www.med-technews.com Issue 40 | Jan/Feb 2019
@medtechonline
PLUS
SENSORS AND ELECTRONICS, AND A SPECIAL ON IMM
MED-TECH INNOVATION | NEWS MED-TECH
innovation
THE YEAR AHEAD WHAT 2019 HAS IN STORE FOR MEDTECH
ADVANCING HEALTHCARE
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Our experts can provide specialist support in: ●
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We encourage innovation in the sector and nurture collaboration between academics, clinicians and industry. With offices based across the UK, members of Medilink UK have access to opportunities and events on both a national and a regional level.
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New product development and market research Selecting and reaching your target market, whether it’s in the UK or abroad Clinical research and NHS procurement Sourcing funding and finance
CONTENTS 6.
MED-TECH INNOVATION | NEWS
Regional news
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Med-Tech Innovation Expo
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Opinion 16
13.
Recruitment
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On the cover
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Sensors and electronics
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Injection moulding
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Digital Health Age
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STARTR THE TEAM group editor | dave gray +44 (0) 1244 680 222 david.g@rapidnews.com
senior sales executive | amy miller +44 (0)1244 680 222 amy.miller@rapidnews.com
head of content | lu rahman lu.rahman@rapidnews.com
head of media sales, plastic & life sciences | lisa montgomery +44 (0)1244 680 222 lisa.montgomery@rapidnews.com
web content editor | ian bolland ian.bolland@rapidnews.com
head of studio & production | sam hamlyn
brand director | colin martin +44 (0) 1293 710 042 colin.martin@rapidnews.com
art | matt clarke publisher | duncan wood
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medtech | digital healthtech | medical plastics manufacturing | software | inspection and metrology regulation | design | early stage innovations pharmaceutical manufacturing
MED-TECH INNOVATION
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2019
MAY
from The editor
[
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018 wasn’t a great year for the image of the medical device sector. Netflix’s ‘The Bleeding Edge’ put the sector right in the spotlight, and for all the wrong reasons.
put at risk by medical devices, every stakeholder in the supply chain must be held accountable.
Take the pharma sector, for example. Yes, I realise horrible things do happen Then in November, a group in pharma. It is an industry of 58 media organisations where price gauging, rallied together to hold the addiction, and ethically questionable sales tactics industry to accountability exist, and it needs to stop. over the international But, as a consequence of rules and regulations for the (by the way, excellent) implants. investigative reporting that has been carried out in The Bleeding Edge took recent years, Big Pharma as its focus the FDA’s approvals system, pointing is facing a lack of public trust which it will probably out what the filmmakers deemed to be loopholes in never recover from. That doesn’t mean it’s curtains the approvals process. for the sector, obviously the bottom isn’t about to November’s Implant Files drop out of the market. story also honed in on But it is a tragedy that the what journalists felt were hundreds of thousands of inherent failings in the researchers, technicians regulatory system. and engineers in pharmaceuticals have had But it’s important to the outward image of their distinguish between the medical device community life-saving work tarnished by greed and the resultant and the regulatory bad press. community here. Not that medtech manufacturers I probably worry too are absolved of ensuring much about the media’s the safety of their devices representation of the – quite the contrary. But medtech industry. But outwardly, this negative these two major stories press puts the industry’s in 2018 set alarm bells reputation under serious threat. It is right that where ringing. That’s why, as a voice for the sector, lives and livelihoods are
it’s important that this magazine works hard to champion many success stories, whilst not choosing to ignore harsh realities, either. For example, the BBC did run coverage of the STIMO (STimulation Movement Overground) study, the results of which emerged from the Swiss Federal Institute of Technology, Lausanne in November. Three men regained their ability to walk without the use of crutches thanks to an electrical stimulation device inserted around the spine helps boost signals from their brain to their legs, and helps damaged nerves in the spinal cord to regrow. What’s more, the team behind the project are now launching a spin-out to scale the technology up. It’s the nature of scandals that they will make more of an impression with the public than stories like the STIMO one. But, for our part, in 2019 we’ll continue working to get your innovations in the headlines – and not just within the medtech echo chamber, but in the wider world as well.
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NEWS AND VIEWS FROM HEALTH ENTERPRISE EAST
NOTES FROM THE EAST IM FISHLOCK, HEAD OF TECHNOLOGY TRANSFER AT HEALTH ENTERPRISE EAST, AND RHANDA TAJDEEN, INNOVATION MANAGER AT HEALTH ENTERPRISE EAST OPEN THIS NEW REGULAR COLUMN FOR 2019.
