MTI Issue 33 by Med-Tech Innovation Magazine

Issue 33 | Sep/Oct 2017

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PLUS The Irish market UDI - whatâ&#x20AC;&#x2122;s your strategy?

MED-TECH INNOVATION | NEWS MED-TECH

innovation

Navigating through the dark Compliance Navigator lights up the way to medical device compliance - page 16

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CONTENTS MED-TECH INNOVATION | NEWS

6-7.

Headlines

8-15. Opinions

16.

Navigating compliance

22.

3D printing for wearables

24.

UDI – what’s your strategy?

27-38.

A guide to Ireland

40.

STARTR

THE TEAM editor | dave gray +44 (0) 1244 680 222 david.g@rapidnews.com

sales director | colin martin +44 (0) 1293 710 042 colin.martin@rapidnews.com

reporter | reece armstrong reece.armstrong@rapidnews.com

commercial & operations manager | scott masheder +44 (0) 1244 680 222 scott.masheder@rapidnews.com

group editor | lu rahman lu.rahman@rapidnews.com

art | sam hamlyn publisher | duncan wood

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The Publisher endeavours to collect and include complete and current information in Med-Tech Innovation, but does not warrant that any or all such information is complete, correct or current. The Publisher does not assume and hereby disclaims any liability to any person or entity for any loss or damage caused by errors or omissions of any kind, whether resulting from negligence accident or any other cause. Med-Tech Innovation does not verify any claims or other information appearing in the advertisements contained in the publication and cannot take any responsibility

for any losses or other damages incurred by readers in reliance on such content. All submissions are handled with care. Every precaution is taken to ensure accuracy, but the Publisher cannot accept responsibility for the accuracy of the information herei ©Rapid Medtech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher. ISSN 2046-5424

from The editor

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A Kodak moment

n January 2012, photography giant Kodak – once the unrivalled leader in that sector – filed for bankruptcy. What went wrong with Kodak was that its executives failed to acknowledge that a day could come where the art of traditional print photography would be all-but superfluous. Ironically, it is a Kodak engineer that is often credited with the invention of digital photography. That was in the 1970s. In the years that followed, Kodak did patent some digital stuff, but the truth is, it didn’t want to cannibalise its own business. Today, Kodak’s story has become the stuff of legend for those who advocate an evolutionary approach to product development. It is one of the best-known examples of a company that had it all, but dug its heels in as the rest of the photography market inched closer and closer to an alldigital model. I’m writing this just a day after NHS Expo closed its doors in Manchester for

another year. Wearing my other hat as one of the founders of the website Digital Health Age, I would normally attend the NHS Expo – a sellers event for innovators looking to gain access to the NHS. This year however, I couldn’t make it. My colleague Lu (you will know her as the editor of our sister title Medical Plastics News) did attend however, and sent me a text within the first hour. It read simply: it’s ALL digital. Why is this significant? Because when we first attended that show, back in 2015, it wasn’t ALL digital. The shift in the exhibitor profile is very telling – it’s now or never for the NHS to digitise. The NHS is teetering on the edge of its own ‘Kodak moment’ as we speak. Commentators agree the adoption of new technology has, historically, been slow at best. That means the NHS must do it all it can to simplify the process, to foster innovation and thereby avoid disaster. Kodak had a different

motivation for being tentative with digital. It was all about the profit margin. The NHS, of course, has the far more important task of saving lives. In that sense, it is right for an organisation with such a high mandate to act in a risk-averse way. Having said that, one recent statistic finds the continued use of out-dated pagers across the NHS is costing the service about £6 million every year. The solution is not as simple as just issuing iPhones however. Pagers have one distinct advantage – they don’t require a wifi or data connection. The good news is that the architecture of NHS IT is set to change at pace. Jeremy Hunt announced during the expo that every patient in England will have online access to their records via an official NHS app by the end of next year. Coincidentally, the NHS will also be 70 years old in 2018 – a fitting milestone, and a good opportunity to prove that it can adapt and adopt. Dave Gray, editor

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TEN THINGS

PATIENT ACCESS TO MEDICAL TECHNOLOGY FARES WORSE IN THE SOUTH

about... EU MDR

Here’s ten things you really need to know about the new European Medical Device Regulation:

1. TRANSITION PERIODS You have three years to make the transition if you’re working in medical devices. Well, actually, a bit less – the transition period began on May 25th 2017. If you work in in vitro diagnostic devices, it’s five years. 2. EARLY ADOPTION Paul Brooks from the Regulatory Affairs Professionals Society (RAPS) says that early adopters will retain a competitive advantage, as the market may be sensitive to new products which don’t comply. 3. RE-CLASSIFICATION Some devices will end up being reclassified under the new regulations. This could put them into a higher risk category.

