MPN EU Issue 37

MEDICAL PLASTICS news

Shaping the future ACCUMOLD TALKS ABOUT THE CHANGING FACE OF TECHNOLOGY

+ INJECTION MOULDING SPECIAL DIGITAL HEALTH IN FOCUS EXTRACTABLES & LEACHABLES

ISSUE 36

May-Jun 2017

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CONTENTS May-Jun 2017, Issue 36

Regulars

19 In focus The vaginal mesh scandal: Update

5 Comment

50 06:2017 An MD&M East special

7 News focus Industry 4.0 – why it’s so important

Features

8 Digital spy

20 Step change HP 3D Printing explains how 3D printing is reshaping foot orthotics

11 News analysis EMDR – what you need to know 12 News focus Why NHS barcoding is important for the medical device sector and a new 3D printing method for superior implants 16 Cover story Accumold talks about the changing face of technology and how it reacts to manufacturing needs

22 The shape of things to come Injection moulding special 31 Is digital health enough?

Lu Rahman examines the digital health sector plus expertise from Phillips-Medisize and Cyient 36 Material fact Pyam Ramnes looks at how catheter material can be improved

39 The real deal Reece Armstrong talks to Clariant about its work to prevent counterfeiting 40 Play it safe Clariant Plastics and Coatings looks at extractables and leachables testing for plastics 43 Service with a smile Solvay’s move into medical devices has begun with a dental care business line 46 Part of the process Nelson Labs, look at third-party reprocessing of single-use medical devices 49 Everything’s bigger in Texas GW Plastics explains what the growth of its healthcare business means for the company

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CREDITS

EDITOR’S

group editor | lu rahman

comment

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

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

Don’t get hacked off

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our or five years ago we didn’t give too much thought to cyber attacks. How times have changed. In 2014 the FBI issued two warnings that connected medical devices were at risk. In 2016 Trend Micro’s Udo Schneider demonstrated how easily it was to hack into devices by placing one on a desk and bringing it to life through his computer. This came hot on the heels of the FDA telling hospitals not use certain products because of the risk they could be hacked. One device highlighted was Hospira’s Symbiq infusion system.

The warning came that this device, that delivers medications directly into the bloodstream could, if hacked, lead to over or under-infusion of critical patient therapies and severe harm could have come to patients using the device.

It’s a sign of the times that these warnings have turned into full-blown hacks. With the recent news in the UK that the National Health Service had suffered a huge cyber attack, the threat to health systems, devices and patients became very real indeed.

And with the global connected health and wellness devices market forecast to reach US$612.0 billion by 2024 – according to a report by Grand View Research – it’s a threat the global device sector is having to take seriously. Populations are living longer, add to this the trend for healthier lifestyles, so the demand for wearables is increasing – more devices with the potential to be hacked.

With increased technology comes increased risk. Devices and organisations are vulnerable, something that Tony Rowan is chief security officer at SentinelOne told

MPN’s sister title, Digital Health Age: “Old school antivirus technology is powerless to halt virulent, mutating forms of malware like ransomware and a new, more dynamic approach to endpoint protection is needed.”

Whether attacking a hospital or a device, all threats endanger to lives.

This has been recognised by the FDA which has produced guidelines for post-market cybersecurity risk management of connected medical devices.

The threat is real and growing closer.

Organisations, countries, continents – cyber attacks don’t recognise boundaries. And we saw this when the WannaCry ransomware that affected the NHS also infected devices from life sciences company Bayer.

According to Forbes at least two of the company’s medical devices were hit by the attack – Forbes received an image of an infected Bayer Medrad radiology device in a US hospital.

The device is used to improve imaging for MRIs. Bayer confirmed to Forbes that it had received reports of the ransomware attack affecting customers in the US.

“

It’s a sign of the times that these warnings have turned into full-blown hacks.

But it doesn’t end here - medical device companies such as company Siemens Healthineers and BD have also been affected by the attack.

As a part of a global industry we do need to act an treat cyber threats with the utmost concern. It’s up to us to ensure we understand, and implement the systems and security required to minimise the effect of these attacks.

They’re not going away – and if anything they’re likely to increase – it’s time to start thinking about how we can globally lessen the impact they have both now and in the future...

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www.phillipsmedisize.com NEWS FOCUS

Why you need to think seriously

about Industry 4.0

Industry 4.0 is making its mark in the manufacturing sector, and medical devices are no exception. Lu Rahman looks at the relevance of this ‘fourth Industrial Revolution’

E

arlier this year, at the Industry 4.0 Summit in Manchester, Lord Prior of Brampton, parliamentary under secretary of state for business, energy and industry strategy, outlined the importance of Industry 4.0. He said: “If a company’s management does not take a longer term strategic view – even if that means sacrificing short term results and difficult meetings in the meantime – then they simply won’t be here in 10 years’ time.”

Industry 4.0 will see industry and manufacturing moving towards increased digitisation, automation and integrated control systems, creating smart factories.

It looks set to transform the manufacturing sector via use of the Internet of Things (IoT) and artificial intelligence (AI).

Last month Electronics Week reported that the project Productive 4.0 was looking for Industry 4.0 partners and that companies including Bosch, Philips, Infineon, Fraunhofer and the Karlsruhe Institute of Technology have already pledged their involvement.

The CEO of Infineon, Dr Reinhard Ploss, told the publication: “Real-time connected value chains will dramatically increase agility in development and production. They will thus help shorten time to market…microelectronics is a key enabler for further digitisation of the manufacturing industry and for an optimized and integrated supply chain management.

With its high level of automation, our industry can serve as a blueprint showing how to secure important parts of the value chain and qualified jobs in Europe. We now want

to share our know-how with other industrial sectors.”

combines the advantages of smart machines, smart production and smart service.

In the medtech sector Ireland is preparing business for this manufacturing shift. Last month the country saw the official opening of Irish Manufacturing Research, Ireland’s first Independent, industry driven, research and technology organisation, creating 40 jobs. The centre specialises in advanced manufacturing technologies and the positions will be high tech research roles in the areas of Industry 4.0, collaborative robotics, industrial IoT, data analytics, additive manufacturing/3D printing, design thinking and knowledge management.

Likewise, Arburg has taken up the Industry 4.0 mantel and recently exhibited technology at the Hanover Messe highlighting this smart manufacturing.

The centre’s aim is to carry out cutting edge research, development and innovation in collaboration with manufacturing companies to ensure industry in Ireland can become, and remain, world-class using in next generation manufacturing.

In the UK, events like Industry 4.0 Summit and 4IR are helping to explain the scale of this movement, what it means and how businesses can prepare. Jonathan Lee Recruitment recently held an engineering and manufacturing recruitment event in Telford where topics such as how to engage workforces in Industry 4.0, the impact of robotics and automation on competiveness and how the UK can be at the forefront of ‘on-demand’ manufacturing were discussed.

For medtech manufacturing, Engel has entered the market offering Inject 4.0, which

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But Industry 4.0 isn’t just for established big companies. SMEs may feel that discussions about smart manufacturing processes and using data to aid the way a facility functions, are a step or two removed from smaller-scale operations.

As with any new practice, workforce engagement is a key priority and whatever the business size, technology can be incorporated to improve and better current processes.

David Woakes, group business development manager at Jonathan Lee Recruitment, said: “Many savvy, Midlands-based SME businesses are embracing the so-called Fourth Industrial Revolution which will see the manufacturing industry revolutionised once again by breakthrough emerging technologies such as automation and robotics, the internet of things, 3D printers, artificial intelligence and nanotechnology.

“Organisations that adapt their business models and implement the shift towards digital and disruptive technologies will find themselves more competitive on the global stage, vastly more productive and with the capability to mass-customise products.”

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DIGITAL

DIGITAL NEWS

spy

BREAKTHROUGH DISCOVERY prevents infection spreading in medical device

DEVICE UPDATE

www.tcd.ie

www.idcmodels.com

How user experience can help with device re-design

C

hinese medical manufacturer, Arahelio asked IDC (Industrial Design Consultancy) to redesign one of its disposable electric surgical pens.

Arahelio recognised the opportunity to develop a new device which offered the same good value but with new features to make it more appealing to medical staff.

Arahelio worked with IDC’s design team in Shangha.

YiFei Dai, IDC China’s MD commented: “A major focus of innovation for mature products is how to achieve a new product with a superior user experience. We have to truly understand user needs so we can modify the product in the best possible way - we do this through a thorough process of research.”

The disposable electric surgical pen is used during surgical operations to cut and cauterise human tissue, and consists of a pen-like shape with a tip, handle, and connecting cable for electrical heating. The first stage of the redesign involved ergonomic research, so the team could understand areas of priority to improve the performance of the device. This research took place in the hospital, observing surgical procedures and by interviewing medical staff.

IDC’s team identified ways that the device could be improved. Feedback from surgeons suggested the cutting devices were prone to sticking to bodily tissues when cutting, causing an unpleasant burning smell. The team explored special hightemperature biochemical coatings and selected a high-conductivity, non-stick coating that offered a better non-stick blade solution than Teflon. This coating greatly reduced adhesion and odour problems.

The ergonomic styling also needed to be addressed to make it more comfortable and better balanced during use. IDC’s designers developed a shape that could be well supported in the hand while rotating at different angles, with materials that gave sufficient friction to prevent slipping.

M

icrobiologists from Trinity College Dublin have discovered how to prevent bacteria from growing on medical devices such as hip replacements and heart valves that are implanted in the human body.

Their discovery is a step towards developing new preventative strategies that could have a direct impact on the recovery of patients in the immediate aftermath of a surgical operation.

Medical devices are routinely used in modern medicine to prevent and treat illness and disease but their use is compromised when an accumulation of bacteria called “biofilms” attach to the device surface after it is implanted in the human body.

Communities of staphylococci bacteria grow on catheters, heart valves and artificial joints, and avoid being killed by antibiotics and the human immune system, which means healthcare professionals often have

The research team – led by Dr Joan Geoghegan, assistant professor of microbiology in Trinity’s School of Genetics and Microbiology – is studying new ways to prevent medical device-related infection.

Dr Joan Geoghegan and Leanne Hays’ work may pave the way to new options for surgeons that reduce the risk of bacterial infection for patients.

Dr Geoghegan said: “These new findings show that it is possible to stop bacteria from building communities using molecules that specifically target proteins attached to the surface of the bacteria.

This exciting breakthrough will inform the design of new, targeted approaches to prevent biofilm formation by staphylococci and reduce the incidence of medical device-related infection.“

DIGITAL SPY

IDC also created a special structural design for the device, making the cutting tool free to be adjusted and extended according to the type of tissue it was cutting.

As the device is disposable, IDC explored safety options to avoid re-use. Currently, there is nothing to prevent disposable electric pens from being reused, so the team developed a new feature within the electronics to block electrical current after 7-8 hours of operation.

www.vancive.averydennison.com

V

Vancive Medical Technologies in antimicrobial dressing collaboration

ancive Medical Technologies has teamed up with Eloquest Healthcare on a line of transparent post-operative dressings designed to enhance patient care. The device has received 510(k) clearance from the FDA. The new dressings, called ReliaTect, incorporate BeneHold CHG, an innovative adhesive technology from 8

to remove and replace the medical devices. Each incident of biofilm infection costs the healthcare system €50,000 - €90,000.

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Vancive that comfortably secures the dressing to the skin, absorbs fluids and protects the site from external contaminants. The CHG contained within the adhesive preserves the dressings from microbial growth, making them ideally suited for postoperative sites. Eloquest Healthcare is the exclusive distributor of the dressings in the United States and Canada.

www.phillipsmedisize.com DIGITAL SPY

DIGITAL NEWS

Korean medical device patents triple in three years A

ccording to Business Korea, patent applications in the Korean medical device sector have increased by almost a third in the last three years.

Business Korea says that the Medical Device-Patent Classification Connection Table issued by the Korean Intellectual Property Office showed that 9,163 medical devices were patented last year.

In 2013, 6,997 applications for medical devices were filed, but they grew 30% in the three years.

It appears that Samsung Electronics leads the way filing the largest number of patents (1,964) in the past ten years.

The Korean Intellectual Property Office (KIPO) decided to create a “medical device-patent classification connection table” so that small and medium-sized enterprises (SMEs) in the medical devices sector can discover promising future industrial items. This table divides medical devices into 14 categories and 80 subcategories. It matches each category with the International Patent Classification (IPC) on a one-to-one basis and analyses and provides patent applications and registration trends in each field over the last 10 years. Therefore, the table enables people to understand technology development trends in the sector at a glance.

talking

POINT How can a balloon help you lose weight?

AN INGESTIBLE BALLOON COULD HELP REDUCE OBESITY WITHOUT THE NEED FOR INVASIVE SURGERY What’s the technology behind this device?

When swallowed the Elipse balloon is filled with water and it stays in the stomach for 16 weeks. After this, the balloon spontaneously opens and is passed naturally through the body.

Is it a new technology?

Not really. Intrasgastric balloons (IGBs) have been available for decades – they have traditionally required endoscopy and sedation. The device could be used as an alternative to bariatric surgery which is used to reduce the size of the stomach and can cost up to £8,000 per patient.

MATERIAL UPDATE

New ultra-soft medical TPE gels for enhanced adhesion WWW.TEKNORAPEX.COM

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edalist MD-16100 and 10100 Series TPEs from Teknor Apex have been designed to overcome the limitations of standard gels and provide device makers with cost-effective alternatives to silicones The ultra-soft thermoplastic elastomers (TPEs) known as gels are valued in medical applications for their cushioning properties, but they have challenged device designers because of their surface tack and limited adhesion to polypropylene (PP) substrates. Two new series of Medalist medical elastomers from Teknor Apex Company address these challenges: Medalist MD-16100 low-tack gels exhibit less surface friction than standard TPE gels, providing smooth surfaces and improved haptics.

