MPN EU Issue 28

MEDICAL PLASTICS news

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MPN’s best of the best Medtech influencers – who are they?

SMOKE SIGNALS - Phillips-Medisize joins a smoke-free zone ISSUE 27

Nov-Dec 2015

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CONTENTS Nov-Dec 2015, Issue 27

Regulars

Features

5 Comment Lu Rahman looks at the effect of implant scandals

22 Selection box A round-up of the best of MPN’s best

7 News analysis What were the sector winners in 2015?

30 The In-Crowd Who makes the biggest impact in medtech?

8 Digital spy

32 Combined studies Compounding expertise from Compounding Solutions

10 News analysis Absorbable stents in focus 13 New profile Compamed in the spotlight 17 Speech therapy Including Avacen and DP Medical Systems

35 X-ray vision Testing advances from Sikora 40 Materials science Bioabsorabable polymers

18 Cover story Phillips- Medisize talks nicotine devices 48 Beady eye Bedale in the spotlight

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MPN

All Medical, All Plastics

CREDITS group editor | lu rahman deputy group editor | dave gray

EDITOR’S

comment

editorial assistant | emily hughes 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.

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ISSN No: 2047 - 4741 (Print) 2047 - 475X (Digital)

POSITIVE THINKING Recent news that yet another implant scare had hit the sector was disappointing to say the least.

Following the announcement that some of Silimed’s implants were contaminated by unknown particles, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) suspended CE certification for all medical devices manufacturers by the Brazilian company.

Stressing that at the time there was no indication that the implants posed a threat to patient safety, anyone using a product from the company was advised to seek professional assistance. More than 20,000 women were thought to have had Silimed products implanted.

Following the PIP scandal some years ago, which affected around 50,000 women in the UK and 400,000 globally, measures were taken to prevent a repeat. This included a national register logging each breast implant operation and a re-visiting of the way in which implants were marketed. The training of surgeons also came under the spotlight.

Of course, for an industry that works to constantly improve standards and products, not one but two

implant scandals within memory of each other is something of a blow.

For businesses that are working legitimately and according to global regulations, it is right and proper that health bodies such as the MHRA react in this way where companies may be allegedly manufacturing sub-standard products. The medical plastics sector is at the forefront of devices aimed at improving the health and well-being of us all. Where there may be a threat to this, it’s reassuring for both patients and industry to see positive action being taken.

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The medical plastics sector is at the forefront of devices aimed at improving the health and well-being of us all.

Taking a look through this issue of MPN alone highlights the innovation and technology that the medical plastics sector uses and develops on a regular basis. We run the risk of the public focusing on any negative events that occur – this is only to be expected when we are dealing with issues related to health.

However, given the proliferation of new materials, devices and technology on offer coupled with the tight and necessary regulation designed to protect both business and end-user, hopefully medical device scandals should be an even rarer occurance than they are now and we can shine the light on the medical breakthroughs the industry offers to an even greater extent.

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Visit us at Compa med Booth 8 b/F20-3

NEWS ANALYSIS

MYSTIC MEDTECH: HOW TRUE WERE 2015’s INDUSTRY PREDICTIONS? D

igital health was tipped for huge success in 2015 and it hasn’t disappointed. With key players such as Philips, Samsung and Apple making headway in this sector, the digital health space has become increasingly relevant to the medtech market.

This time last year a range of predictions were made for the medtech sector. Lu Rahman looks at some of the trends that made it big and what they mean for the market going forward

Apple - one of the most influential names in recent years – took a stance on digital health stance as it launched its ResearchKit to aid research on asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s. The technology’s latest development is that it can also turn the iPhone into a tool for medical research on autism, epilepsy and melanoma.

ResearchKit software was designed for medical and health research, helping doctors and scientists gather data more frequently and more accurately from participants using iPhone apps. “iOS apps already help millions of customers track and improve their health. With hundreds of millions of iPhones in use around the world, we saw an opportunity for Apple to have an even greater impact by empowering people to participate in and contribute to medical research,” said Jeff Williams, Apple’s senior vice president of operations.

With digital health so prominent in the life science sector, MPN launched a sister website www.digitalhealthage. com into this market and its growth has highlighted the relevance digital health has in medtech. Not only has the concept of smart phone diagnosis become widely accepted but we have seen a rise in digitally-enabled devices in order to address the growing needs of the healthcare sector. As the pressure on the NHS in the UK becomes apparent, the need for devices that allow the patient to self-administer new drug formulations and for healthcare professionals to be able to track medication adherence are growing significantly. In the UK alone we are hearing discussions on connected communities and cities that take digital health into account as a positive way to tackle the growing needs of the healthcare sector.

While digital health was a prediction that came true, it would be fair to say that the increasingly significant role of medical plastics wasn’t stressed enough. With the new wave of devices for use in homes and hospitals came a new role for materials. Rumours rumbled that Blackberry was launching an anti-bacterial device and companies such as FutureNova highlighted the growing relevance digital products have in the hospital setting with the launch of a medical-grade iPad case – the FlipPad – that helps reduce that risk of infection transfer between patients.

While medical device science and the materials these products were made from became key in 2015, so too did manufacture and the technology bringing the products to the market faster and more efficiently.

For some time now the growing importance of 3D printing has hit the headlines and 2015 saw no let up in the significance of this technology.

At the end of last year MPN reported Dr Michael Patton, Medical Innovation Labs, claiming that 3D printing had made medical devices cool again. Additive manufacturing advances included companies such as Carbon 3D offering its CLIP technology that claimed to provide an innovative approach to polymer-based 3D printing with a gamechanging speed, commercial quality and material choice.

Developments in this field continue at a pace – recent breakthroughs include scientists at the University of Groningen in the Netherlands who have invented a 3D printed plastic that can kill 99% of bacteria – it is thought this could have far-reaching consequences for the medical device sector.

3D printing technology has become widely recognised in device manufacture and we are beginning to hear more news about its sister technology, 4D printing having a valid role in the medical device space.

2015 has been an exciting time for the medical device sector.

As health technology gains ground offering new opportunities for both the patient and healthcare professional, so too do avenues open for the device manufacturer, making the market for 2016 look equally if not, increasingly attractive and interesting.

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DIGITAL

spy TECHNOLOGY SPY

Bug-zapping 3D printing material developed

MEDICAL MATERIALS UPDATE

SOLVAY POLYMER PICKED FOR JOINT FUSION TECHNOLOGY

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new 3D printed plastic developed by scientists at the University of Groningen in the Netherlands could have far-reaching consequences for the medical and dental sectors.

Using dental resin polymers for false teeth, researchers at the university embedded antimicrobial quaternary ammonium salts within the polymer which was then placed in a 3D printer and used to make dental items such as teeth and orthodontic braces. The salts used were positively charged, causing negatively charged bacterial membranes to burst and die. The objects made were then hardened with UV light.

Bacteria can damage dental implants as well as real teeth.

When researchers coated the objects with saliva and Streptococcus mutans, they found that over 99% of the bacteria was killed. This compared with only 1% of bacteria being killed using the resin on its own.

The research was published in the Advanced Functional Materials journal – ‘3D Printable Antimicrobial Composite Resins’.

olvay Specialty Polymers has announced that Vertera Spine has chosen the company’s Zeniva polyetheretherketone (PEEK) polymer to develop PEEK Scoria, a novel porous surface technology for stable, cost-effective intervertebral joint fusion. The porous character of Vertera Spine’s biomaterial facilitates integration of bone tissue with the company’s Cohere cervical interbody fusion device. According to Solvay it offers excellent biocompatibility, toughness and fatigue resistance, as well as characteristics very similar to bone and has proved to be a key enabler for this medical device.

Backed by extensive research at Duke University and the Georgia Institute of Technology, Vertera Spine’s PEEK Scoria represents a significant leap forward in how surface treatments are applied to intervertebral joint fusion devices, claims Solvay. Where conventional approaches coat the fusion device, this surface treatment is grown directly from the bulk PEEK material of Vertera Spine’s Cohere system.

Solvay’s Zeniva PEEK comprises both the porous surface technology and the device on which it is grown.

“Given the fast-changing economics of healthcare, we developed PEEK Scoria to address growing clinical demand for fusion devices that integrate more effectively with bone at a cost-competitive price point,” said Chris Lee, co-founder and CEO of Vertera Spine. “The superior toughness of Solvay’s Zeniva PEEK was critical to our success. The seamless interface it enabled between the porous and bulk materials is more durable than metal coatings and yet two times stronger in shear than trabecular bone. Solvay’s material and industry expertise helped our Cohere device to become the first fusion system made out of porous PEEK to receive 510(k) clearance from the US Food and Drug Administration.”

Sterimedix reports cost reductions thanks to EDM investment

DIGITAL SPY

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terimedix, manufacturer of singleuse medical devices for ophthalmic surgery and non-surgical aesthetic procedures, has acquired a Sodick AG40L from Sodi-Tech EDM. The machine, say Sterimedix, has enabled it to improve the quality of products and generate cost reductions compared with the outsourced operation used previously.

Sterimedix manufactures a range of cannula, hand-pieces and devices for all types of ophthalmic surgery and aesthetic procedures.

The business has been built up over 25 years, and employs in excess of 50 people who generate an annual turnover of around £6 million. Approximately 80% of output is exported throughout the world.

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“We started manufacturing cannula 21 years ago, gradually increasing our manufacturing capability ever since,” explains Tom Parrott the company’s head of technical operations. “Five years ago we relocated our operation to larger premises and six months ago made the decision to rent additional premises nearby with the objective of creating an up to date manufacturing facility, with EDM machining at its core. We believed that by bringing EDM in-house, we would be able to take control of an important area of our production, introduce product improvements and generate cost reductions.