5. IT’S AN OPPORTUNITY Brooks argues that manufacturers can use the introduction of the MDR as an opportunity to remove poor performers from the market. Before doing so, he says, they must consider whether they have more modern versions or better performing products that can comply. 6. THE LANGUAGE WILL BE CRUCIAL Quality specialist firm InfinityQS issued a statement arguing that “the real challenge for an industry as large as this one, across member states and the UK, is developing a universal language that can be used for internal traceability right along the supply chain. This encompasses everything from vendors, right through to the hospitals where the end product is used.” 7. IT COULD IMPACT CUSTOMERS Brooks admits that failure to comply could ultimately result in healthcare systems and patients being unable to access some devices. Obviously, if suitable alternatives are not sourced, this will impact patients. Brooks says this is the worst-case scenario. 8. THE DEFINITIONS ARE SHIFTING What is a medical device, and what isn’t? Well, according to the MHRA, EU MDR means that some products, including dermal fillers, non-corrective contact lenses and brain stimulation devices will now be regulated in the same way as medical devices. 9. THERE COULD BE POST-MARKET CHANGES, TOO The MHRA says that the new regulation offers clearer requirements on what a manufacturer’s post-market surveillance system should comprise of.

10. HELP IS OUT THERE The BSI has put together a useful presentation which answers many of the questions manufacturers may have – it’s available on the website, bsigroup.com.

eadlines

4. TECHNICAL DOCUMENTATION As a result of some potential re-classification, the BSI says that Notified Bodies will be scrutinising technical documentation more closely. Manufacturers with devices likely to be impacted by re-classification will need to be prepared for this.

A report by the Medical Technology Group reveals huge regional variation in waiting times and access to medical technology. Patients in the south of England are waiting longer to access vital medical treatments such as pacemakers, cataract surgery, and hip and knee replacements than those in the North, the study reveals. The report examined data from all 209 Clinical Commissioning Groups (CCGs) from across England to find out how effective they are at giving patients access to medical technology. It found that nine out of the ten CCGs that performed worse when measured against the NHS 18-week ‘referral to treatment’ target were in the South. Rapid treatment of stroke patients, using technology such as mechanical thrombectomies, can also make the difference between life and death. The NHS recommends that patients are admitted to a specialist stroke unit with four hours of arrival at hospital. However, analysis of data from the Atlas of Variation found a vast range, from over eight out of ten patients being seen within this time (84.5 per cent) in Hillingdon to just a fifth (21 per cent) in Wyre Forest. Chair of the MTG, Barbara Harpham, said, “Delivering high quality healthcare, no matter where you live, is one of the fundamental principles of the NHS. But budget cuts and rationing is having a huge impact on the service patients receive, and the outcome they can expect. “This enormous north-south divide can’t simply be explained by the regional differences in populations. There is an unprecedented strain on the health service and patients are not being given equal access to the treatment – and most importantly – the technology they need. Harpham added, “Quicker and better access to medical technology can save the NHS money in the long term, by avoiding complications and additional treatment, and by getting patients out of hospital and back to work and into the community. It’s time to reassess how medical technology is commissioned and to call these underperforming health services to account.”

