MPN EU Issue 46 by MPN Magazine

EUROPEAN EDITION

MEDICAL PLASTICS news

BEING HUMAN How soft touch plastics are enabling usability

SPOTLIGHT ON DRUG DELIVERY FEMTECH IN FOCUS 40 YEARS OF PEEK

ISSUE 46

Jan-Feb 2019

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CONTENTS Jan-Feb 2019, Issue 46

Regulars

Features

5 Comment Dave Gray thinks 2019 is all about accessibility

12 Time for change? Dave Gray’s 2019 industry forecast

8 Digital spy

17 Mighty medtech Our look ahead at Anaheim’s second most famous attraction – MD&M West

10 News focus Wayne’s world: why Rooney is investing in medtech 15 Analysis Industry collaborations in diagnostics 18 Cover story Trinseo talks innovation for self-care 50 02:2019

20 A bright new future Q&A: Tekni-Plex talks to MPN about its latest buy 25 Get yourself connected 3M on the changing nature of drug delivery in the digital age 29 New tech, old wounds Trelleborg’s role in a new type of dressing

34 Femtech in focus Dave Gray explores why design and material decisions are different in femtech products 40 Not PEEKed yet At 40 years old, PEEK is still going strong. We interview one of the key innovators in the field 45 Back to earth Sean Egan, Nelipak, examines sustainability in medical packaging 49 East meets West Looking ahead to Medtec Japan

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CREDITS

EDITOR’S

group editor | dave gray

comment

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A little more accessible

he start of the new year is a time for renewal and fresh thinking, while learning what we can from the previous year. For the medical device sector, there are lots of lessons to be learned from 2018 – with the Implant Files scandal, as well as exposés such as Netflix’s ‘The Bleeding Edge’ putting the sector front and centre for all the worst reasons. While there are still debates about the next steps raging internally across the sector, most stakeholders agree that now is the time for change. It’s not just the regulatory landscape that might be seeing seismic shifts in 2019, however. I’ve a feeling that the buzzwords – connected health, digital health, disruptive technologies etc. – are all about to fall into a more common parlance. Adoption is happening faster in certain areas than anybody expected. Though digital health will still be big and exciting business, we may soon have to stop using that word ‘disruptive’ when we describe it. The thing that seems to have changed in 2018 is that we’ve gained a greater understanding of the potential of many of the connected technologies on the market. That potential may not be realised yet, but at least we’re putting the framework in place, at the point of care provision. So, what’s next? I always look to the CES consumer tech show in

Vegas at this time of year for my predictions. Digital health and 3D printing were on the agenda again this year, but for me the really interesting thing was the increasing focus on accessibility tech. I have a colleague who remains sceptical about the potential for VR and AR – maybe he should’ve gone to Vegas, I bet it would’ve changed his mind. With speakers from the likes of Microsoft taking to the stage to herald in a new era in accessibility products, it’s fair to say that we could be a lot closer to a futuristic, sci-fi-style healthcare model than many of us realise. So there’s my big bet for 2019 – we will see a new wave of accessibility products entering the market. Where previously the key targets for connected technologies and so-called ‘disruptors’ have been centred around managing chronic illness for the last five years, those same technologies are now set to be applied in a totally different field.

For me the really interesting thing was the increasing focus on accessibility tech

And, of course, accessibility relies heavily on material choice. Grippability, durability and sterility are all considerations for these applications. Human factors design is central to making accessibility products, too. So, you can be assured that in the coming year the plastics community will have its work cut out as healthcare innovations race onwards.

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NEWS ANALYSIS

Turning a corner REGULAR CONTRIBUTOR REECE ARMSTRONG LOOKS FOR THE POSITIVE REPERCUSSIONS IN WHAT TURNED OUT TO BE A CHALLENGING PAST YEAR FOR THE MEDICAL DEVICE SECTOR.

hen news that millions of patients across the globe had suffered serious sideeffects due to medical devices, it seemed like a long time coming. After all, stories on patients experiencing life-changing effects due to devices such as surgical mesh, contraceptives and pacemakers have been circulating for years. The Implant Files highlighted the scale of the issue though and showed the regulatory cracks and loopholes through which ‘faulty’ or ‘poorly-tested’ devices have reached the market and ultimately patients. If anything, the investigation highlights to the public the potential dangers that medical devices can bring with them. Public awareness over the safety of medtech products is inarguably important, especially when information regarding the risks posed by devices has been limited to both patients and doctors. The response from the medtech industry was mixed, with certain groups such as the Advanced Medical Technology Association (AdvaMed) stating stories from the Implant Files “counterfeit the lifechanging and life-saving solutions delivered to billions of people worldwide.” MedTech Europe took issue with the investigation’s view on how the industry works, iterating that “every day millions of people benefit from medical devices,” but that it has “always supported a regulation that better serves patients and provides a predictable, sustainable and appropriate regulatory environment.”

including the Food and Drug Administration (FDA) and Europe’s notified bodies. In particular, the FDA’s 510(k) process has come under strong criticism due to the way it can ‘fasttrack’ medical devices to market on the basis of equivalence. This means that if a medical device manufacturer can demonstrate its device is as safe and effective as another predicate device already on the market, then it doesn’t have to undergo clinical trials. Fortunately the FDA seems to have responded to criticisms regarding the 510(k) process and has announced new steps to ‘modernise’ the premarket programme. Going forward, the FDA will introduce an alternative premarket approval system that aims to do away with the focus on predicate devices and will remove devices that are more than 10 years old as a basis for safety equivalence. The organisation believes that this alternative system will give patients and doctors a choice among older and newer versions of devices, and ensure that medtech products have adopted modern features that improve safety and performance. Additionally, in 2019 the FDA hopes to finalise guidance on its alternative 510(k) pathway which will be based on safety and performance criteria. The FDA’s terminology

is vague, pertaining to manufacturers of certain “wellunderstood” devices, but it essentially boils down to a set of guidelines through which predicates which will be based on to support new devices. This new “Safety and Performance Based Pathway”, is being touted by the FDA as a transparent approach for classifying the safety and effectiveness of low to moderate risk devices. In response to the modernised 510(k) pathway, president and CEO of AdvaMed, Scott Whitaker, said: “While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved, and we stand ready to work with the FDA and all stakeholders toward the shared goal of enhancing the current review paradigm.” Hopefully the medtech industry responds positively to the FDA’s new changes but what’s most important is that the regulatory updates benefit patients in the long run. So far, announcements made by the FDA in regard to post-market surveillance and women’s health products, including gynaecological surgical mesh, appear to be genuine in concern to the efficacy of these devices. The medtech industry has always been a bastion for medical innovation but ignoring the global cry of patients threatens its very foundations. Let’s hope then that the Implant Files investigation represents a landmark moment for the regulation of medical devices all across the world.

Perhaps then more of the blame should be directed at regulatory agencies

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DIGITAL SPY

3D PRINTING

DIGITAL

spy

www.tmh.org

US-UK PROJECT

BRINGS 3D PRINTING TO NEUROSURGICAL PROCEDURES

MATERIAL UPDATE www.hkbu.edu.hk

New nanomaterial could enable early detection and diagnosis of Alzheimer’s disease Researchers from Hong Kong Baptist University (HKBU) have discovered a new nanomaterial which could enable the early detection and diagnosis of Alzheimer’s disease.

cyanine compounds, the team found that the nanomaterial could easily pass through the bloodbrain barrier to specifically target these amyloid-beta plaques.

The team was jointly led by professor Ricky Wong Man-shing and associate professor Dr Li Hung-wing from the department of chemistry at HKBU. The new nanomaterial could also be used to monitor the progression of the disease and the effectiveness of potential drugs. The discovery has already been granted a US patent.

Once bound to amyloidbeta, the nanomaterial fluoresces and exhibits magnetic resonance properties, enabling it to be easily detected by magnetic resonance imaging (MRI) and near-infrared imaging (NIRI) machines, which offer superior resolution and do not require an invasive radioactive trace.

The plaques in the brain, which comprised of a protein called amyloid-beta, are one of the hallmarks of Alzheimer’s disease. The early detection of these plaques could help speed up the diagnosis of Alzheimer’s and enable people to receive treatment earlier. Fabricated using a combination of superparamagnetic iron oxide nanoparticles and

Professor Wong said: “The fact that the new nanomaterial we have discovered is nonradioactive, non-toxic and able to penetrate the blood-brain barrier shows its promise for use in nearinfrared imaging (NIRI) and MRI scanning of the brain. As a result, its application as a contrast agent for imaging is highly important and could lead to earlier detection – and improved monitoring – of Alzheimer’s disease.”

‘

Two medtech firms have announced a new partnership designed to enhance patient outcomes by delivering a transformative approach to presurgical care through the use of 3D printing. Tallahassee Memorial HealthCare (TMH) which operates in North Florida and South Georgia, and UK-based axial3D will collaborate to deliver medical printing services with an initial focus on neurosurgical services. Mark O’Bryant, president and CEO of Tallahassee Memorial HealthCare said: “We have a commitment to bringing the best patient care to our community, this includes identifying, vetting and introducing new technology. Our neurosurgery programme is already the leader in the region and the opportunity to introduce 3D printed models adds a new dynamic to the programme that can lead to better outcomes and greater understanding for our patients.”

US UPDATE www.abhi.org.uk

EVERYTHING’S BIGGER IN TEXAS Clinical trials, research collaborations, new partnerships and sales are all outcomes from the Association of British HealthTech Industries’ (ABHI) work in Texas. At the end of 2018, a cohort of British healthtech companies and medical institutions took part in the tenth mission to the state to showcase medical devices, diagnostic software and digitally-enabled technologies. Companies met with hospital system leaders, clinical leaders and procurement teams across DallasForth Worth, Houston and Austin. This included chief medical directors and senior leadership teams from a range of hospital systems such as Baylor Scott and White Health and Parkland Memorial Hospital. They also had a productive session with the medical director and human health performance diporate at NASA.

As axial3D’s first and only neuroscience industry partner in the United States, TMH will collaborate with other international partners to collate data on the use of 3D printing in neurosurgery. Matthew Lawson, neurosurgeon at TMH added: “Much of what we do in neurosurgery is 2D. Being able to utilise a 3D model and hold it in your hands prior to surgical intervention is very insightful for the patient. 3D models have been shown to increase patient consent rates and aid in patient understanding of the planned procedure.”

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Another highlight was a discussion panel at The Dell Medical School. The event, which featured a range of key UK figures from the healthcare sector, talked about innovative pathways, health systems and the delivery challenges in relation to both the UK and the US.

DIGITAL SPY

FUNDING UPDATE

www.medtechaccelerator.co.uk

Medtech Accelerator injects £430k into new devices and tech Medtech Accelerator, a UK medical technology financial scheme that supports NHS innovators, has issued awards amounting to more than £430,000 to four new pioneering projects. Medtech Accelerator is a joint venture led by innovation hub Health Enterprise East (HEE) in partnership with the New Anglia Local Enterprise Partnerships (LEP), Cambridgeshire & Peterborough Combined Authority, the Eastern Academic Health Science Network (AHSN) and Essex County Council.

Chris Dashper from New Anglia Local Enterprise Partnership said: “Technological innovation has been singled out by policymakers as playing a vital role in addressing some of the key challenges faced by the NHS, yet all too often innovations and great ideas fall at the first hurdle and fail to get to market. Thanks to the Medtech Accelerator, emerging medtech innovations can receive the funding and technical guidance they need to make it through the precarious proof of concept phase.”

This latest round of funding brings the total amount of funding since its launch in 2016 to over £1 million. The projects benefitting from the most recent injection of funding are: an imaging device for cancer surgery; a breakthrough treatment for hernias and abdominal wall repairs; a surgical retraction device; and a bone conduction technology to help children with glue ear to hear.

talking

POINT

www.kcl.ac.uk

Catheter ablation made more successful thanks to computer modelling New computer models that simulate the workings of individual patients’ hearts could boost treatment of a common cardiac condition.

REGULATORY UPDATE

MEDICAL DEVICE REGULATORY TRAINING FACILITY OPENS IN EUROPE www.nsf.org Prosystem, an NSF International company, is expanding NSF International’s services to the European Union’s medical device and pharmaceutical manufacturing industries with the opening of a new regulatory training facility in Hamburg, Germany. The expansion doubles the existing office space with an additional floor in the Berliner Tor Centre, one of Hamburg’s tallest office buildings.

