular devices, drug delivery, orthopaedic devices, medical electronics, dental sector, surgical and hospital hardware, imaging technology, wound care, in vitro diagnostics, plastics manufacturing, radio therapy equipment and much more. www.mtiexpo-uk.com

WWW.MEDICALPLASTICSNEWS.COM

PACKAGING

he importance of successful supply and value chain management in medical device manufacturing is coming even more Collaboration, into focus as patient thorough testing safety issues persist and regulations key to bringing are ever-evolving. HIPS alternative to Manufacturers carry European medical the weight of ensuring packaging market, their sensitive devices successfully navigate says Eastman c o m p l e x s u p p l y and value chains, all the way through packaging, with the devices’ integrity intact. Because of this, something that seemed next to impossible in the past is now becoming a key for success — collaboration throughout the process. Collaboration throughout the supply and value chains can reveal mutually beneficial innovations, leading to improved efficiency and effectiveness.

Collaboration and testing In search of ways to ease the burden to medical device manufacturers and stay ahead of ever-evolving regulations Nelipak Healthcare Packaging collaborated with Europebased extruder Carolex packaging and global material supplier of medical-grade polymers Eastman Chemical Company to help bring a new packaging product to the European medical market. “Collaboration early in the development of this new product helped guide our teams, drive the testing of this new material and ensure all parties were aligned from the start on customer needs and priorities,” said Ferdi Faas, market development manager, Eastman Chemical Company. When testing a new material, collaboration early in, as well as throughout, the process brings the expertise of multiple companies together, builds upon each company’s knowledge and ensures the bestpossible outcome. “The testing process for a new material needs to encompass all companies’ vital expertise,” said Sean Egan, group marketing manager, Nelipak. “We identified the need in the market and then tested trial material. Eastman provided access to its technical teams

STRENGTH

in numbers

Premier product: Eastalite copolyester, is the first opaque offering in the company’s medical packaging portfolio

and delivered data on the material, while we shared our experience and outcomes with the product samples produced.” Testing was conducted over a six-month period and included running tests on tooling, forming characteristics, particulates, as well as heat sealing trials and peel tests. Ultimately, they found a material that tested well compared with styrene and had some additional features, including living hinges, cleanliness, good cushioning and potential to run at a higher speed without increasing processing temperature.

New material The material that came out on top was Eastman Eastalite copolyester, the first opaque offering in the company’s medical packaging portfolio. The most important challenge was met with the new material — it is made without materials of concern, such as butadiene, bisphenol A, bisphenol S, ortho-phthalates, or halogens such as chlorine or bromine. This was a key consideration for Nelipak, a company that is focused on the health care market and whose packaging solutions are specifically designed to protect and maintain the sterile integrity of the product. The material also is compliant with select ISO 10993 requirements for medical-

device biocompatibility and applicable parts of ISO 11607 requirements. “As an extruder, we focused on the material’s thermoformability and potential for lightweight medical packaging with greater yield,” said Laurent Bouchet, commercial director, VitasheetGroup Carolex. “In working with Nelipak, we found that Eastman Eastalite copolyester ran at comparable speeds to traditional material such as HIPS and less heat input was required, which suggests it is possible to run at higher production speeds.” Although sheet extruded from Eastman Eastalite copolyester can be processed with the same thermoforming, trimming and sealing equipment as HIPS, Nelipak and Carolex found the lower process temperatures offer greater opportunities for sustainable packaging. Thermoforming Eastalite into rigid trays can reduce waste and cleaning through a reduced risk of particulates and angel hair generation, as well as lessen processing and inspection times.

Ensuring safety with cleanrooms Because of Europe’s strict guidelines on cleanrooms, Nelipak, Carolex and Eastman worked to ensure the material is easy to use in a cleanroom environment with a process that creates less particulates than HIPS. Eastman Eastalite copolyester is easy to cut with no angel hairs and is not prone to static buildup like HIPS, which can attract particulate to the product during production. Eastalite also can provide greater tear strength while retaining color stability and functional integrity following sterilisation by ethylene oxide (EtO) or gamma irradiation. “Intended for medical packaging, this material went into testing having to meet many requirements and address a variety of customer needs while still performing well,” Egan said. “Eastman Eastalite€ copolyester quickly met many of our expectations. I’m looking forward to the new market opportunities this material will create by allowing brand owners to produce differentiated products that satisfy growing market needs for sustainable and lightweight rigid medical packaging.”