ULSTER UNIVERSITY BECOMES MEDTECH HUB WITH NEW LAB A £7 million laboratory has opened at Ulster University as a result of a partnership between Northern Ireland’s business and education organisations. A collaboration between Ulster University, Invest Northern Ireland, Heartsine Technologies and Randox Laboratories resulted in the Advanced Biomedical Engineering Laboratory. The lab will offer equipment and expertise for companies developing prototypes for the biomedical, engineering, electronic devices and aerospace sectors. At the opening of the new lab, professor Jim Mclaughlin, Ulster University, said: “Developing technology platforms to help translate our world class science and discovery to a device format as promptly as possible is essential for the very best design and performance.a “In healthcare technology, Ulster University leads the way in the development of new patient monitoring systems, stimulation devices, wearable solutions and diagnostic sensing. “The lab will enable our researchers to develop the strong leadership and innovation skills so critical to future industry growth, working in collaboration with our industry partners.” The new lab marks another step towards the medtech sector for Ulster University. Earlier this year the university opened a £2 million medtech hub to develop healthcare technology. About the new lab, Dr Peter FitzGerald, Randox Laboratories, said: “As one of the UK’s leading life sciences companies, we are delighted to be a partner in this innovative collaboration and to promote Northern Ireland as a global life sciences hub. We believe the greatest improvements to patients’ lives are possible through the continuous development of new technologies. “This unique laboratory will facilitate that, as it will allow the rapid development of test prototype devices and also assist us to expand our unique range of high-calibre analyser systems.”

POINT-OF-CARE BIOSENSORS MARKET VALUED AT £25 BILLION BY 2027 3D PRINTED SMARTPHONE ADD-ON SPOTS PANCREATIC CANCER USING SELFIES A screening tool for pancreatic cancer has been developed by researchers at the University of Washington. By utilising smartphone technology and 3D printing the researchers have developed a solution that could effectively screen for pancreatic cancer and other diseases, simply by snapping a selfie. Jaundice, a yellow discolouration of the eyes and skin, is caused by an increased level of bilirubin in the blood. Whilst jaundice is one of the earlier signs of pancreatic cancer, it is still only visible to the naked eye when in severe stages. The tool, named BiliScreen, assesses the levels of jaundice in a person’s eyes when they take a selfie. The image is then tested using computer vision and machine learning to assess if the person has a mild form of jaundice. The researchers propose BiliScreen as a solution to detecting pancreatic cancer at an earlier stage. In a 70-person clinical study, the researchers used the app in conjunction with two accessories that were designed to limit the effects of external lighting, resulting in a clearer picture. As described in the University of Washington study, the accessories include a ‘3D-printed box that controls the eyes’ exposure to light and paper glasses with coloured squares for calibration’. When a selfie is taken, the app isolates the white parts of the eye and measures the colouration of the sclera. Machine learning algorithms then assess the eye’s bilirubin levels by looking at the wavelengths that are being reflected and absorbed. Results of the study showed that the 3D printed box, used in conjunction with the smartphone app, was the best option for identifying accurate levels of bilirubin. Compared to standard blood tests the study showed that the app was able to accurately identify cases of concern 89.7% of the time.

Point-of-care biosensors will grow to be a £25 billion market by 2027 forecasts IDTechEx Research. The firm predicts that point-ofcare (PoC) biosensors will become a £25 billion market by 2027, with molecular diagnostic devices the main driver for this growth. The group’s report gives a complete analysis of the important trends in the field of medical biosensors, and lists the new technologies and devices which are likely to be highly disruptive to the in-vitro diagnostics market. Biosensors are used to detect and quantify biological material associated with a disease state or health condition (biomarkers), making them powerful tools for diagnosis and monitoring. As technological advances allow for such tests to be conducted faster and on smaller devices, these tests are moving out of specialised laboratories and closer to the patient at the point-of-care. In this analysis of the market, ‘point-of-care’ is defined as being portable and able to gives results in under one hour. Commercial biosensors are split in four categories: lateral flow assays; electrochemical test strips; integrated cartridges; and molecular diagnostics. In addition, the report gives a ten-year market forecast segmented by application, including infectious disease selfmonitoring, glucose testing, cancer, cardiometabolic, pregnancy & fertility and genetic testing. The group says that the report, Biosensors for Point-of-Care Testing: Technologies, Applications, Forecasts 2017-2027 will be useful to any company wishing to be in the value chain of biosensors (materials suppliers, reagent suppliers, microfluidics, contract manufacturers, foundries). The two authors of the report, Dr Laura Baers and Dr David Pugh, will be presenting their analysis on PoC biosensors at the upcoming Business and Technologies Insight Forums hosted by IDTechEx in Seoul (1921 September) and Tokyo (27-29 September).