“Previously our subcontractors ported tubes singly. In order to secure a return on the EDM investment, it was necessary to improve throughput significantly. This was achieved by WWW.MEDICALPLASTICSNEWS.COM

working closely with the engineering team at Sodi-Tech.”

Parrott says the Sodi-Tech team indicated the possibility of porting 40 tubes at a time. That indication is now a reality.

Although the acquisition was a significant capital investment for a company the size of Sterimedix, it offered the opportunity to improve quality and achieve cost reductions.

“In the time since installation, Sodi-Tech has continued its support throughout the various validations that we needed to undertake, and we are on target to achieve payback within 18 months,” confirms Parrott.

DIGITAL SPY

MAIN STORY

talking

POINT

MEDICAL DEVICE COVER ON OFFER Markel UK, specialist insurer, has launched a product designed to look after the insurance needs of small and start-up research and development businesses and organisations in the medical devices industry.

ABSOLUTELY FAB

The new policies build on Markel’s biomedical and life sciences product, launched at the end of 2013.

D3D Innovations has high hopes for the success of its FilaFab system which it says is a ‘game-changer’ for 3D printing

The policies offer a range of covers including public and products liability, professional liability, employers’ liability, blanket property damage and flexible first loss business interruption. Directors’ and officers’ and cyber covers are also available.

Simon Webster, technical line manager, life sciences, commented: “The UK remains a vibrant and successful economy for science and technology based businesses and our conversations with brokers about our biomedical and life sciences policy made clear to us that there was need for business critical coverage for smaller and earlier stage businesses. 97% of companies within the sector are classed as SMEs, and they require specialist cover at an affordable price. Having the right level of insurance cover to protect against sector specific risks is crucial to avoid the potentially devastating impact of a claim. Our easy to handle policies provide that comfort.”

TWITTER WATCH

UPDATE

@MedDeviceGurus A useful but often irreverent outlook on the medtech sector We liked… #Chocolate So #Healthy it Could be Eaten as Medicine @SB_Microsystems Live tweets from the R&D engineering firm We liked… , A flexible polymeric material that s capable of self-repairing. Can you imagine the implication for medical devices?

Billed as the complete solution to your 3D printing filament needs, the FilaFab plastic recycling extruder system is designed for the production of professional quality filament and spools it ready for printing, all within the confines of a desk/workshop.

The FilaFab 3D printing system recently raised almost £25,000 on Kickstarter. The product is now on Indigogo until January.

WHAT’S THE POINT OF DOING IT YOURSELF?

@OwenMumford The official Twitter account for the medical device maker We liked...

See how #OwenMumford has expanded into Mexico & Malaysia on @MPN_Magazine #medicaldevices @FDADeviceInfo Updates, recalls and regulation from the FDA We liked…

Want to Help the #FDA? Become a Consumer Representative on an FDA Advisory Committee #medicaldevice

WHAT DOES IT DO?

www.emarketorg.com

A

Home work

ccording to the Global Home Healthcare Device Market 2014-2024: Market Size, Share, Trends, Analysis and Outlook, the global home healthcare devices market will see a rapid growth over the coming years with the sales revenue reaching $40.2 bn (£26.2 bn) in 2019 and $60.1 bn (£39.2 bn) by 2024, representing a higher CAGR than the world overall medical devices market.

This trend is driven by an ageing population, increasing healthcare expenditure and technology advancement WWW.MEDICALPLASTICSNEWS.COM

FilaFab is available from D3D Innovations. According to the company the benefits of producing your own filament are becoming increasingly well known and include the ability to save over 80% on the cost of ready made filament; it enables the recycling of old prints and other plastics; it allows experimentation with new colours and compounds and can be used for the extrusion of ABS, PLA, EVA, HDPE, LDPE and more.

WHO CAN USE IT? D3D Innovations says its technology is suitable for a range of users including prototyping services; filament sellers; professional print hubs; universities, colleges and schools; architects and designers – anyone who uses a FFF 3D printer.

The system already boasts a range of established users such as rapid prototyping department of a major multi-national brand, astronomy research department, pharmaceutical research groups, polymer and composites laboratories and major polymer recycling centres.

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NEWS ANALYSIS

Absorbable stents non-inferior to metal, study finds A

drug-eluting coronary stent made of absorbable material (a biodegradable polymer coating) performed similarly to the gold-standard metal one in a non-inferiority trial among patients with the more serious type of heart attack known as ST-segment elevation myocardial infarction (STEMI), according to results of the Absorb STEMI Trofi II trial, manufactured by Abbott.

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This is the first randomised controlled trial to compare the stent coverage between these two types of stents in the STEMI setting

“This is the first randomised controlled trial to compare the stent coverage between these two types of stents in the STEMI setting,” said senior investigator Patrick Serruys, who presented the findings at ESC Congress 2015, with simultaneous publication in the European Heart Journal.

Unlike metallic stents which remain permanently in place, absorbable stents also known as ‘bioresorbable vascular scaffolds (BVS) eventually biodegrade restoring the natural physiology of coronary vessels – “a factor which may be more important in STEMI patients, who tend to have delayed arterial healing as compared to patients with stable coronary artery disease,” explained Professor Serruys, from the International Centre for Circulatory Health, Imperial College, London, UK.

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The study included 191 STEMI patients (mean age 58.6 years) undergoing primary percutaneous coronary intervention at 8 medical centres.

Patients were randomised to receive either a BVS (n=95) or metallic stent (n=96), both types being ‘drug-eluting’, meaning coated in everolimus, a drug to reduce the risk of vessel reblockage.

The primary endpoint of the study was a six-month score assessing stent coverage and restenosis of the vessel using coronary optical coherence tomography (OCT) imaging.

Given the chosen criteria for non-inferiority, the score was similar (1.74 in the BVS arm and 2.80 in the metallic stent arm), indicating almost complete arterial healing in both groups and meeting the criteria for non-inferiority (P<0.001).

Clinical events measured as a composite of cardiac death, target vessel myocardial infarction (MI), or clinically-driven target lesion revascularisation, were 1.1% in the BVS arm compared to 0.0% in the metallic stent arm (P=ns), with one case of definite subacute thrombosis in the BVS arm.

“This trial provides the basis for further exploration in clinical outcomes trials,” noted Dr. Serruys.

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SP-EU-MBS-1657 10/15

16–19 November 2015 Hall 8a P04

NEWS ANALYSIS

Health is wealth This year’s Compamed offers a host of expertise and advances aimed at bringing the best of medical device From 16-19 technology to visitors.

November, Compamed will return to Dusseldorf highlighting the best in innovation for medical device manufacture.

The event promises a range of opportunities to keep you at the forefront of technology as well as offering networking and collaboration possibilities

The show has developed into a leading international marketing communication platform for suppliers of the medical technology industry. Last year more than 700 exhibitors from 37 countries visited the event. According to the show’s organisers whereas once simple parts, components and equipment for technical devices and medical products were the focus of the show, today Compamed is a hotspot for complex high-tech solutions.

Joachim Schäfer, managing director, Messe Düsseldorf, commented: “The market for medical technology and medical products is very dynamic. The innovation cycle is considerably shorter than is the case in other industries. The German medical technology manufacturers make about a third of their sales with products that haven’t even been introduced on the market

for more than three years. In accordance with this, it is necessary for every specialist who deals with product development in the medical field to continually keep themselves up-to-date.

“Currently, microsystem technology solutions for mobile diagnosis, monitoring, and therapy systems are particularly trendy, whereby the field of optical processes is particularly being developed on a dynamic level.

For example, micro-components for minimally invasive diagnostics must be mentioned or also optical components for use with laboratory equipment. Sample examinations that had to be performed by pathologists under a microscope with a great deal of effort can now simply be done at the press of a button using a device – in just minutes based on the latest findings with regard to the light behaviour of malignant and benign tissue when exposed to a laser pulse.”

Schäfer highlighted the importance of mobile diagnostics systems within the device sector.

He said: “Experts expect that the lack of doctors will particularly increase in rural areas at a great rate. By the year

2021, a decline of 42% in the number of general practitioners is expected.

Therefore, the distance to the nearest medical practice will continually increase for patients. Therefore, there are enormous advantages in modern diagnostic processes that make results already available after a few minutes rather than in several days.”

Schäfer said suppliers are not only coming up with clever ideas for immediate analysis at the location of the treatment but they are also driving the development of ‘wearables’ diagnostic tools. He cites optical micro-sensors as an example.

“There are the first in-ear sensors, which can measure vital signs such as your pulse or even the blood’s oxygen content in a noninvasive manner and transfer this information to a recording instrument. The sensors are designed to be fit into earpieces and should therefore be just as comfortable as inear headphones.”

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NEWS ANALYSIS

ON TREND O

nce again the upcoming Compamed event – 16-19 November, Messe Dusseldorf – will provide an overview of the entire range of medical technology suppliers. The exhibition has something for everyone – from tiny sensors to packaging machines, innovative materials and mobile diagnostic devices plus electronic manufacturing of the leading events services (EMS).

As one for the medical supply sector, Compamed is at the forefront of market trends Klaus Jopp uncovers some of the technological breakthroughs that the show will have to offer

“The success of Compamed can be explained as the result of closely integrating development processes on the part of the suppliers as well as on the part of their customers,” said Joachim Schäfer, managing director of Messe Düsseldorf, explaining why visiting this trade fair offers an opportunity to view future and current trends for medical technology innovations.

Organisers of the event say that Compamed has developed into a leading international platform for suppliers of the medical technology industry. For the first time this year, Compamed will be held at the same time as Medica from 16 to 19 November 2015.