Medalist MD-10100 gels for over-moulding onto PP are made to exhibit excellent adhesion to this substrate, providing the design flexibility of parts consolidation and yielding rigid components with built-in cushioning functionality.

The new compounds are safe for skin contact, process and demould easily.

MATERIAL GAINS: Cushioning prosthetic sleeve. Teknor Apex Company’s new medical TPE gels are safe for skin contact, process and demould easily

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Has the balloon been tested?

Research was presented the European Congress on Obesity (ECO) in Portugal by Dr Roberta Ienca, Sapienza University of Rome and colleagues.

The researchers monitored 42 obese participants who had refused other IGB treatments due to the requirement of an endoscopy and/or anaesthesia.

Participants were placed on a very low carb diet of 700Kcal per day. After 16 weeks the group totalled a mean weight loss of 15.2kg, resulting in an excess weight loss of 31% and a mean BMI reduction of 4.9kg. After the 16 weeks, participants were placed on a Mediterranean diet to help maintain their weight.

And it’s safe?

Dr Ienca said: “The Elipse Balloon appears to be a safe and effective weight loss method... Because the Elipse Balloon does not require endoscopy, surgery or anaesthesia, this may make it suitable for a larger population of obese patients not responding to diet/ lifestyle treatment.”

Gastric balloons are licensed for use by private medical institutions in the UK, but the NHS does not currently use the technology.

Dr Simon Cork, research fellow at the department of investigative medicine at Imperial College London said: “Currently gastric balloons have to be inserted under general anaesthetic or sedation… Gastric balloons are useful for losing weight, but only in the short term. This balloon is only inflated for 16 weeks, after which it is removed from the body… Sadly, the weight lost through this balloon will undoubtedly be put back on soon after the balloon is removed. Nevertheless, gastric balloons are still useful for some patients, and the introduction of a device which doesn’t require surgery to implant is a positive step forward.”

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www.phillipsmedisize.com NEWS ANALYSIS

Paul Brooks, Regulatory Affairs Professionals Society (RAPS), discusses the impact of European Medical Device Regulation on currently marketed medical devices and offers guidance for manufacturers

European Medical Device Regulation: What you need to know

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rom 2020, all new medical device products in Europe must fully comply with the European Medical Device Regulation (MDR). While currently, medical device manufacturers must meet the requirements of the Medical Device Directive (MDD) or the Active Implantable Medical Device Directive (AIMDD), the new regulation will include changes to the classification of some medical devices. In addition, more prescriptive guidance on the content of technical documentation, and in some cases greater amounts of clinical data, will be required.

As we begin the three-year countdown to the changes, the big question on many manufacturers’ minds is what will the MDR mean for currently marketed products in Europe? How many hurdles will medical device manufacturers need to overcome to ensure compliance? And will the new regulations lead to some products no longer entering the market?

managing product ranges under both the MDD and MDR requirements may prove too complex and time consuming for some manufacturers.

Three key considerations for legacy products WILL MY PRODUCTS BE RECLASSIFIED? Under the existing directives, all medical devices are classified from class I to class III (with the latter indicating the higher risk products). The vast majority of medical devices will not be reclassified under the new regulation but for those that are, the impact could be significant. For example, products that are up-classified to class III will require a more significant notified body review and will be subject to greater scrutiny in terms of the clinical data that is available. In fact, the latter is also true for implantable devices that do not change classification.

In Q2 2017, the European MDR will enter into force, with a three-year transition period. During the transition, manufacturers can choose to comply with the MDD or the AIMDD but any certificates issued under these directives will expire four years after the 2020 full application of the MDR.

There is no short-cut to understanding the impact of reclassification on your products.

While in the US, the authorities outline a list of products and clearly state the classification, the European approach is to publish a set of rules and it is then the manufacturers responsibility to review them and define the impact on their products. This process becomes even more complex when you consider that some products may be classified under multiple rules, in which case they must comply with the highest classification stated.

While this gives manufacturers of currently marketed products some breathing space, there are a number of reasons why early adoption of the new requirements could be preferable. For example, the market may become sensitive to the fact that there is a new regulation and some products are not complying with it, giving competitive products that do comply with the MDR an advantage. In addition, simultaneously

IS NOW THE TIME TO RATIONALISE MY PRODUCT RANGE? In any business, return on investment (ROI) must be a factor when considering any major changes to products. For low turnover, legacy products, the cost of compliance may simply not be justified. Manufacturers may use the introduction of the MDR as an opportunity to remove poor performers from the market.

The value of early adoption

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Before doing so, they must consider whether they have more modern versions or better performing products that can comply. This is likely as many devices have evolved over time to incorporate new designs and upgrades in line with postmarket surveillance data— for many devices it is unusual for designs to remain static over a long period. However, it’s important to remember that there are some extremely valuable legacy products with strong market acceptance that help to bring choice to clinicians and healthcare systems. It is more likely that some ‘me too’ products could be eliminated as medical device manufacturers look to rationalise their offerings.

WHAT WILL BE THE IMPACT ON MY CUSTOMERS? In the worst-case scenario, manufacturers that do not comply with the MDR will no longer be able to supply their products. In the event that older, and potentially lower cost, legacy products could no longer be available going forward, this could also have an impact on costs for hospitals and healthcare providers. It’s important to not only consider the implications for your product range, but also the potential effects on the customer and ultimately the patient.

Final thought There are a number of factors to consider when preparing currently marketed products for the MDR requirements, which may see the rationalisation of product ranges and the reclassification of products. There is a strong argument to standardise on the MDR requirements as early as possible during the three-year transition period, applying them to both new and legacy products to generate efficiencies.

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cracking the code Peter Rose, Maetrics takes a look at NHS barcoding and its importance for the medical device sector

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www.phillipsmedisize.com NEWS FOCUS

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n December 2016 the NHS announced that it was going to implement a trial scheme involving rolling out barcode technology across NHS England in a new push towards reducing error and to cut costs. Six NHS trusts are currently going to trial the scheme, which is called Scan4Safety.

As part of the scheme barcodes will be attached to medical supplies and equipment as well as to patients, nurses and doctors. At each stage of a patients treatment the codes will be scanned.

In the past serious mistakes have included implantation of incorrect implants, or the wrong blood transfusion being administered to patients.

In terms of patient safety, the Scan4Safety scheme aims to substantially reduce this type of risk. The cost-cutting benefits for the NHS could also prove significant as initial results from the six pilot trusts suggested this scheme could save the NHS £1 billion.1 The medical device industry is no stranger to the idea of labelling and issuing medical devices with a unique identifier. As the new Medical Device Regulations (MDR) are finalised across Europe, it has become apparent that Unique Device Identification (UDI) (a system which is used to precisely identify medical devices through distribution and use) will ultimately become a requirement for all medical device manufacturers.

Scan4safety and what it means Barcodes in the NHS are not new and many have been using GS1 barcodes for the last few years.

GS1 standards are used in many industries but in healthcare they allow for a global identification of each person, product or drug and place within the NHS. These barcodes are also system agnostic, which means that they allow the exchange of information between different care providers and systems.2 Scan4safety is currently being trialled across six NHS trusts in Derby, Leeds, Salisbury, Cornwall, North Tees and Plymouth. These sites have already noticed that they are reducing unnecessary waste and that they are effectively managing staff stocks. Not only is risk being reduced, but staff time is being saved. Typically (on average) it has been recorded that one hour a day of a nurse’s shift in the UK is spent searching for stock.3 This is time that can instead be spent caring for patients.

Applying barcodes to devices will enable hospital staff to track hospital goods, implement an automatic ordering system ready for when stocks are running low and be alerted when a product is out of date and needs to be removed from an inventory.

The benefits of the trial scheme Scan4safety will have such an impact on the medical device industry by improving patient safety and streamlining the health system. Human inventory errors will be prevented, patients will be provided with the most suitable device/medication. Not only this, but the system can be used to see how effective different equipment is, for example if one type of hip implant wears out more quickly than another, then hospitals will have the information (and evidence) to make repeat purchases of the more durable unit.

Unique Device Identification and its benefits With the imminent publication of the MDR, having unique identifiers on all medical devices is going to be a prerequisite for all medical device manufacturers. When UDI is fully implemented manufacturers will be well positioned to reap the long-term benefits. If UDI is ingrained into systems with the view to restructure operations in order to adopt more thorough tracking and inventory systems – manufacturers too, will achieve significant cost savings. Other business benefits are improved inventory control, increased sales, more time to identify potential issues, improved billing accuracy and reduced fraud.

There are further benefits that come with running an updated platform for tracking, cataloguing and entering information for UDI compliance – manufacturers could see a reduction in counterfeit products entering the market thanks to more efficient tracking processes. Also, having a database of every previously manufactured device means it is apparent when out-dated products need to be removed from a business catalogue.

Another interesting benefit of implementing UDI is the effect it will have on company mergers and acquisitions. Once a proposed merger or acquisition has been announced it is important for both companies to perform due diligence before proceeding. Using UDI information can help ensure a seamless transition as it will facilitate the acquiring company when performing its risk assessment.

The medical device manufacturers who implement processes as soon as possible to become UDI compliant will reap the benefits. Specifically, meeting compliance standards early on means that manufacturers can trial the system at a pace that works for them and can put themselves ahead of competitors. In order for manufacturers to avoid any stumbling blocks during and after the implementations process, it is advisable to appoint a strong team and project manager who has extensive knowledge on the UDI framework and could become invaluable towards helping to avoid fines, recalls, rejections and other unnecessary delays.

Conclusion UK and European manufacturers should not delay in meeting UDI compliance standards, especially once the full requirements of UDI have been laid out in the new MDR. UDI will benefit all aspects of the healthcare industry: hospitals, patients and manufacturers. Hospitals will be able to efficiently manage their inventory and link devices to patient files, reduce manual errors and increase patient safety. Manufacturers will gain better traceability and efficiency in recalls, and improved quality of information through the standardisation of data across the industry.

[1] Scan4Safety, News [2] Digital Health Net, NHS barcode project aimed at improving patient safety, January 2017 [3] Health Media Blog.Gov.Uk, Barcode Technology, 29th December 2016

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NEW 3D PRINTING METHOD promises superior medical implants

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n a paper published in the journal Science Advances, researchers lay out the process they developed for using 3D printing and soft silicone to manufacture items that millions of patients use: Ports for draining bodily fluid; implantable bands; balloons; soft catheters; slings and meshes.

It also could pave the way for new therapeutic devices that encapsulate and control the release of drugs or small molecules for guiding tissue regeneration or assisting diseased organs such as the pancreas or prostate.

Currently, such devices are moulded, which can take days or weeks to create customised parts designed to fit an individual patient. The 3D printing method cuts that time to hours, For the millions who potentially saving lives. What’s more, have medical devices extremely small and complex devices, implanted, a new advance such as drainage tubes containing in 3D printing from the pressure-sensitive valves, simply cannot be moulded in one step.

“The public is more sensitive to the high costs of medical care than ever before. Almost monthly we see major media and public outcry against high healthcare costs, wasteful spending in hospitals, exorbitant pharmaceutical costs,” said team member Tommy Angelini, an associate professor of mechanical and aerospace. “Everybody agrees on the need to reduce costs in medicine.”

University of Florida (UF) promises significantly quicker implantation of devices that are stronger, less expensive, more flexible and more comfortable than anything currently available

With the UF team’s new method, however, they can be printed.

“Our new material provides support for the liquid silicone as it is 3D printing, allowing us create very complex structures and even encapsulated parts out of silicone elastomer,” said lead author Christopher O’Bryan, a mechanical and aerospace engineering doctoral student in UF’s Herbert Wertheim College of Engineering and lead author on the paper.

Silicone is 3D printed into the micro-organogel support material Credit Bernard Brzezinski, UF Photography.

The cost savings could be significant as well.

The new method was born out of a project Angelini and his team have been working on for several years: printable organs and tissues. To that end, the team made a significant discovery two years ago when it created a revolutionary way to manufacture soft materials using 3D printing and microscopic hydrogel particles as a medium.

The problem was, the previous granular gel materials were water-based, so they were incompatible with oily ‘inks’ like silicone. It was literally a case of trying to mix oil and water.

To solve that problem, the team came up with an oily version of the microgels.

“Once we started printing oily silicone inks into the oily microgel materials, the printed parts held their shapes,” Angelini said. “We were able to achieve really excellent 3D printed silicone parts – the best I’ve seen.”

Manufacturing organs and tissues remains a primary goal, but one that likely is many years away from reality.

Not so with the medical implants.

“The reality is that we are probably decades away from the widespread implanting of 3D printed tissues and organs into patients,” Angelini said. “By contrast, inanimate medical devices are already in widespread use for implantation. Unlike the long wait we have ahead of us for other 3D bioprinting technolgies to be developed, silicone devices can be put into widespread use without technologically limited delay.”

Other members of the UF team are Tapomoy Bhattacharjee, Samuel Hart, Christopher P. Kabb, Kyle D. Schulze, Indrasena Chilakala, Brent S. Sumerlin, and Greg Sawyer.

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COVER STORY

Shaping the future The world of micro moulding can be complex and varied. Aaron Johnson, Accumold, talks us through the changing face of the technology and how the business reacts to present and future manufacturing needs Accumold has been using its micro moulding expertise for over 20 years.

How has medical manufacturing changed over that time and how has micro moulding been able to adapt to those changes?

In the mid-1980s as Accumold was beginning, the height of microelectronics was embodied in devices like Motorola’s, grey, ‘brick’ cell phone. It was big, practically took two-hands to use, and only made phone calls. But as time has shown, advancements in electronic design, computing power and software development ushered in the highlysophisticated and complex devices we know today. Medical device manufacturing is an offshoot of these advancements and the industry is only taking advantage.