INNOVATION IN HEALTHCARE Innovative new products transform industries and improve lives every day. The pace of change has accelerated due to massive technological breakthroughs such as smartphones and 3D printing. However, when it comes to innovation, not all industries are created equal.
The healthcare sector is highly complex, and the medical care delivery ecosystem is under increasing pressures due to rising costs and patient expectations. These pressures and the inherent nature of the industry itself make innovation in healthcare more complicated than in most other sectors. To break through the complexity and move innovation in healthcare forward, inventors must first overcome the many barriers to healthcare product development, including how to improve upon the current standard of medical care whilst simultaneously lowering costs. ADOPTING AN ECONOMIC MINDSET Global healthcare systems are shifting towards affordable technologies and models due to the unsustainable growth in healthcare expenditure. In response to this shift, device manufacturers will need to pay greater attention to the ramification of their innovations on the overall cost of care and focus on becoming strategic partners of health systems rather than suppliers. Frugal innovations stand to benefit the healthcare sector
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the most by allowing greater exposure of technologies to a wider patient population. These innovations have the potential to increase value and provision of healthcare and can take the form of simple products with low unit costs (a strategy that many manufacturers are now pursuing with research centres in Asia), but can also include sophisticated products with high unit prices if they can lower the overall cost of care. Such innovations have traditionally been associated with low- and middle-income countries or emerging markets, but are increasingly being used globally as they can eventually become “good enough” to displace established and costly technologies that are in use in the developed world, a process called reverse innovation.
DEMONSTRATING TRUE VALUE-FOR-MONEY When developing a product, it is important to understand the real conditions under which the customer lives and uses the product. Considering the UK as a target market, the NHS would typically be a key customer. NHS Trusts are financially constrained by tariffs on one hand and policies towards introductions of new technologies and patient demands on the other. Consequently, the definition of value-formoney has broadened from clinical efficacy and operator convenience to the effect on real-world clinical and patient-centric outcomes and the overall cost of care per
episode. As a result, day-today purchasing decisions remain driven by costs.
In addition to product prices, implementation of new technologies can be costly to the NHS. Many may require changes to the workforce – professionals learning to work in new ways - or may lead to new workflows requiring clinician buy-in, effective leadership and adaptability. Therefore, to demonstrate value-for-money, innovation should be constructed based on not only affordability but also adaptability and accessibility. It can be difficult to generate data on how innovation affects not only direct treatment but also the downstream healthcare supply chain. The more complex the technology, the more difficult it can be to understand the downstream effects, and consequently the more challenging it can be to determine the true value of the innovation. For early stage technologies a good start point would be to engage a health economist to provide a quantitative evaluation. For example, a cost-effectiveness analysis provides a means of assessing both the costs and health benefits (measured using a nonmonetary indicator) of a new technology, providing a foundation upon which to build an investment proposition. In the complex world of healthcare, rigorous economic thinking can be the difference between a great new device that languishes unused in a laboratory or desk drawer, and one that instead successfully transforms the lives of patients.
THE LATEST ANNOUNCEMENTS FROM THE MEDILINK UK COMMUNITY.
LINKING UP
MERCIA INVESTS £13.3M IN MIDLANDS FIRMS IN 2018 Warwickshire-headquartered Mercia Technologies (a Medilink west midlands member) invested £13.3m in Midlands businesses in 2018. The total is up from £11.3m the previous year after the listed company invested in 22 businesses in the region. That included Sigmavision of Bicester which has created a tyre scanner, Coventry-based Arc Vehicle which developed a new electric motorbike, battery technology firm Aceleron in Birmingham and Adapttech which has found a new way to fit artificial limbs. During the year, the group invested £59.7m in total throughout the UK, with more than 90 per cent of it going to businesses outside of London and the South East. It also increased its third party funds under management from £350m to more than £400m at 31 December.