Nano-robots One area of innovation at the event will be surrounding nano-robots in the bloodstream that autonomously carry out operations. The Max-Planck Institute (MPI) for Intelligent Systems (Stuttgart) has developed two different micro-swimmers which move forward by opening and closing as well as by a screw that moves forward by rotation. With a diameter of only 100 nanometres and length of 400 nanometres, this technology involves an external rotating magnetic field which sets the mini-screw into motion and the manufacturing process is carried out using 3D printing with biocompatible materials such as polydimethylsiloxane. According to researchers one day, nano-robots will introduce tumour therapeutic agents directly into the tumour.

According to Peer Fischer, head of the working group micro-, nano- and molecular systems at MPI for Intelligent Systems, due to the size of these nano-robots, “application within the cell would be conceivable”. The mini devices will be useful for minimally invasive intervention and should also

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allow such procedures to take place in a shorter time spans although it may be some years before this technology is actually put into place.

“The life-science industry is showing an increased demand for the miniaturisation, micro-structuring and an integration of optical and electrical functions in inexpensive components,” said Peter Kirkegaard, CEO of IMT Masken und Teilungen.

IVAM joint stand Along with around 50 other companies, IMT will join other companies including Micreon on the IVAM stand the association for micro-technology.

“This is a new record; our floorspace comprises almost 700 square metres,” explained Mona Okroy-Hellweg, IVAM.

Suppliers forum The Compamed Suppliers Forum will provide presentations from leading companies. These will look at issues involving manufacturers, suppliers and users. Topics covered will include materials, technical innovation and user-centred design and this year presentations on delivery performance in the medical technology field, including presenting tools and parameters for improved performance, will also be on offer.

Coatings to kill bacteria Coatings are an eternal hot topic at Compamed, especially those with antimicrobial action. Biofilms on catheters can lead to infection in patients. In the USA two thirds of all catheters on the market have antimicrobial coatings and/ or antithrombogenic coatings.

Using the ‘non-leaching method’ Cikautxo, located in northern Spain, has developed catheters with a surface treated with a substance that kills off bacteria at the moment the bacteria come into proximity of it. Using this method, no substances are released into the vascular system so that no side effects result. Cikautxo works with an antimicrobial coating made of polymers and their antithrombogenic effect, which is based on heparin.

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 contamination 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

SPEECH THERAPY

VOCAL

Q&A

exercise Who are you and what do you do?

I am Thomas Muehlbauer, CEO and the founder of Avacen Medical. The concept for Avacen, which is an acronym for Advanced Vascular Circulation Enhancement, grew out of doing research on relieving migraine pain..

How would you sum up your company?

We are a single product company. Our patented US FDA-cleared medical device was designed to help the billions of chronic pain suffers in the world. The Avacen 100 medical device is a non-invasive medical device that is designed to allow consumers and patients to systemically treat chronic pain from a single convenient body location (the palm).

Simply place your hand into the Avacen 100 for a comfortable treatment session. The system uses heat therapy and negative pressure to increase local circulation and infuse heat into a vascular network, located in the palm of the hand. Raising the blood temperature at this ‘single point treatment’ (the palm) increases blood temperature throughout the body naturally via the circulatory system. This can benefit the entire body. Although it’s more complicated than this we basically provide the healthy benefits of a sauna from the inside out.

Name a business achievement you are most proud of.

That’s a tough question because we have achieved so much in the last four years!

Designing a safe (almost 500,000 treatments without a negative side effect), easy to use medical device that can help so many people has to be at the top of the list.

Our fibromyalgia clinical study which produced results showing a significant reduction in widespread pain for sufferers, who have very few options, has lead us down a very difficult path in getting regulatory approval. I’m very proud that we haven’t given up on getting WWW.MEDICALPLASTICSNEWS.COM

marketing approval, especially when funding dried up more than once. Then we made it through FDA clearance.

And finally, over the last two years the company has been awarded three US and multiple international patents for our apparatus and methods that support the medical process called The Avacen Treatment Method (ATM).

ATM provides whole-body muscular relaxation by rapidly and non-invasively infusing heat into the circulatory system to increase microvascular circulation, reduce blood viscosity and enhance deep tissue nutrition.

The patents also cover multiple therapeutic uses to alleviate symptoms associated circulatory, neurological, lymphatic or endocrinal dysfunction.

What excites you about this industry?

Medical devices that can reduce or eliminate pain associated with diseases that are now only treated by dangerous drugs is a very exciting prospect.

The fact that we have actually been able to relieve chronic pain resulting from numerous diseases for people who have tried everything possible is also very exciting.

Recently we have discovered that our product significantly reduces, and sometimes eliminates, the pain associated with Complex Regional Pain Syndrome, a disease that charts higher than giving birth on the pain intensity scale. Even though the path will be long and extensive to obtain regulatory approval, it is exciting to think that this segment of the population will at some point be able to escape the terrible drugs and expensive and extensive treatment regimes.

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

Healthcare in the US is under pressure to reduce costs and the use of opioids. Devices that offer a solution to these issues will experience exceptional growth.

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

To be honest, there is no other medical device that I wish would have invented. The Avacen Treatment Method will change the future of palliative care worldwide. The dream that billions of people will someday use our product is hard to top.

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COVER STORY

Singled out: Phillips-Medisize is the exclusive manufacturer of this Nicotinspray device – a dispenser with precision plastic components

SMOKE SIGNALS

A sign of the times – Phillips-Medisize has used its expertise for a nicotine therapy spray device.

From project to production the company was involved in the project which used automatic assembly through indexing machines

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mokers who want to give up cigarettes can overcome their urge to smoke by using the nicotine therapy spray which starts to act in 60 seconds. This gives relief from cigarette cravings and helps patients stay smoke-free long-term.

The benefit of these sprays is that no tar or condensate gets into the lungs through cigarette consumption and the need for nicotine successively decreases. Phillips-Medisize is the exclusive manufacturer of this innovative nicotine spray device in Nürensdorf (Switzerland) in the form of a dispenser with precision plastic components. Filling is done by the end customer, the drug company.

Single-release As Christof Plätzer, sales & marketing director Europe at Phillips-Medisize explained, one spray from this nicotine dispenser is equivalent to the dose of a cigarette: “The spray is a good alternative to the patch and is only used as required.

In contrast to the patch, it is not constantly releasing nicotine.”

Phillips-Medisize manufactures plastic components for medical devices and the pharmaceutical industry. The parts for the dispenser are manufactured and assembled under the hygiene standards required.

“Our client’s idea was to complement chewing gum and patches with a nicotine spray. The client commissioned a design agency to develop a dispenser.”

Winning ways Requirements included child safety – which is an important factor in the planned market launch, including the US market – and a PET container due to the innocuousness of the plastic material. Suppliers were then evaluated to realise the design agency’s idea. Phillips-Medisize was awarded the contract as the company was able to manufacture all plastic parts of the nicotine spray in the Nürensdorf facility under one roof, with the exception of the pump.

COVER STORY “The pump manufacturer, being the supplier of an essential part of the dispenser, was also integrated into the process.

The only external purchases required are small metal springs for the spray trigger mechanism as well as the pump,” Plätzer continued.

“

Phillips-Medisize was awarded the contract as it was able to manufacture all plastic parts of the nicotine spray under one roof, with the exception of the pump

“Not everything was designed to be manufacturing-friendly.

We therefore revamped the components in design-formoulding so that they could be readily produced from plastics.”

Injection-moulding and injection stretch blow moulding were selected as processes.

For the latter, the nozzle piece (neck) of a bottle is formed in a first step; the bottom part is then blown separately.

This ensures air tightness. Precision workmanship and good closability of the sprayer are also crucial due to the child-proofing lock.

“The product will be marketed worldwide with a staggered launch,” explained the Phillips-Medisize sales & marketing director.

By awarding Phillips-Medisize the contract, its technological capabilities as well as its holistic approach of handling the new project were recognised. Plätzer said, “In total, it takes 18 months to two years until products like these are ready to go and manufacturing can start.”

Phillips-Medisize provides the general equipment and the moulds are financed by the client.

Machinery expertise There are now several injection moulding and injection stretch blow moulding machines in operation for the nicotine spray device. The dispenser is made up of seven parts (one is manufactured by injection stretch blow moulding process and five by injection moulding process). The container manufactured by injection stretch blow moulding process is made of PET. The differently formed parts made of, PP

or POM necessitate the use of different moulds with up to eight cavities on different injection moulding machines with clamping force from 50 to 200 tonnes. The raw materials are dyed completely by Phillips-Medisize in-house in order to guarantee the uniformity of the individual components. Here, three components are dyed black with two parts remaining transparent. Before manufacturing began, a number of tests with the tools were required to find process windows for continuous production.

Plätzer explained: “We conducted extensive validation processes, starting with DQ (design qualification) followed by IQ (installation qualification), right through to OQ (operation qualification) and PQ (production qualification).” Since 2011, the nicotine spray device has been mass produced; the project began in 2010.

“We work as a three-shift operation. Our blowing and injection division are located in two separate sectors, with a dedicated production management department coordinating the work,” said Plätzer.

In the assembly area, at the top end of the conveyor belts, the components are isolated and undergo 16 assembly stations until the so-called subcomponent is completed.

At station one, feeding into the There are now several slider takes place, at station three, the steel springs are injection moulding and inserted, at station five, the injection stretch blow hot calking of the springs, moulding machines at station seven the cap is mounted, at station 11, the in operation for the actuator is ultrasonically nicotine spray device. welded to the cap, station 13 checks the slider, station 14 checks the belt components and implements them and finally the empty control is performed at station 16.