The medical device manufacturing industry may have been slower to commercially adopt the latest technologies, the demand within however was not. R&D departments followed right along with consumer electronics as these companies looked to make their products better for doctors and patients.

Of course, there are all sorts of good and obvious reasons why medical devices take their time to reach the market, however, the medical device industry is full-steam ahead on providing the best diagnostics and care products possible through as many technological advancements creativity will allow.

What Accumold has observed over these years specifically in medical device manufacturing has more to do with the services around micro moulding than the moulding itself. Initially it’s the micro moulding technology that creates interest.

We have seen tremendous growth in the medical space as the OEMs surge growth through technology. Reducing form factor, wall thickness, cost and other major trends in device design have grown the need for micro plastic parts and components. But what we’ve seen lately, behind this miniaturisation drive, is the growing demand for scalability and sustainability.

The tremendous pressures medical OEMs are under today when dealing with regulations, reimbursements, and the politics of it all, are trickling down to the suppliers like never before. This pressure has changed what medical OEMs demand from their supply base. Not that long ago it was just preferred that suppliers were ISO 13485 certified, had 16

cleanroom facilities or were capable of IQ/ OQ/PQ strategies-now these kinds of services are flat-out necessary if a suppler wants to participate in this market.

Along with the increase in demand for services from suppliers, medical OEMs are experiencing a lot of consolidation efforts.

Not only consolidation through acquisition of other companies, but consolidation and/or reduction in the supply base. Risk management has driven medical OEMs to take longer and harder looks at suppliers. The risk is not just quality. With all the economic pressures the OEMs can’t afford any time wasted with a supplier that can’t provide the best of services.

What do you see as the biggest challenges in manufacturing at the moment and how does micro manufacturing help

overcome them?

Micro moulding has enabled device designers to break barriers between the possible and the impossible. Because advancements in computing power and electronic device design is capable of some incredible computations and analysis, the form factor designs need to keep up. For example, medical devices like blood glucose monitoring need to find the most efficient ways to deliver samples to the sensor.

This design constraint pushes the limits of the supply base to produce smaller and smaller features, in complex little carriers, all while being disposable. Traditional moulding methods may fall short when working to achieve high precision micro structures for these kinds of applications.

What design characteristics can present the biggest challenges for micro moulding? How do you go about overcoming them? What decisions influence material choice?

While micro moulding can produce some very complex micro-sized parts, there are limits to what can be achieved. The most common constraints usually fall in designs with thinWWW.MEDICALPLASTICSNEWS.COM

COVER STORY

wall sections and high aspect ratio features.

A lot can be achieved. One can ‘technically’ build the moulding tools with these features.

However, once the material is introduced to the process several challenges occur. Sometimes a desired feature would require such long, thin steel that during the moulding operations the tool would simply break. Long, small diameter core pins have the same problem. The steel is just too fragile at times for the pressures of the moulding process.

In addition to the fragile steel, most often the challenge is the material itself. There is such a variety of materials to choose from and they will all react to filling small spaces differently.

It’s literally physics getting in the way. We have found there is a direct correlation between the material choice and the feature performance of a given design.

To solve this challenge projects must start with a design for manufacturability (DFM) phase.

The first question our engineering team asks after looking at the model and drawing is, ‘what’s the material?’ We know from our vast experience what materials have what chance of filling any given geometry.

Working though this DFM process will not only address any material concerns, it will also walk through the design to ensure the best opportunity for success is developed.

The biggest challenge is when the chosen material is just not compatible with the design. It’s very common for PEEK to be chosen for many medical applications because of its natural properties. The problem is, it can push like cement into small spaces. Not all the same extreme features can be accomplished with PEEK that an LCP, PC or other higher-flowing materials will. This can be frustrating since the desired geometry can be achieve, just not with the desired resin. In these cases, compromises are usually made to ultimately build the device.

How big a part does cost play in the overall manufacturing process?

Cost of course, is always of concern. Everyone wants to maximise the efficiencies of any given project. The challenge comes when there is a disconnect with the value. It’s common for one to expect that since micro moulding makes small plastic parts they should be cheap - at least cheap in relation to larger, less complex moldings.

The general rule is the smaller, more complex, and/or the tighter the tolerances, the higher the cost can be. The infrastructure to produce micro moulded parts can be quite sophisticated. Sometimes part handling or measuring dimensions can be more challenging then the moulding itself.

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It’s not only piece part price that can be more expensive, the tooling and engineering also requires expert tool builders and equipment to achieve such fine details. Cutting steel to microns is skill that can require more time in the tool shop then less detailed work. It’s a very delicate process to produce such tooling.

In the end, micro moulded parts are usually designed to achieve more. Reducing the form factor, or adding more functionality to a device should more than make up for the costs involved in producing them.

What steps do you take to maximize performance of the part?

At Accumold we tend to work from the end goal first. During the DFM process we will often ask questions about the desired goals for any given project. Understanding the annual volumes, critical features, or areas of concern in the beginning, help ensure a robust process can be developed. The more we know about the part, its function, and environment the more we can drive to efficiencies. In addition, we will suggest a quality plan so everyone knows what success will look like.

In the UK and Europe we are hearing more and more about Industry 4.0 - what’s Accumold’s take on this and how do you see it affecting manufacturing processes going forward?

At Accumold Industry 4.0 is already well integrated. Many years ago, we began developing systems and processes around connected machines and organised data to help us achieve and stay competitive.

Manufacturing in the US has changed a lot from decades past and we saw the kinds of innovations Industry 4.0 is encouraging as necessary for survival. There is no doubt the future of manufacturing is heading more and more that way.

As a service provider how do you go about offering more than just manufacturing?

At Accumold we are deeply committed to three things – capability, scalability, and sustainability. We have worked hard to provide the most innovative micro moulding capabilities we can. We know it can’t just stop there. In today’s manufacturing world there is little room, if any, for disruption. That’s why building an organisation that can grow with our customers and sustain the years to come is as important as the moulding capabilities themselves. (For example: We’ve tripled our facility in the last five years. Our latest addition is a hardened structure designed with dedicated resources to provide assurance of supply). We believe our customers need to know they can rest assured when they partner with Accumold - their future is ours too.

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IN FOCUS

The vaginal mesh scandal: Update

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aginal mesh implants, made from polypropylene, are used to treat pelvic organ prolapse and incontinence following childbirth.

However, some have been found to cut into the vagina, causing discomfort.

Some of the women say With the news that over 800 they have women with vaginal mesh been left implants were planning to unable to take legal action against the walk or have sex.

NHS and medical device manufacturers such as Johnson & Johnson – the largest maker of vaginal mesh – Lu Rahman looks at some of the issues surrounding this product

Bloomberg reported t h a t Johnson & Johnson had been ordered to pay $20 million to a woman from New Jersey who said her TVT-Secur mesh had left her in constant pain.

Issues surrounding these implants aren’t new. According to the Aberdeen Evening Express, last year an allegation was made against Boston Scientific that it had used polypropylene from an area of China known for its use of counterfeit materials and that it had been used in mesh implants used in Scotland.

According to the newspaper, Boston Scientific said: “These allegations are simply not true. We stand by our products, our testing and verification of the Marlex used in our products, and we continue to reject any allegations that this resin is counterfeit or adulterated.”

In 2016 Johnson & Johnson agreed to pay over $120 million in relation to 2,000-3,000 US legal cases brought by women who claimed to have suffered organ damage due to vaginal mesh.

In the same year, the FDA reclassified

surgical mesh for transvaginal repair of pelvic organ prolapse (POP) from a moderate-risk device (class ll) to a high-risk one (class lll) and gave manufacturers 30 months to prove that their products safe and effective.

In the UK, the debate continues. In The Guardian, Kath Sansom said: ‘The NHS and MHRA say the risk of complications with these operations is 1-3% but a report in the journal Nature by nine leading medics puts that risk at 15%. In the US the Food and Drug Administration recently released figures that said the trocar hooks used to implant the mesh cause injuries for up to 39% of women having a prolapse mesh and 29% of women having a mesh inserted for incontinence.’

Mediplus has been working with clinicians to develop a range of silicone pessaries which are an effective way to manage pelvic organ prolapse. The company is championing this nonsurgical alternative – devices placed in the vagina which lift the walls and uterus back into place. The company says its products help more than 32,000 UK women each year.

Pelvic floor product manager, Francesca McCabe said: “Often, when women seek medical advice, they are offered surgery as the only solution without discussing the non-surgical options such as lifestyle, physiotherapy aided pelvic floor exercises and pessaries.”

Pessaries are non-invasive, improve the quality of life for the patient and it enable women to continue normal, everyday activities.

McCabe said: “We have had excellent results with many women reporting results similar to those expected with surgical correction. It has also shown a significant improvement in enjoyment of life and physical activities.”

Research carried out by the Mayday University Hospital, in Croydon, supports this view. The study evaluated prolapse, bladder, bowel and sexual symptoms 12 months after pessaries were inserted, demonstrating that vaginal pessaries were a simple and effective method of alleviating prolapse symptoms even in the longer term. It also concluded that it offered improvements in quality of life compared to the debilitating effects of pelvic organ prolapse. Overall, the research highlighted the effectiveness of pessary use.

Currently there are no UK protocols for pessary management. To address this, a James Lind Alliance Pessary Priority Setting Partnership has been set up by the Nursing, Midwifery and Allied Health Professions research unit at Glasgow Caledonian University to identify the top ten priorities for future research in relation to pessaries.

McCabe, who is a member of the Steering Group, added: “The research group is made up of people with relevant expertise, experience, and involvement with pessaries and by working together we can add to the current knowledge and evidence-base regarding pessary use.”

Andrew Loughney, medical director, Liverpool Women’s Hospital added: “Prolapse of the uterus or of the vaginal wall is very common, especially in women who have previously had children or who are older. Sometimes it needs no treatment but if it is causing symptoms, simple lifestyle changes and pelvic floor exercises can be effective.

“Pessaries can also be useful. They were first used more than two thousand years ago in the time of Hippocrates.

They have an excellent safety profile and with the modern materials and designs now available, they can give significant long term benefit.”

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3D PRINTING

Step change F

or as dramatic a difference medical foot orthotics can have on someone’s quality of life, the process of making them remains pretty low tech and slow, often taking weeks from the initial doctor appointment to get the orthotics into the patient’s shoes.

3D printing is starting to change that.

While 3D printing is just beginning to take hold in the world of medicine, the technology will dramatically change how orthotics are prescribed and produced.

Lee Dockstader, HP 3D Printing Business, explains how 3D printing is reshaping foot orthotics 20

3D printing is revolutionising healthcare in many ways. Surgeons are able to practice complicated procedures on 3D-printed models of their actual patients before ever

cutting into their skin. Amputees are getting better fitting replacement limbs. Teenagers with scoliosis can now get braces that perfectly fit their bodies and carry less of the stigma that causes many not to wear them. The majority of hearing aids are manufactured using 3D printing to improve the fit. Every day hundreds of thousands of medical parts are 3D printed, mainly in the medical segments of orthodontics, dentistry, audiology and orthopaedics.

People suffering from flat feet, unusual walking gaits, plantar fasciitis, bursitis, tendinitis, diabetic foot ulcers, pain or other serious problems require more than just overthe-counter arch supports, heel liners or foot cushions.

They need custom-made medical orthotics from a trained medical professional. Traditionally, custom orthotics have been made by taking a mould of the patient’s foot and the doctor then recommending an orthotic size and shape based on an examination of the foot mould and the patient’s gait over a few steps. For the most part,

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3D PRINTING

Once the dimensions and shape of the orthotic are determined, manufacturing the orthotic is simply a matter of printing the PA 12 plastic orthotic base and affixing to a fabric insole pad

that method has worked, but has a number of dependencies and is not 100% effective.

The traditional model relies heavily on human judgment, the doctor’s eyes and a trained orthotic technician, leaving room for human error.

Mark Twain famously said the difference between the almost right word and the right word is the same as the difference between the lightning bug and the lightning. That is true of orthotics too. A millimeter or two of incorrect foot measurement has a ripple effect: not only would the contour of the insole be off, but the patient could experience leg or back pain as a result and then have to go through the process again.

Plus, it usually takes a few weeks from the time the doctor orders the insole for it to be manufactured and delivered. In some ways, that’s really fast, but if you’re a patient struggling with pain, it can feel like an eternity.

“

With 3D printing and the associated foot scanning and analysis technology, doctors will be able to produce better orthotics more quickly

It’s also unnecessary. With the capabilities of 3D printing, doctors can now use specialised pressure plates to analyse each individual’s dynamic walking or running gait. The plate and accompanying software called footscan 9 from RSscan International can measure the properties of 10 different zones of the foot while still and in motion. It analyses not only arch shape but ligament and joint stress, muscle activity and movement throughout the rear foot, midfoot and forefoot. That level of specific calculation throughout the foot is simply not possible with visual examination and some plaster of Paris. A proper foot orthotic is less likely to be created from a static foot analysis and observing someone take a few steps. Even more challenging are photogrammetry based solutions that take a picture of your foot with a smartphone.

”

Improving how orthotics are prescribed and produced will also likely help millions of people who don’t suffer from severe foot problems but do have some discomfort or fear of injury. The pressure plate, software and 3D printed shoe insert would likely benefit anyone with comfort or stability issues.

High-performance athletes and runners often order custom-made shoes and insoles to make sure their feet hit the ground correctly. Some land on the inside edge of the foot and roll outward. Some land on the outside edge and roll inward.

Some run with toes angled out, some angled in. There is an ideal way the foot should make impact with the ground to maximise comfort and minimise the possibility of injury, and orthotics can help – if they are designed correctly.