NSF opened the new training facility in anticipation of a rise in the need for regulatory education, especially as the deadline for the European Union Medical Device Regulation (EU MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU IVDR) enters into force in 2020.

What’s the story? A team at King’s College London - in collaboration with St Thomas’ Hospital and with funding from the UK’s Engineering and Physical Sciences Research Council (EPSRC) - has taken the first steps in developing models designed to optimise a procedure that corrects atrial fibrillation, a condition which causes abnormal heart rhythms. How does it work? The new personalised computer models aim to increase the effectiveness of this procedure (which is known as ‘catheter ablation’) by making it possible to explore, in advance, different strategies for its use geared to the specific needs of individual patients. Developed using skills in computational modelling, software development and image processing, and based on detailed data about the patient’s heart obtained through medical imaging, the models depict tissue condition and blood flow, and enable simulation of around 10 cardiac cycles lasting a few seconds in total. What is atrial fibrillation? Atrial fibrillation reduces blood supply, leading to dizziness, breathlessness and fatigue, and increases the risk of a stroke. Every year, around 10,000 people in the UK have a catheter inserted in order to treat the condition using radiofrequency energy. But the procedure is not always effective, there is a small risk of it causing a stroke or death, and the condition often recurs.

NEWS FOCUS

WAYNE’S WORLD

ROONEY’S SUPPORT FOR MEDTECH COMES ‘SHINNING’ THROUGH

UNIVERSITY TO COLLABORATE WITH MANCHESTER METROPOLITAN UNIVERSITY (MMU) ON PROJECT BACKED BY ENGLISH FOOTBALL STAR, WAYNE ROONEY.

ommon sports injuries can be treated by a portable tech-enabled lightweight device that has been developed with the help of researchers at two universities to both cool, heat and compress muscles.

expertise is applied to private sector product development or work processes – so that Manchester Metropolitan University’s professor James Selfe can work along professor Jim Richards from UCLan to help develop the device.

The Swellaway, a shin guard-type sheath mounted with a fan that clips around the affected body part, does not require ice, water or heavy items of equipment that are normally needed to treat such injuries.

Professor James Selfe, lead academic from Manchester Metropolitan, said: “Traditionally, there has been a lack of devices that provide all-in-one solutions to common sports injuries.”

Swellaway’s shareholders include professional footballer Wayne Rooney, of Everton, Manchester United, D.C. United (Washington) and England fame, who is the lead investor in the company that bears the product’s name.

“Our research will provide evidence as to what the best dose response is for the device. By the end of the project, we hope to have a number of protocols that will guide practitioners to optimum use of this device. We also hope to see improved patient outcomes as a result of its use.”

The piece of kit allows physiotherapists and healthcare professionals to accurately treat injuries through controlled compression,

UCLan’s professor of biomechanics Jim Richards said: “The exploration of the interaction between temperature and pressure, using the Swellaway device, provides an opportunity to explore the optimisation of treatment through a better understanding of the relationship between these factors.”

combined with cooling and heating in a fully portable device for the first time. It has been developed by researchers at Manchester Metropolitan University and the University of Central Lancashire (UCLan). Swellaway’s shareholders have sponsored a Knowledge Transfer Partnership (KTP) where academic

To help take the product to market, the company needed a strong evidence base to highlight its benefits. Over the past four years, professor James Selfe and professor Jim Richards have been working with the company by offering independent research and development consultancy. They are now at a stage where their team will be testing the product to see how well it works. They will be working with a KTP associate, Olivia Greenhalgh, to develop optimal clinical protocols by measuring the temperature of the

device, the pressure applied, and the length of time that temperature and pressure are applied. Having established these parameters, the team will then be able to determine the factors that produce the best treatment response. For example, they will test whether the device is most effective when applied at cool temperatures at low pressures for a long period of time, or if it is better to apply it at warmer temperatures at high pressures for a short period of time. The device will cool, heat and compress muscles. This project is an outstanding example of how real-world research impact can arise through partnerships with other institutions – in this case through collaboration with UCLan and Swellaway. Robin Slinger, chairman of Swellaway, said: “The research developed by Manchester Metropolitan University and UCLan will be instrumental for the success of our product. We are sure that it will help us successfully develop our current product together with our future planned devices.” Professor Richard Greene, pro vice-chancellor for research and knowledge exchange at Manchester Metropolitan University, said: “This project is an outstanding example of how real-world research impact can arise through partnerships with other institutions – in this case through collaboration with UCLan and Swellaway. “James and his fellow researchers both here and at UCLan should be congratulated for producing this innovative research, which has real potential for improving outcomes for athletes with sports injuries.”

Image credit: lev radin

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THE YEAR AHEAD

Time for change? AS WE BREAK INTO THE NEW YEAR, WHAT DOES 2019 HAVE IN STORE FOR MEDTECH? DAVE GRAY LOOKS AHEAD.

t’s been said many times before that progress is gradual in the medical device sector. Nevertheless, we’re still living and working through a transformative moment in healthcare delivery, where the ageing population, rising costs, obesity, diabetes and cancer are coming together in a critical mass, and blustering the sector’s innovators into action. M&A: IS IT ALL JUST WHISPERS? At the time of writing, there’s not a lot to say with regards to mergers and acquisitions, except that based on the last couple of years, we can expect to see more seismic shifts in the market – but where they will come from is anybody’s guess. But, full disclosure, I’m writing this in 2018, trying for once to get ahead. So, by the time this lands early in 2019, Apple, Amazon and Google may well be at the head of the medical device table, with only a couple of hopefuls watching from the sidelines. Only joking. Sort of. That said, there is speculation about some big plays that would seriously rock the boat in 2019 if they ever came into fruition. Probably the most significant here would be those whispers about J&J’s potential interest in either Boston Scientific, or perhaps one of its rivals, Edwards. This story stemmed from a report in US paper Barrons in late summer 2018, which suggested that such a move would come with the aim of making inroads into the field of transcatheter heart valves. But this sort of rumour is rife after a period of aggressive acquisitions from most of the key players – maybe we will see another super takeover in 2019, but for now, it’s merely speculation. One deal that looks a lot more likely to close in 2019 is Boston Scientific’s agreed offer to acquire UK firm BTG – a player in minimally-invasive technologies for oncology. Subject to regulatory approvals, the deal is scheduled to close in the first half of the year. “The acquisition of BTG and its rapidly growing peripheral interventional portfolio is an exciting extension of our category leadership strategy that will augment our capabilities in important areas of unmet need such as cancer and pulmonary embolism,” said Mike Mahoney, chairman and chief executive officer, Boston Scientific.

“We are confident that the addition of these therapies to our portfolio will ultimately advance patient care in ways that could not be realised by either company alone, while also allowing us to realise substantial revenue and cost synergies and provide a strong return for investors.” LESS IS MORE If you really want to see change happening year-on-year, probably the best way is to attend Compamed and Medica. The last couple of years have definitely demonstrated increased prevalence of miniaturised technologies, driven in part by the wearables and diabetes markets. One innovator in this field is Jaume Palau, creator of sleep apnoea device Airmony. Writing for Med-Tech Innovation News recently, Jaume believes the trend towards miniaturised devices and portability will be most emergent in six key areas: ECG monitors, glucose monitoring systems, blood pressure monitors, continuous positive airway pressure (CPAP) devices, air quality monitors, and massage devices. “With the rise of portable medical devices and the proliferation of smart home technology, people are now increasingly able to live with their conditions at home and look after their own health as they travel.” All of this innovation impacts on material choice, and material combinations, too. According to Nigel Flowers, MD at injection moulding machinery supplier Sumitomo Demag UK, “almost every material you would expect in medical could crop up in micro moulding – there is no specific material of choice for implantable devices. It is dependent on what the part is being used for – there have been cases where the plastic is coated in gold for some cancer treatments.” DO-IT-YOURSELF HEALTH The trend towards self-care is another factor set to impact manufacturing choices in 2019. Especially in applications for the elderly, disabled, and paediatric care, we’re likely to see more examples of rigid plastic components with soft touch, grippable materials overmoulded on the outside. This trend draws on the principles of human factors design. Where more and more drug delivery or monitoring devices are intended for home use by the patient, designers are choosing outer materials which simple operation.

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THE YEAR AHEAD

IT’S HOW YOU PACKAGE IT THAT COUNTS It’s official: smart packaging is here. We’re seeing it in every industry, not just medical, and its emergence goes hand in hand with stricter global regulations on goods and services. Intelligent ink has seen increasing usage in medical applications, but I expect that the coming years will propel advanced printed electronics to the fore of medical device packaging. The August Faller Group for example recently announced a prototype of a ‘counting device’ – a folding carton for medicine which uses an e-paper display and electronic controls. The user just has to press a button on the display each time he/she takes a pill, and the packaging can track their dose. Another prototype from the firm, currently just called ‘Medical Prescription’ keeps track of the amount of pills and connects to a smartphone app via bluetooth, which in turn sends the signal to order a repeat prescription. At what point does medical packaging and drug delivery become one and the same? It can’t be far off. The other news, which will be welcome to certain manufacturers, is that the FDA has issued an extension to the compliance deadline for certain aspects of Unique Device Identification (UDI). Manufacturers of certain non-sterile, class I, and unclassified devices will now have until 24th September 2020 to comply with standard date formatting, labelling and Global Unique Device Identification Database (GUDID) data submission requirements. According to Medical Design and Outsourcing, the move was a response to concerns that manufacturers might simply dispose of non-complying inventory rather than undertake costly revisions, thus leading to supply shortages for patients. FEMTECH Femtech is an increasingly prevalent term, but more work is needed to make it a pervasive field within healthcare. Don’t be fooled into thinking that it applies only to ‘female’ health problems either. Femtech encompasses an unbiased approach to medical device design, which I believe we can expect to see more of in 2019. In a recent article, Forbes points out for example that Zimmer Holdings has a gender-specific solution for its high-flex knee prosthetic, the design of which acknowledges the

anatomical differences in women’s and men’s knees that need to be catered to while making prosthetics. That said, the last few years have seen a surge of femaleled enterprises launching new tech specifically for women’s health, and that trend, too, is set to continue. What’s needed, however, is support from the VC, accelerator and adoption communities. Forbes claims that ‘women’s health accounts for only 4% of the overall funding for research and development for healthcare products and services’ – that cannot be good enough for 50% of the population. Let’s hope that 2019 will bring investment into this vital field. EMERGING MARKETS Asia continues to be the land of promise for many Western medtech players. The question is, do we still need to refer to Asia’s territories as ‘emerging markets’? China, in particular, looks set to be centre stage in 2019 as a key prospect. A recent announcement from the Chinese ministry of health stated that the country will issue licenses for 154 new surgical robots by the end of 2020. This news sends a clear message – China wants its healthcare provision to be the best and most innovative it can be. After all, surgical robots are still in their (relative) infancy, and automated procedures are not cheap to perform – particularly in countries with massive populations. But despite the perceived drawbacks of the technology, China’s announcement sent stocks in Intuitive Surgical (the maker of the da Vinci robot assisted surgical system) up by 6.6%. It seems that not only is China continuing to shine in medtech, the country is now targeting the big ticket items – something to consider. A POSITIVE START There are plenty of reasons to be optimistic about 2019 – not least the unusually fast pace of change in the innovator sphere. And in terms of the calendar, it all kicks off in Anaheim in February, where we’ll be on-site at MD&M West. Then, in May, we look forward to welcoming you to the NEC in Birmingham, UK – the new home of our very own Med-Tech Innovation Expo, which this year promises to be more international than ever.