DIGITAL HEALTH START-UPS SELECTED BY BAYER ACCELERATOR Global healthcare company Bayer has selected four digital health start-ups from around the globe to help develop their ideas. The start-ups were selected as part of the Grants4Apps (G4A) Accelerator in Berlin, developed to bring digital health solutions to patients. The accelerator received over 450 digital-health related applications from over 61 countries. The four start-ups were awarded €50,000 and will be mentored by Bayer senior managers and external experts to help develop their business models and products until late November. The companies, which have projects in areas such as medical adherence, endometriosis, atrial fibrillation, deep vein thrombosis and ultrasound diagnostics, have now moved into the G4A Accelerator premises at Bayer’s pharmaceutical division in Berlin. Reinhard Franzen, head of Bayer Pharmaceuticals Commercial Operations Europe, Middle East and Africa, said: “We recognise the huge creative potential outside of Bayer and we believe that combining expertise is key to innovation and success. The Grants4Apps Accelerator offers new partnership opportunities in the digital health area with its vibrant development in the past years. We are very excited to welcome the four new start-ups for 2017.” The selected start-ups include ThinkSono and aparito from the UK, Oratel Diagnostics from the US and Sky Labs from South Korea.

Tech talk: Dr Chris Subbe

OPINION

DG: Chris, you recently collaborated with health giant Philips when testing its new ‘General Ward Systems’ vital signs monitoring package. Why is it important for healthcare providers to work with industry on the next generation of technology? CS: How could healthcare providers possibly not want to work with industry to develop the next generation of technology? The evidence for codesign with users is strong and working with industry partners like Philips means that the needs of clinicians and patients are linked to know-how of the tech-company. Better fit for our needs and better innovation results! And what an exciting partnership. A real front seat for innovation.

DG: What are the priorities for medical technology in the healthcare setting? CS: Oh dear, that’s a tough one. There are so many areas where technology is driving better and safer care: diagnostics, imaging, treatment, communication, it starts with wearable technology to monitor health and goes to implantable devices. My current concern is the presentation of complex data from multiple sources. I am not sure whether we have made enough progress in this and the amount of data that we are generating is still exploding! DG: How can healthcare providers be more involved in technological development?

DR CHRIS SUBBE IS A CLINICIAN WORKING IN ACUTE MEDICINE, AND LECTURER AT BANGOR UNIVERSITY.

HE’S ALSO AN ADVOCATE FOR CLINICIANS WORKING TOGETHER WITH INDUSTRY TO CREATE BETTER MEDICAL TECHNOLOGY. MTI’S DAVE GRAY SPOKE TO DR SUBBE TO FIND OUT WHAT MAKES FOR A SUCCESSFUL HCP-INDUSTRY COLLABORATION.

CS: Make friends with your colleagues at trade fairs! Be clear about the areas where you feel innovation is needed. Ask your tech partners questions about the innovation that you want to see. Offer your help as a test partner. There is always joint learning. DG: And what does industry need to do to be more involving?

are now working for a number of years with Philips and I have had great insight into some of the areas where they are creating innovative solutions and this has inspired me to apply the learning to areas where I am conducting research. These are now quite personal relationships. DG: What made the GWS system so successful?

CS: Time limited trials are probably a good way to test whether a partnership with a healthcare partner works. There is obviously intellectual property that needs to be protected, but clinicians can keep secrets and trusting, long-term relationships will eventually bear fruits. That is the way I would see it. I feel very privileged: we

CS: The Guardian Solution from Philips is successful because it mirrors natural workflow and it is very reliable. Now workflows are always changing and this will be a challenge to adapt the technology to this. But the IGS system is very organic in our clinical environment and that is a key feature of its success.

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plastics industry shines spotlight on medtech

OPINION

MTI: Why is 2017 the year for Mediplas@ Interplas to make its debut? LR: The UK device market is strong - according to Emergo. It is the third largest in Europe. With around 3,000 medical device companies operating in the UK, and many large US companies using the country as a base for the subsidiaries, the UK offers opportunities for the entire medical device supply chain, particularly in the areas of imaging, cardiovascular and diagnostics. Within this framework, Medical Plastics News will be hosting the Mediplas@Interplas zone. It’s a great opportunity for visitors to hear a range of high quality experts discuss issues that are making and will make a difference to their business now and in the future.