“

Plätzer is proud that the reject rate in production is very low: “Considering the fact that the various plastic parts have to snap into one another with precision and each part has a different tolerance level which is in the 2/100 millimetre range.”

Winning ways: By awarding PhillipsMedisize the contract, the company says its technological expertise and holistic approaches were recognised

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27.10.15 15:01

SPEECH THERAPY

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Arrive home â&#x20AC;&#x201C; settle down to answer emails and update CRM records.

Arrive at RNTNE and meet with senior staff nurse.

Collect flexible nasendoscope and light source that has been on trial. Get feedback and agree on follow up date with procurement lead.

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12

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Grab lunch - in between phone calls and voicemails!

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MPN HIGHLIGHTS

Selection box 2015 has been a busy year for the medical plastics sector.

Lu Rahman handpicks her favourite stories of the year that highlight the innovation that keeps on coming from the sector

COVER STORY As always, the MPN team took its annual trip to Compamed at the end of 2014. Eastman drew visitors’ attention with its new Eastalite copolyester, the company’s first opaque offering to the European medical packaging portfolio. The company teamed up with Carolex packaging to showcase the new material at the event. Eastman Eastalite copolyester is billed as a sustainable alternative to high-impact polystyrene (HIPS) for opaque rigid medical packaging and has been designed to be a cost-effective, styrene-free material that is easier to process.

“Eastman Eastalite copolyester is the first step toward creating lightweight packaging, and the unique product will open new opportunities for specific medical applications,” said Laurent Bouchet, commercial director, VitasheetGroup Carolex.

F O G IN H T E SOM STANCE SUB

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MPN HIGHLIGHTS

LIFE LINES More innovation came later in the year via an injectable polymer from the University of Washington which could prevent soldiers and trauma patients from bleeding to death.

University of Washington researchers alone after tourniquet developed a new injectable polymer that strengthens blood clots, called PolySTAT. Administered in a simple shot, the polymer finds any unseen or internal injuries and starts working immediately and when a tourniquet won’t stop the bleeding.

The new polymer, described in a paper featured in Science Translational Medicine, could become a first line of defence in everything from battlefield injuries to rural car accidents to search and rescue missions deep in the mountains. It has been tested in rats and researchers say it could reach human trials in five years.

NanoGriptech was another company pushing forward innovation in this field. Strange as it might sound, the company has produced a gecko-inspired adhesive, Setex, that it says is the world’s first dry adhesive inspired by the microscopic hairs of a gecko’s foot.

The technology is being put forward as a solution to a range of medical applications and is said to offer friction enhancement to skin. The company says that current gripping material used on orthotics, braces, prosthetics, face masks and other medical equipment that comes in contact with skin often slip, become contaminated or use materials that smell over time. Such materials do not work well with concave surfaces or in situations that need low profile, non-tacky gripping. NanoGriptech says that Setex offers an alternative in this area.

The technology can also be used for surgical tool grip. The current challenge is surgical tool design is to create tools that improve grip without tacky contaminants or adding profile that decreases touchsensitivity and NanoGripTech says this technology enables surgical tool providers to create sterile tool grips improve gripping performance, without residue or bulkiness.

Bridging the gap: Eastman believes its Eastalite copolyester helps fill an unmet need in the medical industy

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MPN HIGHLIGHTS

LET’S GET DIGITAL It would have been difficult to miss plethora of digital health devices and wearables to hit the sector in the last year. The MPN team launched a sister website dedicated to this important and growing market – www.digitalhealthage.com – as well as the #Let’s Get digital campaign to support the work being done in this field by medtech companies.

Let’s Get Digital was launched in August this year as a sounding board for people who actually use medical devices (specifically digitally-enabled ones) to work with industry on improving designs, features and software. Making use of social media, surveys and other online forums, the project’s founders are busy compiling a list of the most important things for device makers to consider.

Track & trace: Healbe’s GoBe fitness tracker can track calorie intake purely from a wristbased sensor

The project also hopes to work with government and policymakers to help improve digital switchovers and transition processes within hospitals.

In the January- February issue, Gavin Wheeldon, Purple WiFi asked whether wearable technology will help us live a healthier life. He said: “This is just the tip of the iceberg.

Expect to see more wearable technology introduced to your local gym or running club, or we could even be experiencing the beginning of the end for the gym, at least as we know it. Wearable technology is enabling us to exercise how we want, when we want, with all the motivation of a personal trainer as well as the best advice, simply through technology you wear.”

Wheeldon picked pout some key wearables: “At this year’s CES in Las Vegas we saw a range of exciting health and fitness wearables, including Emiota’s smart belt, which is an activity tracker that also automatically adjusts belt settings to your standing and seated position so that it’s never uncomfortable, and it can also loosen when you’ve had a large meal.

“Healbe’s GoBe fitness tracker can track calorie intake purely from a wrist-based sensor and Quell offers wearable pain relief by using sensors to stimulate nerve endings in the calf, which send signals to your brain encouraging it to release your natural opiates.

“UpRight focuses on improving your posture, a preventative aid to eliminate your chances of developing back problems. This small wearable device sits in the small of your back and delivers gentle vibrations to alert you when you are slouching and need to straighten up.”

Meanwhile Dr Cees Van Berkel, principal scientist at Philips Research UK, summed up how important collaboration is in the digital health market: “Telehealth has traditionally been seen as a patient monitoring tool following a hospital discharge, but by working in true collaboration with partners and GPs, we’ve managed to look at ways where telehealth can help in the primary care setting. Collaboration was essential to gaining the insights required and ensuring that what was suggested didn’t impede on the GPs’ roles and responsibilities but instead brought them into the mix from day one. The resulting ideas and services have consequently been widely championed in the region.”

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MPN HIGHLIGHTS

THE PRINTED WORD The last few years have all been about 3D printing but in March 4D printing took centre stage.

4D printing is self-reconfiguration or self- transformation – printed elements in a strand, sheet or 3D object that transform into another shape through the use of energy. The materials being developed are capable of transforming themselves without human intervention. These ‘smart’ materials have properties which allow them to transform from one state into their programmed state through the use of water as an activation energy.

Skylar Tibbits, Massachusetts Institute of Technology, spoke to MPN about the potential this technology has for medical manufacture: “We have an opportunity to make every material a smart material that will respond to any energy source – the medical space right for this. There are a range of sectors showing interest in 4D printing and medical is one of them.”

Tibbits said the only barriers to the uptake of 4D printing in the medical sector will be the industry itself and regulations.

While there was excitement about 4D printing, its 3D counterpart was still very much at the forefront of the sector.

According to a study presented at the Society of Interventional Radiology’s Annual Scientifi c Meeting, 3D printing could become a powerful tool for customising radiology treatments to a patient’s needs, allowing clinicians to construct devices to a specific size and shape.

“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,” said Horacio D’Agostino, lead researcher and interventional radiologist at Louisiana State University Health Sciences Center (LSUH).

Carbon dating Other innovation came from Carbon3D which offers polymerbased 3D printing that promises to advance the industry beyond basic prototyping to 3D manufacturing. The new Continuous Liquid Interface Production technology (CLIP) harnesses light and oxygen to continuously grow objects from a pool of resin instead of printing them layer-by-layer.

According to Carbon3D its CLIP technology raises the bar in 3D printing in three ways: It has a game-changing speed which is 25-100 times faster than conventional 3D printing; commercial quality – produces objects with consistent mechanical properties and material choice – it enables a range of polymeric materials.

26

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According to Skylar Tibbits, MIT, the only barriers to the uptake of 4D printing in the medical sector will be the industry itself and regulations

MPN HIGHLIGHTS

TAKE MY DEVICE In the summer Medirio claimed that its integrated insulin delivery device was ‘revolutionary’ allowing every insulin pen user to manage insulin injections in an easier, discreet and more comfortable way.

The device has been designed comfort in mind and so that the user needs no more than one prick every three days. Medirio says the device is cost-effective and unable to be hacked.

Dassault Systèmes’ Living Heart Project proved to be of great interest to MPN readers. Offering a high-fidelity scientifically validated 3D simulator of a four-chamber human heart this device gives manufacturers, researchers and medical professionals the ability to perform virtual tests and visualise the heart’s response in ways that are not possible with traditional physical testing.

The Living Heart model offers a baseline healthy heart, which can be used to study congenital defects or heart disease by modifying the shape and tissue properties in an easyto-use software editor. Medical devices can be inserted into the simulator to study their influence on cardiac function, validate their efficacy and predict reliability under a range of operating conditions. For example, coronary stents can be evaluated for optimal type, size and placement to achieve the best performance.

Offering a new twist on an old device, the Eko Core stethoscope allows doctors to see heartbeats in wave form on a mobile device as well as hear the sound at an amplified level.

Both the visible and audible data can be recorded and shared between physicians and hospitals. This can take a lot of the guesswork out of detecting murmurs, valve problems, and blockages in the arteries.

The device came about when a member of Eko Devices was diagnosed with a heart murmur as a child. This experience was behind the decision to develop a tool that would increase the diagnostic accuracy of clinicians and support them in differentiating between innocent and pathologic heart murmurs at the point of care in order to avoid unnecessary referrals, anxiety, and expensive screenings.

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All product development involves numerous uncertainties, such as: will this work in practice, have we chosen the right thickness of material, will this spring tolerate the number of compressions required by the customer? Uncertainties that depend on uncontrollable factors such as what temperature the product will be used in, humidity and how the user handles the product.