With 3D printing and the associated foot scanning and analysis technology, doctors will be able to produce better orthotics more quickly. More importantly, millions of people may be able to walk and run without pain, something most of us simply take for granted. This same technology, but with less range of corrections, will also be available to consumers in the not too distant future.

STEPPING OUT: Athletes often order custom-made shoes and insoles to make sure their feet hit the ground correctly

With dynamic gait analysis, once the specific dimensions and shape of the orthotic have been determined, manufacturing the orthotic is simply a matter of printing the PA 12 plastic orthotic base with an HP Jet Fusion 4200 3D printer or comparable device and affixing it to a fabric insole pad.

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21

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The shape of things to come

Injection moulding

IN FOCUS

INJECTION MOULDING

THE BIG TIME Starlim-Sterner is a big player in the market of silicone components. The company currently produces 14 billion small components a year, specialising in making small silicone components, as well as offering multi-component injection moulding

I

f you’re a customer of Starlim-Sterner, you can expect big things, says the company: Large factories; large machines; an equally large amount of expertise but, small components. With its office in the Austrian town of Marchtrenk, the company specialises in both manufacturing small components from silicone, as well as multi-component injection moulding. Whether it’s one, two or three components, it doesn’t matter as long as at least one component is made from silicone.

Injection moulding machines manufacture products in enormous quantities. “We recently finalised a project with one of our customers which involved a year’s worth of components totaling 400 million,” explains Karl Großalber, head of sales. “We have eight injection moulding machines working on one project.”

As a contract manufacturer, Starlim-Sterner says it is sharply focussed on mass production.

The international group manufactures 14 billion products per year – that’s equivalent to almost two small components per person.

Its production sites are located in Canada, Germany, Italy and Austria, with a sales office in China.

All-in-one solutions A substantial amount of the company’s manufacturing output is for the life science sector. Seals, valves, protective caps, surgical tools, dummies, jets – Starlim-Sterner currently produces around 1,100 different products. The in-house product development team assists customers, checking whether products will work in real life by using simulations before production goes ahead.

“For example, we can show our customers whether their new seal will be 100% reliable in reality, taking into account all external factors such as pressure and temperature.

In this way, we can make any changes before any sort of prototype is produced. This saves customers a lot of VARIETY SHOW: Seals, valves, protective caps, surgical tools, dummies – StarlimSterner currently produces around 1,100 different products

MAKING IT WORK: Starlim-Sterner manufactures 14 billion products per year – that’s equivalent to almost two small components per person

time and money,” explains Leopold Pühringer, head of Starlim-Sterner’s product development team, describing the advantages of the ‘Finite Element Simulation’.

“We follow the full-service provider principle,” explains Großalber. “From development, to design, to tool manufacture, to production and all the way to logistical solutions tailor-made to customer requirements - we can offer the full package. And if one of our customers wants to have a silicone component in pale lavender-blue and covered with stars, we have partner companies who can do just that!” he adds.

INJECTION MOULDING

Top class In partnership with StarMed, S&S Plastics, has developed an innovative product to help European medical professionals when operating in gastroenterology suites using hi-tech endoscopy equipment

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round the world today, gastroenterologists rely heavily on endoscopic technology to investigate medical conditions which are increasingly common due to rising rates of obesity, IBS (irritable bowel syndrome) and gluten intolerance. Used to assist professionals in confirming diagnosis through biopsies, endoscopic technology further helps gastroenterologists treat conditions relatively safely and quickly.

S&S Plastics teamed up with StarMed to develop a new product that will help European medical professionals operating in gastroenterology suites using hi-tech endoscopy equipment.

The challenge It’s essential to keep a camera lens clean during endoscopy procedures to ensure a diagnosis is not only swift but correct but that brings its challenges.

In order to solve this issue, StarMed designed and developed a new, innovative top for an endoscopy bottle. However, it was difficult to get the design ‘off the drawing board’ and into commercially-viable production.

The solution Working in partnership with S&S Plastics and following a set of stringent procedures, S&S Plastics was able to successfully convert StarMed’s idea into a finished product.

Primarily, S&S Plastics’ role was to provide technical expertise, advanced machinery and materials as well as contacts to bring the product to market.

The S&S Plastics team then designed the precision part of the product in a fully-

dimensioned CAD drawing. Once the drawing was completed, it was costed to ensure it could be produced cost-effectively. The S&S team then prepared the tooling for prototyping to finesse the part followed by a full-scale, plastic injection moulding run.

The technical specification of the product included the use of an advanced polymeric material to ISO 10993, USP Class VI medical grade polycarbonate. The finished product is also resistant to chemicals and heat to 126 Celsius and is autoclave-compatible.

The result StarMed’s innovation helped bridge the gap between design and production with the introduction of a superior endoscopy bottle top.

This innovation reduces cross-contamination during gastroenterological investigations which vary from those involving the oesophagus, stomach, duodenum, small intestine, large intestine, colon, bile duct, rectum and anus.

StarMed’s new endoscopy bottle top performs to the world’s most stringent medical standards.

All products are CE-marked and conform to ISO 9001:2008 and ISO 13485:2012.

Furthermore, the product’s USP 6 medical grade material means it complies with UK, European and USA standards. StarMed’s range of products includes the Endoflow water bottle and tubing and the new Scope Flow Pure, the premium version of Endoflow and features an integral filter in its cap to remove contaminants from the outside environment entering the bottle.

StarMed’s founder and owner, Justin Biggs, said: “We’ve worked with S&S Plastics since 2010 mainly designing and developing endoscopy accessories. They will recommend different – often advanced – materials to the WWW.MEDICALPLASTICSNEWS.COM

ones we originally had in mind. That can bring a whole host of benefits such as FDA-approval when selling to the States.

“From the start, S&S understood what we wanted: Durability, thoughtful design, high quality, quick turnaround and value for money.

That approach has endured.

“They keep on adding value. We identify the market gap, come up with the solution and a concept. S&S takes that outline idea and uses CAD to draw it up and they will often add to the design at that stage. Once we’re happy with it, we then progress to tooling, 3D design, prototyping and finally production. S&S does all of it whether that involves metal parts or not as well as any jigs and presses for assembly.

“It’s been interesting over the years to see what works in terms of aesthetics and functionality.

We share a ‘can do’ attitude which conquers any problems we come across. We’re a reliable partnership.”

Richard Munyard, general manager at S&S Plastics, said: “Partnering with StarMed for over five years now, together, we’ve successfully designed and used state-of-the-art technology to produce a world-class portfolio of products.

You can get almost reach perfection and I think we almost achieved that with StarMed. “The healthcare sector continues to grow which is driving the demand for various technical products. This new endoscopy accessory is a neat example of what can be achieved.

Simply put, what we’ve developed together is a bottle top. But the incremental gains we’ve made in its design and manufacture will assist gastroenterologists in procedures – both diagnostic and treatment – perhaps make them safer ,quicker and that all adds up to a star performing product for StarMed.”

25

INJECTION MOULDING

MOVING ON UP Trelleborg Sealing Solutions explains how it’s taking 2C LSR technology to the next level

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relleborg Sealing Solutions says it is revolutionising the healthcare and medical market with its liquid silicone rubber (LSR) and two-component injection (2C) technology, which are said to produce innovative solutions for medical device manufacturers and end-users.

The benefit to the device manufacturer is a hygienic, robust and cost-effective product design, often combining multiple components and functions into a single one, eliminating the risk and cost associated with a secondary assembly.

Helping healthcare Ursula Nollenberger, LSR components product director for Trelleborg Sealing Solutions, said: “LSR lends itself perfectly to medical applications because it is inert, very pure by nature and very versatile in its use, suiting it to a broad range of application conditions. It is also ideal for a large variety of medical grades which facilitates specification choices, making it a preferred choice within the healthcare sector.”

2C LSR technology Nollenberger continued: “One of our most outstanding capabilities is the simultaneous injection of LSR in combination with technical plastics, 2C LSR technology. One of the key advantages of this is the ability to mould several components into a highly complex single part.

“

The simultaneous 2C LSR process is available in many hard-soft and soft-soft combinations, including multi-colour and multi-hardness options and is extremely efficient for high production volumes.

“We use highly advanced, sophisticated tools and process engineering to develop the most innovative solutions, combining two, three or more individual materials into one fully bonded, robust component.

PERFECT ANSWER: Trelleborg Sealing Solutions says its LSR and 2C technology produce innovative solutions for medical device manufacturers

fully automated closed-loop production process and in a controlled cleanroom environment, offers the purest available product in manufacturing.

Trelleborg’s 2C LSR technology allows medical device manufacturers much more latitude in their design solutions

”

“Trelleborg’s 2C LSR technology allows medical device manufacturers much more latitude in their design solutions, for example utilising space more effectively, saving or cutting out weight, or integrating extra functions. This ground-breaking technique offers a wealth of options for integration and miniaturization, resulting in better and more effective solutions in the long run.”

In life sciences applications it is particularly important to counter the prominent challenge of unwanted bacterial growth and inherent impurities either by way of inferior material properties or unsuitable production methods. 2C LSR technology enables more hygienic design solutions by eliminating, for example, dead space through the use of a customised 2C solution versus a classic O-Ring sealed package.

LSR as a material, in combination with a hygienic product design including 2Component solutions, produced in a 26

Working in collaboration with its customers, Trelleborg’s basic mode of operation provides the first concept stage all the way through to the end of the product life. To start with, Trelleborg’s design team currently works with the customer’s designers to either propose a black box solution or to value-engineer a customer’s concept or existing product.

Future plans

Nollenberger revealed that Trelleborg plans to continue to push the boundaries and lead the way with continued investments in infrastructure and skill set at its global locations.

“We continue to push forward with tool, process and automation technologies to let us produce ever smaller parts, down to micro and now even nano-gram weights, enabling the many ground-breaking and exciting technologies our customers are developing. Finding solutions to the so far thought impossible with LSR is what we thrive on.

“We are proud to be one of the world’s leading developers, manufacturers and suppliers of high precision LSR and 2C parts and we intend to stay at the top.”

WWW.MEDICALPLASTICSNEWS.COM

INJECTION MOULDING

Safety first Emanuel Boettcher, product manager medical at Schöttli, describes the company’s screw-on systems and how these high precision medical components meet maximum safety requirements

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edical products such as disposable plastic syringes, needle holders and other connection components are frequently connected to the syringe cylinder using a standardised, simple, conical push connection (luer slip).

For more demanding applications – where safety requirements are more stringent, for example – the additional luer lock threaded connection provides a more secure connection.

Swiss mould-maker Schöttli, acquired

by Husky Injection Molding Systems in 2013, has developed high-precision screw-on systems for the injection moulding of these luer lock threads on syringe cylinders and other medical components. These systems are used as the standard for applications with a female thread, ensuring that extremely high production requirements from customers can be consistently met.

Since the syringe cylinders have a cylindrical sleeve with a female thread in addition to the conical connection, the shaping, rotating thread cores in the injection moulding tool have a corresponding male thread. Electrical servo motors are ideally used as actuators to generate this rotation.

Alternatively, the rotation can also be achieved using hydraulic cylinders.

The force is mainly transferred from the actuator to the rotating cores via gear wheels and toothed racks. This concept has been used for multicavity tools with up to 128 cavities.

Higher numbers are inspected on a case-by-case basis and can be

Servo motors on the drive

adapted and implemented to suit the customer’s requirements.

The screw-on systems are available with a quick-change design for the threaded core. An auxiliary tool made from brass with a corresponding male thread is available for this purpose and ensures that parts can be replaced simply and securely. If necessary, a screwable threaded core can be dismantled even more quickly and easily from the separating plane itself. The procedure takes around 30 seconds per item and there is no need for the injection moulding tool to be completely or even partially dismantled. Maintenance work can be carried out when the tool is locked,

Screwable core and threaded core with toothed rack

reducing downtime and increasing the availability of your mould. This means significant productivity increases for customers.

Electric motors are preferred for use with the screwable cores, as electrically-driven servo motors deliver reliable production with minimal energy consumption. In addition to ease of maintenance, these servo drives offer maximum precision at varying speeds and with varying levels of force control. This significantly reduces the risk of the mould parts wearing prematurely. Customers benefit from maximum quality of the injection moulded parts and from increased operating hours. Unlike hydraulic systems, electric drives cannot suffer oil leaks; consequently tools with this set-up are ideally suited for use in a cleanroom environment.

The space-saving and straightforward cluster design that underpins these tools is an innovative tool concept that supports lateral injection from one or both sides of rotationally symmetrical, tubular injectionmoulded parts. A sophisticated and precise system for centering lids on dies eliminates errors during assembly and reduces offset of the components to a negligible level. This enables low-maintenance, compact tools to be built, supporting the manufacture of high-precision injection moulded parts coupled with easy access to all shaping components in addition to the injection nozzle. Additionally, the nozzles for lateral injection can be installed centrally or flexibly in the cavity. This means that, depending on requirements, the nozzles can be designed for cavities to be injected from one or both sides.

In my opinion Schöttli highperformance, multi-cavity tools are a strong solution for processoptimised medical production lines.

The servo-controlled screw-on technology equipped with the quickchange concept enables efficient manufacture of high-precision medical components that meet maximum safety requirements. This customer benefit is supported by the compact design and innovative cluster concept. Screw-on tools have proven their worth in recent years in numerous applications in the growing medical market, including syringe cylinders and cone stoppers.

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27

INJECTION MOULDING

Seeing is believing T

oday, there are estimated to be 125 million global wearers of contact lenses in a sector that’s worth nearly US$15 billion. Sumitomo (SHI) Demag is a major player in supplying the machinery Lens moulders set that produces the moulds that make the sights on global contact lenses.

growth with the help of Sumitomo (SHI) Demag

Because no two eyes are the same, there is a broad spectrum of styles and parameters to meet when producing lenses. Every contact lens that is produced requires a bespoke mould, which is where Sumitomo (SHI) Demag’s injection moulding expertise comes in.