WWW.MEDICALPLASTICSNEWS.COM

ORTHOPAEDICS

Walk the walk

orsiflexor weakness or drop foot are not commonly known terms but the symptoms they describe are familiar to many. These terms Recent innovations in refer to the inability Functional Electrical to raise the foot due Stimulation (FES), to a weakness in, or paralysis of, the Dr Salim Ghoussayni, dorsiflexor muscles Ottobock in the leg and the foot. This condition is a frequent result of damage to the central nervous system which could be a result of stroke, cranio-cerebral injury, multiple sclerosis, incomplete spinal cord Injury and infantile cerebral palsy. For those suffering with the condition it means that walking becomes a daily challenge and a slow inefficient process with the foot often dragging along the floor. This in turn leads to a reduction in mobility and independence as well as the increased risk of falls. Individuals with drop foot often become fatigued easily when walking; they sometimes avoid long distances and can gradually withdraw from social life. As such, it can have a sizeable impact both physically and mentally. Conventional treatment options for drop foot are mainly physiotherapy and the use of an Ankle Foot Orthoses (AFO) as a supportive device. However, due to the passive nature of the AFO, it does not stimulate the user’s own muscles to enhance walking. Medical therapy can also be used in the form of muscle relaxant drugs or botulinum toxin type A injections. Functional Electrical Stimulation is another therapy used for drop foot. While FES was originally introduced in 1961, the technology has developed significantly since its beginning.

The technology works by stimulating the surface of the leg, acting on nerves via electrodes placed on the skin to lift the foot. During the swing phase of the gait cycle, it assumes the function of the damaged central nervous system and gives the intact peripheral common peroneal nerve the signal to lift the foot. The signal is then transmitted to the muscles responsible for foot lift. The most recent development is the introduction of the first double channel wireless surface stimulator. The MyGait system by Ottobock, launched in 2013, has a unique second channel aspect which is something that had not been previously explored on other devices. The first channel is used for the dorsiflexor muscle and the other can be used for a variety of other purposes such as supporting knee flexion and extension or providing hip stability. This improves stabilisation and gait function. The MyGait system is made up of various components that can easily be fitted by patients independently, without the help of others. The stimulator is secured to the lower leg with a cuff where the electrodes for transfer of the pulses are already correctly positioned; therefore the patient does not have to reposition the electrodes every time the device is put on again. It is important that the electrodes are accurately placed each time the FES is used so the correct movement can be produced.

The MyGait Functional Electrical Stimulation device by Ottobock and how it works: 1.The sensor in the heel switch is activated when the foot is lifted. 2 The heel switch sends a radio signal to the stimulator. 3 The stimulator sends electrical signals to the nerve via electrodes. 4 The foot is lifted.

is then used which allows data to be transferred from the device to a computer, so it can be evaluated. Following use of the MyGait system, a patient’s gait pattern is improved and in many cases, an increase in walking speed and distance can be gained. This is an important aspect in regards to everyday safety when walking on uneven surfaces and on stairs and ramps and active participation in a social life outside of the home. The patient no longer has to look at the ground at every step, is able to walk longer distances and in many cases can regain a more active lifestyle, having postive physiological benefits. Walking tall: Following use of the MyGait system, a patient’s gait pattern is improved and in many cases, an increase in walking speed and distance can be gained

The MyGait system also includes a heel switch housed in a special sock. It is used for wireless transmission of information about heel lift (start of stimulation) and heel/foot strike (end of stimulation) to the stimulator. A remote control is then used for calling individual functions and for making stimulator settings. Software

WWW.MEDICALPLASTICSNEWS.COM

5 01

–

pr il 2

Ri c C oh ov A en ren A try a,

The Med-Tech show that’s 100% dedicated to medical technology, research, development, design and manufacture

Pre-register for the expo today and you will automatically be entered into the FREE PRIZE DRAW with the chance of winning a Stratasys ‘Mojo’ 3D printer worth more than £7,000!*

Med-Tech Innovation Exhibition The largest UK medical technology manufacturing exhibition