Itâ&#x20AC;&#x2122;s pretty standard to try to avoid uncertainties by reducing the range for the highest and lowest application temperature, opting for more expensive materials and adding certainty factors such as thicker material. But these all lead to making the product more expensive than it actually needs to be. â&#x20AC;&#x153;There are a lot of examples of a safety margin being added to all of a productâ&#x20AC;&#x2122;s components,â&#x20AC;? says Anders Nilsson, a technical physicist and product developer at Nolato Medicalâ&#x20AC;&#x2122;s Technical Design Centre (TDC). â&#x20AC;&#x153;Or where small adjustments are still being made here and there to get the product to work optimally years DIWHU WKH ODXQFK RI WKH Ă&#x20AC; UVW YHUVLRQ Âľ

Robust design $ VLJQLĂ&#x20AC; FDQWO\ EHWWHU VROXWLRQ LV WKHUH fore to test the product virtually before itâ&#x20AC;&#x2122;s manufactured so that a â&#x20AC;&#x2DC;robust designâ&#x20AC;&#x2122; can be ensured from the very start. â&#x20AC;&#x153;Robust design is based on optimising the productâ&#x20AC;&#x2122;s ability to allow for the variations that occur in manufacturing, use and the environment in which the product is used,â&#x20AC;? says Anders Nilsson.

This method is based on the approach developed in the 1950s and 1960s by Japanese quality management expert Genichi Taguchi. The approach has since been UHĂ&#x20AC; QHG DQG DGDSWHG WR WKH SRVVLELOLWLHV offered by todayâ&#x20AC;&#x2122;s advanced computer simulations. ´7KH Ă&#x20AC; UVW WKLQJ ZH GR WR DFKLHYH D robust design is to identify the requirements of the customer, users and regulatory authorities that the product has to meet. Some of these correlate with each RWKHU VR WKH Ă&#x20AC; UVW VWDJH DQG WKH RQH WKDW provides the best value for money, is to GHYHORS D GHVLJQ WKDW IXOĂ&#x20AC; OV WKHVH UHTXLUH ments,â&#x20AC;? says Anders Nilsson.

A simple example of the advantages of testing a product before itâ&#x20AC;&#x2122;s manufactured: Nolatoâ&#x20AC;&#x2122;s developers are able to use simulations at the design stage to identify, for example, that the spring in this automatic dosage device for subcutaneous mediFLQHV FDQ RQO\ FRSH ZLWK Ă&#x20AC; YH LQMHF tions instead of the required ten. By continuing to conduct virtual testing, they are able to achieve an optimal design so the spring has exactly the right strength. Or perhaps come up with a completely different design that is even more innovative and sustainable. n

BACKGROUND: Robust design Robust design is a development methodology that makes it possible to test a new product virtually before itâ&#x20AC;&#x2122;s produced, allowing for the creation of a better product that is less sensitive to variations in production and use. n

Virtual testing is best 5HTXLUHPHQWV WKDW FRQĂ LFW ZLWK HDFK other remain, however, and may be hard to resolve. Anders says there are four ways of managing these: 1 ,JQRUH FRQĂ LFWLQJ UHTXLUHPHQWV DQG hope for the best.

2 3UHYHQW FRQĂ LFW E\ IRU H[DPSOH VHW ting reduced temperature ranges for use.

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Instead, we carry out virtual testing of all a productâ&#x20AC;&#x2122;s properties and functions using advanced computer simulations before the product is made. This allows us to test the product before itâ&#x20AC;&#x2122;s produced, which both reduces development costs and saves time.â&#x20AC;?

Get it right from the start 7KH FKDOOHQJH LV WR Ă&#x20AC; QG VPDUW VROX WLRQV WR UHVROYH FRQĂ LFWLQJ UHTXLUHPHQWV Developers use simulations at the design VWDJH WR LGHQWLI\ SUREOHPV DQG Ă&#x20AC; QG JRRG solutions. â&#x20AC;&#x153;So in practice robust design is about being able to do things right from the beginning when the product starts to be manufactured,â&#x20AC;? says Anders Nilsson. â&#x20AC;&#x153;Before that we can perform virtual tests, PDNH FKDQJHV DQG Ă&#x20AC; QG WKH EHVW VROXWLRQV while maintaining control over costs and time.â&#x20AC;? n

23/10/2015 10:53

SOCIAL INFLUENCERS

THE IN CROWD Y

ou’ve just set up your shiny new Twitter account but where do you start building your audience? Dave Gray gives ten suggestions for the most influential social media users in medtech, based on their sharing klout

These brands and users have been collated based on a typical month’s social activity and influence. We looked at popular hashtags, users who engage with industry, audience sizes and a host of other analytics data to find these accounts and groups.

1 ) FDA MEDICAL DEVICES

3 ) MEDICAL PLASTICS NEWS

A genuinely influential, not to mention useful resource, this Twitter account owned and operated by the FDA is approaching 57,000 followers. It’s the first port-of-call for recalls and approvals data, as well as guidelines and other updates.

As the only news account dedicated to polymer innovation in medical devices, we felt we had to include ourselves in this list. Follow @mpn_magazine to stay up-to-date on original stories and features that you won’t in the print title.

Okay, that’s it for the shameless plug.

We also use it here at MPN HQ as a great place to sniff out news on up-coming devices under development, so if you’re interested in watching the market, this is one for you.

4 ) ADVAMED

2 ) MEDICAL DEVICES GROUP/ JOE HAGE Last year we caught up with Joe Hage, owner of the Medical Devices Group on LinkedIn. The ‘facebook for business’ platform has proven itself a worthy contender in the stakes for medtech’s most useful social media outlet.

The Twitter account for the Advanced Medical Technology Association is currently using social engagement to great effect in protest against medical device tax in the US. A great voice for medical device manufacturers, the group has amassed over 10,000 highly active followers.

It keeps an eye on global medical developments as published in the world’s mainstream media outlets (e.g.

Huffington Post, The Times) and combines this with its own insights. A must-follow account for anyone looking for a bird’s eye view of the market.

Hage’s group is approaching 300,000 members now, and is one of the largest and most active online communities for our sector. In his interview with MPN last year, he advised readers: “If you’re selling catheters, convince me you’re knowledgeable about the whole category – not just your product line”.

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SOCIAL INFLUENCERS

5 ) BAYLIS MEDICAL This is a corporate Twitter account, but interestingly, the firm takes away the usual veil of mystery by naming the tweeter responsible for the content – in this case, one Luc Desaulniers, marketing and communications at Baylis.

Desaulniers has done a great job of helping Baylis break from corporate traditions like only posting links to the firms’ own products. In fact, most of the content shared is intended as light reading or sometimes inspiring tales of medtech in use. Baylis has a respectable following and regularly appears as a top contributor in the wider medtech discussion.

6 ) MEDICAL DEVICE GURU On LinkedIn, this forum has evolved into a 46,000 strong community for designers, innovators, engineers and users to share common problems and launch new products.

It’s quite business-heavy, but as always with medtech the ultimate focus is on improving patient outcomes.

7 ) POLYMER SOLUTIONS (TWITTER) This is the Twitter account for the US-based polymer test lab, Polymer Solutions. It’s another must, if for no other reason than its light-hearted approach to tweeting. Like Baylis, it shares great content from across the web, often adding a humorous slant.

Polymer Solutions goes even further by regularly posting its own multimedia. One recent post shows what happened when the firm’s latest intern had a run-in with an exploding egg! It’s all chemistry-related, but really these posts are great for a quick look on your lunch break.

8 ) OWEN MUMFORD Device maker Owen Mumford has done something really clever. Reflecting its business model, the corporate Twitter page targets content at both professionals and patients.

In one tweet, the company looks at recent studies into diabetes diagnosis methods, and in another it points readers to its in-house ‘good injection guide’. Owen Mumford succeeds in creating a social outlet that is inclusive of the two major stakeholders in medtech – doctors and patients.

9 ) DIGITAL HEALTH NEWS Do connected devices, patient empowerment and wearables make you tick? This fast-growing Twitter account is working hard to spread the word from the digital health revolution. Its unique selling point is that it caters not just for patients, consumers and doctors, but also has dedicated news streams for manufacturers and product designers.

10 ) MEDICAL DEVICE ENGINEERING PROFESSIONALS This is a great community for job seekers, as it pools the very specific skills required by the medical device sector.

It’s also another great starting point if you’re looking to get quick, informative solutions to manufacturing problems.

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COMPOUNDING

COMB INED

S

pecialty plastic compounding is more than mixing two or more components together. A superior quality compound starts with the selection of the right inputs; the rest is science devoted to maintaining the high quality that the medtech industry requires and deserves. After input selection, the next steps include drying the materials to ensure the integrity of the materials is maintained; process Nathan Doyle development to prevent degradation during compounding; selecting the appropriate and Nick Norton, pelletisation method and selecting pellet Compounding size that device manufacturers are able to Solutions offer process eďŹ&#x192;ciently.

an overview of plastics and rubber compounding for the medtech sector

STUDI ES fillers, such as barium sulfate, bismuth subcarbonate, and tungsten. Even selecting a radiopaque filler is not cut and dry; there are polymer and filler combinations that do not react well when combined. One of those combinations is thermoplastic polyurethane (TPU) with bismuth subcarbonate. Combining TPU and bismuth subcarbonate results in the rapid degradation of the polymer and all desired physical and mechanical properties are greatly compromised. There are also certain polymer combinations that are incompatible, such as polyethylene with nylon and TPU with nylon.

Consult with your compounder about your formulation for any potential compatibility problems.

Colourants

Materials selection

Perhaps the most important part for materials selection is that device manufacturers should always partner with their compounders. Making the compounder aware of information about the final application of a material greatly helps custom compounders develop a material formulation and process that results in excellent filler and pigment dispersion, meets specifications and will work in the desired application for the desired amount of time. When it comes to catheter tubing or micromoulding applications, the wall thickness of the tubing extrusion or micromoulded part is critical information, as this will help to ensure a welldispersed compound free of surface imperfections.