The process starts with the injection moulding of a front and base curve mould.

This mould is then filled with a monomer (a molecule that can be bonded to other identical molecules to form a polymer) and is then closed and cured before the lens is then hydrated and packed. Every single mould used to make a contact lens is produced to a very high level of precision and cannot be reused.

Nigel Flowers, managing director of Sumitomo (SHI) Demag UK explained: “Because the final lenses are moulded against a surface that has already been injection-moulded, any imperfection within the mould will find its way into the lens.”

A variety of moulds is used in the production of contact lenses, representing the different magnification levels (graded in quarter diopters) that are prescribed for each lens. The differences are in the variation in the space thickness between the front and rear of the mould, which dictates the thickness of the lens. There are a finite number of combinations and a standard number of magnifications and variations on the curve. Nevertheless, production must still be carefully controlled.

To accomplish this required quality and accuracy, Sumitomo (SHI) Demag installs its activeFlowBalance technology into its all-electric IntElect machines. This helps to combat uneven filling of multi-cavity moulds.

“When we’ve got to a certain part of the fill and the materials are moving under their own inertia, we stop pushing and let the mould fill naturally. We are not forcing it in at high pressures and forces. The key is to ensure that the manufacturers that specialise in making contact lens moulds can do it repeatedly and with the highest precision in order to mass-produce the moulds cost efficiently,” explained Flowers.

Typically, there are between eight and 16 cavities in each moulding tool. While contact lens moulds are not technically classed as medical devices, any airborne contaminants, such as dust and particles from the raw materials, as well as human contaminants like bacteria, could affect the lens function.

For the production of lens moulds, both all-electric and hydraulic injection moulding machines are used – with the bias heavily weighted (90% to 10%) towards all-electric.

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THEN AND NOW: The first contact lens was made of glass in 1887.

Today, more than 125 million people globally are regular contact lens wearers

Repeatability is the main rationale, as well as meeting ISO Class 8 cleanroom standards.

Moulders venturing into this specialist sector may also opt for a self-contained cleanroom moulding and packing system which are fully compliant with any GAMP and FDA requirements and have the required DQ, IQ and OQ documentation.

Automation plays an equally big role in maintaining cleanliness and efficiency levels, as each mould is typically produced in under three seconds. Tasks undertaken by these robots include unloading the mould tool and packing into sterile carriers.

Currently, only one Sumitomo (SHI) Demag UK customer automates the entire lens production process. Here, the company’s IntElect injection moulding machine forms just one small part of a huge production line whereby raw material is put in and, when it comes out the other end, the final product is packed and ready to ship.

“Packing and sealing the lens at the point of manufacture reduces the risk of contamination during moving and storage,” said Flowers, who noted that complexity, investment costs and potential downtime issues are the downside to this approach.

Batchmaking the moulds and then shipping to local markets where the lenses are produced offers more flexibility and operators have the ability to stop the injection moulding machine and compensate somewhere else in the system. In both instances preventative maintenance and management of downtime has to be well managed.

So what’s next? Bifocal lenses are now manufactured on a larger scale to correct both near and far vision. Asia is one of the fastest growing regions for cosmetic coloured lenses. The next milestone could be smart lenses that monitor a user’s health through a series of circuits, sensors and wireless technology.

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29

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www.phillipsmedisize.com DIGITAL HEALTH

Is digital health enough?

I

n the last few years the digital health sector has grown at a considerable rate offering digital devices, apps and innovation When we launched from all areas of the Digital Health Age – a medtech market – all aimed at improving sister publication to processes for both Medical Plastics News t h e healthcare – just over two years professional and the ago, we knew from our patient. It’s hard not to be impressed by work in the medical the level of digital device sector, that the innovation hitting the market held promise. healthcare sector.

We didn’t realise From apps that monitor the way we just how much. Lu take medication, to Rahman explains systems that track our vital signs, the technology now includes artificial intelligence (AI) systems that have the potential to track when you’ll actually be ill.

Medical device and pharmaceutical companies are harnessing AI and apps to be used in conjunction with their products. A recent report – The Future of Apps – was commissioned by app security and cloud solutions company F5 Networks. It looks at technological and sociological trends across automation, biometrics, IT and technology sectors. It found that one of the major factors that will affect app development, is AI and the rise of machine learning. If it’s all starting to sound pretty far-fetched and the stuff of the latest Hollywood blockbuster, you’d be forgiven.

One company already using AI to diagnose, is Babylon Health. Users input symptoms into the app to

receive a response. The app uses algorithms, clinicians and data analytics to consult a large database of illnesses and symptoms.

story. We wait to see what happens to us and when it does, we lean on the healthcare system for solutions and cures.

Medical device company Medtronic is working alongside IBM’s Watson AI platform on diabetic management.

The companies claim they have developed a ‘cognitive app’ which acts as a personal assistant and can predict diabetic events before they happen. By changing the way healthcare is managed, potential savings can be accrued alongside an improvement in patient outcomes.

We know the UK the National Health Service is under pressure. It’s old news that obesity and diabetes are rocketing. Giving patients digital tools to record their data and receive medication is a fantastic use of technology. But wouldn’t it be even greater if we could engage with them before the damage was done?

It’s technology at its best. But are we missing something? Digital health aims to empower the patient and the clinician. But how much of the technology actually frees up the doctor’s time? Isn’t logging on to read patient stats another task to fit into already-overloaded schedules?

Every doctor wants to improve the patient experience. If we have a medical device that allows the user to administer correct doses of medication at home and record his or her data remotely for the doctor to monitor, then of course this is a step forward in medicine and the treatment of patients.

But do we actually need to take a step back? Patients are also consumers and digitally take control of all aspects of their modern lives – whether it’s when the grocery shopping arrives, the way calendars are accessed, insurance organised, insurance switched, or finances managed. The consumer takes control, digitally. But when it comes to health it’s a different

Self-care should be part of the digital health mix. We should be encouraging every one of us to examine our lifestyles, our activity, our genetic make-up and take that as a starting point for future health conditions using the very technology we have become so accustomed to using in a daily basis.

There is a growing movement to understand the patient and their make-up. Personalised medicine has become the new way of tackling illness and healthcare professionals are increasingly considering all aspects of a patient – not giving a homeless person refrigerated medicine, for example.

Isn’t it time to think about the individual aspects of our lives so we can build and manage our own digital health profile? Taking more responsibility, managing our day to day choices – digitally – aware of the long term effect some of those may have, might save resources. It would also save valuable time for clinicians too.

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31

DRUG DELIVERY

SMART THINKING Drug delivery connectivity beyond the smartphone

A

s drug delivery devices such as inhalers have become smaller and more portable over past decades, they have simultaneously Phillips-Medisize become more complex highlights the and smarter in their most challenges and f u n c t i o n s recently, featuring opportunities in drug the ability to provide delivery connectivity and communicate from incorporating information through modern technologies appropriate modern connectivity methods.

with patient requirements.

According to Bill Welch, chief technical officer, Phillips-Medisize Corporation, drug delivery device producers need to respond to this trend by a ‘systems engineering’ approach. This aims at reducing financial and other risks in efficient device development meeting more advanced technical requirements, as well as ensuring

required devices reach the market within agreed schedules. These risks go right through the value chain, from the biopharmaceutical customer, to the developer and producer of drug delivery devices through to users, patients and health system payers.

The systems engineering approach, as applied by Phillips-Medisize, requires the company to pay attention to each individual component contained within drug delivery systems, as well as to the components, sub-systems and overall system. Welch says this approach is more robust than a conventional linear product development route in that it requires some engineers dedicated to systems and others to sub-systems development, as ‘this is what makes the whole system work together’.

System engineering needs to be performed on components, subsystems and overall systems at an early ‘proof-of-concept’ stage. This involves on one hand, higher up-front early development stage costs than with linear product development, on the other hand it saves other expenses later on (eg. if a need arises to trace back the cause for a device not properly functioning at a later stage in development or marketing).

Up-front development costs mentioned

by Welch can be minimised by integrating design for manufacture (DFM) and design for assembly (DFA), as ‘80% of product cost and quality is often determined during the first 20% of the product development timeline’.

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Morten Nielsen, president of the company’s Medicom Innovation Partner subsidiary, said: “If DFM and DFA are abruptly introduced at the end of the design phase, manufacturing strategy is not aligned with the device strategy, likely introducing late-stage changes that threaten stakeholder requirements or programme feasibility.”

Smart connectivity solutions While drug delivery device development has tended to be more involved with mechanical functions, incorporating today’s compact electronic technologies into devices requires additional attention. Not only is it important to note how electronic data can be collected by the device, but also how the collected data can best be used to benefit patients, carers, nurses, doctors, payers, insurance companies and so on.

So, there is development emphasis on how sensors can be embedded in drug delivery devices, to communicate by wireless or Bluetooth technology to a smartphone or tablet app, rather than having to plug the device into some other equipment or storage device.

Once data has been captured it can be presented to all those with a justification in receiving and analysing data to optimise treatment solutions.

This can include treatment correction communicated back to the patient via a smart device app, potentially reducing exacerbations or the need for hospital

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www.phillipsmedisize.com DRUG DELIVERY

treatment. It is the patient who does the monitoring and applies treatment correction.

This an important factor with pulmonary diseases such as asthma, where patients can self-administer today with established dry powder inhalers (DPIs) and metered dose inhalers (MHIs), as well as more recent soft mist inhalers (SMIs).

It also means more attention has to be paid to patients’ data security and privacy rights as there will be an increasing amount of it to be handled and protected. For example, a vast increase in the production of largemolecule biologics drugs is expected to increase the market value for selfadministration of such drugs, which will overtake the value of the selfadministered insulin market — the largest and fastest growing selfadministration area so far.

However, before drug delivery device producers start looking at connectivity requirements to provide effective outcome-based healthcare in this new market, they need to have solved how drug delivery devices can be designed to provide primarily self-administered injection of the viscous solutions involved. This is quite a different challenge compared with that of powder inhalation devices.

Patients need to have devices they can easily use for self-administration, as otherwise the ‘Big data’ connectivity reports a poor outcome for the patient due to lower dosing adherence.

Additionally, less understanding of the disease is acquired by health system stakeholders.

The problem of poor adherence has been brought to light by the University of Texas Medical Branch (UTMB) in results of a study revealed in December 2014. UTMB found that only 16% of patients surveyed used an epinephrine auto-injector properly. It pointed out: “More than half missed three or more steps, the most common error being not holding the unit in place for at least 10 seconds after triggering epinephrine release.” Other common errors included failure to place the device’s needle on the thigh and not depressing the device forcefully enough to activate injection.

It was further established by UTMB that ‘only 7% of users demonstrated perfect technique and 63% missed three or more steps’. The most common ‘misstep’ here was not completely exhaling before inhaler use, while failure to shake the inhaler before the second medication ‘puff’ was also a common error.

These are the types of problems that can be addressed by incorporating real time error detection, notification and correction in smart drug delivery devices, with audio, visual and tactile feedback. It has also been suggested that problems of device clogging and patients forgetting device advisory information, received from healthcare professionals (HCPs), and/or instructions accompanying the device should be addressed in this way.

Furthermore, it is suggested that patient error may also be prevented through the use of electromechanical inhalation devices with breath sensing and other advanced technology.

Smart devices and connectivity were addressed in a joint workshop in April 2017 by Welch and his colleague Kevin Deane, executive VP, Front End Innovation at Medicom Innovation Partner at the RDD Europe Respiratory Drug Delivery conference in Antibes, France.

The workshop participants gravitated around patient-centric benefits as the primary source of value drivers and opportunities for connected health.

Themes around improved treatment, better patient education, patient empowerment and social support were discussed by a majority of the groups.

In the interactive workshop presentation, titled ‘Realizing benefits of connected health in respiratory drug delivery’, the authors referred to healthcare costs taking increasingly high shares of gross domestic product, while ‘dosage forms evolve and connected devices proliferate’. They maintained that increasingly complex, targeted and personalized drugs mean devices are becoming ever more critical to patient acceptance and drug performance.

Connectivity was seen as an enabler for reducing waste, saving costs, personalising treatments, improving clinical trials and even evolving device designs. Furthermore, the challenges to implementing connected health seemed to align around technical issues, poor business cases, concerns around data ownership/security/privacy, regulatory risks and general reservations about ‘change’.

new ‘patient-centric’ approach means the delivery method becomes the key connection point between the drug, its producer and the patient for many therapies entering the market today.

Welch and Deane said that secure cloud storage is a key central element in a fully connected respiratory health service set up, in which two-way interaction takes place via the cloud between the delivery device and the patient, as well as between the patient’s app and a ‘dashboard’ for nurses and other HCPs. While data in the cloud can be a source of information for trend analysis by health system payers and the pharmaceutical industry on a ‘no cure, no pay’ basis, Welch and Deane suggested.

Within individualised treatment scenarios in a fully connected health system, they said automated patient adherence monitoring and symptom/ event logging benefit above all respiratory drug delivery. Patients can benefit here from individual diseaserelated information and alerts, such as data on local pollen and pollution levels, and HCPs can remotely monitor their patients.

Pharmaceutical companies also have benefits such as automated supply chain logistics for medicine re-ordering.

However, Welch and Deane questioned whether longer term costs of running and maintaining a well-functioning connected health setup are known.

Whether there is clarity on the return of investment (ROI) achievable from upfront investments, or on reimbursement to HCPs for provision of added value services.

The authors emphasised that a successful delivery device design must be, useful in meeting a specific need, user-friendly, desirable through its appeal to the user and capable of efficient and reliable manufacture in commercial volumes. The device strategy to address an outcome-based solution should be combined with a manufacturing strategy to get to market at target quality, cost, time and risk, Welch and Deane maintained.