MEDIPLAS@ INTERPLAS IS A NEW FEATURE AT INTERPLAS – THE UK’S LEADING PLASTICS TRADE SHOW – WHICH WILL SERVE AS

MTI: So, what’s the plan?

there a conference too?

LR: Mediplas @Interplas will provide a focus for medical manufacturing in the UK and beyond, bringing together industry experts to offer practical advice and guidance for manufacturers from initial concepts and design ideas, through to materials and process optimisation. Interplas visitors will have the opportunity to immerse themselves in the world of medical plastics in a dedicated zone on the Interplas show floor featuring exhibitors such as Allied Automation, Andel Plastics, EFI Systems, Elite Mold & Manufacture, Guardtech Cleanrooms, Labthink Instruments, Plascolour Group, Polymermedics and Thormac.

LR: That’s correct. A special Mediplas @Interplas conference track on the afternoon of Wednesday 27th September will enable medical stakeholders to see exactly what the latest innovations in plastics can do for them. Visitors will be educated with presentations from PVCMed Alliance, the Centre for Healthcare Equipment and Technology Adoption (CHEATA), Connect 2 Cleanrooms and the London Bioscience Innovation Centre.

MTI: But it’s not just an exhibition area, isn’t

MTI: Sounds good – any chance of a sneak peak at the speakers? LR: I’m really excited to have professor Dan Clark, Centre for Healthcare Equipment and Technology Adoption (CHEATA) who will

A PLATFORM FOR THE LUCRATIVE MEDICAL PLASTIC DEVICES MARKET. MTI SPOKE TO LU RAHMAN, GROUP EDITOR, MEDICAL PLASTICS NEWS, TO FIND OUT MORE ABOUT THE INITIATIVE.

be explaining how businesses can make their medical device NHS-ready. This type of sound advice is crucial to medical device designers and manufacturers who need to look to the NHS from the offset to achieve longlasting business success. Another expert I’m thrilled to have on board is Jane Gardner, PVCMed Alliance. She’ll be sharing her expertise with visitors on how healthcare can contribute to the circular economy. It’s always important that manufacturing companies consider their social and ecological impact and we’re seeing increasing numbers of businesses wanting to know more about the circular economy and how to be part of it. Having Alexander Seifalian, director & professor of nanotechnology & regenerative medicine, the

London BioScience Innovation Centre, on board is a major coup for us. His medtech credentials are exemplary and he boasts the development of the world’s first synthetic trachea as one of his many achievements. He was awarded the European Life Science Awards winner for this as the most innovative product in 2012. Seifalian’s presentation promises a valuable look at the future of materials in biomedicine and how the next generation of plastics will be based on carbon-based nano materials. It’s a stellar line-up and we look forward to seeing many from the medical plastics and device communities there. Interplas will take place in Hall 4 of the NEC, Birmingham, UK, 26th-28th September. Attendance is free, register now at www.interplasuk.com

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is your medical device clinically sound and cost-effective?

OPINION

Today thousands of start-ups, academic centres and small and large companies are inventing and developing medical devices, diagnostic tests and health apps at an ever-increasing pace. Will the market have the capacity to absorb and adopt the new technologies? Will these technologies make a real difference to patients? Can these technologies save resources for cashstrapped healthcare systems? Consumers might be persuaded to pay for a product based on marketing slogans, but when it comes to procurement in cash-tight health services, promises, packaging, and sleek design become insufficient. Payers want to be reassured with robust clinical evidence and the economic rationale that they are acquiring products which generate savings and improve quality of care. Technologies of different classes

NICEâ&#x20AC;&#x2122;s online tool helps product developers understand and generate the evidence needed to show that their products are clinically sound and cost-effective. Leeza Osipenko, NICE scientific advice writes.