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NEWS ANALYSIS

DIAGNOSTIC DUOS MIRANDA CONARY, PRODUCT SPECIALIST AT WEB INDUSTRIES, DISCUSSES HOW DEVICE MAKERS AND CONTRACT MANUFACTURERS COLLABORATE FOR SUCCESS IN DEVELOPING MEDICAL DIAGNOSTIC DEVICES

n today’s fast-moving medical device industry, original equipment manufacturers (OEMs) are increasingly turning to resources outside of their four walls to bring products to market. The reasons why they choose to collaborate with contract manufacturers vs. go it alone are as varied as the businesses themselves, but a few drivers include: • Bridging capability gaps. Perhaps a start-up has strong new product ideas but little experience with product development and the path to commercialisation. Or a device maker lacks a biochemistry lab or quality control team experienced in lateral flow immunoassay (LFI) devices. • Optimising high-speed, highvolume automation. A contract manufacturer may have machinery to handle very wide material rolls or robotic assembly lines to eliminate manual labour. • Qualifying a secondary supply source to mitigate risk in case a primary supplier reaches capacity or has a production interruption. • Accessing a more extensive supplier network, presenting the chance to use novel and different materials supplied in diverse formats. DEVICE MAKER-CONTRACT MANUFACTURER RELATIONSHIP: STEP BY STEP Every contract manufacturing relationship is different. In some situations, a device developer may

turn to a converter to perform a single but specialised process, such as supplying a pad material with a deposition on it. In other cases, a contract manufacturer may be engaged with the device developer from the very earliest design phases all the way through to commercial-scale production and packaging. Regardless, there are some common steps in the collaborative process. PROJECT DEFINITION PHASE During this step the device developer and contract manufacturer typically conduct a technical meeting to review the product, its status in the development process, documentation, studies that are completed or underway, the desired timeline and any forecasts for anticipated volume. There are advantages to involving a contract manufacturing partner as early as possible in the development process. The contractor can weigh in regarding design or raw material changes that could be made to significantly enhance manufacturing efficiency and speed. For example, if the device developer’s pad material supplier only provides 50-metre rolls, and the converter’s operations can support 100-metre rolls, it makes sense for the device developer to take advantage of the larger batch sizes possible with using larger rolls. Such issues often rise to the surface during the project definition phase. From this phase, the OEM usually receives a full report from the contract

manufacturer outlining an estimated project timeline, preliminary pricing, risk assessment and point-by-point review of how the project will flow through its operations. TECHNICAL TRANSFER PHASE During this phase the contract manufacturer presents the device OEM with a more formalised project plan and starts conducting activities such as raw material supplier assessments, engineering studies and equivalency testing. Equipment is calibrated to deliver products within precise specifications, and the partners continually verify and validate results every step of the way. As with the other two phases of development, this should be a stage-gated process in which the partners pause at each gate to evaluate how things are going and are free to walk away if the relationship is not satisfactory. COMMERCIALISATION PHASE During this stage, the OEM and contractor enter into formal supply agreements, nail down quality requirements for the commercialscale production and start manufacturing devices for sale to the market. In conclusion, throughout the device development process there must be communication, trust and transparency between a device OEM and its contract manufacturing partner. These qualities and a strong spirit of adaptive engineering go a long way toward ultimate product success.

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MD&M WEST

THE ANAHEIM MIGHTY…

medtech show TO MANY, IT’S FAMOUS FOR TWO THINGS: THEME PARKS AND A LEGENDARY ICE HOCKEY TEAM. BUT TO THOSE IN THE KNOW, ANAHEIM IS ALSO THE FIRST STOP IN THE CALENDAR YEAR FOR THE LATEST DEVELOPMENTS IN MEDICAL DEVICE INNOVATION. DAVE GRAY EXAMINES WHAT’S ON SHOW AT MD&M WEST 2019.

or the plastics community, MD&M West has plenty to offer. In fact, the majority of the exhibitors there intersect with the market for plastic medical innovation, either directly or indirectly. Ineos Styrolution, for example, one of the key players in the materials market, will be at this year’s show, and while the firm says it will be focussing on digital health (it’d be mad not to) it will also be launching new grades for older applications. One of the new grades on offer is targeted at medical tubing, including multi-layer tubes, and will be available with Ineos Styrolution’s Essential HD Package (risk class 1 & 2) with 12 months notification of change (NOC) with a signed long-term supply contract. Food contact statements, USP Class VI, ISO 10993 and drug master file (DMF) are also part of the package. Teleflex Medical OEM will also be returning to Anaheim this year, with a host of new products on offer. First up is its new hydrophilic surface coating for polymer-based devices that are to be navigated through the vascular system. The coating performs favourably in terms of lubricity and extended durability when compared to other coatings on the market, the group claims. It reportedly also demonstrates biocompatibility and shelf-life stability, exhibits low particulate count in testing, and boasts good adhesion to the substrate material. The coating can be customised to optimise certain performance characteristics based on specific user needs, says the firm. In terms of benefits for the end-user, the coating may reduce the required insertion force which may result in improved control, placement, and tracking of a device, says Teleflex Medical OEM. Applications for this surface technology include introducers, diagnostic catheters, balloon catheters, and components. The coating is applied through a fully-automated process in a temperature and humidity-controlled cleanroom. The coating is just one recent development from the group, which will also bring its new braiding technology which can divide a suture into multiple end branches or integrate several “loops” within the strand. This continuous braiding process can produce variations of complex, divided segments at the end of a suture, or between singular round or flat tape segments, says the group. This, it says, means that the need for expensive and time-intensive manual sewing is eliminated. The braiding technology allows for a broad range of configurations that are expected to be used in orthopedic applications where two sutures are presently used for fixation. The show floor will also play host to plenty of contract moulders jostling for position. One group with something to shout about is MTD Micro Molding, which recently announced new investments that expand on its capabilities. The firm’s new gas chromatography system for example is a piece of analytical equipment that can measure residual monomer and assist with material characterisation, which further supports R&D projects by looking at materials on a molecular level. When used in conjunction with DCS equipment for material characterisation, MTD can build robust profiles for materials to analyse behaviour—crucial for manufacturing intricate components with critical medical functionality. This provides an in-house suite of equipment for material characterisation/science: molecular makeup (GC testing), thermal behavior (DSC testing), and viscosity and rheology behaviour (IV testing).

MTD claims it is also the first company in North America to own a Mitsubishi MX600 oil wire EDM machine, which lets machining operators use ultra-small wire in the range of .0008”–.001”. “The machine has doubled our wire EDM capacity and has made getting down to the smallest wire diameters much easier,” said operations manager, John Clark. “Although our lead time to build new tools is driven by the complexity of it and its components, on average, we were anywhere from six to eight weeks in production. Now, we can get components out to our customers in two to three weeks.” MTD has also acquired a Mitsubishi 6-axis robot, which adds greater functionality for sophisticated in-line inspection and complex packaging schemes in a small footprint. Two new Sodick moulding machines increases production volume and speed.

MD&M West will take place 5-7 February at the Anaheim Convention Center.

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COVER STORY

TRENDS IN HEALTHCARE CREATE DEMAND FOR SOFT-TOUCH OVERMOULDING

Overmoulding is the solution that’s emerged and it’s becoming commonplace. Through co-injection or insert-moulding, a thermoplastic elastomer (TPE) overlay is created to enhance an application’s surface. Overmoulding is used to differentiate products. It improves ergonomics and makes products safer. Automakers have known the importance of overmoulding as a way to create a luxurious feel for high-end customers. Houseware manufacturers have been attuned to the ergonomic implications. Consumer electronics companies have known the added value that comes with colour or texture. “Overmoulding can be found in a wide range of healthcare applications ranging from surgical instruments to wheel chair grips to drug delivery devices to medical wearables,” said Aldo Zanetti, business mamager for Trinseo’s medical TPE business. “The demand for the overmoulding process is being driven by several trends – a move toward home healthcare, growth in selfadministered treatments, and an overall ageing population.” Zanetti notes that the U.S. Food and Drug Administration (FDA) may have contributed to the interest in overmoulding. The FDA recently issued a guidance document called “Applying Human Factors and Usability Engineering to Medical Devices” (revised February 2016). The intent of this report is to encourage manufacturers to make sure their devices can be used safely, without causing harm or lessening the effectiveness of treatment. Trinseo has been a leading supplier of rigid thermoplastics for medical devices for decades. Now, to better support the industry, the company has added thermoplastic elastomers (TPEs) to its portfolio though a 2017 acquisition of Italian manufacturer API S.p.A, which has specialised in the research, development and production of soft polymer compounds for more than 60 years.

Trinseo is announcing its expanded portfolio of plastics for medical device applications offering global manufacturers and moulders rigid and soft-touch plastics that have been known and trusted for decades. As a manufacturer of both the TPE and the rigid substrate, Trinseo says it has full control of the chemistries of both the materials enabling it to provide optimal adhesion. Trinseo plastics for medical are as follows: RIGID PLASTICS (THERMOPLASTICS) • CALIBRE polycarbonate resins • CALIBRE MEGARAD polycarbonate resins • EMERGE advanced resins • MAGNUM ABS resins • STYRON polystyrene resins SOFT-TOUCH PLASTICS (THERMOPLASTIC ELASTOMERS) • MEGOL MED TPS-SEBS compounds • MEGOL SK TPS-SEBS compounds • RAPLAN MED TPS-SBC compounds

APPLYING A HUMAN TOUC H

lastics play an important role in the medical devices industry. Not only do they help control cost (e.g., light weighting and parts consolidation), they’ve improved patient care (e.g., noninvasive surgical devices), and contributed to patient safety (e.g., glass replacements). Now plastics are assuming an even greater role as manufacturers realise that rigid, hard-touch surfaces can benefit from a soft-touch feel.

COVER STORY

A LOOK AT THE DRIVERS OF DEMAND HOME HEALTHCARE As healthcare services move from traditional settings such as hospitals, clinics, and physician’s offices to non-clinical and personal living spaces, people want medical equipment that blends in with their surroundings. The use of TPEs provides aesthetically pleasing, softtouch surfaces to help devices look more attractive and less institutional. They also offer benefits such as reduced vibration and noise as well as soft-touch, easy-to-grip knobs and handles that can improve functionality for professionals familiar with medical equipment and those who are not. SELF-ADMINISTERED CARE Patients want convenient, effective treatment that can be administered “on the go.” This has created a need for drug delivery devices such as autoinjectors, asthma inhalers, and portable respiratory equipment. Along with the actual device, is a need for easy administration and error-free performance. Part design and/or textured surfaces can help guide proper handling. Coloured inserts or moulded-in labels can provide instruction and non-slip grips can help ensure accurate administration. AGEING AND SPECIAL NEEDS POPULATIONS According to the World Health Organisation (WHO), the number of people 60 years or older will jump from 900 million to two billion between 2015 and 2050. Medical device OEMs need to adjust to this growth by developing devices that take a variety of factors into consideration. Not only is patient age important, but physical dexterity, flexibility, and coordination are all key as manufacturers work to create ergonomic designs for patients of all types and abilities. OVERMOULDING EXPLAINED Overmoulding is an injection moulding process in which a thin TPE layer is applied to a second material, or substrate, typically a rigid plastic. The substrate can either be non-polar, a polypropylene (PP), or polar, either a polystyrene (PS), acrylonitrile butadiene styrene (ABS), polycarbonate (PC) or PC/ABS blend. The actual TPE chemistry used for the overlay – and there are six classified TPE categories according to ISO 18064 standards – depends on the substrate chosen. The most important element in overmoulding is good adhesion of the TPE onto the thermoplastic, i.e., bond strength. Due to the wide variety of TPE types and the large number of cross-industry manufacturers using the technology, reaching qualitative, quantitative, and comparative consistency regarding bond strength has been difficult. The automotive industry has led the way in the use of overmoulding and, in the last three decades, the industry’s demand for combining soft TPEs with

hard materials has increased. Today, more and more applications require a soft, rubbery-touch surface to cover rigid substrates and as a result, the industry had been using various test methods to determine the quality of adhesion. In 2008 in an effort to develop overmoulding standards, the Association of German Engineers embarked on an initiative to define a common testing protocol. The automotive-industry-driven initiative focused on creating an international standard to define bond strength, with the aid of a systematic peelingtest procedure. The resulting “VDI 2019 Standard” has been developed and is now applicable to TPE testing on any rigid thermoplastic material. It also includes specifications for required documentation. Central to the VDI standard is a Peeling Test, which measures the quality of the adhesion. In essence, a dynamometer measures the resistance of the materials to separation. In a controlled environment the soft components are subjected to constant tensile stress until failure, and then fracture patterns are assessed and the type of fracture provides an indication of the strength of the bond. According to Zanetti, the importance of testing during the application design process is critical and, by adopting this discipline, product manufacturers can realise the benefits of reduced cycle time and cost in final production. “In the course of testing, if a moulding sample doesn’t meet quality standards, several possibilities exist,” said Zanetti. “Bond strength can be improved by either modifying the injection moulding variables or the chemical formulation; better bonding can also be achieved through changes in the TPE polymerisation process. “A total system solution approach to problem resolution is essential, meaning it’s important to look at the rigid material in combination with the TPE, particularly if adjustments need to be made to the materials simultaneously. This is the best way to achieve optimal adhesion, which is especially critical in the medical devices industry where the final application ultimately impacts patient comfort, satisfaction, or safety.” Trinseo’s Specialised Overmoulding Testing Centre (SOC) in Mussolente, Italy is dedicated to overmoulding excellence and has been fulfilling the requirements of VDI since 2014. The SOC is equipped with a stateof-the-art laboratory designed to measure bond strength and determine adhesion in relation to main injection moulding variables: material temperature, mould temperature, and injection speed and pressure. Trinseo, then API, contributed to the writing of the VDI standard.