The UK Medical Device Manufacturing Conference

Workshops and Seminars Covering topics such as design, testing, sterilisation and regulatory

Hosted and developed by Medilink UK

*Please note that you must pre-register and attend the event to qualify for this offer

The Medilink UK Healthcare Business Awards and Gala Dinner 2015 @medtechonline #mtiexpo

Supported by

I N N O VAT I O N

For further information visit www.mti-expo-uk.com or call +44 (0)845 0348901

BEADY

Seeing is BELIEVING

eye

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

MPN: Who are you and what do you do? RT: Since I began Blink Medical, ten years ago, I have always wanted to manufacture our products here in the UK, however due to their complex nature this has always proved a challenge. I set up Blink to produce high quality single use surgical instrumentation which is used during cataract surgery, cosmetic surgery, ear nose and throat, plastic and dental surgery.

MPN: What products / developments have you been focussed on recently? RT: I had seen an opportunity back in early 2000 where the majority of cataract procedures were Roger Tyler, Blink performed using Medical outlines the throw away packs which companyâ&#x20AC;&#x2122;s latest contained the innovations helping to necessary items improve health and well for the surgeon being as well as increasing to perform the the accuracy for surgeons surgery. At the end of the procedure the pack and its contents would be disposed of in the surgical waste bin.

This was common practice and helped to reduce cost, waste and most importantly cross infection which, in the most severe of cases could lead to loss of sight in one or both eyes. All items were now single use except for the surgical instruments which were still being cleaned and reseterilised between patients. Amongst these instruments were very fine scissors, forceps and needle holders which, over prolonged reuse, would develop a build up of tissue, blood and other matter in the hinges. At the time there were many reports in the press of instances of cross infection, vCJD and HIV were hot topics and the labour government as a result decided to outlaw the use of little microwave oven style sterilizers which had previously been very popular throughout Europe. MPN: Describe your latest innovations RT: Blink was established in 2004 and we have been manufacturing single-use instruments out of Pakistan and China ever since. All the instruments we sell have very fine tips and complex hinges which cannot be made by a machine, hence the reason why they are handmade and for cost reasons we use Pakistani and Chinese labour to manufacture them. Recently I have been given the chance to begin manufacturing here in Birmingham. We needed to develop a small marking device which is used during Lucentis and Avastin injections for patients with wet age related macular degeneration which is the biggest cause of blindness in the western world. To place in the injection in the correct area of the eye, the surgeon needs to mark the sclera, (the white part of the eye), to enter at the correct angle and avoid hitting other structures. We previously made a marking

Price point: Roger Tyler, Blink Medical reveals his plans for his latest costcutting device

WWW.MEDICALPLASTICSNEWS.COM

device in Pakistan out of metal however, we were concerned that the level of accuracy was not sufficient to meet the needs of the doctor, so recently we have teamed up with a plastic injection moulding company in Birmingham called Andel Plastics to begin injection moulding the devices ourselves. This has had a number of benefits. Firstly the accuracy and quality of the devices has dramatically improved. Secondly, the cost has come down, and thirdly the volume of units we can produce has massively increased. Currently we produce over 250,000 units per year and we have plans to introduce more innovative products moving forward. MPN: What does it mean for the medical sector? RT: We now have many surgeons coming to us with new ideas however, my main goal is still to find a way to produce standard single use instruments in an automated way here in the UK rather than being dependant upon manufacturing goods in countries which are not always the most stable. Every year new technologies like micro injection moulding and 3D printing for prototyping allows us to explore new opportunities in manufacturing exciting devices. There is no doubt that the need and hunger for single use medical devices is there, as manufacturers we must look to develop methods which enables us to feed that hunger. MPN: Plans for the future? RT: This year I am planning to launch a UK-made, innovative new device which will help us to reduce the cost of anesthesia during ophthalmic procedures. Saving money for the NHS is a prime motivating factor for me and in these austere times finding low-cost manufacturing techniques to enable us to offer those savings is in my mind, where it all begins.

www.netstal.com

Outstanding quality High returns Are you looking for an injection molding system for certified production to the highest of standards? Do you need to supply your customers with superior quality health-care products? Then Netstal injection molding systems are a must have! Our team is made up of experts specialized exclusively in the manufacture of medical components. This guarantees maximum output at a consistently high level of quality.

Engineering Excellence