require various levels of evidence packages to convince the payers of their value proposition. Many developers of devices, diagnostics and health apps are unaware of the reimbursement requirements, especially in the earlier stages of product development, or are unable to formulate or narrow down the value proposition for their products to become attractive for national or regional reimbursement. Evidence generation is expensive and for product developers it makes sense to do all they can to make this process as efficient as possible. Where feasible, companies are encouraged to initiate early dialogues with regulatory authorities and payers to ensure that the evidence generation plans meet key stakeholder requirements. But in many cases, companies are unable to progress

towards such detailed discussions for a number of reasons. These can include the inability to formulate relevant questions, early development stages, lack of time and resources, or the lack of relevant staff to lead such engagements, etc. In July 2017 NICE Scientific Advice launched a new service - an online tool to help product developers understand and generate the evidence needed to show to the payer that their products are clinically and cost effective. The Medtech Early Technical Assessment (META) tool has been brought to market in partnership with Greater Manchester Academic Health Science Network. The tool helps companies efficiently and affordably identify what evidence they already have and what gaps need to be filled to satisfy payer requirements. This

process aims to help companies prepare for a dialogue with health technology assessment organisations and payers and potentially speed up time to market. The original version of the META tool is designed for the UK market and is a paid for service aimed at, but not limited to, small and medium sized companies. Developers can use the service at any time in the product development cycle and it is suitable even for products which are already in the market but which are unable to gain relevant adoption levels in the healthcare system. META provides a rapid assessment of the product to highlight gaps in the evidence via a discussion with a trained facilitator. A key output from the META tool is a set of future steps for the developer to help with their future market access strategy. Importantly, undergoing the

META process may help some organisations make decisions about discontinuing or modifying their product development plans. The META tool can be licensed for use by partner organisations working with medtech companies. These could include Academic Health Science Networks, Healthcare Technology Consortiums and consultancies who may have their own bespoke approaches to using META and assisting product developers prepare their products for adoption into a healthcare setting. This accessibility will maximise METAâ&#x20AC;&#x2122;s potential and make it available to companies not just in the UK but internationally as well. Consulting companies and other organisations interested in acquiring META licenses from NICE receive relevant training and accreditation.

MEDILINK UK Medilink UK is the UK’s largest network of life science and health technology organisations, with a total of 1,600 members and a database of 48,000 contacts. We encourage innovation in the sector and nurture collaboration between academics, clinicians and industry. With eight offices based across the UK, members of Medilink UK have access to opportunities and events on both a national and a regional level. Our experts can provide specialist support in: ●

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breaking it down: brexit and medtech

OPINION

Counsel Fabien Roy from legal expert Hogan Lovells examines the potential implications of Brexit for medical device companies

ACCESS TO THE EU MARKET The right for medical device manufacturers to affix a CE Mark to their products is based on their demonstration of compliance with the obligations laid down in the EU medical device Directives and related guidance documents that currently form the basis of related UK law. Brexit will mean that UK medical device manufacturers will no longer be able to take advantage of the right to claim automatic entitlement to market medical devices throughout the EU on the grounds that they have conducted a conformity assessment on the basis of EU device rules and affixed the CE Mark to their devices. Similarly, the CE Mark affixed to a medical device on the basis of the EU legislation may not necessarily be sufficient to market a medical device in the UK if different or additional requirements apply in the UK, postBrexit.

UK AUTHORISED REPRESENTATIVES The current Directives on medical devices provide that companies that do not have an establishment within the EU and who wish to affix a CE Mark to medical devices and to market these products in the EU must either: (i) establish an EU presence; or (ii) select a local representative to serve as its “Authorized Representative”. When the UK leaves the EU, depending upon the exact terms of the UK’s withdrawal, UK medical devices manufacturers, might, like all other non-EU manufacturers, be required to appoint an Authorized Representative established within an EU Member State to allow the continued marketing of their products within the EU. Alternatively, UK manufacturers may choose to establish a presence in one of the EU Member States and to transfer their responsibility as legal manufacturer of the medical

devices to this new address. As a consequence of Brexit, UK Authorized Representatives may lose their right to be appointed as the point of contact for third country manufacturers with competent authorities in the EU Member States. Manufacturers not established in the EU and which currently work with an Authorized Representative based in the UK may, therefore, also be required to appoint an Authorized Representative established in the EU to continue fulfilling the requirements of the Directives. UK NOTIFIED BODIES As a result of Brexit, UK notified bodies such as BSI, SGS United Kingdom Limited, Lloyd’s Register Quality Assurance Ltd, Amtac Certification Services LTD, UL International (UK) Ltd. might no longer be entitled to conduct conformity assessment on the basis of the Directives.