BARKER BRETTELL GOES FROM STRENGTH TO STRENGTH Despite Brexit having adverse incremental effects in the medical industry in areas such as imports and exports, Barker Brettell, a Midlands-based IP specialist, says it has seen vast growth in revenue and profit in the last two years. Working in sectors such as aerospace, automotive, medical and cosmetics, the company has ambition for growth. Aside from its extremely positive P&L accounts, Barker Brettell says it is looking to expand further, increasing its core team and working on new projects to “really stamp its footprint in the industry”. MOLECULE DISCOVERY HOLDS PROMISE FOR PSORIASIS A breakthrough has been made at the University of Birmingham relating to the chronic disease that affects 2% of the British public. The protein JARID 2, which until recently was only known to be present in an embryo, has been discovered in adults in a different form. The discovered protein (now labelled N-JARID 2) controls skin cell development in adults, withholding rapid production which is the cause of psoriasis. As a result, and with the backing of University of Birmingham Enterprise, further study is taking place in the hope of finding a longterm fix. This could be a quantum leap in the search for a cure for this persistent disease, and a welcome step forward especially for those affected by it.
FUNDING AVAILABLE FOR EAST MIDLANDS MEDTECH FIRMS Life science companies in Derbyshire and Nottinghamshire can become ‘inspired’ with their business operations, thanks to a project delivered by Medilink East Midlands and part-funded by the European Regional Development Fund (ERDF). Inspiring Networking to Stimulate Technology Innovation in Life Sciences (INSTILS) is a £7.39million scheme, part-funded by ERDF, to provide support for companies in the Derby-shire and Nottinghamshire area. Help is available for small and medium enterprises (SMEs) who work, or want to work, in life sciences. Companies can apply for funding and support to develop products and services, attend specialist events and conferences and undertake medical technology trials. Medilink East Midlands – the industry support organisation for the East Midlands which sup-ports new and existing life science businesses - is delivering the INSTILS project and helps companies to access support and advice, working in partnership with the East Midlands Aca-demic Health Science Network, The University of Nottingham and Nottingham University Hospitals NHS Trust.
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This exclusive preview provides a look at the conferences
MTI EXPO
ed-Tech Innovation Expo will deliver a jampacked conference and seminar programme for 4,000+ visitors at the Birmingham NEC in May. With the introduction of a third conference stage for the 2019 show, the organisers of the UK & Ireland’s leading medical device design and manufacturing technology event are offering even more learning opportunities for their visitors. Med-Tech Innovation Expo is a platform for new products, services and even company launches. As the event grows year on year, so too does the number of new products and ideas on the show floor. Providing a platform for these developments, the annual exhibition will now include a brand-new conference stage; MedTech Introducing. On the Med-Tech Introducing stage, exhibitors and their partners will deliver quick-fire presentations introducing the latest news, innovations, applications, materials and more. Speakers
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already confirmed include MD-TEC, Boddingtons Plastics, Bemis Healthcare Packaging and Datalink Electronics. Returning after a smash-hit introduction at last year’s expo, the HealthTech Stage speaker programme is filling up fast. Attendees are advised to get to their chosen presentations early to avoid disappointment. It was a standing room only in 2018 and with the likes of Innovate UK, ABHI and the NIHR Office for Clinical Research Infrastructure presenting, you can expect the same to be true in May. As in previous years, the Med-Tech Innovation Conference (produced in association with Medilink UK), will provide insight and intelligence from a wide range of blue-chip users, government officials and industry experts. With presentations from Boston Scientific, MHRA, NHS England and more, the conference will continue to set the agenda for debate in the medical technology
sector for the coming year. Dave Gray, Group Editor at Med-Tech Innovation News said: “There is a lot to be gained from attending any one of the three conference stages. You’ll find worldleading innovators, medical practitioners, scientists, engineers and manufacturers offering insights on everything from implantable devices, the impact of Brexit on the medtech industry and digital start-ups to women in medical plastics, the recycling of medical devices and efficient design for patients and organisations. “Our approach to curating conference content in 2019 has been to source speakers who will be able to provoke new conversations. Innovation and collaboration can only happen when the right people are in the room. With this year’s lineup, we think we have those people, as well the stimulus to help get some new ideas into conception. We’ve also tried to offer something for every type of stakeholder. Between
taking place at the Med-Tech Innovation Expo 2019
the three stages, there is content aimed at engineers, startups, clinicians, corporate leaders, regulators and much more besides.” Med-Tech Innovation Expo will be held 15 - 16 May 2019 in Hall 2 at the NEC, Birmingham (UK). Visit www.medtechexpo.com to find out more about the event, conference programme and 200+ exhibitors, and to register for your free visitor badge.
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OPINION
In 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, high-volume 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.