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EXTRUSION

A BRIGHT NEW FUTURE

eyers will now become part of Tekni-Plex’s Tekni-Films business unit. It specialises in producing PE packaging for pharmaceutical, medical and other industries such as food, aerospace, solar energy, semi-conductor and chemicals. The Beyers Plastics purchase is the tenth acquisition Tekni-Plex has made in the past four years, supporting its strategy to grow its business though transformative acquisitions and strategic add-ons. WHAT NEW TECHNICAL CAPABILITIES DOES THE BEYERS PLASTICS ACQUISITION BRING? With the acquisition of Beyers Plastics, Tekni-Plex is adding cleanroom blown film extrusion to its film manufacturing portfolio for pharmaceutical and medical applications. Blown film extrusion is the preferred polyolefin film production technique to achieve thicknesses required for bags and drum liners. These are used to package pharmaceutical bulk products or moulded components used in pharmaceutical delivery or medical devices. Beyers Plastics is also converting blown films into bags by sealing to customer-specified dimensions. These bags are considered primary packaging components for pharmaceutical and medical applications and are regulated as such. These capabilities are new to Tekni-Plex, making Beyers Plastics our global centre for blown film and bag sealing. WHAT ARE BEYERS’ CORE STRENGTHS IN MEDICAL EXTRUSION? Pharmaceutical and medical bags and films have similar strict regulatory requirements. With film extrusion and bag sealing under one operation, Beyers Plastics controls the entire process from film composition, cleanroom standards, weld seal performance and dimensions. Additionally, the finished goods can be sterilised upon request of the customer. HOW COMMON IS IT TO FIND A CLASS 7 PE FILM EXTRUDER ON THE MARKET? Cleanroom made PE film is quite common in the healthcare industry. The requirements of the pharmaceutical and medical manufacturers for cleanroom films are currently serviced by many converting companies, just like Beyers Plastics, who specialise in producing these materials. YOU ALSO HAVE EXPERTISE IN TUBING EXTRUSION FOR MEDICAL APPLICATIONS - CAN YOU ELABORATE ON THAT SIDE OF THE BUSINESS? Tekni-Plex has two business units that manufacture tubing for medical applications—Natvar and Dunn Industries. Collectively, these businesses extrude a variety of tubing sizes and configurations from a wide range of materials, including polyvinyl chloride (PVC), thermoplastic elastomers (TPE), thermoplastic polyurethane (TPU), polyamides, polyolefin, and much more.

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EXTRUSION

US PLAYER TEKNI-PLEX RECENTLY ACQUIRED BEYERS PLASTICS, A CLEANROOM CLASS 7 EXTRUDER AND CONVERTER OF POLYETHYLENE (PE) FILM, FROM BELGIUM. DAVE GRAY CAUGHT UP WITH MICHIEL VAN DEN BERG, DIRECTOR, GLOBAL PHARMACEUTICAL DEVELOPMENT FOR TEKNI-PLEX’S TEKNI-FILMS BUSINESS UNIT, TO FIND OUT WHAT THIS MEANS FOR BOTH FIRMS. Natvar is an innovative global supplier of medical tubing solutions for a broad spectrum of medical device products that target hospital, physician, dental healthcare and in-home use. Its global footprint is supported by five manufacturing facilities located in the United States, Costa Rica, China and Belgium. Natvar’s precisioncrafted tubing solutions are used by leading medical device companies around the world for applications such as intravenous therapy, dialysis, cardiac surgery and many others. Acquired earlier this year, Dunn is a leading global supplier of extruded tubing used in medical device applications. Custom tubes are available for prototype development and full-scale manufacturing of advanced catheter shaft assemblies and minimally invasive device components. Dunn also manufactures solid polymer cores used to retain inner lumen dimensions during the manufacture of advanced catheter shafts. WHAT ARE THE TRENDS YOU’RE SEEING IN FILM AND TUBING EXTRUSION? Globalisation of medical device design, development and manufacturing is requiring film and tubing companies to expand services in new geographies. For example, device companies in China and Brazil are increasingly designing and developing products for their local market. Meanwhile, device manufacturing continues to migrate to more economical regions in Southeast Asia and Central America. Suppliers must be able to provide technical support and prototypes quickly during early stage development at new design locations, while offering timely delivery of quality products at new production locations. Additionally, medical device regulations continue to develop and change in emerging regions, such as China and India. Medical film and tubing suppliers must be able to comply with a broader range of global regulatory requirements, such as contamination controls and validations. WHAT ARE COMMON CHALLENGES IN MEDICAL DEVICE PACKAGING, AND HOW CAN TEKNI-PLEX’S BUSINESS SUPPORT THIS? Similarly to pharmaceutical companies, medical device companies are continuously being challenging to meet both performance and cost objectives. For example, Tekni-Plex’s Tekni-Films business unit has developed its TekniMD PX film series as a drop-in, cost-effective replacement to PETG for thermoformed medical tray packaging. We have seen the development pipeline increase two-fold over a year ago, with activity both in the

United States and Europe. The material is gaining traction globally in a number of sterile barrier tray applications whose companies want a costeffective alternative to PETG for products such as orthopaedic devices, pre-filled syringes and infusion assemblies and tubing. TekniMD PX films also are being specified for nonsterile totes and retainers that are used for workin-progress transfers between different company facilities. Additionally, the PX film line offers a wider processing window than PETG and bears recycling code #1. WHAT ARE COMMON CHALLENGES IN MEDICAL TUBING, AND HOW CAN TEKNIPLEX’S EXTRUSION EXPERTISE SUPPORT THIS? Medical tubing challenges often differ by device type. For example, tubing used for medical pumps, blood management and respiratory devices, is often supplied in large quantities to exacting, repeatable standards. Device companies often prefer suppliers with a global manufacturing footprint that offers validated tube extrusion in locations proximal to their manufacturing. Natvar manufactures tubing in five locations around the world, including North America, Central America, Europe and Asia. Each location is equipped with extensive quality management and validation resources for production. Challenges in endovascular tubing can often be associated with new designs to reach distal regions within the body and/or provide novel interventions. In many cases, this requires catheter tubes with smaller diameters, wall thicknesses and tolerances. Designers of these devices require companies that can provide tubes quickly for evaluation of early stage prototypes. Dunn has an extensive library of extrusion tooling and materials that facilitate rapid development of small singlelumen and multi-lumen tubes with tight tolerances, such as those used in neurovascular microcatheters. IS WIDENING YOUR FOOTPRINT IN EUROPE A KEY PART OF YOUR STRATEGY GOING FORWARD? The Beyers Plastics purchase is the tenth acquisition Tekni-Plex has made in the past four years, supporting its strategy to grow its global business though transformative acquisitions and strategic add ons. Tekni-Plex has a solid track record of successful business integrations, having acquired companies with innovative plastic and rubber products to further drive growth.

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DRUG DELIVERY

MAKING ADVANCES DAVE GRAY SPEAKS TO PASCALE FARJAS, GLOBAL CATEGORY MANAGER FOR EAR, NOSE AND THROAT, AND BENOÎT GUILLARD, SENIOR DESIGN ENGINEER, AT DRUG DELIVERY EXPERT NEMERA, TO FIND OUT HOW TO DESIGN A DRUG DELIVERY DEVICE FOR OPTIMUM PATIENT COMPLIANCE.

DG: What are the design considerations to ensure a full dose is delivered for each actuation? PF: First, we need to make sure the nasal spray pump delivers the dose with a full stroke regardless of patient age or how the patient uses Advancia. This is achieved via a user-independent feature: at the beginning of the pump stroke, a stiff point is felt making the patient apply the required force to perform the full stroke of the pump in one unique movement. This full stroke enables the full delivery of the content of the chamber dose, with high precision and consistency. DG: What measures did you take to ensure regulatory compliance? BG: Advancia PF is compliant with EP/USP standards, and with applicable regulation for nasal sprays which I will not detail here. We are currently finalising validation of sterility according to ISO 11137. DG: What were the human factors engineering considerations in designing this product? PF: Engineering considerations during Advancia development were based on our marketing brief. On the performance side, the unique selling point of Advancia is user-independence. On the design side, ergonomy and convenience were the key drivers of our engineers. For instance, the full overcap of the snap-on version is here to respond to a triple need: hygiene while protecting the actuator, nomadic use for transport in a bag or pocket, and no accidental actuation during transport. DG: Tell us about the design of the mechanical closing tip PF: The objective of such a closing tip is to avoid any contamination through the orifice and clogging of the tip. How does it work? Purely mechanically: at rest position, the tip seal is closed under a spring force. Tip seal opens during spray delivery as bulk pressure exceeds closing spring force. After dose expulsion bulk pressure reduces and tip seal is closed immediately. DG: How does the design ensure better compliance? BG: Better compliance is achieved through the different design features of Advancia PF. It relies on a new pump engine technology, with a userindependent feature. What does that mean for the patient? On a userperspective, the patient feels like they’re having the full dose delivered due to Advancia’s actuation profile. On the performance side, the dose is 100% delivered, with high precision and consistency through product life. No matter how the patient uses Advancia, he/she will have the full dose delivered each time. The mechanical closing tip avoids evaporation & clogging issues, which ensures the patient will have a spray for each delivery.

DG: Why is it important to have no interaction between metal parts and formulation? BG: Some drug formulations and/ or active ingredients can oxidise in contact with metallic parts. Hence the active ingredient could lose its therapeutic efficacy or even become toxic. Moreover, these oxidation reactions also alter and degrade these metallic parts, thus liberating toxic particles for the brain. Last but not least, some deterging agents can be used during the manufacturing process of metallic parts, with the possibility to migrate into the drug formulation. That’s why, in general but for some drugs in particular, it is recommended the fluid pathway is metallic-free. DG: Why did you decide on a onestep assembly version? PF: Snap-on is the standard today for preservative-free nasal pumps. In order to differentiate our product on the market, Advancia has a patented specific snap-on system, with a full overcap, allowing a onestep assembly during drug filling. This new feature is intended to facilitate device assembly onto different containers (plastic or glass). Indeed, the assembly force required to snap the Advancia system onto the bottle is very similar from one bottle to another, as opposed to standard snap-on systems where the bottle neck design can have a high impact on the assembly force profile.

The anti-actuation overcap avoids any accidental spray delivery when transported in a purse or a pocket. Moreover, its hygienic overcap protects the actuator from dust/ external environment, which reassures the patient and corresponds to the patient lifestyle for a nomadic. Hence the patient can transport their nasal spray very easily for using it during the day, all that increasing patient adherence. DG: What is PureFlow technology? BG: PureFlow Technology is a patented technology developed by Nemera, which consists of filtering air entry by permeation through a silicone membrane. Air ingress is then sterile, without having any filter.

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MED-TECH INNOVATION

EXPO

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2019

MAY

DRUG DELIVERY

NN CHRISSY BELL, GLOBAL BUSINESS LEADER, 3M DRUG DELIVERY SYSTEMS, LOOKS AT WHAT THE DIGITAL REVOLUTION IS DOING FOR DESIGN AND COMMERCIALISATION IN DRUG DELIVERY.

oday, patient empowerment is at the centre of the conversation surrounding healthcare and drug delivery technology. By using technology to augment existing care and provide the tools to allow patients to better manage their own conditions, we may empower patients to take back control of their own health, through the use of data and other insights.