That there are already more connected devices than people, with the average person soon to have as many as six devices online, should be seen in the context of the uptake rate of digital infrastructure occurring five times faster than the adoption rate of electricity and telephones, the authors stressed.

They advocated that a ‘connected health approach’ should cover the entire ‘patient care journey’, saying that the

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33

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www.phillipsmedisize.com DIGITAL HEALTH

Why digital needs to come first in modern medical devices Bhoopathi Rapolu, Cyient explains why manufacturers need to create digital-first devices for modern healthcare

A

ccording to Gartner, there will be over 20 billion connected devices globally by 2020 – the Internet of Things is increasingly impacting our lives, professionally and personally. The proliferation of connectivity among both medical and personal health tracking devices is leading to an explosion in data. This is opening up possibilities for device manufacturers to embed artificial intelligence (AI) into equipment. Medical devices and fitness trackers collect terabytes of data every day – monitoring heart rate, steps, calories burned and blood pressure etc – most of which goes unused. However, the application of advanced analytics and AI on healthcare data has farreaching implications for the industry.

Manufacturers are looking at new methods to process this data. Traditionally, it has been processed in the cloud, but as the volume has increased, so too has the challenge of shifting it all to a remote server, analysing it and returning the actionable information back to the device.

New methodologies, such as edge computing, are coming to the fore.

The rise of edge computing Many devices now have the computational power to process more data and adapt performance accordingly. This is based on one of the multitude of sensors on a device generating data, which is subsequently processed via a complex series of algorithm.

These can make predictions about the device and recommendations to improve its performance; otherwise known as embedded intelligence.

Using edge computing, only the most insightful, actionable data is shipped to the cloud, freeing up a huge amount of capacity and improving efficiencies. Equipment vendors can use edge

computing to crunch the most meaningful information and apply the intelligence to enhance device development, resulting in better patient care.

performance levels, and in response helps them to redesign, improve or fix. This also creates scope for interoperability between devices.

Here are my six principles for designing connected medical equipment that supports embedded intelligence:

ENABLE REMOTE CONTROL While monitoring is one-way, remote control creates a bilateral flow of information and recommended actions between the manufacturer and the device. This enables equipment manufacturers to act quickly if their product develops an issue, by deploying software to clear bugs. This will require a change in the way that products are designed, shifting the emphasis from user feedback to tangible device performance statistics.

SOFTWARE-DEFINED Most of the manual functionality we had in medical devices – switches, buttons and dials, for instance – is now being replaced with software. Software-defined devices require less maintenance, enabling routine checks and updates can be undertaken quickly for minimal outlay.

AUTONOMY We can make systems automonous by incorporating remote monitoring and selflearning capabilities. By introducing autonomy, medical devices will be able to monitor themselves and self-heal if they develop problems, removing the need for any user intervention.

EFFICIENCY Improving the performance and efficiency of products in an aesthetic way has been a driver for designers. We can now take it a step further by using the capabilities afforded by IoT and AI. While the IoT allows us to generate the right data from the systems, AI can be used to make sense out of that data and generate actionable insights. This design is the first step towards building intelligent medical equipment.

MONITOR AND REPORT Whether it’s a heart monitor, MRI machine or fitness tracker, there needs to be monitoring.

This enables each device or application to report back to the equipment vendor on its WWW.MEDICALPLASTICSNEWS.COM

OPTIMISE FOR NEW BUSINESS OPPORTUNITIES Connected equipment can unlock business opportunities. By paying more attention to product design, the data devices generate may allow companies to build new offerings such as remote service software, sell data to selected third parties, or combine data with other systems to create a more comprehensive, valuable package.

Design optimisation like this enables manufacturers to alter medical equipment through remote action and to provide an everimproving user experience. With improved customer service, manufacturers can begin to identify new business opportunities.

The connected medical equipment of tomorrow will have embedded intelligence at its heart, enabling clinicians to benefit from improved devices and offer better patient care. It’s critical, that equipment manufacturers look closely at design to remain competitive and create digital-first devices for modern healthcare.

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CATHETERS

Material fact Pyam Ramnes examines the improvement of the design of catheter material

T

he existing cerebral spinal fluid (CSF) shunt systems typically contain three main components:

DESIRED STATE Skin flora is identified as the main source of bacteria that causes shunt colonisation. Thus, an agent that specifically reduces the accumulation of infectious organisms in the vicinity of the implanted shunt resulted from skin flora would be desirable. Also, the catheter material can be impregnated in such a way that the infection is more efficiently and in a longer duration prevented from growth. Regarding the fact that currently, the antibioticimpregnated catheters are used only in those patients who are at risk of non-curable infections; this solution should not present any new risk and should be cost efficient.

Consideration 2: Radiopacity

1. Inflow catheter (ventricular catheter) 2. Valve 3. Outflow catheter (peritoneal catheter) According to the FDA, infection, shunt malfunction, and improper drainage are some of the most common risks of CSF shunts. The primary objective of this design concept is to address the risks associated with shunt malfunction.

Shunt malfunction is commonly due to a blockage or some obstruction within the shunt system. This concept is based on speculating the possibility of improving the design of the material from which the catheters of the CSF shunt is made. This improvement will be focused on reducing the risk of blockage or obstruction in these catheters.

Subsequently, the major considerations in material design need to be identified, the material of the existing catheters and properties of this blockage need to be studied, and the desired state should be evaluated.

Consideration 1: Infection Shunt colonisation is one of the major categories of shuntrelated infections. The commonly used material from which the shunt catheters are made is silicone. This material is a surface where colonisation occurs. The traumatised tissue in the immediate vicinity of the implant, in the absence of a proper host defence mechanism, provides ideal conditions for colonisation by organisms. Therefore, the surface of the material used plays an important role in the process of colonisation.

EXISTING SOLUTION Currently, antibiotics such as rifampicin and clindamycin are used for the impregnation of these catheters. There are other technologies as well to prolong the antimicrobial properties by incorporating silver and copper in the carrier.

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According to ISO 7197:2006, Neurosurgical implants – sterile, single-use hydrocephalus shunts and components, all parts of the shunt shall be identifiable via X-ray examination.

EXISTING SOLUTION Currently, the silicone elastomer from which the shunt catheter is made is barium impregnated to allow visualisation via X-ray. However, barium impregnation could be factored in the development of calcification which leads to the progressive deterioration of implanted catheter longer term (more than five years), and eventually promotes breakage.

DESIRED STATE The compound developed for manufacturing the catheter should be visible with X-ray. However, this compound should not present the risk of breakage or could improve the current solution with a higher durability.

Consideration 3: Biocompatibility ISO 7197:2006 requires that the biocompatibility of hydrocephalus shunts and components shall be assessed based on the guidance given in ISO 10993-1, Biological evaluation of medical devices.

EXISTING SOLUTION Evidently, the products and material currently used for the shunt system shall meet the biocompatibility requirements.

DESIRED STATE The compound developed shall pass the tests and meet the biocompatibility requirements.

Considerations 4-7: Resistance to leakage, ability to withstand overpressure, dynamic breaking strength, and bursting pressure

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CATHETERS

Consideration 8: Geometry The first step in ventriculoperitoneal shunting surgery is shaving the area; the second step is making cuts behind the ear and belly, then, a small hole is drilled in the skull and a thin ventricular catheter passed into a brain ventricle.

Next, the peritoneal catheter is placed under the skin behind the ear and sent down the neck, chest, and into the belly area. Lastly, a valve connected to both catheters is placed underneath the skin behind the ear. As it appears in the procedure of surgery, the holes through which the catheters are passed are relatively small (approximately 2.5mm in diameter). Thus, the ventricular catheter outside diameter (OD) shall be equal or less than 2.5mm. Similarly, the peritoneal catheter OD needs to be small in order to be placed in the body and sent down to the belly. The inside diameter (ID) of the catheter is a function of the flow and design of tubing and usually about 1 – 1.5mm.

The length of ventricular catheter is 3 – 15 mm and the length of peritoneal catheter is 120cm. Both ventricular and peritoneal catheters can be geometrically variable but generally have a cylindrical shape. The ventricular catheter usually has some rows of holes along the proximal tip with a slit tip. The peritoneal catheter usually has some slit openings along the distal end.

EXISTING SOLUTION The below figures show some of the existing catheters:

EXISTING SOLUTION An approach to reduce friction or add lubricity to the catheters is coating. However, before exploiting this approach, the consistency of the coating with medical device usability should be evaluated. Thus, the coating biocompatibility, internes (coating must not contaminate the substrate), cure temperature (must be within the performance range of the substrate), cure forces (must not degrade or distort the substrate), conformability, finished thickness, mechanical loading, resistance to flaking, sterilisability, etc should be studied with respect to the application. There are several coatings currently developed which is used to enhance lubricity. For example, PTFE (Polytetrafluoroethylene) coating reduces the coefficient of friction by as much as 50% for certain applications.

Another coating developed for lubricity enhancement is lubricious coating which is based on nonreactive hydrophilic/hydrophobic polymer matrices. The hydrophilic type of coating absorbs and retains the moisture in contact with aqueous body fluids using the hydrophilic characteristic. The absorbed moisture creates a slippery surface. Then, the hydrophobic components hold the matrix together and firmly anchor it the surface. Another approach to reduce friction in catheters is slip additives.

This approach is based on compounding the base material with a monomer to improve the lubricity characteristic of the material surface. As a result, the coefficient of friction will be reduced.

Heparin is an anticoagulant which is used for coating the medical devices to reduce the effect of introducing the foreign material into the patient’s body. The natural reflex of patient’s tissue upon contacting the medical device may cause protein disposition and platelet activation leading to coagulation.

Medtronic’s Ventricular Catheter

DESIRED STATE The catheter with slippery lumen could be more appropriate for the cerebral shunt use as it could potentially mitigate the obstruction risk. Possibly, the correlation between friction and shunt performance can be identified through an in vitro test. In so doing, the coefficient of friction of the developed catheter can be studied with regards to the obstruction time, pressure, and flow. In case the friction reduction plays a significant role in mitigating the obstruction risk, catheter with slippery lumen will be desirable.

Medtronic’s Ventricular Catheter

Heparin is mainly used as blood thinner and heparin coating commonly used for reducing blood clotting caused by introducing the medical devices into the patient’s body.

However, hypothetically, the anticoagulant property of heparin can reduce the obstruction risk of the shunt’s catheter which can be studied further. Also, hypothetically, studying the chemical properties of cerebrospinal fluid and its obstruction may lead to the development of a new biocompatible and durable coating that counteracts to the agglomeration inside catheter.

Medtronic’s Peritoneal Catheter

DESIRED STATE The optimal geometry of the catheter made from the developed compound, shall be accomplished.

Consideration 9: Occlusion One major malfunction of the existing CSF shunts is occlusion, which impedes the flow of cerebrospinal fluid in the catheter and results in excess accumulation of the fluid and causes brain damage. The occluded catheter requires an immediate replacement through a surgical procedure. One solution to reduce the opportunity to this malfunction could be the enhancement of the flow through friction reduction or boost lubricity in the catheter. Another solution could be a using chemical agent in the structure of catheter that prevents the occlusion.

References Fritsch, M., Kehler, U., Meier, U., Lemcke, J. & Miethke, C. (2014). Normal pressure hydrocephalus : pathophysiology, diagnosis, treatment. Stuttgart New York: Thieme.

Kurtz, S. (2011). PEEK biomaterials handbook. Norwich, N.Y. Oxford: William Andrew Elsevier Science distributor. fda.gov sciessent.com http://www.biointeractions.com/astute.htm medtronic.com ncbi.nlm.nih.gov

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COUNTERFEITING

The real deal

Counterfeit medical products pose a serious threat to the health of patients, as well as to brand recognition of device manufacturers . Helping fight the counterfeiting epidemic with their collaborative system Plastiward, is specialty chemical company Clariant and security provider SICPA. MPN reporter Reece Armstrong finds out more about the companies’ efforts Speaking to MPN was Clariant’s head of global healthcare polymers solutions Steve Duckworth, SICPA’s director of news channels and partnerships Yan Ischi and Julien Liew, communications manager at SICPA Management.

A

ccording to Ischi the collaboration came about due to both companies wanting to bring a “system or solution to the market to help fight counterfeiting.

Plastiward was announced at the end of 2016 during CPhI India. The decision to announce the system in India relates to the country’s own developments in the medical device and pharmaceutical markets. In particular India’s medical device ‘market is placed at somewhere between $4.4-7 billion’ Duckworth tells me.

“We launched Plastiward in India at the end of last year at CPhI. That was with a deliberate intent because India is an important marketplace not only for domestic consumption but it’s also an attractive marketplace for people starting to produce devices there,” he says.

The rising market in India means medical devices there are at risk of being counterfeited just as others around the world are. The companies hope that Plastiward can help stem the problem and make drugs and devices safer around the world.

Plastiward works by using proprietary taggants developed by SICPA which are delivered to Clariant’s Mevopur production plants. The taggants are then embedded into polymers used in medical devices and pharmaceutical packaging where they can be

monitored in real-time using SICPA’s deployment and monitoring platform.

the outside as part of their mission to bring safe medicines to the patient.“

“The whole idea here is to bring safe medicines to the market and the key idea is really to be as close as possible to the drug. By working with plastic, on plastic we get very close to that.

When you actually put a mark on the device in the plastic you then allow a whole monitoring system starting from risk management to be put in place,” Ischi says.

It’s unsurprising considering the sophistication of some of the counterfeit products. Duckworth explains the difficulty of the situation saying: “You have copies which are extremely difficult to detect and often even somebody who is skilled like a doctor cannot really tell the difference.