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MIRANDA CONARY, PRODUCT SPECIALIST AT WEB INDUSTRIES, DISCUSSES HOW DEVICE MAKERS AND CONTRACT MANUFACTURERS COLLABORATE FOR SUCCESS IN THE DEVELOPMENT OF MEDICAL DIAGNOSTIC DEVICES.
• 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-meter 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 pointby-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 commercial-scale 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.
INDUSTRY 4.0
Digital manufacturing ‘top priority’ for life sciences 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.
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he 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. Nearly 60% of those surveyed believe that Industry 4.0 will drive the most change in life science over the next 5 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.”
Medical moulding gets in sync Sumitomo Demag has developed a new programme that synchronises the ejector and mould speed, shortening the mould open time to optimise productivity, reduce avoidable plastic waste and improve the quality of parts used in medical devices.
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esigned for the company’s newest IntElect series, which has a mould open time of 0.9 seconds, this latest advancement ensures that components are clear of the mould before it closes again. As well as preventing falling parts being crushed, it helps to mitigate damage to expensive medical device mould tools. The movement between mould open and ejector forward has a big impact on the ejection of the parts. This synchronised programme, installed on the NC5 Plus control panel, enables machine operators to select the ideal setting for the ejection of moulded
components to ensure they have cleared the mould space before the moulding cycle starts again. Nigel Flowers, managing director of Sumitomo Demag UK explained: “All-electric moulding cycle times are getting faster and faster. This is great for productivity, especially for moulders that mass produce medical device parts. In an ideal world the parts are ejected with zero inertia and drop in a central line out of the mould space. However, when the toggle clamp operates faster than the ejector mechanism, there’s less control over how and where the moulded components will fall.”
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HE SPOKE TO MTI RECENTLY TO GIVE AN UPDATE ON THE MEDTECH SKILLS ACADEMY, WHICH LAUNCHED EARLY IN 2018, AND DISCUSS PLANS FOR THE FUTURE.
BACK TO SCHOOL
PROFESSOR IAN ROBERTSON IS ACADEMIC LEAD FOR THE NATIONAL MEDICAL TECHNOLOGIES SKILLS ACADEMY AT THE UNIVERSITY OF LEEDS’ SCHOOL OF ELECTRONIC AND ELECTRICAL ENGINEERING.
The Academy is implementing the first phase of its vision for which it is involving education providers and industry working together to deliver the next generation of skilled medtech engineers. Learners, who may be students, recent graduates or those returning to education, that are employed in medtech businesses will acquire a broad-based technical and managerial education, and combine this with the development of practical and work-based professional skills.
he Leeds City Region is recognised nationally and internationally as a centre of excellence for medtech. It is home to over 250 businesses specialising in medical technologies and a further 200 digital and technology businesses operating in the health and social care space. The success of the industry creates an increasing demand for specialist technical skills, while the dominance of small businesses means that companies often struggle to provide the necessary training and skills development. The purpose of the National MedTech Skills Academy is to develop a workforce with skills in the research, design and manufacture of advanced medical devices, which are underpinned by convergent technologies and digitally enhanced products and services. The aim is to work with industry, education partners and clinicians to establish a talent pipeline that will train, develop and supply the next generation of the medtech workforce at all levels.
Robertson explained: “We are developing a multidisciplinary approach to address the breadth of challenges and training needs in the medical technologies industry sector. For example, in the first tranche of work we will be providing new online and blended learning opportunities for engineering students, industry and health professionals working in conjunction with the awardwinning Digital Education Service at Leeds.
RECRUITMENT AND SKILLS
and Bradford College, builds on a number of key existing strengths including the Leeds Academic Health Partnership and the Translate: Medical Technologies & Grow MedTech innovation initiatives. “We are interested in building our network of industry and academic partners and welcome all those who have an interest in shaping and informing the work of the Academy as is it progresses. We are particularly interested in connecting with industry partners to shape the programme and provide a sustainable route to ensuring the work we do meets the standards & needs of the MedTech sector.”