This is especially important for very thin walled applications that can be as thin as 0.001â&#x20AC;?.

In recent years, the United States Food and Drug Administration (FDA) has put limitations on the colourants that can be used in medical devices. The creation of Title 21 CFR Part 73 Subpart D has a limited number of colourants that have been deemed acceptable for use in medical devices without batch certification. Using the appropriate colourants can help speed up the FDA review process to save time and money.

These requirements greatly limit the end colours that are achievable for devices and tubes. If there are any doubts about whether a colour should be used for the development of a new product, compounders should be able to provide the advice needed to avoid any setbacks due to colourants.

The processes used involves more than the temperatures used during compounding. There are a number of technologies Opposite effects: Left shows the effect of bad dispersion that can set a compounder during the compounding process compared with good apart from the rest, whether Material selection is dispersion (right) it is how they dry materials, about more than choosing the feeding systems they materials simply because use, or designing an the properties look good on paper. There are right and wrong decisions and the optimal screw design to impose the correct amount of material combinations selected can make or break any shear and residence time, the pelletisation methods or new project. A large portion of materials used in medical the frequency and type of quality checks being performed devices are combinations of polymers and radiopaque during compounding.

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COMPOUNDING

Drying process There are numerous materials that require drying prior to processing, whether for compounding or device manufacturing through extrusion or injection moulding.

These requirements are often critical, as certain materials do degrade if processed without being dried properly.

Drying not only requires the equipment for the actual drying but you should also have the ability to check moisture levels with an appropriate moisture analyser. Whether you are a compounder or a device manufacturer, moisture analysis is a key part to ensuring product quality and functionality.

It is also vital to keep materials dry throughout processing, as some can quickly absorb moisture from the air and cause material degradation. Compounders and processors should have effective methods for maintaining appropriate dryness for all components.

Feeding systems play a large role in achieving highquality product that is consistent pellet to pellet and lot to lot. Volumetric feeding systems are less accurate and feed by discharging a constant volume of material;

pushing the material out of the extruder as fast as possible so the polymer is not subjected to an unnecessarily long heat history. Exposing polymers to high shear rates or longer heat histories than what is needed leads to polymer degradation.

Pelletisation of the materials can effect a device manufacturerâ&#x20AC;&#x2122;s process and it is very important to work with your compounder to ensure a proper pellet size is produced. Compounders may have their own internal pellet size specifications, but those may not feed right into small, single screw tubing extruders. An incorrect pellet size or shape can lead to feed and pressure fluctuations during processing, which leads to issues including lower yields and higher scrap rates for device manufacturers.

Importance of partners Making sure you partner with a compounder that has an audited quality system is a must. The proper quality checks must be done to ensure consistency and quality.

In the round: Cylindrical pellets (left) and spherical pellets (right). According to Compounding Solutions itâ&#x20AC;&#x2122;s important to work with your compounder to ensure a proper pellet size is produced

this is an efficient feeding method for less technical applications, where accuracy is not overly critical.

Compounding for medical materials requires a very high degree of feed accuracy to ensure consistency and quality; that is where loss in weight feeding systems come in. These systems feed based on a set discharge rate. Feeding by weight ensures that every pellet is a consistent formula.

Screw designs are often customised by compounders for certain applications and materials. There are two types of mixing that can be targeted via screw designs: distributive and dispersive. With dispersive mixing, particles (ie. second polymers, liquids, etc.) are reduced in size but it does not typically spread the particles evenly in the polymer.

Distributive mixing, on the other hand, homogenises a material; it distributes fillers and additives more evenly in space but does not change the size of particles. Each material and filler likes its own type of mixing to ensure maximum dispersion. Maintaining plastic properties in screw design is a balance between shear and residence time in the extruder. The goal of compounding should be to impose the right amount of shear to disperse fillers while

Properties such as dispersion and melt flow rate are always vital in medical compounds, no matter the final application.

Filler and colourant dispersion is especially critical in thin walled catheter applications and it is very important that compounder has the proper technology to properly evaluate dispersion. Ultra fine microscopy is a great tool for evaluating dispersion and particle size. Melt flow index or capillary rheometry should always be performed to ensure there is no thermal degradation of the polymer after compounding.

The many processes and technologies involved in compounding for the medical device industry are constantly evolving. It is important to find a compounder with a high commitment to quality, technology and a willingness to partner with device manufacturers to ensure open communication of specifications.

Compounding Solutions has long had an open door policy; meaning customers are encouraged to take an active roll in the development of their materials.

Compounded plastic materials save lives; compounding is about being partners and having more than just a supplier/customer relationship.

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33

POLYMERS & SOLUTIONS FOR HEALTHCARE Quadra™ Polyurethanes - USP VI & ISO 10993 Compounds & Masterbaches Coatings & Dipping Hydrophilic, Antimicrobial, Antithrombotic, Balloons

Tubings Multilumen, Coextruded, Bump tubes, Multidurometer

Prolix™ OEM High Pressure Braided Tubings

Catheters & Assembly

Groupe FORMULANCE SAS medical@formulance.com www.formulance.com

HALL 3 STAND E12 12. - 14.04.2016

HALL 8B FRENCH PAVILLON 16. - 19.11.2015

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TESTING

X-ray vision Abstract The quality standards in the plastic manufacturing industries are permanently increasing. Therefore, plastic material has to be inspected and analysed for different types of defects before it enters the final product.

Contamination, defects or inhomogeneities Dr. C Frank, down to a size of 50µm in the material have Sikora, discusses to be detected. This is achieved by a modular the use of an X-ray scanner and analysis equipment that can either be used continuously ‘online’ or x-ray scanner for for sample testing. In this way, transparent, pellet, flakes and opaque, coloured or black pellets and flakes film inspection as as well as thick coloured films and tapes well as analysis can reliably be inspected and analysed.

Consequently, highest material quality and in the compound stable production processes can be assured.

and masterbatch industry

Rising quality demands & challenges

For industrial production, highly pure and flawless plastic material is an important quality aspect. Due to the continuously increasing requirements, it is necessary to detect and monitor defects and impurities of decreasing size in plastic and intermediate products. Impurities of 50μm may already cause damage to production systems, such as to the crosshead of the extruder, or to the end products with high follow-up costs.

In the different processing steps for the production of plastic products, defects may repeatedly occur. This affects the processes of material producers as well as the compound and masterbatch producers, the processing industry, the recyclers and the whole supply chain.

Accordingly, it is necessary to control and monitor the quality of the material used before it is further processed.

Today, there are various systems and technologies available in order to inspect materials in laboratories or during production. Most of the technologies are based on optical film inspection technologies, where a batch sample is extruded to a film. [1], [2], [3]. There are several limitations to these optical inspection systems: Optical inspection systems such as pellet inspection systems only inspect the surface of pellets, not the inside the pellet. This applies especially for opaque and coloured pellets.

Optical film inspection is only applicable for transparent, thin films. Coloured pellets cannot be inspected without accepting major drawbacks. The only possibility to inspect coloured material through film inspection is to produce a very thin film. However, this means that only a very low quantity of pellets can be inspected. Therefore, the results of thin film inspections are not representative.

The limitations of the today’s optical inspection systems require new ways and technologies to meet fully the requirements of the plastic industry. With new X-ray test technologies and methods production related parameters such as inhomogeneity, contamination and defects, material differences, cross contamination, etc can be analysed.

X-ray technology to inspect and analyse By the use of X-ray technology, both transparent as well as non-transparent plastics are inspected for contamination.

The basic principle is the different attenuation of raw material and impurities or defects respectively. The attenuation (μ) of the X-rays is mainly determined by the nuclear charge of elements as well as of the thickness of the material to be inspected [4]. It is proportional to the atomic number raised to the 3rd power (μ~Z3).

Plastics consist mainly of carbon (Z=6). Thus, they have only a very low attenuation. An iron contamination with comparatively strong attenuation (Z=26) can be detected clearly. An additive, for example titanium dioxide, also affects the attenuation. Titanium dioxide agglomerates significantly contrast in the dispersion with the surrounding material. This is possible because the titanium (Z=22) in the titanium dioxide strongly contrasts with the plastics.

With a specifically developed X-ray camera system, it is possible to detect contamination or defects during continuous and discontinuous inspections, during film inspection or as an ‘online’ continuous quality monitoring system. X-ray cameras are taking pictures of the plastic pellets or of the film, which are then processed by mathematical algorithm. The mathematical algorithm clearly identifies the difference in the attenuation, even for a contamination size down to 50μm.

X-ray to monitor and optimise quality The production processes in the plastic industry are complex. Different materials are mixed together to receive different end products and there are many sources of contamination and other defects, which can enter the product. X-ray technology does not only detect metallic impurities in plastic pellets but gives also information on the condition of the overall production process. With X-ray, it is for example possible to identify cross-contamination of different plastic materials in one production process. This cross-contamination can be clearly visible, even if a plastic pellet has the same colour, but a completely different attenuation.

A main advantage of X-ray technology is that it is colour independent.

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35

TESTING

Image 3: X-ray scanning and analysis equipment with conveyor belt for a continuous inspection flow (eg ‘online’)

Further tests show, that it is also possible to detect an organic contamination, for example a piece of tissue, as well as a small metallic contamination. It is also possible to see air holes inside, which could lead to the conclusion that some parameters in the production process need to be adapted.

smallest contaminants in the film and therefore gives information on the contamination level of the overall material.

X-ray can also be used to detect agglomerations of additives in polyethylene pellets. These agglomerations can lead to major problems when they are used in a further production process to manufacture final consumer products.