SOLVING PROBLEMS

those problems. For example, the 3M Intelligent Control Inhaler, which is currently in development and not available for commercial sale, is breathactuated so that patients do not have to coordinate their in-breath with triggering of the device. It can provide feedback and tips on the user’s technique to encourage and promote correct use. The device can also send reminders to a patient, to help empower patient adherence.

By building technology into drug delivery devices, we can help address

The benefits of this technology may not only improve patient outcomes, it may also drive down healthcare costs, which is one of the major factors driving technological advancements in the healthcare industry. We know preventive care saves money. By getting a drug more effectively and efficiently into a patient, we may prevent costly doctor visits, hospital stays, etc. I firmly believe that empowering patients in this way is key to reducing healthcare costs in the long term.

With the arrival of new technology, we have the ability to address problems that have persisted for decades without a solution. For example, for patients suffering from asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy hasn’t changed much in the last 50 years. Meanwhile, studies have shown that a vast majority of patients aren’t using their inhalers correctly or simply not using them at all.

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Medical Packaging Specialists • 40 years of experience • Manufacturing facilities in Europe & the U.S.

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DRUG DELIVERY

GAINING TRACTION

While technology makes it possible to collect real-time data on a patient’s condition, in order to gain traction, innovations in drug delivery need to go beyond that. The days of data dumps without guidance on how to take action are behind us. We have to help a patient understand what the data means and how to use it. The focus needs to be on action-oriented devices that help coach patients to better outcomes. Another factor that will help new drug delivery innovations gain traction is in the design phase. As scientists and engineers begin drafting new designs for drug delivery methods, they are now starting with the patient at the ground level and working their way up. That has not always been the case, and it has caused a disconnect that has inadvertently left patient circumstances out of the equation. The benefit of this new approach is the ability to first understand patient circumstances and the challenges they present. Technology makes it easier to address those issues on the frontend, with the goal to increase better results on the back-end.

GOING MAINSTREAM

As high-tech drug delivery devices arrive on the market, we need to make sure patients and their healthcare providers are willing to embrace them. Whenever new technology is introduced, growing pains are inevitable. Learning how to use a new device takes time. It is a short-term investment for long-term gains of efficiencies and improved care, but, in their busy dayto-day lives, patients and providers may not always see it that way. Due to these factors, when developing a new drug delivery technology, we must include input from patients and providers at all stages of development and make the process as easy for them as possible. When we talk to doctors, they tell us that sometimes technology is one more thing standing between them and their patients. Our challenge is to make sure digital drug delivery devices help the doctor-patient relationship, rather than hinder it.

Another challenge facing the digital drug delivery industry is high-profile security breaches. People are already cautious about sharing their personal information in the digital space. When it comes to sharing something as private as their health data, patients have reason to be reluctant. It is incumbent upon us to prove they can trust us. Gathering that data may do more than just help individual patients. As we begin to aggregate patient data, we’ll be able to capture population trends for the first time. Those trends will open up insights and uncover information that may ultimately create better treatment plans that may result in better outcomes for the patient population as a whole. I think we’ll really feel the impact when patients begin to realise that sharing their own data benefits the greater good.

CONCLUSION

It is truly a time to be excited and optimistic. We are on the cusp of the digital revolution of healthcare. There is so much opportunity to improve the lives of patients and potentially fix problems that we know exist within our healthcare system. I believe, over the next five years, we’ll see that shift happen right before our eyes.

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INDUSTRY 4.0

Digital manufacturing ‘TOP PRIORITY’ FOR LIFE SCIENCES

MEDICAL MOULDING gets in sync With the growing demand for wearables, it’s not surprising that the adhesives market has become a focal point for the medical plastics sector. When Tony Kaufman, and Del R Lawson, 3M’s Critical and Chronic Care Solutions Division, outlined the role that adhesives play in digital wearable medical devices, it was interesting to get their view on how adhesives may impact the future of wearable medical devices.

Zenith Technologies, a specialist in GMP manufacturing software solutions to the life sciences industry, recently conducted an industry survey that suggests the digitalisation of manufacturing is a top priority. The company conducted a survey of business and operational leaders across the life science sector on the trends and technologies that may revolutionise the industry over the coming years. The research suggested an increasing appetite for Industry 4.0 – which focuses on using data and information to revolutionise GMP manufacturing.

Kaufman and Lawson outlined how many people habitually wear a device to track fitness or daily steps, nightly sleep and what they’re eating. Some people also wear devices to help manage chronic illness, such as diabetes. Consumers and patients are taking more control of their health by using real-time data collected by wearable devices to help make health-related decisions and want to proactively manage and improve their health without a device getting in their way. As a result, the wearable medical device market has seen rapid growth in recent years. The wearable medical device market will further evolve as researchers determine ways to improve current non-pharmaceutical therapies and digital monitoring. Manufacturers will need to put those findings into practice and build products that enable more effective, personalised monitoring to keep pace with market need. Their article examined the psychosocial impact of wearable devices; band vs. stick-to-skin applications; the danger of information fatigue; device size and weight; resilience and durability and comfort.

Nearly 60% of those surveyed believe that Industry 4.0 will drive the most change in life sciences over the next five years, with 75% of those aiming to invest in people to take advantage of emerging technologies. It also uncovered the main motivators for technology investment were cost and time saving, with more than 70% of respondents citing these reasons. Following on from these findings, Zenith published a whitepaper ‘Industry 4.0: Revolutionising life science manufacturing through connected systems and data’ written by global services director, David Staunton and MES project manager, Ryan McInerney. The paper examines technological advances that are driving the next phase of pharmaceutical manufacturing, improving quality and reducing waste. David Staunton said: “The life science industry has used data and information to drive improvements in GMP manufacturing for decades and there is now an opportunity to take it to the next level.” “The foundation of life science GMP manufacturing is to know your process and industry 4.0 allows us to stay true to who we are, while at the same time revolutionising GMP manufacturing.” 28

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WOUNDCARE

New tech for

HEALING OLD WOUNDS WHEN PIONEERING BURN AND CHRONIC WOUND CARE SPECIALIST DR AUBREY WOODROOF TURNED TO TRELLEBORG SEALING SOLUTIONS TO HELP BRING HIS NEW HEALING CONCEPT PERMEADERM TO MARKET, THE COLLABORATION GAVE RISE TO A RANGE OF BIOSYNTHETIC SKIN PRODUCTS THAT HAVE TAKEN TREATMENT TO A WHOLE NEW LEVEL.

n the academic and medical community Dr Woodroof is known for his pioneering treatment of patients with burns and chronic wounds.

Dr Woodroof is the inventor of PermeaDerm, a groundbreaking acellular biosynthetic skin substitute. He and Paul Butorac, principal development engineer at Trelleborg Sealing Solutions, have spent the past three years working to transform his dream into a market-ready range of products. In addition to Butorac, a key team of specialists at Trelleborg in Tustin, California, have worked together to make PermeaDerm a reality: Sean McPherson, sales engineer, healthcare and medical, and Mark Gordon, product manager for Trelleborg Sealing Solutions in Tustin. “When Dr Woodroof first called us in 2014, he was hoping that we would be able to provide just the silicone element of his proposed wound dressing system,” McPherson says. “Little did he know that we would actually be able to bring a whole range of capabilities to the table, including raw material research and selection, equipment design, process development, packaging, validation and sterilisation management.” While Dr Woodroof had a theoretical concept and some basic handmade prototypes, Trelleborg Sealing Solutions was able to provide formal drawings, material controls, work instructions, certification

of active ingredients, a quality control system and a world-class manufacturing system. This would ultimately produce a high-quality marketable product while securing global regulatory acceptance for a complete combination drug-anddevice solution – in other words, the entire framework that would make his products a success. STREAMLINING PROCESSES While Dr Woodroof had a winning concept, the manufacturing strategy involved in bringing it to market was complex. “It was quite a challenge to develop and optimise a manufacturing process that would make this whole project feasible,” Butorac said. “At the beginning, the work was very manual – for example, we were sizing product with scissors. This was never

The demand for biosynthetic wound and burn care solutions is significant, with burn centres and long-term woundcare providers always on the lookout for new, effective forms of treatment.

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sustainable. We systematically applied our quality management framework and manufacturing expertise to help PermeaDerm achieve clinical success and commercialisation of their products.

While PermeaDerm owns, markets and sells its products, it relies on Trelleborg’s backing and support resources.

“It was very gratifying to see how excited our operators were to come on board for PermeaDerm production. Extensive training was conducted to educate and motivate the operators, to ensure the process was consistent and to help continuously improve quality while reducing manufacturing times. By providing a complete manufacturing solution we helped Dr Woodroof focus on writing critical scientific publications, identify new investors, promote PermeaDerm and develop new ideas.”

“If Dr Woodroof can get to a point where his products are not only being used in hospitals and burn centres but become available over the counter like Elastoplast, we’re looking at highvolume sales,” Butorac said. “Let’s face it: if I had a child with a wound or burn that could cause pain and permanent scar tissue, I would happily use this product. What parent wouldn’t?”

CHANGING LIVES Butorac continued, “Working with such a significant yet elegant solution designed to help patients recover from their wounds and change their lives makes for rewarding work and a great sense of fulfillment. This is especially pleasing now that the first two products have been released – PermeaDerm B for burns and PermeaDerm C for chronic wounds – with very positive results. “We have observed the remarkable healing process in patients after treatment with PermeaDerm, often with reduced pain and scarring as a result. Having seen the results of this work, it feels really good to collaborate with and contribute to Dr Woodroof’s success. “I have been fortunate to play a role in advancing the art of medicine for the successful management of acute and chronic wounds (such as diabetic ulcers) and burns with PermeaDerm,” he said. THE ROAD AHEAD The demand for biosynthetic wound and burn care solutions is significant, with burn centres and long-term wound-care providers always on the lookout for new, effective forms of treatment. The team is now busy developing PermeaDerm G – the “G” is short for glove. People’s hands are more susceptible to burn wounds, and the demand for an effective treatment solution is currently overwhelming.

Trelleborg Sealing Solutions provides the silicone element of Permeaderm

DID YOU KNOW PermeaDerm is a biosynthetic skin substitute for the temporary treatment of burns and chronic wounds. This thin, elastic, nonadhesive, porous covering material is made of a threedimensional nylon matrix embedded in silicone, with a collagen and aloe vera extract coating. The first two products are currently available: PermeaDerm B for burns and PermeaDerm C for chronic wounds. The glove product, called PermeaDerm G, is still due to be launched.

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PHARMAPACK

IT’S AN EXCITING TIME FOR THE MEDICAL PACKAGING INDUSTRY, WITH MANY NEW PRODUCTS ENTERING THE MARKET THAT DEMAND MULTIFACETED PACKAGING. PHARMAPACK EUROPE, HELD IN PARIS THIS FEBRUARY, WILL BE A MEETING OF MINDS FOR THOSE LOOKING FOR A NEW APPROACH.

ew packaging regulations have led to contract packaging organisations taking a more significant role in producing advanced packaging and drug delivery solutions.

Pharmapack Europe will take place 6-7 February 2019 at the Paris Expo, Porte de Versailles, France. This year, Pharmapack is expected to play host to over 410 exhibitors and 5,290 attendees from more than 100 countries over two days, making it the most international edition to date. The conference agenda will consist of a two-day programme delivered by high-level industry expert speakers discussing current pharmaceutical packaging market trends, along with an overview and analysis on regulatory changes in the EU and US markets. Some of the major topics will include: patient adherence, challenges in usability, regulatory updates, biologics and biosimilars, drug delivery devices, sustainability, and devices. Highlights from the conference agenda include Dr Alex Cole of the CPI, who will discuss the future of smart pharmaceutical packaging and smart medical devices. The agenda also includes an entire session devoted to new packaging materials and drug delivery systems, as well as a session on the challenges and solutions when developing a custom primary container. The 2019 Technical Symposium, designed to promote exhibitors, will provide insight from pharma industry leaders on tackling the challenges and technical problems associated with novel approaches. This will include case-studies on pre-filled on body Injectors, drug-device combinations, drug repurposing, glass pre-fillable syringes, QBD and nasal delivery innovations. Additionally, this year, sustainable approaches to medical plastic packaging will be a topic of discussion.