“Our primary focal points are; increasing the opportunities for placements for students; a curriculum driven by researchers, industry and clinicians; digital healthcare, regenerative medicine, advanced manufacture, robotics and AI; understanding the regulatory environment; and enhanced professional development opportunities”, he continued. The team is based in the Faculty of Engineering at the University of Leeds and has been established with Catalyst Fund support from the Office for Students. The consortium, including Leeds Beckett University
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cover story
THE YEAR AHEAD 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 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
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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 minimallyinvasive 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
COVER STORY
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. 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 simplify operation. 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 female-led 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. 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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PACKAGING
S
eán Egan, Director of Global Marketing & VoC Development, Nelipak Healthcare Packaging looks at the latest sustainability trends in medical packaging. There is an estimated one million tons of clean, non-infectious healthcare plastic generated in healthcare facilities each year, accordingly 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 health care programs in the U.S., who
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increasingly strive to drive purchasing behavior 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 whenever 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-forpurpose 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 favoring 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 laseretch 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 wellinformed 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 plastic isn’t the most sustainable material, it’s the most efficient one to use when a sterile barrier is needed.
GREEN 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 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 PROGRAMS
Education around recovery and reuse is growing. Medical device packaging manufacturers and medical device OEMs are working with hospitable 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.
PACKAGING
landfills. Together, through this initiative they are examining ways of helping hospital staff more readily segregate waste material through education programs 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.
Hospital recycling programs can range from comprehensive to almost nonexistent. 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
Copyright Nelipak Healthcare Packaging 2019.
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regulation
anufacturers need to set a clear roadmap to compliant clinical evaluation reports, says David Egbosimba, solutions delivery manager, Maetrics Clinical 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 timeconsuming 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
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The Clinical Evaluation Process In brief, the steps of the clinical evaluation process are as follows: Define the CER Scope and Objectives Feed output into risk management and PMS activities and future CER updates
Develop a Clinical Evaluation Plan to ensure a robust approach
Identify and justify sources of data (including selection of equivalent devices)
Identify and appraise available clinical data (Clinical Investigation, clinical literature, clinical use-internal and external) Evaluate data and reach conclusions on suitability of the data to meet CER objectives Generate clinical data (PMCF) needed to address residual risks
Generate clinical data (Clinical Investigation) to demonstrate conformity with the ERs
regulation
NEW MEDDEV 2.7/1 REV.4
1. Defines CER approach 2. Represents state of the art 3. No transition period
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.
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-
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.
NEW MDR 2017/745
1. Expands on MEDDEV 2. Harder to demonstrate equivalence 3. Pushes for own clinical data
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 time-sensitive 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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EXCEPTIONALLY FAST RESPONSE ACCURATE TEMPERATURE SENSING Fast. Accurate. These are just some of the key features that as engineers you will look for in sourcing thermal components for your medical devices. ATC Semitec offer a wide range of thermal components ideal for sensing temperature – whether non-contact, surface or intravenously. Our thermistors are already used in thermometers, catheters and wearable technology, and many emerging healthcare products. Coupled with innovative suppliers and our extensive technical knowledge, we will work with you to provide the optimal solution for your products.
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Innovation in Miniature
WANTED:
SIMPLE STICKERS MAY IMPROVE THE LIVES OF HEART PATIENTS, ATHLETES AND LOWER MEDICAL COSTS.
SENSORS AND ELECTRONICS
partners to collaborate on wearable sensors
esearchers from Purdue University in the US have developed a stickerbased sensor technology which they believe could hold serious potential for the medtech sector. The research was recently published in ACS Advanced Materials and Interfaces. The researchers say they are looking for partners to test and commercialise their technology.
anniversary. This is one of the four themes of the yearlong celebration’s Ideas Festival, designed to showcase Purdue as an intellectual center solving real-world issues.
“For the first time, we have created wearable electronic devices that someone can easily attach to their skin and are made out of paper to lower the cost of personalized medicine,” said Ramses Martinez, a Purdue assistant professor of industrial engineering and biomedical engineering, who led the research team.
The “smart stickers” are made of cellulose, which is both biocompatible and breathable. They can be used to monitor physical activity and alert a wearer about possible health risks in real time. Health professionals could use the Purdue stickers as implantable sensors to monitor the sleep of patients because they conform to internal organs without causing any adverse reactions. Athletes could also use the technology to monitor their health while exercising and swimming.
Their technology aligns with Purdue’s Giant Leaps celebration, acknowledging the university’s global advancements made in health as part of Purdue’s 150th
These stickers are patterned in serpentine shapes to make the devices as thin and stretchable as skin, making them imperceptible for the wearer.