Conclusions

The determination of the correct degree of foaming or expansion is also a possible analysis, which can be realised

by X-raying the respective pellets. In contrast, an optical inspection of the pellets would have given the information that all the pellets are flawless.

However, an incorrect degree of foaming or expansion of the pellets causes major defects in the end product, which can be prevented by using X-ray.

Quality standards in the plastic manufacturing industry are constantly increasing.

Contamination, inhomogeneities or any other defects need to be detected and analysed. Today, even the smallest contamination need to be detected during the production process. With the X-ray technology, we are able to detect contamination of 50µm.

Different inspection and analysis requirements need a modular concept approach for the equipment. Such equipment can be either used as a discontinuous lab scanner for pellets and flakes or as a continuous quality monitoring In a further test, we used black device at a production line. pellets with different metallic In this case the equipment is contamination in order to installed as an ‘online’ quality prove the efficiency of X-ray monitoring and analysis device Image 1: Metallic contamination in fl akes technologies. We clearly and can be used for pellet identified contamination of and flake inspection as well. the size of 50μm or 100μm in The images demonstrate the black pellets. modular concept of an X-ray scanning and analysis device.

With the X-ray analysis it is also possible to detect contaminants in flakes. The following picture shows small The concept is applicable for different material types as and major metallic contaminants in flakes (image 1). An for instance TPE, TPU, etc. or any coloured masterbatch optical analysis would not be able to provide these detailed or recycling product. The detection is independent of results as the flakes are reflective and therefore would the colour of the pellet or the colour and the thickness disturb the picture analysis of an optical camera. With of the film or tape. Therefore, the material quality can be the X-ray analysis system, it is possible to detect metallic constantly monitored and, hence, significantly improved. contaminants and also classify their size. Due to this information it is possible to determine the quality degree of the flakes.

References The same principle can be used for coloured thick film inspection and analysis. As already mentioned, optical film inspection needs transparent thin films and therefore cannot be used for an inspection and analysis such as shown in image 2. Here the film has a dark colour and is several millimetres thick. An X-ray analysis system is able to detect

[1] Tomra demonstrates optical sorter, http://www.plasticsnews.com/article/20131030/ NEWS/131039997/tomra-demonstratesoptical-sorter#, (10/2013) [2] Laura Tarrach, OCS GmbH, Pellet Scanning in “Free Fall”, Kunststoffe international (12/2010) [3] Satake, Pellet Sorter, http://www.satake-usa.com/ documents/Satake-Pellet-Sorter-Brochure.pdf, (2014) [4] Robert Fosbinder, Denise Orth, Lippincott Williams & Wilkins, Essentials of Radiologic Science (01.02.2011)

Image 2: Contamination in colored thick films

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BIOABSORBABLE POLYMERS

Materials science Products of Conmed Linvatec Biomaterials like SmartPin are produced from extruded rods, like the ones shown here with (white) and without (transparent) ceramic components

A

lthough a variety of bioabsorbable materials are available, polylactides are the most commonly used bioabsorbable polymer materials for clinical implants. By producing copolymers with L-lactide, D-lactide and How nonlinear models glycolide in different their of crystallinity and strength of proportions, degradation dynamics polylactide/glycolide implants as well as mechanical speed up product development properties can be tailored

by Abhay Bulsari, Nonlinear to suit the application.

Solutions, Mikko Huttunen, Kimmo Lähteenkorva and Esa Suokas, Conmed Linvatec Biomaterials

Most of the implant development work today is done by trial and error experimentation which is inefficient and expensive. Raw material suppliers offer only a limited variety of materials, and the implant developers select from that. Conmed Linvatec Biomaterials instead worked with the suppliers and tested non-standard polylactide/glycolide compositions extruded under different conditions.

Since experimentation was quite expensive and time-consuming, there was no sense in carrying out a lot of trial and error experiments. Instead, nonlinear models of shear strength, bending (flexural) strength and crystallinity were developed from limited experimental data combined with production data.

38

Mathematical modelling Mathematical models represent knowledge of quantitative effects of relevant variables in a concise and precise form. Mathematical modelling can be performed in various ways and different ways are suitable in different situations. Physical or phenomenological modelling is not particularly suitable for predicting material behaviour. Physical modelling usually requires assumptions and simplifications.

Empirical and semi-empirical modelling do not need any major assumptions or simplifications. They simply describe the observed behaviour of a material or a process. It is feasible when the relevant variables are measurable, as is often the case. Conventional techniques of empirical modelling are linear statistical techniques. These tend to have limitations because nothing in nature is very linear and particularly so in materials science. It therefore makes sense to use better techniques which take nonlinearities into account.

Nonlinear modelling Nonlinear modelling can be performed with several techniques including feed-forward neural networks. They have turned out to be particularly valuable in materials science and chemical engineering [1]. Besides their universal approximation capability [2], it is usually possible to produce nonlinear models with some extrapolation capabilities [3].

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International exhibition and conference on additive technologies and tool making

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BIOABSORBABLE POLYMERS

Nonlinear modelling in materials science Nonlinear modelling has been utilised successfully for various materials [4] including plastics, metals, concrete, mineral wools, semiconductors, glass, etc. Some things are common to modelling material behaviour. Material or product properties depend on composition variables, process variables and dimension variables, as summarised in figure 2.

Nonlinear models of strength and crystallinity

Figure 2. Material properties depend on composition variables, process variables and dimension variables

After some amount of pre-processing and data analysis, a large number of nonlinear models in the form of feed-forward neural networks were attempted using the NLS 020 software from the available data for shear strength, bending strength and crystallinity.

One or more parameters of the models were fixed or restricted. A fairly large amount of data was available for shear strength from several years. 330 observations were usable for model development. The nonlinear model which was taken into use had the following prediction error characteristics. rms error

of shear strength:

6.554

mean |error|

of shear strength:

5.019

rms % error

of shear strength:

7.42

max |error|

of shear strength:

22.102

Correlation

of shear strength:

0.9601

Figure 3 shows a comparison of the measured values of shear strength and the values predicted by the nonlinear model. Unlike linear regression models, this model will never predict negative values of shear strength.

Figure 3. Comparison of measured values with values of shear strength predicted by the nonlinear model

For bending strength, only 67 observations were available, but the quality of the data seemed to be better. As a result, the models were also better. The nonlinear model for bending strength which was taken into use had the following prediction error characteristics. rms error

of bending strength:

4.9506

mean |error|

of bending strength:

3.6516

rms % error

of bending strength:

3.41

max |error|

of bending strength:

17.187

Correlation

of bending strength:

0.9787

Figure 4 shows a comparison of the measured values of bending strength and the values predicted by the nonlinear model.

For crystallinity, only 63 observations were available.

The nonlinear model for crystallinity which was taken into use had the following prediction error characteristics.

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Figure 4. Comparison of measured values with values of bending strength predicted by the nonlinear model

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BIOABSORBABLE POLYMERS

Figure 5. Effect of D-lactide content on shear strength for different draw ratios

rms error

of crystallinity:

2.446

mean |error|

of crystallinity:

1.804

max |error|

of crystallinity:

7.411

Correlation

of crystallinity:

0.9787

The nonlinear models were then implemented in a LUMET system, which is a set of software components for efficient use of nonlinear models.

It was then used to see the effects of various input variables on strengths and crystallinity. Figure 5 shows the effect of D-lactide content on shear strength for different draw ratios, while keeping other input variables constant. Figure 6 shows the effect of draw ratio on shear strength at different area to volume ratios. Figure 7 shows the effect of glycolide content on crystallinity for different inherent viscosities.

It is now easy to determine compositions which will lead to a desired combination of shear strength, bending strength and crystallinity. More variables can be added when suitable data becomes available.

Conclusion

Figure 6. Effect of draw ratio on shear strength at different area to volume ratios

Implant development work is expensive and timeconsuming. It usually aims at achieving a desired combination of a few material properties. Those material properties depend on the composition of the material, process variables of extrusion and dimension variables. The relations between these variables tend to be complicated and nonlinear.

New techniques of nonlinear modelling are very effective for describing material behaviour.

Implant development work can be speeded up significantly by nonlinear models. It results in savings on experimentation costs as well as development time. The final result is better than what is usually achieved by trial and error experimentation.

References [1] A. Bulsari (ed.), Neural Networks for Chemical Engineers, Elsevier, Amsterdam, 1995

Figure 7. Effect of glycolide content on crystallinity for different inherent viscosities

[2] Hornik, K., Stinchcombe, M. and White, H., “Multilayer feedforward networks are universal approximators,” Neural Networks, Vol. 2, (1989) 359-366 [3] A. Bulsari, ”Quality of nonlinear modelling in process industries”, Internal Report NLS/1998/2 [4] http://www.nonlinear-solutions-oy.com/articles.html

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41

CHINAPLAS

CHINA IN YOUR HAND Next year’s Chinaplas – Shanghai, 25-28 April at the Shanghai New International Expo Centre – sees the event celebrate its 30th birthday.

A key global trade fair for the plastics and rubber sectors, organisers say it will contain more attractions than previous years

W

hen Chinaplas was first held in Beijing, the exhibition area was only 2,000sqm, and 90% of the exhibitors were from overseas. At the time production technology in China was still at a very low level and Chinaplas visitors mainly came to learn the advanced technologies from overseas countries. Today, China has become a key manufacturing country with strong production ability. In the past three decades, Chinaplas has developed into a showcase for both overseas technologies and Chinese machinery for export. Its international nature attracts overseas visitors from more than 150 countries and regions, which accounts for nearly 30% of visitors.