So this is quite scary. There are numbers that are floating around, they say between 8%-10% of all medical devices are fake.”

The ability to monitor products in real-time is also hugely beneficial according to Duckworth who explains that whilst taggants already exist, companies are hindered by having to collect them from the field before they can be analysed. This means that there’s more chance of counterfeit medical devices reaching patients and potentially putting their lives at risk.

Duckworth says: “The quicker you can authenticate the quicker you can get real-time data and the quicker you can take action. One of the major advantages you see from the Plastiward system is you’re able to go into a warehouse to detect any issues and back in the HQ you’re able to see in real-time where the problem has occurred, and then take action.”

But whilst Clariant and SICPA are aware of the issues of counterfeiting, I ask whether the general public are conscious of the dangers that it poses to them.

Liew says: “Most of them are not.

It’s a huge issue and a number of pharmaceutical companies are actively creating awareness around that. What we’re doing is giving the pharmaceutical companies the means to do something about it on

The risk of encountering a counterfeit medical device increases with chronic diseases such as diabetes or asthma, Ischi explains to me: “Importantly critical diseases like diabetes or asthma, where people will use devices again and again all through their life, increases the chance to encounter a counterfeit enormously, especially if you travel and also where you buy your drugs your devices. The awareness of population is rising as is the demand for a very strong monitoring system.”

But to simply have one solution to challenge counterfeiting isn’t good enough and Clariant realises this. Both the EU Falsified Medicine Directive (FMD) and the US Drug Supply Chain Security Act (DSCSA) will strengthen the monitoring of medical devices and pharmaceuticals across the world.

Clariant and SICPA’s contribution is a system that intends to support these laws going into place.

“One of the things that’s quite clear with anti-counterfeit technology is that there is no magic bullet. I think most people who are the experts on this realise that you have to have a kind of layered approach” Duckworth says.

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EXTRACTABLES & LEACHABLES

STAYING SAFE: Plastic used in medical devices and pharmaceutical packaging can be a potential source of contamination since substances in the material may ‘leach’ into the products

P

Play it safe

lastic materials used in medical devices and pharmaceutical packaging play a vital role in delivery of safe treatments. However, they can also be a potential source of contamination when they contact pharmaceuticals, Stephen J. Duckworth, since substances in plastic materials Clariant Plastics and may interact with and ‘leach’ into the Coatings looks at pharmaceuticals.

For years, extractables and leachables extractables and (E&L) studies have been required to leachables testing for plastics evaluate and understand the risks of these – its vital role in the design material/drug interactions. Today, these and their limitations, the related of safe treatments tests challenges of material selection and control, and the new Quality by Design (QBD) process are not only driving industry debate, but significant changes in regulations affecting devices and packaging.

The new Quality by Design (QbD) process, developed by the International Committee for Harmonization (ICH), does two important things early in the development process.

First, it identifies Critical Quality Attributes (CQAs) for a drug product’s safety, efficacy, and quality. Then, it examines whether any elements of a proposed product or package design would present ‘critical’ or’ high-impact’ risks to achieving the CQAs. The presence of unacceptable leachables is one of those risks.

The QbD process suggests that with a careful process of material evaluation and selection, backed by a disciplined supply chain, pharmaceutical device and packaging makers could dramatically reduce material related risks.

Then, they could leverage evolving test standards and conduct fewer and more relevant ‘as needed’ tests, rather than a full battery of E & L tests for every product. Let me explain further.

What are E&L and why are they important?

Plastics materials contain many substances, either by design (for example, colorants), or by accident (impurities are called ‘Non-Intentionally Added Substances’ or ‘NIAS’).

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Such substances can be mobile in the polymer matrix and can ‘leach’ into the drug, from which they can potentially enter the patient’s body.

Under current industry practice, described in USP chapters <87> and <88> (sometimes referred to as ‘USP Class VI’), E & L testing occurs at different phases in product development. First, extractables testing subjects a proposed device or package to defined extraction conditions (time, temperature, solvent). The substances that migrate into the solvents are defined as ‘extractables’ and studied further. Analytical techniques are used to identify the substance, followed by biological evaluations (such as USP <87>, <88>) to assess toxicological behavior.

Detailed extractables testing is used to get a ‘head start’ on subsequent leachables testing, which can take anywhere from six months to three years. Leachables testing exposes a pharmaceutical to the actual device or packaging material for an extended period of time. It determines whether substances actually leach into the drug and if those leachables exceed permissible exposure levels.

E & L testing process is specific to a precise material/ device/package (polymer grade, supplier, additives, pigments, downstream processing, etc). So, an E&L study may be completely invalidated if there are changes in the types or suppliers of pigment or additives, the grade or supplier of the polymer, or the downstream processing (eg adding printing onto the plastic container).

On numerous occasions, pharmaceutical companies who selected and accepted ‘food contact materials’ for their products were later surprised that an unacceptable leachable was found and that their supply chain ‘change control’ didn’t work. Unfortunately for them, regulatory bodies such as the FDA understand this topic well, and address it very clearly in guidelines such as the recently published draft relating ‘changes’ and 510(k) submissions.

Reliance on ‘historically used materials’ may present the highest risk of life-cycle change because the principles of QbD were not fully applied.

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EXTRACTABLES & LEACHABLES Medical Devices

Pharmaceutical Packaging

USA

Biological evaluation – USP<87> (in vitro), <88> (in vivo) tests depend on device class.

However, tests for ‘permanent’ implants (Class VI devices) are used as a ‘catch-all’ Irritation, acute system toxicity, muscle implantation

USP <661.1> (new 2016) plastic packaging materials Extractable metals USP <87> : in vitro - cytotoxicity - ALL drug types <88> in vivo - compulsory for parenteral, ophthalmic, nasal drugs

Europe

ISO10093-1, Part 18 - Chemical characterization - including extraction tests: All devices, with selection of tests based on device contact type and time.

Pt 5 Cytotoxicity, Pt 10 Irritation, Pt 11 acute systemic toxicity included in most device types

EPh 3.1. - Plastics packaging materials Evaluation based on polymer type.

European Medicines Agency (EMA) Guideline on risk-based assessment depending on drug type.

USP <88>

ISO10993

1. NaCl 0.9% 2. Sesame oil 3. Alcohol / saline mix 1:20 4. Polyethylene glycol (PEG400)

1. NaCl 0.9% 2. Sesame oil

The changing landscape of E&L testing Relying on history alone is problematic because applicable regulatory standards including USP, EP, and ISO (see table above) have historically defined different solvents, conditions, and pass/fail criteria for device and packaging materials.

Tables 1 and 2, for example, show how device evaluations in USP chapters <87>, <88> differ from IS010993.

As seen in Table 2, USP<87> and <88> Class VI testing uses two additional extraction fluids (simulants) that the more recent ISO standard does not. Scoring for resulting biological reactivity also differs, with the ISO10993 standard being more severe.

So, how can a pharmaceutical device maker or packager overcome such differences in E & L testing? For more than a decade, Clariant has been testing the basic ingredients used in MEVOPUR concentrates and compounds under a single test protocol that covers both of these standards. This protocol was developed in collaboration with an experienced testing organization specifically because the ‘interpretation’ of different test methods is not always clear.

In light of the differences between USP Class VI and the newer ISO10993 standard, one might ask, “Why do biological evaluation testing at all?” ISO10993 clearly states that the first step should be part 18 chemical characterisation – including extraction into hexane, isopropanol and water – and identification of extractables. Based on this, a risk assessment can be carried out, with biological testing done only if necessary, based on how products will be used.

The standard then recommends which tests are needed on materials / final articles according to ‘patient contact type’ and ‘contact duration’.

This approach is very different from the USP Class VI approach. Class VI refers to materials used in permanent implants. Its logic is that, if a material passes these biological evaluations, then it is good for all devices. Similarly, if a material passes muster for pharmaceutical packaging, then it must be good for all packaging, too. However, the future will likely be different.

Many USP chapters are under revision in a five-year cycle that concludes in 2020. Based on revisions already issued, USP is clearly moving toward a more risk-based approach to material selection and evaluation. In June 2016, new USP chapters <661.1> and <661.2> for plastics packaging materials were

Table 1: Differences in applicable pharmaceutical and medical device materials evaluations.

Table 2: Differences in extraction test fluids used for USP and ISO10993 biological evaluation.

issued. These chapters move toward closer alignment with test methodologies in the equivalent monograph in European Pharmacopeia 3.1. USP<661.4> is planned to cover the ‘grey zone’ between what constitutes pharmaceutical packaging and drug delivery devices. Chapter <87> and <88> revisions are in process, with indications that there will be a move away from biological evaluation towards the ‘characterize first – test if necessary’ approach of ISO10993.

Clarifying the road ahead The long-debated Medical Device Regulation (MDR) Europe is expected to become a statute by Q3 2017, with enforcement for all devices coming into the EU three years later, by Q3 2020. This long and complex regulation, together with another new regulation for In-vitro Diagnostic Devices (IVD), needs to be analyzed in more depth than this article allows.

These coming regulations will reclassify some devices, potentially reducing the need to carry out extraction studies, and require new studies of carcinogenic, mutagenic, and toxic to reproduction (CMR) substances that might be present.

Unlike E & L testing which tries to assess ‘what comes out’ of a material or device, the new MDR instead would try to assess ‘what is in it?’ For any of a long list of substances listed or potentially listed as CMR, manufacturers will need to demonstrate that their devices do not contain greater than 0.1% w/w. It is not yet clear how this data will be collected from a complex supply chain, who will conduct testing, and how material change information will be communicated in the supply chain. However, a cross-industry group represented by MedPharmaPlast Europe is lobbying the EU Commission for clear technical guidance on these issues.

Summary E&L testing is highly complex and closely linked to how plastic materials are manufactured and controlled. The move towards more ‘risk-based’ analysis and to the structured approach of the QbD process is a positive development. Clearly, regulators now better understand the impact of supply-chain changes and how reliance on ‘one-time’ E&L studies can lead to product-approval problems. In Clariant’s view, addressing these issues at the start of the materials supply chain, through a ‘controlled, consistent, compliant’ approach — specifically the MEVOPUR product range of compounds and concentrates developed for the healthcare sector — helps reduce the risk of expensive surprises.

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olvay’s entry into medical devices builds on its portfolio of high-performance polymers with a new dental care business line. Solvay Dental 360 includes innovative material to replace metal Solvay’s move into medical in removable partial denture frames, devices has begun with a up to enabling a digital workflow dental care business line that accelerates the work of dental laboratories and dentists.

Removable partial denture (RPD) frames replace missing teeth and are typically made of metal. Under Solvay Dental 360, Solvay’s new high-performance material allows for metal-free, biocompatible, more comfortable, natural-looking RPD frames which the company says are over 60% lighter than a metal frame.

SMOOTH OPERATOR: Ultaire AKP is said to eliminate the mess of metal finishing, reduce the finishing and polishing time compared with metal

Solvay uses its new Ultaire AKP (aryl ketone polymer) material to make its Dentivera milling disc. From this device, trained and qualified dental lab technicians use software tailored to this material to design and mill the RPD frame. This is said to enhance speed and efficiency as fewer manufacturing steps are needed compared with the metal frame.

“Solvay’s entrepreneurial initiative to launch into medical devices is driven by our innovation power as a world leader in metal-replacing materials and their proven track record in healthcare,” said Jean-Pierre Clamadieu, CEO of Solvay.

“We are looking forward to expanding the availability of Ultaire AKP for use in removable partial dentures around the globe,” said Shawn Shorrock, global director, Solvay Dental 360. “Ultaire AKP provides a previously unattainable level of comfort, performance and aesthetics for removable partial dentures, as well as a more streamlined digital workflow for the technicians and dentists working to provide a superior product and experience for their patients.”

“Ultaire AKP is the first RPD material we’ve worked with that completely supports our lab’s digital CAD/CAM workflow,” said Jonathan Hughes, director of Hughes Dental Laboratory.

“We’ve seen significant time savings because we’ve been able to eliminate the waxing, investing and casting steps, allowing us to go direct to mill. Incorporating Ultaire AKP into our existing processes was very easy – it was a truly seamless transition.”

The Dentivera milling disc has earned the European Commission CE mark and 510(k) clearance from the US Food and Drug Administration (FDA) and is made in the United States under strict FDA and International Organization for Standardization (ISO) guidelines.

Ultaire AKP high performance polymer According to Solvay, Ultaire AKP is an innovative aryl ketone polymer (AKP) formulated to meet critical performance requirements for dental applications. It is developed for milling RPD frames. The base materials are currently used in permanent medical devices and non-implantable orthopaedic, cardiovascular and renal devices today. The material is biocompatible and monomer (MMA)-, BPA- and nickel-free.

The company says that unique specifications create benefits to patients: it’s lightweight, comfortable and similar to bone – tooth-supported RPD frames avoid point loading and may limit bone loss, and flexural properties allow engagement of deeper undercuts than metal. It singles out one particular feature – a more natural-looking smile with no shiny metal. Ultaire AKP is also taste-free and eliminates the risk of metal sensitivity.

Solvay adds that the new high-performance polymer increases lab efficiency. It should eliminate waxing, investing and casting procedures, be accurate than investing and remove the dangers of spin-casting and high-heat burnouts.

Ultaire AKP is also said to eliminate the mess of metal finishing, reduce the finishing and polishing time compared with metal and it can be polished to a glass-like finish using standard tools.