Since paper degrades fast when it gets wet and human skin is prone to be covered in sweat, these stickers were coated with molecules that repel water, oil, dust and bacteria. Each sticker costs about a nickel to produce and can be made using printing and manufacturing technologies similar to those used to print books at high speed. “The low cost of these wearable devices and their compatibility with large-scale manufacturing techniques will enable the quick adoption of these new fully disposable, wearable sensors in a variety of health care applications requiring single-use diagnostic systems,” Martinez said. The technology is patented through the Purdue Office of Technology Commercialization. The researchers say they are looking for partners to test and commercialise their technology.
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ANALYSIS
inNOVATION IN healthcare:
R
ory Bibb, PR and marketing exec at specialist healthtech PR firm Silver Buck writes.
For those of you who don’t know – and as an unwelcome reminder for those of you who do – the National Programme for IT (NPfIT) was a top-down, centrally managed NHS digitisation programme, introduced as the solution for bringing the NHS’ information technology into the 21st century. And yet, 16 years since its inception – and with an £11.4 billionpound hole smouldering in our pockets – we’re still talking about the very problems the NPfIT set out to resolve. By now, most of us harbour a practical and/or comprehensive understanding of why NPfIT is deemed to have failed – poor clinical engagement, lack of innovation and a top-down, onesize-fits-all approach – and it is with this knowledge and experience that we should expect to build real and lasting changes to IT in healthcare today. But have we really learned from our mistakes? In answer to that question, we might look no further than Matt Hancock’s recently assembled Healthtech Advisory Board (HAB) – amongst which, practising clinicians are the most notable absentees. And it is because their absence that, for some, the appointment of the HAB regretfully serves as yet another example of our healthcare system failing to connect high-level strategy with ground-level action. Indeed, this is not an isolated instance of disconnect existing between the “centre” and the
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frontline in contemporary healthcare strategy. Such is the significance and scale of the problem that, before the HAB had been assembled, the Silver Buccaneers – the advisory board for the PR and marketing company, Silver Buck – had been discussing it within the context of driving innovation. “I think it’s almost oxymoronic: the idea that very large, highly centralised institutions and bureaucracies – no matter how good the people within them – can deliver innovation. The best they can do is remove some of the barriers for those that are closer and at the right scale to actually make stuff happen,” explained Jon Hoeksma, the CEO and founder of Digital Health. Hoeksma is not alone in his criticisms of a top-down management culture within the NHS, with it often cited as the Achilles heel of innovation in UK healthcare. However, there is a strong counter-argument to the notion that all national organisations are restricting innovation by trying to deliver it themselves: “Our job nationally is more about trying to make sure that we’re not a barrier to brilliant local innovation, rather than taking responsibility for making sure there is top-down driven innovation,” said Matt Neligan, the Director of Data Transformation at NHS Digital. Nevertheless, and while some national organisations might well have begun to understand and recognise how best to foster and drive innovation in healthcare, the Buccaneers agree that the “centre” can do more to maximise UK innovation by permitting and furthermore encouraging more ground-up solutions. “We need to enable people on the ground to move away from command and control models of leadership,” explained Yvonne Goff, the Chief Clinical Information Officer of the Health Service Executive. “We need to give them the bandwidth to be able to self-govern and self-organise. I believe that the best way to make a success of a team, is by giving them what they need, getting out of their way and letting them deliver; innovation is about engaging and empowering people who actually deliver healthcare.”
Of course, this isn’t a new idea – when empowered with the licence and ability to adopt their own healthcare solutions, local organisations can and are championing innovation – the Leeds Teaching Hospitals NHS Trust, for example, allows its clinical team to work closely with companies to deliver and refine new, innovative healthcare solutions. “I think there’s nothing better than allowing our clinical team a little bit of space to work in innovative ways with companies,” explained Richard Corbridge, the Chief Digital Information Officer for Leeds Teaching Hospitals NHS Trust. “We’ve had instances where, rather than paying a supplier, we’ve given them a member of our IT staff and an A&E clinician for one day a week. This has completely revitalised them and allowed them to deliver something that I genuinely believe will be huge for how they do stuff. Because they have real clinical experience of front-line, they are able to test things out as part of each of their delivery phase.” In fact, there’s a strong and growing number of professionals – operational, clinical and technical – rebuffing the more traditional approach to healthcare innovation and saying “no, we want to do more than just take a product off the shelf.” “From my experience, a lot of people actually want to go through that process of understanding that journey of the initial idea, right through to development,” explained Dom Cushnan, the Digital Programmes Manager at NHS Horizons. These signs are encouraging, but they need to be sustained and furthermore encouraged by the “centre” – which can and invariably should do more to maximise UK innovation. Indeed, it’s time to move away from a system whereby centralised institutions and bureaucracies make decisions on behalf of healthcare professionals, to one that takes more seriously their individual needs and requirements.