Last year’s awards saw an influx of entries of exceptional calibre. All exhibitor innovations submitted for the Pharmapack Awards are showcased in the Innovation Gallery, which gives a comprehensive overview of recently launched products. Moreover, there will also be hour long guided Innovation Tours, delivered by industry experts, to highlight exceptional exhibitors throughout the innovation gallery. To celebrate, young companies, at the centre of the show will be the 2019 Start-up Hub, providing a platform dedicated to emerging new and innovative technologies in the fields of pharmaceutical packaging, labelling, drug delivery device design and engineering. Exhibitors here will showcase product innovations and take part in the Start-up Pitch – retained from last year, this opportunity gives exhibitors the chance to pitch their company to a panel of experts in front of a live audience of industry professionals.

The 2019 edition of Pharmapack will also feature the Learning Lab, situated directly on the exhibition floor, it is designed to inform visitors on the latest exhibitor products and services. Session highlights include a presentation from by Hiroki Hasegawa, researcher at Mitsubishi Gas Chemical Company, Inc., on the best plastic vial & syringe for oxygen sensitive drugs and a talk from Arnaud Guillet, business development director at Biocorp on how smart devices are changing drug delivery.

Finally, the International Meetings Programme is a complementary online service provided by goMed2Med that enables all attendees to pre-arrange mutuallybeneficial meetings at the event. Meetings can be arranged to take place either in the International Meeting Lounge – stand G70 – or on the exhibitor’s stand.

The Pharmapack Awards will be hosted alongside Pharmapack Europe 2019 and will celebrate the latest innovations from the pharmaceutical packaging industry. The awards have two categories – health products and exhibitor innovations. Each are judged by a panel of independent industry experts and decisionmakers, and the awards will be presented on 6 February.

Pharmapack Europe 2019 will take place 6-7 February 2019 at the Paris Expo, Porte de Versailles, France Paris.

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FEMTECH

HOW DESIGN AND MATERIAL Decisions created an award winning femtech device UK FIRM FEMEDA RECENTLY SCOOPED PRODUCT OF THE YEAR AT THE BIONOW AWARDS FOR PELVIVA - A PELVIC FLOOR MUSCLE RE-TRAINER WITH ‘REACTIVE PULSE TECHNOLOGY’ (RPT). DAVE GRAY CAUGHT UP WITH JULIA HERBERT, CLINICAL DIRECTOR, FEMEDA, AND ANDREW TASKER, CEO TO FIND OUT ABOUT THE DESIGN PRINCIPLES BEHIND FEMTECH PRODUCTS.

elviva is a new pelvic floor re-training device which works using a pattern of neuromuscular electrical stimulation via a programme developed by professor Jackie Oldham at The University of Manchester. Each device contains a microprocessor that delivers RPT to the pelvic floor muscles. The pulse mimics the way the body works naturally, causing the pelvic floor muscles to contract. This helps restore speed and strength to the fibres, to help prevent bladder leakage when women cough, laugh, sneeze or exercise. It also re-trains the endurance fibres to hold on when a woman urgently needs the toilet, giving back control over urgency bladder leakage. Pelviva is made of a body responsive foam, which adapts to individual shapes. The Pelviva RPT delivers a series of intensive reactive pulses every alternate 10 seconds, to stimulate the pelvic floor muscles. Each 30 minute treatment using the Pelviva innovative stimulation programme delivers up to 25% greater penetration of the deep pelvic muscle than conventional stimulation, according to the company. In a 12 week randomised single-blind clinical study involving 123 women, 84% of women using Pelviva reported improvement in bladder control. The Pelviva women reported a four times greater improvement in quality of life versus women who only followed an unsupervised pelvic floor muscle exercise programme.

The UK’s National Institute for Health and Care Excellence (NICE) recommends a three-month programme of supervised pelvic floor muscle exercises. However, research shows that up to 50% of women have problems correctly contracting their pelvic floor muscles, many fail to adhere to an effective exercise programme and only 25% of women with urinary incontinence (UI) seek professional help.

Pelviva 3D without pull tab

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FEMTECH

Designing an award winning product for the female health market is not without its challenges. Tasker explains: “The overall design consideration is to react to the real needs of the female consumer. To do this in-depth, market research is required, starting with the end female user to understand their condition from multiple angles. Market research is then required with all health professionals who can be, or may in the future be involved in the care pathway. “All our design and development work is based on consumer and health professional insights. Having women in the development team is important – though its our end consumers and patients who drive our strategy. “Our research confirms that women need a product that is discrete, effective, easy to use, and increasingly, able to meet the needs of busy lifestyles. Female health is such a major area where innovative solutions are required meaning from a design perspective we need to look at both devices for use in primary and secondary care, and which can be sold both over the counter via the pharmacist and direct to the consumer. Therefore route to market needs consideration at design and development stage to ensure the appropriate level of advice and support can be matched at point of recommendation or point of sale.” Herbert added: “I am so pleased to have been able to work with Femeda to develop Pelviva. I believe Pelviva will really improve the lives of women whose quality of life is negatively impacted by the symptoms of urinary incontinence. Over my many years as a pelvic health physiotherapist I have met many women, who although they know pelvic floor muscle exercises will help them, they have really struggled with doing them; many don’t know how to use these muscles correctly and others simply don’t remember to fit them into their busy days. Pelviva has been specifically developed to fit into busy lives, it’s easy to use and has been designed so that women can continue with their everyday activities whilst having their Pelviva treatment.” Materials choice and processing options were limited by the unique requirements of the product, according to Herbert and Tasker. “PU foam was selected for the main body of the device as no other materials have been found to possess all the characteristics required to satisfy the product’s design requirements. These materials require significant additional processing and a high level of R&D input from our teams to tailor some of the characteristics to ensure ease and comfort during use”, said Tasker.

Materials that can satisfy the stringent biocompatibility requirements are difficult to process in discreet mouldings of the size required

He added: “Materials that can satisfy the stringent biocompatibility requirements are difficult to process in discreet mouldings of the size required for Pelviva. This challenge is compounded by the highly specific physical characteristics required from the foam to ensure optimal performance of the device in terms of its weight and compressibility. “Consequently, it has been necessary to establish a specialised foam manufacturing facility in the North East of England. This has been a substantial investment and required significant product and process design effort over a three-year period, after the initial five year R&D development phase.” Herbert agrees that investing in the manufacturing was crucial to the success of the product. “Establishing the manufacturing facility in Cramlington has been a primary focus for the company over the past three years to finalise the development of the product. We have worked closely with a range supply partners and academic groups to optimise the chemical formulations of materials and to develop additional processes to modify the moulded products’ final characteristics”, she said. “The equipment that is employed has been developed to provide process control is the latest technology, combined with pharmaceutical standard clean environments. Building a highly skilled internal team has also been fundamental to delivering a highly consistent product that satisfies all design requirements.” Innovating in a regional hub has been another one of the keys to success for Femeda. Tasker said: “In recognition of the major support the business has received from clinicians and academics in the Manchester area to bring Pelviva to the market, Femeda would like to invest back in the Greater Manchester community. The business is committing to provide up to £50k of Pelviva product to women with urinary incontinence in the region, via the appropriate clinicians and hospital trusts. Femeda is looking to work with primary and secondary care providers to make this product available to women who as yet have had limited alternatives, and will be seeking advice from Health Innovation Manchester and Manchester Foundation Trust how they can best recommend this product is allocated.”

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REGULATION

DON’T FOLLOW

your nose

MANUFACTURERS NEED TO SET A CLEAR ROADMAP TO COMPLIANT CLINICAL EVALUATION REPORTS, SAYS DAVID EGBOSIMBA, SOLUTIONS DELIVERY MANAGER, MAETRICS

linical Evaluation Reports (CERs) are a requirement for any medical device sold into Europe, irrespective of its classification. They are part of the product Technical File and must be kept up to date. But ask a handful of manufacturers or even Notified Bodies (NBs) exactly what process this entails, and the answers are likely to be varied. There are in fact some common misunderstandings relating to CERs that may lead to misfiling and leave manufacturers feeling uncertain as to whether their CER process will be considered compliant and their medical devices adequately supported or not. Not passing an inspection may result in an expensive product recall and reputational damage. Having to repeat reviews of clinical data in response to deficiencies is also highly time-consuming and a drain on resources. In this scenario the new Medical Device Regulation (MDR) came into force on the 25th May 2017 making proactive implementation of CERs highly critical. The MDR specifically places greater emphasis on supporting clinical data requirements and highlights the need for planning and documenting the CER process. In addition to this, NBs are also under increased scrutiny and need to improve their performance in terms of safeguarding public safety. In particular, they have been called upon to increase the use of unannounced inspections and limit their activities to devices where they have proven competence. TWO COMMON MISCONCEPTIONS Clinical evaluation is defined as the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance when used as intended. However, this definition doesn’t avert the misconception held by many manufacturers that it is a once-

in-a-lifetime duty rather than an ongoing activity that needs to be updated and refreshed throughout the product’s entire lifecycle. The new MDR and the unannounced inspections by the NBs clearly highlights the importance for manufactures to put more focus on achieving ongoing compliance. The first misconception is therefore not grasping the cyclical nature of the task, while a second typical challenge is caused by the underestimating of how long it takes to complete a properly documented CER. A methodical best-practice CER can actually take up to three months to finalise depending on expertise and resources available. This is a particularly difficult obstacle for manufacturers who have multiple devices which require new, updated or revised CERs, especially when these deadlines are grouped around the same date or fall at the same time. Underestimating the time it takes to complete a CER can have repercussions on the whole production cycle as inhouse professionals are taken away from their key tasks to complete the CER. Yet ensuring that the CER is completed by qualified individuals who harbour the expertise to deal with the clinical data, such as writers who have the knowledge of the device and therapy area as well as knowledge of research methodology and critical review skills, is critical. Expertise and familiarity with the CER process itself is also important to avoid non-compliance, improve efficiency and overcome gaps in the guidance through expert interpretation.

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REGULATION

Heightened expectations regarding the appropriate use of clinical data to support devices need to be met and manufacturers should not delay reviewing the CER process. Drafting a roadmap to CER compliance will help them meet regulatory changes and unannounced inspections with confidence.

KEY CHECKLIST Once the manufacturer has come to terms with these common misconceptions it is critical that manufacturers ensure they tackle the fall out from them. And therefore: 1. Develop CER and internal QMS procedures The very basis for developing a CER procedure is ensuring that the business understands what the internal sources for the clinical evaluation are and ensures that the required information is available and can be obtained in the correct format when required. When it comes to the CER, a standard operating procedure (SOP) needs to be developed to include comprehensive standard templates for evaluators to use to uniform the process and increase efficiency.

2. Appropriately resource the CER The availability of dedicated staff is critical to help ensure the time-consuming elements are completed as swiftly as possible but needs to be sensitive to existing workloads. If a manufacturer does not have an experienced CER writer in house, it is critical to source the right level of expertise elsewhere and this too is a timesensitive task.

3. Invest in training CER writers need to be specialised and trained on the CER process. Developing inhouse expertise is essential, whether for writing or for reviewing outsourced CERs. There are training courses available on clinical evaluation and also for other aspects of research methodology if necessary. 4. Accurately select CER writers and staff To approach the CER efficiently and reduce time spent to complete it, savvy manufactures will allocate certain elements of the process to different (appropriately trained) internal or external personnel that has the specific skill set.