CUTTING EDGE: The Dentivera milling disc has earned the European Commission CE mark and 510(k) clearance from the US FDA

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– detects contamination of various kinds on the surface and inside the pellet by X-ray and optical cameras – purest material and highly qualitative end products due to automated sorting – for highest flexibility available with optical high-speed cameras as well as X-ray, color and infrared cameras depending on type of the expected contamination and application

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LASER MARKING

Make your mark

M

arking medical devices, implants and disposables enhances traceability, improves long-term quality control, prevents counterfeiting, fraudulent returns and unregulated distribution, and facilitates Frank Gaebler, compliance with increasingly strict government regulations. For example, Coherent, describes several countries mandate marking of a how short ultraviolet unique device identifier (UDI), including lasers produce cost- date and location of manufacture. Marking effective permanent also enables tracking; if any part is found to be defective; the entire batch can be marks on plastic flagged and recalled if necessary.

devices and packaging

For device and implant manufacturers, the main marking requirements are permanence, and that the mark not interfere with product functionality, including avoidance of contamination or introduction of allergens.

Ideally, marks should also be difficult to counterfeit. For pharmaceuticals (tablets, capsules and caplets) and their packaging, marking must be non-toxic, and usually includes a product identifier, the manufacturer’s logo, and possibly the date of manufacture or lot number.

Limitations of ink marking The main drawback of traditional printed marks is that they are often easy to remove or alter (especially if they’re on a paper label). They can be difficult to read after shipping, handling or storage, and also permit purposeful counterfeiting. In addition, although the inks themselves are usually non-toxic, high speed printing involves mechanical handling that may require lubricants or solvents that might contaminate the product.

Limitations of thermal laser marking Infrared lasers are well-proven as a superior option to traditional ink printing in many industries, but often are not ideal for medical devices and pharmaceutical products. The issue is that an infrared laser produces a surface mark through intense localised heating – either bleaching or charring the target material (eg paper cartons), or by actually removing material in a process akin to engraving. In addition to causing damage by thermal effects, these surface marks are also potential focal points for contamination in sub-cutaneous and intra-venal implantable devices.

Most plastics that appear white utilise TiO2 as a pigment, which strongly absorbs UV light and then undergoes a change in crystalline structure. This renders the substance dark, producing a smooth, highly legible mark within the bulk material, rather than at the surface. Because the mark is actually subsurface, it doesn’t provide a possible home for bacteria, and it is nearly impossible to alter or deface without destroying the material itself. And, the higher absorption in the UV means that material can be processed with lower laser power (or pulse energy). Finally, since UV light can be more tightly focused than IR, ultraviolet lasers support complex, high resolution marks, such as 2D barcodes.

Despite these advantages, UV lasers haven’t been widely employed in medical marking applications in the past because of their cost. But, over the past decade, companies such as Coherent have made improvements in UV laser lifetime, reliability and output power. These have been achieved through improvements in laser design, materials and the implementation of stringent cleanroom procedures during production. Also, automated assembly methods and economies of scale as sales volumes have increased have helped to reduce UV laser price by a factor of nearly five over this period. An example of this new generation of cost-effective UV lasers is the MATRIX 355 from Coherent. The figures show marks produced in the Coherent applications laboratory using this laser.

They illustrate the contrast and readability, as well as the absence of visible thermal damage. In the case of the silicone rubber tubing, the laser was focused inside a transparent substrate. This is useful in silicone tubing used for intubation or other intravenous applications because it allows marking on the inside surface of the tube.

Figure 1: Silicone rubber tubing marked on its inner diameter with white characters.

Figure 2: A HDPE pill bottle marked with 2D barcodes.

Ultraviolet laser marking An alternative method utilises pulsed ultraviolet (355 nm) lasers, which are readily available based on frequency tripled, diode-pumped, solid-state (DPSS) technology.

Ultraviolet light is absorbed more strongly than longer wavelengths by nearly all materials, so much less laser power is needed to produce a high contrast mark. More importantly, UV light directly breaks interatomic bonds in the plastic substrate causing a cold, photochemical interaction with any fillers or pigments, thus avoiding any heat affected zone (HAZ) or changes to the surrounding material.

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DEVICE REPROCESSING

PART OF THE PROCESS

A

leading third-party reprocessor claims to divert more than 2.9 million pounds of medical waste from landfills each year.

Medical devices that have been validated and marketed as single-use devices (SUDs) Emily Mitzel and Paul are intended to be disposable Littley, Nelson Labs, look with no return on investment at the justifications and outside their initial use. validations for third-party Reusing devices that have been safely reprocessed by reprocessing of single-use a third-party reprocessor can medical devices enable healthcare providers to maintain high-quality patient care while saving cost and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection, and sterilization processes to ensure safety and compliance with regulatory requirements.

Reusing devices intended for single use without having the correctly validated processes in place may have detrimental effects on the patient’s health.

Current guidelines and regulations for the reprocessing of SUDs are lacking. Regulatory bodies have recommended the guidance document “Medical Device User Fee and Modernization Act (MDUFMA) of 2002,” along with “Enforcement Priorities for Single-Use Devices Reprocessed

by Third Parties and Hospitals,” and “Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals.” The limited amount of detailed regulatory guidance, requirements, or specifications necessitates that third-party reprocessors develop a risk-based approach to device reprocessing.

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Justifications and validations A number of considerations and steps are required to successfully reprocess SUDs. ORGANISING DEVICES FOR VALIDATION ACCORDING TO FAMILY GROUPING: Given the expense involved, it is impractical for manufacturers to validate every type of device they intend to market. Luckily, similar devices can be grouped together as a family and tested as such. In each family grouping, a worst-case device is chosen. That device will be validated and considered the master product of that family. To perform family grouping, reprocessors must have knowledge of the devices and the requirements for reprocessing.

CLEANING: Every reprocessed device should be evaluated for cleanliness. One of the first steps when considering which processes are necessary in reprocessing a device is to assess the device’s level of patient contact and determine the residual soil characterisation. Questions such as, “How is the device used on the patient?” and “How much organic soil or bodily fluid comes into contact with the device?” should be asked.

Answers to these questions will determine the level of cleaning the device will need. For example, a device that has only incidental contact with the patient might require only spot cleaning, perhaps with a spray cleaner. Devices that have contact with a patient’s secretions may need to be fully immersed in a detergent bath, undergo an ultrasonic soak, or require manual brushing. Other factors to be considered include the appropriate cleaning procedure and the justification of the acceptance criteria. These factors will form the basis for the cleaning validation, along with validated parameters.

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DEVICE REPROCESSING

It is important to clarify the difference between a device that is clean and a device that is disinfected or sterile. A device that is clean is free of organic soils and detergent residuals. For a device that has been disinfected, viable microorganisms have been reduced or eliminated. A device that is sterile has undergone a process in which viable microorganisms, including spore forming organisms, have been eliminated to an appropriate sterility assurance level (SAL).

DISINFECTION AND STERILISATION: Not every device requires disinfection or sterilization; therefore, it is crucial to know how the device was initially marketed by the original equipment manufacturer (OEM), as well as how it was used in a clinical setting. In certain instances, it is not uncommon for a device that is marketed as non-sterile by the OEM to receive high-level disinfection (HLD) or sterilisation when being reprocessed. This is due to the potential contamination associated with the device’s prior use in the healthcare environment. Critical devices must be sterilised, while some non-critical devices might only need to be cleaned and disinfected. Clinical use and future patient contact are key factors in determining whether a device will need disinfection or sterilisation. The degree of disinfection or sterilisation should be part of the third-party reprocessor’s risk-management system and should have a sound justification based on the degree of clinically based microbial contamination.

In addition, packaging and a traditional sterile barrier system must be appropriate to maintain the level of disinfection or sterilisation achieved when the device is reprocessed. Packaging design and validation must conform to the applicable ISO 11607 standards.

ASSESSING WATER SYSTEM(S) DESIGN AND MANAGEMENT: Many cleaning processes are water based; therefore, it is of significant importance to determine the appropriate quality of the water used in the cleaning processes. Water system design, validation, and monitoring are crucial to ensuring the water grade is compliant with regulatory specifications. A valuable reference regarding the use of water in reprocessing medical devices is the Technical Information Report 34 (TIR34) produced by AAMI, with the most current version published in 2014.

ENSURING REGULATORY COMPLIANCE: Following applicable current good manufacturing practices (cGMP) and the requirements specified by ISO 13485 (which governs quality management systems in the manufacturing of medical devices) is key to a successful validation. Because regulations regarding the third-party reprocessing of single-use devices are unclear, it is best to take a risk-based approach to device reprocessing including cleaning, disinfection, or sterilization to ensure that the device is safe and effective for the next patient.

Conclusion The motivating factor driving the demand for third-party reprocessing of single-use devices is a desire to provide safe and effective care that is also economical—ultimately benefiting the patient. In addition, medical waste sent to a landfill can be reduced significantly. Paramount to these efforts is validated functionality testing and using validated cleaning, disinfection, and sterilisation processes.

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IN PROFILE

Everything’s bigger in Texas

I

capabilities centre around manufacturing medical devices, including surgical instruments, high-volume disposables for diagnostics, drug delivery devices, and medical packaging.

business means for the company

“Our customers are some of the largest and most innovative in the industry, so we have to be able to support their technical demands and global growth needs,” said Timothy Reis, GW Plastics VP of healthcare business development.

GW

n response to its growing healthcare and automotive business, GW Plastics has recently completed an expansion of its San Antonio, Texas manufacturing facility. The Vermont-based contract Plastics explains manufacturing company has expanded into what the growth a new warehouse facility while converting its of its healthcare existing warehouse into advanced contract manufacturing space.

GW Plastics began work on a 14,000 square foot expansion in January to accommodate the additional growth of its medical device and automotive safety-critical business in the southwestern US. Now complete, the facility has a total of 51,000 square feet of advanced manufacturing and external warehouse space, allowing for improved process flow and future growth.

In addition to the new 14,000 square foot external warehouse, GW Plastics has converted its existing warehouse into a new 5,000 square foot white-room manufacturing floor, which will feature advanced moulding equipment and material feeding systems. The space will be capable of housing an additional 12-14 injection moulding machines, and the company will begin adding new machines in May with the flexibility to grow as needed.

Converting warehousing space into additional manufacturing facilities is a model that GW Plastics has done before. Its Tucson, facility completed a similar expansion in 2014, where it offloaded the majority of finished products into an off-site warehouse and converted the previous warehousing space into a manufacturing floor to allow for the continued growth of the plant. GW Tucson has since been able to significantly increase its moulding and medical device contract assembly capabilities, adding new multi-shot moulding machines and automated assembly equipment.

Specialising in the advanced manufacturing of safetycritical medical devices and automotive components and assemblies, GW San Antonio focuses on tight-tolerance and high-volume thermoplastic programs. Its healthcare

“It is not enough to have ISO-certified facilities. Contract manufacturers have to be in the right locations, have the right processes and quality standards in place, and have and the ability to invest for their customers. We want to be a true partner for our customers, and this US–based expansion allows us to continue growing with them.”

“GW San Antonio has come to the point where we cannot continue growing without investing in this new space,” said Rafael Sojo, GW San Antonio plant manager.

“All of the GW Plastics facilities are rapidly growing, especially in the area of contract manufacturing, and we want to continue expanding our corporate strategy of developing new business within our current healthcare and automotive markets.”

In the last two years, GW Plastics has completed expansions in its Bethel, Vermont; Tucson, Arizona; and Dongguan, China facilities, as well as its thermoplastics and silicones manufacturing facilities in Royalton, VT. The company also celebrated its 60th anniversary in 2016.

“GW Plastics has enjoyed ongoing year-over-year record revenue, and we are committed to supporting this growth by investing in our people, infrastructure, and facilities,” said Brenan Riehl, GW Plastics president and CEO. “We are willing to proactively invest for our customers to ensure we are staying ahead of their supply chain growth requirements.”

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Five reasons to visit MD&M East...

This year’s keynote will be with Apple co-founder Steve Wozniak

1

The 2017 event features a new focus – 3D printing and smart manufacturing

2

It’s estimated that 66.7% of manufacturers have adopted 3D printing and 24.7% of companies are planning to

3

If you’re involved in medical device manufacture – from concept right through to manufacturing – it’s the place to be

4

5

It’s in New York!

06:2017 I

n an increasingly digital world, face-to-face connections matter. Inperson industry networking is designed to help you build relationships faster and more easily than on the phone. More than 9,000 industry professionals from leading companies such as Medtronic, Siemens, St. Jude Medical, 3M and many others will be there, providing access to the connections needed to advance projects – and your career – all in one place.

Q: Name one factor that makes MD&M East stand out A: It can help you make industry connections

Building a network of industry contacts can seem intimidating, not to mention time consuming!

That’s why MD&M East is making it easy with a fast, fun, one-on-one speed networking activity. This allows you to get in front of professionals for five-minute sessions. From engineers and executives to suppliers and key decision makers, the opportunity is there to let you sit across the table from others looking to connect, learn and share.

There’s no need to sign up for speed networking in advance, as seats are given on a first-come, first-served basis, but the activity always fills to capacity, so organisers advise getting there early to reserve your spot!

T

REACH THE SUMMIT

his year MDM East’s 3D printing i n n o v a t i o n summit and smart manufacturing innovation summit will bring together experts for these two growing topics.

The two-day 3D Printing Innovation Summit will cover materials selection, making 3D printing cost-effective, troubleshooting issues in

additive manufacturing and lightweighting, overcoming challenges in end-user production, medical applications for 3D printing, and more.

The two-day Smart Manufacturing Innovation Summit showcases experts and innovations in robotics, artificial intelligence, security, IOT and IIOT, big data, machine control, and more.

Check out...

The Tech Theater where innovative exhibitors will be showcasing their latest products and services. It’s an opportunity to ask questions, get answers and discover new solutions that you can engineer into new products

Brilliant performance | ENGEL medical

ENGEL medical Fully-electric machines impress with great performance. The ENGEL e-motion medical series combines best-of-class performance with maximum cleanliness.

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

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

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