ANALYSIS
have we learned from our mistakes?
I think there’s nothing better than allowing our clinical team a little bit of space to work in innovative ways with companies
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COATINGS AND LUBRICANTS
FINISHING
W
TOUCHES
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.
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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. 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. 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 hand-held 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.
COATINGS AND LUBRICANTS
Jay Tourigny, senior vice president of MicroCare Medical explores how the trend
towards miniaturiSation is affecting coating and finishing decisions.
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. 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 percent, 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 sterilizing 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 miniaturization, 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.
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INNOVATIVE MATERIALS
C
ovestro, formerly Bayer MaterialScience, is back with materials for new and exciting medical applications. At this year’s MD&M West in Anaheim for example, the group showcased Embr Wave, manufactured by Embr Labs, a bracelet-type wearable that is designed to act as a personal thermostat. It has been developed to stimulate a person’s thermoreceptors to use the body’s natural systems to make the wearer feel cooler or warmer by five degrees within a few minutes. Embr Labs developed the product through prototyping and customer testing. When it came time for the production design, the company wanted to use a frosted light pipe with LEDs as the primary user interface. Sam Shames, co-founder of Embr Labs said: “We turned to Covestro to help select the right material and optimise the design for optical performance.” Based on the requirements, Embr Labs chose Makrolon 2407 polycarbonate. For the Embr Wave, diffusers and optical brighteners were compounded into the resin to achieve the desired visual effect.
IT IS WHAT YOU MAKE IT Joel Matsco, senior marketing manager, polycarbonates – electronics and appliance, Covestro, said: “Instead of using text or symbols, colour and light are simple, minimalist — yet effective — means to convey information to the user. Covestro has deep expertise in helping brands and electronics manufacturers design with light.” In addition, the group recently provided materials for the TransMedics Organ Care System, a system that allows an organ to function outside of the body and enables organ optimisation and assessment. The TransMedics device aims to improve the way organs are preserved during transportation with the system delivering warm, nutrient-rich blood to the organ.
John Sullivan, vice president of engineering, TransMedics said: “Makrolon polycarbonates offer the combination of transparency and toughness needed for this medical device.” Makrolon polycarbonates for medical applications has several attributes for the OCS platform. Lauren Zetts, Americas market manager, healthcare – polycarbonates, Covestro, said: “Safely transporting organs can literally mean the difference between life and death. It’s very gratifying that our materials play a role in helping TransMedics fulfil its mission to deliver healthy transplants in a timely manner.”
TransMedics has three OCS products – OCS Heart, OCS Lung and OCS Liver, each of which has three primary components: a portable console with a wireless monitor, a disposable perfusion set and nutrient-enriched solutions. The perfusion set’s clear enclosure protects the organ using Makrolon 2458 and Makrolon Rx1452 polycarbonates from Covestro, while the attached connectors utilise Makrolon Rx1805 polycarbonate.
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FEMTECH
K 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. Pelviva 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 ten seconds, to stimulate the pelvic floor muscles. Each thirtyminute treatment using the Pelviva innovative stimulation programme delivers up to 25% greater penetration of the deep pelvic muscle than
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Materials that can satisfy the stringent biocompatibility requirements are difficult to process in discreet mouldings of the size required
FEMTECH
How to make an award-winning femtech device conventional stimulation, according to the company.
patients who drive our strategy.
In a twelve-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.
“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.