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PEAK AND HIGH PERFORMANCE POLYMERS

PEEK has yet to peak AS MATERIALS SPECIALIST VICTREX NOW CELEBRATES THE 40TH ANNIVERSARY OF PEEK, INVIBIO IS MAKING SIGNIFICANT PROGRESS WITH ITS IMPLANTABLE PEEK, PROVIDING NON-METAL SOLUTIONS FOR IMPLANTABLE MEDICAL DEVICES. MPN RECENTLY HAD THE OPPORTUNITY TO TALK WITH JOHN DEVINE, BUSINESS DIRECTOR AT INVIBIO BIOMATERIAL SOLUTIONS, TO ASSESS THAT PROGRESS.

n 1978, PEEK (polyetheretherketone), a member of the PAEK (polyaryletherketone) family of high-performance polymers, was invented. Beyond the tongue twisting names are materials with significant properties. These exceptional polymers have come to play an important role in replacing metal within several sectors, including automotive, aerospace and energy. The first commercialisation of the new polymer came in 1981, in the form of Victrex PEEK. In 1993, a company called Victrex was formed around these polymers, focusing on the development of the PAEK family, and in particular PEEK – new materials that clearly had an enormous potential. The focus sectors now include the medical field. In 1999, PEEK-OPTIMA Natural was launched as the world´s first implantable PEEK polymer, which resulted in the manufacturing of an intervertebral cage – in other words, a spinal implant. The rest, as they say, is history. That spark of innovative genius was instrumental in the formation of Invibio Biomaterial Solutions in 2001. Operating as a division within the Victrex group of companies today, Invibio continues to actively pursue R&D and forge partnerships as it develops the potential of PEEK as an alternative to metal in spinal fusion, trauma, orthopaedics (total knee replacement) and even dental prosthetics. Today, Victrex and Invibio remain ardent pioneers of PEEK, with a long track record of impressive achievements.

Interbody Fusion Device examples. These products are not available for implantation or distribution. Invibio

MPN: PEEK’s 40th anniversary seems a good time to assess the impact of the high-performance polymer on the medical field. We know that Invibio’s PEEK is now being used to make implantable medical devices, for example. What are your thoughts on the future of PEEK as a material for medical implants? JD: Over the last 15 years we have made enormous progress in the use of PEEK-OPTIMA-based solutions for medical implants, and we are absolutely sure this will continue to be the case. In spinal fusion, our PEEK-OPTIMA Natural has become one of the leading interbody fusion (IBF) biomaterials. Today, its many advantages, including a modulus similar to cortical bone, as well as radiolucency for artefact-free imaging, are maintained with PEEK-OPTIMA HA Enhanced, where hydroxyapatite (HA), a well-known osteoconductive material found within bone, is fully integrated, encouraging bone ongrowth.1 Similarly, for the treatment of trauma, Invibio has developed PEEK-OPTIMA Ultra Reinforced, which combines the mechanical properties of PEEK-OPTIMA Natural with the additional strength imparted by continuous carbon fibres. Compared to metals typically used in anatomic trauma plates, PEEK-OPTIMA Ultra-Reinforced may offer earlier and greater callus formation for improved secondary bone healing,2 greater material fatigue life allowing healing to occur before the implant fails,3 and all the advantages of radiolucency for 360° fracture visibility during and after the procedure. The PEEK-OPTIMA Knee Implant, meanwhile, has the potential to offer surgeons an alternative to metal implants for total knee replacement (TKR). Together with Maxx Orthopedics, we are progressing this program and fully expect it to contribute, in the long term, to improved operative procedures and economic and patient outcomes, with the potential to improve the patient’s quality of life. Our vision for the future also includes the potential use of additive manufacturing techniques in the production of medical implants using PEEK OPTIMA. Victrex, our parent company, is currently cooperating with Exeter University in the development of VICTREX PAEK polymers for 3D printing processes and recently announced a high-strength PAEKbased material for laser sintering (LS), plus a filament with better Z-strength than existing PAEK materials and better printability for filament fusion (FF), although these are not currently available for use in medical implants.4

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PEAK AND HIGH PERFORMANCE POLYMERS

MPN: Can you highlight two or three clinical results that have unequivocally demonstrated positive patient outcomes? JD: A summary of peer-reviewed published literature showed that the clinical history of PEEK in interbody fusion indicates that among comparative cervical interbody studies, fusion rates range from 88-100% for PEEK-OPTIMA Natural, while 47-93% fusion is achieved with titanium cages.5.6.7 Subsidence rates range from 0-14% of levels for PEEK-OPTIMA Natural, whereas it has consistently been reported as higher in titanium cage groups, from 16-20%.8.9.10 Odom criteria was available for three of the studies, demonstrating good or excellent outcomes in 64-80% of the patients receiving PEEK-OPTIMA Natural cages compared with 55-75% of patients receiving titanium cages. Cranio-maxillofacial studies have been conducted, on embedded cranioplasty (CP) and covered cranioplasty. In one study, including 185 patients, the reoperation rate was lower (1.3%) and brain function improvement was higher (25.3%) with PEEK compared to titanium, where there was a high patient reoperation rate (10%) and lower brain function improvement (10.9%).11 In 2017, Alex Jahangir, MD presented results for a study using continuous carbon-fibre reinforced PEEK (CFR-PEEK) plates in the treatment of distal femur fractures.12 Distal femur fractures are most commonly treated with stainless steel (SS) or titanium lateral locked plating. CFR-PEEK plates are an alternative fixation, with a potentially higher fatigue strength compared to metal implants and a modulus of elasticity close to that of cortical bone. In a study of 38 patients, with an average age of 54 years, CFR-PEEK plates showed a similar time to radiographic union and full weight bearing as SS plates, with no hardware failures, reoperations, or non-unions in short-term follow-up. In contrast, while the patient population receiving SS implants was healthier, not all patients healed and plates broke. These data suggest that CFR-PEEK plates may be a viable alternative to SS plates in the fixation of these fractures. I think that these are three compelling examples of positive patient outcomes where PEEK-OPTIMA-based implant solutions have been applied.

medical costs are threatening to escalate out of control, can they offer a significant value proposition? At Invibio, we are confident we are offering innovation as we partner with medical device manufacturers to deliver implants that have the potential to offer improved outcomes and quality of life for patients. We are also confident that the potential to reduce post-operative complications will save costs for healthcare systems. It’s this conviction that gives us the resilience to keep driving innovation into the market. MPN: I understand there is also a prosthetic solution for use in dentistry, the JUVORA dental disc, made from Invibio’s PEEK-OPTIMA, and that this is now under longterm study. What would you say is the likely future role of PEEK prosthetics in dentistry? Is this yet another example of PEEK’s versatility? JD: The JUVORA disc is CAD/CAM millable, so it can be used with all the advantages and efficiency of digital workflows. We expect computerised design techniques to have an increasing impact on PEEK-based implants and prosthetics, in dentistry, and quite possibly in other medical fields. Dental clinician Bernd Siewert, at the Clinica Somosaguas, Madrid, has used the JUVORA disc extensively, evaluating patients long-term as his practice moved to fully digital workflows and a current thirdgeneration of JUVORA-based prosthetics, reducing manufacturing time while delivering all the benefits of implantable PEEK. Very positive findings at the Clinica Somosaguas, obtained from 21 patients with full-arch implant-supported screw-retained bridges on a PEEK framework, certainly indicate that PEEK has a potentially major role to play in the field of dental prosthetics due to its excellent biocompatibility and the many advantages of being metalfree. In this particular study there was no corrosion, and healthy soft tissue was maintained. References 1-12 Supporting information available upon request from Invibio Biomaterial Solutions for all claims.

MPN: Despite a wealth of increasingly convincing clinical evidence that PEEK-based devices can result in more favourable patient outcomes, metal implants remain the first port of call in many, if not the majority of cases. What challenges are you facing? JD: Invibio is attempting an enormous sea-change, as we develop and supply PEEK-based devices. In this situation, progress is understandably gradual. Across all industries, driving innovation is challenging, but even more so in the medical field, for a variety of reasons. This applies in particular to the smaller makers of medical devices, who may not have the resources to support sufficiently large and long-term clinical studies. This is where Invibio can perhaps assist through some form of collaborative arrangement. The social phenomenon of the diffusion and adoption of technological innovation is an interesting one. It’s been observed that the early adopters of innovative technologies and products are a minority. The vast majority in the community are slow to adopt change, even when it is clearly for the better. In the medical field, that’s compounded with the risk factors that are involved with the adoption of innovative products and practices. It’s important for medical device manufacturers to address two questions. First, are they offering a solution to a significant medical problem? Second, in an era when

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Distal femoral plate Invibio / This product is not available for implantation or distribution.

FINISHING

TOUCHES

COATINGS

hile the healthcare industry has had a long-standing reputation of being slow to adopt change, there’s been a recent shift that’s brought about new innovative thinking. One example where this is prominent is within medical device design. Patients have been demanding smaller and more portable devices which has created new challenges for designers and engineers. They must now consider new options and application methods for product finishing, as well as how to properly clean them to meet the strict guidelines.

INNOVATIVE CLEANING OFFERS A SOLUTION

It’s important that the cleaning methods of medical device components meet the highest standards of cleanliness as it can impact device performance and ultimately, any steps in the finishing process. This can be challenging as some traditional processes like water cleaning, for example, can leave behind spots. Also, water’s high surface tension inhibits its ability to reach, and therefore clean, small interior and intricate spaces. There have been recent advances in cleaning fluids which offer more options for cleaning complex components. They are not only effective at satisfying the strict regulatory requirements needed in medical component manufacturing, but they also meet environmental standards and can provide an overall lower cost-per-part cleaned. LUBRICANTS TO MANAGE STACKED TOLERANCES

Guaranteeing device performance is important, equally as important is knowing that the lubricating material will not migrate into the human body. Many medical device manufacturers are finding great success with using polytetrafluoroethylene (PTFE), or “dry” lubricants, as opposed to traditional silicone lubricants as it stays on the instrument and does not transfer to the patient. It also can lubricate for multiple actuations and can be annealed to the instrument (substrate) so that it is semi-permanent. PTFE also can effectively address the issue of stiction (the combination of sticking and friction). Some surgical and medical procedural equipment is actuation-based, such as surgical staplers. This increases friction and mechanical movement requiring lubrication to eliminate stiction to ensure continued smooth movement.

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CATHETERS COATINGS

JAY TOURIGNY, SENIOR VICE PRESIDENT OF MICROCARE MEDICAL EXPLORES HOW THE TREND TOWARDS MINIATURISATION IS AFFECTING COATING AND FINISHING DECISIONS. Also, recent design incorporates single-use devices created to be minimally invasive to the patient. These however are more complex with many small parts. The higher the part count, the more likely ‘stacked tolerances’ will become an issue. This occurs when the tolerances of individual components “stack up” against each other and effect the performance of the device. Stacked tolerances can also be commonplace when dealing with multi-part mechanical assemblies with moving parts. One option to address this is to design everything with tighter tolerances; however, this results in higher production costs. Alternatively, lubrication can be used on the components to reduce movement friction and minimise actuation forces.

FINISHING TOUCHES

The changes in medical device design have created new challenges and opportunities for innovative finishing options. There are now more application methods which are solving these problems: • DIPPING: Frequently used in high volume production, the benefits include consistency and uniformity in coating nearly any external and internal surfaces. Small parts, coils of wires and unique geometries can be coated via this method.

Previously, carrier fluids posed safety and environmental concerns, for example flammability. Commonly used silicones do not work well with carrier fluids that are low in flammability or toxicity. These carrier fluids featured improved safety and environmental profiles, but the amount of silicone that they could be mixed in was only 1-2%, far lower than the threshold required for most medical devices. Advancements in carrier fluid chemistries have produced medical grade formulas with nonpyrogenic properties, ISO 10993 certification and full compatibility with sterilising processes. Plus, there are very few toxicity or handling issues with PTFE materials.

THE ANSWER’S OUT THERE

While there are many trends impacting today’s medical device design, it’s important to consider their implications on product finishing in order to select the best, most cost-effective solution. Today’s cleaning fluids, lubricants and coatings have come a long way, and innovations have kept pace with trends in miniaturisation, automation and application. By examining factors like safety, application method and overall effectiveness, you can make confident decisions about which solutions will work best for your needs.

• WIPING OR BRUSHING: Covering longer, ongoing surfaces including rods, tubing or sheeting can be accomplished through wiping or brushing. It can also be used if only small, select areas of a larger part requires coating. • SPRAYING: Requires equipment such as a handheld spray gun or automatic spray heads to apply diluted dispersions. Spraying can be used on a variety of devices. It is also more selective than dipping since material can be applied to small areas with more precision.