GREENOVATION FOR A SMART FUTURE Like other manufacturing industries in China, plastics and rubber industries are facing transformation to meet the new era of intelligent production. The world’s leading manufacturing countries have launched national strategic plans to meet the challenges in the new era and to strengthen their industrial competitiveness. Examples include Industry 4.0 in Germany, Advanced Manufacturing Partnership of USA, and New Robot Strategy of Japan. China has launched the Made in China 2025 strategic plan recently to boost its industrial growth, with the aim of upgrading Chinese manufacturing industries. Intelligent manufacturing plays a vital part in all of these national plans in adapting to new market environment.

The Greenovation for a Smart Future will focus on green and innovative technologies, as well as intelligent manufacturing solutions in response to the development of the industry.

MORE TO SEE Next year’s show is supported by a number of country and region pavilions including Austria, Germany, Italy, Japan, Korea, Swiss, Taiwan and the USA. Themed zones will this year will include the Automation Technology Zone, Composite & High Performance Materials Zone and Recycling Technology Zone. Intelligent production lines and systems, industrial robots, high performance materials, composite materials, the latest and most complete recycling solutions as well as other plastics and rubber technology breakthroughs will be also be showcased.

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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

Meet MELITEK at Compamed 2015 in Düsseldorf - Stand 8BL09

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43

BUYERSGUIDE Drug Delivery Devices

Orthopaedics

Medipack AG  (0041) 52 630 3636  Muhlentalstrasse 184-188, Schaffhausen, 8200, Switzerland

Nemera  (0033) (0)474 9505 46  20 Avenue de La Gare - B.P. 30, La Verpilliere, Cedex,

38292, France

Sil-Pro  (001) 763 972 9206  740 Seventh Street, South Delano, Minnesota, MN55328, United States

Sunstar Degradable Solutions AG  (0041) 43 433 6200  Wagistrasse 23, CH-8952 Schlieren, Switzerland

Packaging

Schott  (0049) 6131 660  H attenbergstrasse 10, Mainz, 55122, Germany

Eastman Chemical B.V.  (0031) 10 2402 111  Fascinatio Boulevard 602-614, 2909 VA Capelle aan den IJssel, The Netherlands

Extrusion – Tubing

Herrmann Ultraschalltechnik GmbH & Co.

Qosina  (001) (631) 242-3000  150-Q Executive Drive, Edgewood, New York, NY 11717-8329

 (0049) 7248 79-729  Descostrasse 3-9, Karlsbad, D-76307, Germany

Nelipak Healthcare Packaging  (00353) 91 757 152  Unit 6D, Mervue Business Park, Galway, Ireland

Injection Moulding

PEEK & High Performance Polymers

Arburg  (0049) 7446 330  P.O. box 1109, Lossburg, 72286, Germany

Foster Corporation  (001) 860 928 4102  45 Ridge Road, Putnam, CT 06260

Carclo Technical Plastics UK  (0044) (0)208 685 5116  47 Wates Way, Mitcham, Surrey, CR4 4HR, United Kingdom

CI Medical Technologies  (001) 724 537 9600  149 Devereux Drive, Latrobe, Pennsylvania, PA 15650,

United States

Teleflex Medical OEM  (001) 847 596 3100  1425 Tri-State Parkway, Suite 120, Gurnee, Illinois 60031

Zeus  (001) 803 268 9555  3737 Industrial Blvd., Orangeburg, South Carolina, SC 29118, United States

Polymers

p oly f lon We contract manufacture tubing components for medical device companies. Using novel heating methods we can create complex tip forms and micro-mouldings on the distal and proximal ends of thermoplastic medical tubing.

Tight control of the heating process allows us to produce very closely toleranced tip geometries to the customer’s own design.

Get in touch with Polyflon: info@polyflon.co.uk +44(0)1785 859 054

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Polymers

Seals

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Distrupol Limited

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Elasto UK Ltd  (0044) (0)161 654 6616  Don Street, Middleton, Manchester M24 2GG, United Kingdom

Invibio Ltd  (0044) (0)1253 898000  Technology Centre, Hillhouse International, Thornton Cleveleys, Lancashire, FY5 4QD, United Kingdom

Trelleborg Sealing Solutions Germany GmbH  (0049) 711 786 40 Handwerkstrasse  5-7, DE-70565 Stuttgart, Germany

Sterilisation Sterigenics  (001) 704 947 2505  2015 Spring Road,Suite 650, Oak Brook, Illinois, IL 60523, United States

Tubings Formulance

Melitek  (0045) 70 250 255  Hartvig Jensensvej 1, Nr. Alslev, DK-4840, Denmark

 (0033) 967 30 6463  Tour Oxygene, 10-12 boulevard Vivier Merle, 69393 Lyon Cedex, France

Microlumen

Polyurethanes

 (001) 813 886 1200  One Microlumen Way, Oldsmar, Florida, FL 34677, United States

DSM  (001) 510 809 1232  2810 7th Street, Berkeley, California, CA 94710, United States

Foster Corporation

Polyflon  (0044) (0)1785 859054  16 Raleigh Hall, Eccleshall, Stafford, ST21 6JL, United Kingdom

Qosina

 (001) 860 928 4102  45 Ridge Road, Putnam, CT 06260

 (001) (631) 242-3000  150-Q Executive Drive, Edgewood, New York, NY 11717-8329

Formulance

Vention Medical

 (0033) 967 30 6463  Tour Oxygene, 10-12 boulevard Vivier Merle, 69393 Lyon Cedex, France

 (001) 508 597 1701  261 Cedar Hill Street, Marlborough, Massachusetts, MA 01752, United States

Lubrizol Advanced Materials  (001) 216 447 6782  29400 Lakeland Boulevard, Wickliffe, Ohio, OH 44092, United States

Zeus  (001) 803 268 9555  3737 Industrial Blvd., Orangeburg, South Carolina, SC 29118, United States

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45

Keeping an eye on the next big thing can be hard.

Each issue of MPN selects a company, service or technology it thinks is the one to watch . . .

BEADY

Dressed for SUCESS

eye

MPN: Who are you and what do you do?

AVD: Bedal is a medical company that has been developing the Bedalpatch, a dressing that allows patients receiving intravenous therapy to wash safely, without disconnecting the infusion line or interference of the nursing staff.

Bedal started after one of the founders was diagnosed with cancer. David De Munter was admitted to the hospital for long periods, where he noticed how difficult taking a shower was with an infusion line.

Bedal started the development of a new dressing in close collaboration with the University Alexander Van Damme, Hospital of Bedale, explains the Leuven, a leading hospital, expertise behind the Belgian with a nursing companyâ&#x20AC;&#x2122;s Bedalpatch team focused on dressing catheter hygiene.

This collaboration ensured a good understanding of the market needs and the clinical relevance of the product.

MPN: What projects have you been focussed on recently?

AVD: We have focused our efforts on the development of the new patch, production startup, the set up of clinical trials and finding investors.

For the development of the patch - determining user needs to developing the final product was important, as well as the selection of the best materials: very different properties are needed in different elements of the product. For example the transparent dressing should be made of a breathable and transparent film, so that no condensation is built up under the patch during use, and that the patient can always see the exit site.

As well as the clininical trials that have been done in collaboration with the hospital, a larger scale trial was executed, involving more

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Patch testing: The Bedalpatch is a consumable dressing that allows patients with intravenous therapy to wash safely

than 100 patients that use the product and report on a variety of parameters, such as the change in autonomy and time requirements of the hospital staff.

Recently Bedal also finished a capital round with external investors. The investment deal was closed with a VC and several business angels.

The new shareholders are LRM (the Limburg investment company) and a consortium of business angels. The newly acquired funds will allow market development of the Bedalpatch.

MPN: Describe your latest innovation?

AVD: The Bedalpatch is a consumable dressing that allows patients with intravenous therapy to wash safely. The infusion line can stay connected during washing, excluding the need for the nursing staff to disconnect the infusion line. The Bedalpatch consists of a transparent dressing, with an integrated plastic snap part. This snap part will fit around the infusion line, and will provide a watertight seal around it. The Bedalpatch is a medical device class I, that will cover the exit site and the fixation dressing.

MPN: What does it mean for the medical sector?

AVD: This new product brings benefits to both the patient and the hospital. First of all there is the time reduction of the nursing staff required to help patients shower. Usually an adequate shielding of the exit site has to

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be provided, the infusion line is disconnected, and afterwards the fixation dressings needs to be replaced. The Bedalpatch aims to avoid these time-consuming manipulations by providing a dressing that will protect the full exit site without the need for disconnecting the infusion line.

Furthermore, a higher degree of autonomy of the patient can be expected, since the patient becomes less dependant from the availability of the nursing staff to be able to shower.

Additionally, the usage of the Bedalpatch is more in line with the recommendations for infection prevention from the CDC (Centre for Disease Control), that state that the number of manipulations of the exit site should be as low as possible, that fixation dressings should remain on site for long times and that showering is allowed if adequate shielding can be provided.

The majority of patients in the hospital receive intravenous therapy, so the problem of washing with an infusion line is a very significant one.

MPN: Plans for the future?

AVD: The market launch for Belgium, Netherlands and Luxembourg is planned for the end of 2015. Later on, we plan to expand to other European markets.

In parallel we wish to broaden our portfolio of products, so we are currently developing new products that have a strong fit with the Bedalpatch.

NEC BIRMINGHAM, UK | 26-28 SEPTEMBER 2017

INJECTION MOULDING

EXTRUSION

ROTATIONAL MOULDING

BLOW MOULDING

RECYCLING

THERMOFORMING

M AT E R I A L S

VAC U UM FOR M I N G

DESIGN

FILM EXTRUSION

EXHIBIT NOW www.interplasuk.com