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 UI seek professional help. 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 indepth, 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
“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. 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 3-year period, after the initial 5 year R&D development phase.” Herbert agrees that without 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 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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INJECTION MOULDING
T
rend Technologies Ireland, a contract moulder of devices for the medical and life sciences sectors, recently opened its third ISO Class 7 cleanroom at its extensive 7,000 square meter manufacturing facility in Mullingar, Ireland. Trend’s capital investment in the facility and additional cleanroom space and equipment, including a number of Sumitomo Demag 50-tonne IntElect machines, has enabled the company to boost process stability and achieve shorter production runs. Trend’s site in Ireland is the company’s ‘Centre of Excellence’ for injection moulding, and provides tooling, project management, Moldflow and Scientific Injection Moulding support to Trend Technologies sites globally. “The Irish and UK medical device sector is in a sustained growth phase,” noted Trend’s manufacturing manager, Tom Kelly. “We are in the process of building another cleanroom, which when complete in the summer will expand our
cleanroom manufacturing capacity by an additional 400 square meters. This is in response to the positive outlook for the sector and the increasing demand for high quality medical device components.” Items moulded on site by Trend form part of Class I, IIA, IIB and III medical devices and include wound care products, diagnostic laboratory consumables, ventilator housings, surgical handles and stent delivery subcomponents. Most of these are highly customised, so when making the investment in new cleanroom machinery Trend focused on sourcing equipment that would automate process stability and increase product integrity. Although this isn’t Trend’s first foray into all-electric machines - it installed its first over a decade ago - senior processing engineer Trevor Thornton reported that the Sumitomo Demag IntElect’s are proving to be particularly flexible and reliable. The manufacturing site also has 32 Demag hydraulic machines.
lot of bother when dealing with such small shot weights. It means we don’t have to run any decompression, which can draw air into the melt. This ultimately reduces rejects.” Since installation, Trevor said activeLock has reduced defects in the process significantly.
Putting into context how they see the cleanroom injection moulding contract market evolving, Tom comments: “With the continuing implementation of Lean Manufacturing and continuous improvement, there’s been a definite shift towards shorter runs. As a result we are “We knew that all-electric accommodating more moulds machines are more energy and faster changeovers. efficient and better for repeatability,” says Trevor. “Yet, This is only made possible given that we can mould larger by complete equipment standardisation and the products that weigh from connectivity of the machines one kilo right down to 0.025 grams, geometrical tolerances and associated ancillary equipment. This is an evolving can be extremely tight.” and improving process that can only be made possible To accomplish the by working with aligned combination of precision and suppliers.” repeatability, Trend makes full use of the activeLock Industry 4:0 is certainly technology installed on firmly on Trend’s radar and each IntElect. “We use it on the company has been every product moulded and approached by Sumitomo activeLock saves us an awful
(SHI) Demag’s UK Managing Director, Nigel Flowers to participate in a predictive maintenance trial. “From a production perspective, we are fairly Industry 4:0 advanced and use real-time data to work smarter, reducing programming complexity and production lead times,” said Tom. Already, the technology is improving the company’s 24hour breakdown response time by 80%, as well as increasing first time fix rates to over 90%.
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DIGITAL HEALTH AGE
INCORPORATING D
USHERING IN A NEW ERA Today, 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.
hrissy Bell, global business leader, 3M Drug Delivery Systems, looks at what the digital revolution is doing for design and commercialisation in drug delivery.
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.
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SOLVING PROBLEMS 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.
By building technology into drug delivery devices, we can help address those problems. For example, the 3M Intelligent Control Inhaler, which is currently in development and not available for commercial sale, is breath-actuated 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. 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
DIGITAL HEALTH AGE
G DIGITAL TECH IS ERA IN DRUG DELIVERY 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. 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 actionoriented 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 front-end, 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 day-to-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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STARTR Our guide to the latest young up-starts in medtech
AI COLOUR COMBAT
A Cambridge University spin-out which develops AI-driven intra-operative imaging technologies. The company is developing a device that allows a colour-coded image to be superimposed onto the surgeon’s safety or prescription glasses as an assistive technology to facilitate operations and provide precise, objective tumour margin detection during surgery. This is in order to combat local reoccurrence of cancer that can take place following cancer surgery.
TAKE THE PAIN AWAY
An over the glove tissue retraction device that is designed to minimise trauma in the surrounding during surgical dissections – given surgeons an area to operate on rather than relying on surgical assistants. The device has been developed by a team at Cambridge University Hospitals NHS Foundation Trust led by Amit Agrawal with the team now working on a design concept and to develop a prototype for testing.
BACKING FOR SCREENING
Lancor has developed a new AI-based device that is able to detect cervical cancer at 90% accuracy and can further screen for other types of cancers. The startup recently received backing from the Austrian government to develop its Tumour Trace OMIS device, which detects the change of electromagnetism within tissue on quantum levels.
LET IT FLOW
Flow has developed a new concept to treat depression combining neuroscience and AI. Featuring a brain stimulation headset and an app, the user receives medicationfree treatment with the headset providing electrical pulses, and the app acting as a virtual therapist which provides guidance surrounding lifestyle changes including improved sleep, meditation, healthier eating and effective exercise.
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