CARRIER FLUIDS TO CONSIDER

Just as important as a good lubricant is a good carrier fluid when necessary for dilution and application. For example, medical grade silicone is provided in concentrated form, so a carrier fluid must be used to dilute the lubricant, allowing for a very thin film of silicone to be applied to a surface.

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Asia s largest tradeshow & conference dedicated to the design & manufacture of medical devices

18 th

Mon

20 th

Wed

2019 March

Tokyo, Japan @Tokyo Big Sight, East Hall Held at the same time Exhibition

Medical Electronics Expo

Medical ICT / Home Healthcare Expo

Care Welfare Robot & Device Expo

Test Kit Expo

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PACKAGING

SEÁN EGAN, DIRECTOR OF GLOBAL MARKETING & VOC DEVELOPMENT, NELIPAK HEALTHCARE PACKAGING LOOKS AT THE LATEST SUSTAINABILITY TRENDS IN MEDICAL PACKAGING.

here is an estimated one million tons of clean, noninfectious healthcare plastic generated in healthcare facilities each year, according to The Healthcare Plastics Recycling Council (HPRC). Finding a way to minimise the waste stream that ends up in landfills -- and the resulting impact it can have on the environment -- is challenging but important. One area where there is an opportunity to reduce waste through increased design innovation and process and material optimisation is in healthcare packaging. More and more OEMs are expecting their partners to participate in environmentally responsible practices, and rightfully so. Healthcare organisations are increasingly pushing back on OEMs to look at both device and packaging sustainability during development. One example is GPOs, Group Purchasing Organisations for healthcare programmes in the U.S., who increasingly strive to drive purchasing behaviour through responsible sourcing decisions. Medical OEMs bidding for contracts need to show they can meet attributes such as device and packaging recyclability, removal of polystyrene from packaging and potential use of recycled content in primary packaging. Medical device packaging manufacturers are rising to the challenge by increasing the emphasis they place on the sustainability of their products and operations. Packaging manufacturers are looking to reduce packaging size, eliminate unnecessary components, streamline shipments wherever possible, and some are even working with the end-user hospitals to increase education around proper recycling and reuse.

This article illustrates the strategies that packaging manufacturers are using to drive effective sustainability practices, which will continue to grow in importance for the foreseeable future. GREEN DESIGN Involving a packaging partner at the earliest stages of product development can allow for the creation of innovative packaging that is both fit-for-purpose and as sustainable as possible. Designers are coming up with new ways to decrease material and energy use required to manufacture packaging. Packaging manufacturers are decreasing packaging volume by favouring sealed trays instead of pouches. In addition, they are aiming to reduce the number of components required in the overall package. One way to do this is to laser-etch instructions directly on to the tray, potentially eliminating the need for an IFU and increasing compliance. The introduction of tools such as design and package integrity simulation allow packaging providers to make a well-informed prediction at the concept stage about how design choices – such as downgauging materials or reducing the overall footprint – will impact the performance of the package, allowing higher confidence and greater efficiency before moving into the prototyping and manufacturing stages. ENVIRONMENTALLY FRIENDLY MATERIALS & PROCESSES Over the last two to three years there has been an increase in new materials to market with greener credentials looking to address some of the challenges of downstream recovery and recycling. While medical OEMs and pharmaceutical companies are open to change, they still must address regulatory issues around the introduction of any new materials. Validation costs and resources often make switching difficult and increasingly OEMs

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PACKAGING

are turning to their packaging partner to help understand the benefits through production trials and product integrity testing. Packaging audits aid medical device OEMs in evaluating their existing product packaging and can minimise costs and offer more environmentally responsible alternatives in the overall product cycle. While plastic isn’t the most sustainable material, it’s the most efficient one to use when a sterile barrier is needed. When it comes to choosing the right plastic, packaging providers are performing their due diligence to determine the options offering the lowest environmental impact. They test, looking for the ones that have the potential to increase the use of recycled content. EFFICIENT AND COST-SAVING TRANSPORTATION To lower energy and cost, companies can perfect their transportation strategies via simulation tools. Many take advantage of software that helps to optimise planning, maximise load, and minimise costs. Using it allows manufacturers to prevent obstacles by learning the outcomes and solutions ahead of time. Waste minimisation occurs not only through material reduction but also in transport costs, CO2 emissions, and optimising costs when bulk sterilising product by either gamma or EtO. A widespread way companies focus on sustainability is via bulk freight shipments that reduce packaging, impact on the environment, and transport/inventory expenses. Moreover, medical device manufacturers are working with CMOs (contract manufacturing organisations) that provide end-to-end services. Choosing a packaging partner that can perform everything from design and development, to prototyping, to tool building to manufacturing under one roof means components don’t need to be transported between various phases of the process, reducing fuel and greenhouse gases produced during shipping between multiple contractors. In addition to being more environmentally friendly, choosing a single contractor who can do everything streamlines the process and may ultimately help save the OEM time and money. Additionally, selecting a packaging partner that has multiple global locations can benefit the OEM – and the environment – by offering them a regional manufacturing facility to work with, reducing the necessary transport distance.

EDUCATION & RECYLCING PROGRAMMES Education around recovery and reuse is growing. Medical device packaging manufacturers and medical device OEMs are working with hospital groups and recyclers to recover more plastic, diverting it back into the circular economy. Once companies settle on a choice of the most sustainable material, they inform the end-user of how to reuse, and later recycle the packaging accordingly. Hospital recycling programmes can range from comprehensive to almost non-existent. HPRC has partnered with healthcare institutions such as Stanford Healthcare to perform detailed assessments of healthcare plastics use through pilot programs and establish an appropriate recycling process for clinical settings. Through its membership in the HPRC, Nelipak Healthcare Packaging is working with industry partners to create awareness of the need to divert more plastic packaging from landfills. Together, through this initiative they are examining ways of helping hospital staff more readily segregate waste material through education programmes and clearer marking of thermoformed rigid packaging to help remove uncertainty on the material composition of the plastic used in the trays. Research and evaluations are being performed around new materials and packaging innovations which can offer sustainability benefits. For example, Nelipak has been involved in trials around HDPE materials gathered for use in downstream applications. Sterile plastic barriers are often a low-melt HDPE that can be used in extruded products. Post-processing, the material is commonly used in drainage pipe and lawn edging. CONCLUSION Working with healthcare-focused packaging designers and engineers provides medical device companies with the ability to proactively innovate products even at the earliest stages of development. As a result, OEMs can have more efficient and environmentally responsible device packaging that reduces material waste during development and production; lowers packaging ownership costs; provides for optimum volume and efficient logistics in the supply chain; and allows for products that can be used and recycled more effectively in hospital environments.

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MEDTEC JAPAN

East meets West MEDTEC JAPAN IS PART OF A SERIES OF EVENTS TAKING PLACE IN MARCH 2019 FOR THE COUNTRY’S LIFE SCIENCE COMMUNITY, AND ITS ORGANISERS ARE HOPING TO DRAW A SIZEABLE INTERNATIONAL CROWD.

apan’s Life Science Week 2019 will involve a variety of events targeted at fostering innovation and international co-operation in the medical space.

Asia’s largest exhibition and conference dedicated to the Medical Device Design and Manufacturing industry, Medtec Japan 2019 will be held in Tokyo from 18-20 March 2019. Over 560 exhibitors from 25 countries around the world exhibited their latest technologies and services last year in Japan, which is the second largest medical device market in the world after the United States. With a rapidly ageing population and rising demand for increasingly sophisticated treatments, the medical devices industry is one of the few that have seen continuous and steady growth. Over 31,000 visitors attended the previous event from nearly 30 countries, including the United States, Europe, ASEAN countries, China, Korea and many more. Medtec Japan is a highly targeted event, with over 60% of visitors coming from medical device manufacturers. Among them are buyers and R&D staff from numerous companies comprising the top industry players.

Medtec Japan is co-located with five other exhibitions: ELECTROMED JAPAN Exhibitors include experts in the fields of: semiconductors, ICs, sensors, processors, EDAs, laser technologies, batteries, power adapters, cameras, Lenses, monitors, MEMS technology, graphics interfaces, motors, communications & Networking Devices, X-ray, CT, MRI, etc. SMART HEALTH JAPAN Exhibitors include experts in the fields of: wearable devices, apps, software, OS, interface hardware, health entertainment, wireless technology, telecommunication equipment, telecommunication carriers, integration, procurement electronic components and OEM products, etc. TEST KIT JAPAN Exhibitors include experts in the fields of: finished products, manufacturing technology, parts and materials for testing kits such as blood test kits, influenza test kits, allergy test kits, STD test kits, cancer test kits, DNA test kits, etc. CARE/WELFARE ROBOT & DEVICE EXPO Exhibitors include experts in the fields of: finished manufacture and development of care support robots & machines, communication robots, rehabilitation and welfare devices, etc. MEDICAL CITY Exhibitors include experts in the fields of: connected services/ technology, wifi services/technology, telecommunication service/

technology, signal, power saving technology, security systems, security cameras, GPS, cloud service, smart hospital technology, technology for ultra-ageing societies, healthcare management service/facility/technology, smart homes, AI, manpower services, hursing human resource development services, and medical equipment/technology for disasters..

MEDTEC JAPAN IS DIVIDED INTO NINE SPECIFIC AREAS: Plastics technology Metal processing and machine tool Measurement and inspection Robots & mechatronics Packaging/sterilisation/disposables Cad/Cam/RP Consulting Bionics technology area Security

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Five things to see at MD&M West 2019

Ineos Styrolution’s new material grade for medical tubing and multilayer tubing.

Teleflex Medical OEM’s new hydrophilic surface coating for polymerbased devices.

MTD Micro Moulding’s gas chromatography system can assist with material characterisation.

Teleflex Medical OEM’s new technology can divide a suture into multiple end branches.

Carville’s latest diffusion bonded, multi-layer plastic fluidic manifolds technology.

02:2019 Magnetic bacteria may hold clues into medical nanorobots Researchers have long-studied magnetotactic bacteria (MTB): aquatic microbes that have the ability to orientate themselves to magnetic fields. This unusual behaviour makes them a subject of interest for improving our understanding of biomagnetism, and potentially harnessing their abilities for future technologies, such as medical nanorobots. An international collaboration of researchers from University of the Basque Countries, University of Cantabria and the Institute Laue Langevin (ILL), have elucidated the precise structural configuration of the magnetosomes in the MTB strain Magnetospirillum gryphiswaldense. They carried

out small angle neutron scattering (SANS) on a colloid of MTB, a technique that allows them to see the magnetic microstructure of the organisms in detail in aqueous solution. The findings, published in Nanoscale, facilitate a better understanding of how the chain behaviour might affect applications of MTB. They could guide the development of biological nanorobots, which may deliver drugs or perform minor surgery inside the body. Nanorobots would enable minimally-invasive medical procedures to be carried out, relieving patients of much of the trauma caused by current intrusive surgical methods.

HOW VR CAN REDUCE PAIN AND STRESS Experiencing virtual reality (VR) is having positive effects on patients during treatments, according to a recent study by Cedars-Sinai Research. The study found that patients experienced a 24% reduction in pain after only 10 minutes of using VR. Immersive platform provider Blend Media is working with medical professionals to see tools like VR used within the wellness space. Its aim to is to help relax employees working in stressful environments, patients leading up to operations, and students during busy study periods. Other examples include Rescape Innovation, a company using immersive experiences to distract patients whilst they undergo different treatments. Glenn Hapgood, head of innovation and product development at Rescape Innovation, said: “There is a lot of evidence to suggest that VR and 360-degree video can be used to improve the patient experience, reduce stress, anxiety, and pain, but until now the high cost and complex technology has prevented mass adoption.”

Did you know… First patient implanted with eye-pressure sensor during study Developed by ophthalmic medical device company, Implandata, the Eyemate-SC sensor enables glaucoma patients to monitor their own eye pressure and reduces the risks of visual loss or even blindness. The study is assessing the sensor’s efficacy for continual monitoring of intraocular pressure.

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5 THINGS THINGS TO TO CONSIDER 5

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5 THINGS TO

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6 & 7 FEBRUARY 2019, PARIS

www.phillipsmedisize.com PARIS EXPO, PORTE DE VERSAILLES

www.phillipsmedisize.com Visit us at stand A 78

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