Manufacturers working with UK notified bodies in relation to the conformity assessment of their medical devices may be required to appoint a new notified body established in an EU Member State. This is likely to lead to a new conformity assessment to permit the continued marketing of their medical devices in the EU. In light of the current workload of the notified bodies in the EU, which are already preparing for the new Regulations on medical devices, it is expected that Brexit will lead to additional delays in conformity assessment procedures. CLINICAL INVESTIGATIONS AND DATA PRIVACY Brexit is expected to have important consequences for the conduct of clinical investigations and data privacy. In the context of on-going clinical investigations conducted in the EU it may be necessary for the informed

consent signed by a study subject to be revised to permit the transfer of that study subject’s personal data to the UK. Additionally, if a UK manufacturer is the sponsor of a clinical investigation conducted in the EU, it will be required to designate a Data Protection Representative in each EU Member State where there is a clinical investigation site and where the personal data of the patients is processed. This essentially means that UK companies will be required to appoint a Data Protection Representative in each EU Member State in which an investigational site is established. When the UK leaves the EU, investigation subjects in the UK will be subject to a new set of data protection laws. These may, particularly in on-going clinical investigations, differ from those referred to in the informed consent signed by the study subjects at the beginning of the investigation.

on the cover

Navigating T through the dark

The British Standards Institution (BSI) tells Med-Tech Innovation why it developed Compliance Navigator â&#x20AC;&#x201C; a workflow tool that takes the leg-work out of managing medical compliance.

echnological developments and continuous innovation have made the regulatory landscape for medical devices a rapidly changing one. After receiving positive votes in the European Council and Parliament, the Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746 - have been published. The new Regulations are calling for increased requirements for safety and put patient welfare at the core of the medical device manufacturersâ&#x20AC;&#x2122; processes. Failing to interpret and meet the compliance demands can not only cost companies millions and result in product withdrawal from the market, but also endanger patient safety. BSI developed workflow tool, Compliance Navigator, to help manufacturers manage their medical device compliance with UK and EU requirements, simplifying their processes, so that they can get to market faster and maximise ROI. Compliance Navigator is the only tool on the market that provides manufacturers with an array of features to help them gain competitive advantage, ensuring that they are always a step ahead, throughout their development pipeline. Not only are the new regulations changing the way manufacturers develop and monitor their devices, but they are also changing the medical device standards industry, as up to 400 standards will be amended in order to align with the new regulations. For manufacturers, reviewing and interpreting each changing standard is not only time consuming and costly, but also prone to risk and leaves room for omission. No longer do manufacturers need to scour the internet, their notified bodies and standards organisations to maintain vigilance, nor do they need to spend hours manually comparing PDF copies of standards. Compliance Navigator guides manufacturers with advance warnings to upcoming changes before and after they happen, so that they can reduce risk and prepare ahead of time. Missing the slightest detail can be detrimental, so users are able to interpret changes with redlining and expert commentary, allowing them to understand what the changes mean to their business and giving them a competitive edge. Compliance Navigator helps manufacturers to find standards and regulations quickly and then organise their files by device specific profiles,

on the cover

so that they only monitor information that’s relevant to their business. With the new regulations and growing industry uncertainty, Compliance Navigator also seeks to help manufacturers prepare for the transition with a new feature called MDR and IVDR Smart Support. Here, prevalent topics in the new regulations, such as clinical data requirements, reclassifying devices and UDI are analysed by industry experts and an easy to interpret review is provided to manufacturers. This includes, an executive summary suitable for senior management; detailed practical guidance on what has changed and what this means for organisations; and actions to take now and a summary of what is still to change, so that manufacturers can feel confident in their transition plans. One convert to the tool is Axonics Modulation Technologies. The Axonics Modulation team brings over 15 years of medical device design and development experience to its products, which include a new implantable system to treat urinary and bowel dysfunction. Biomedical engineer Rinda Sama comes from a medical device design background and as VP for operations, quality and regulatory affairs now heads up the team responsible for design, engineering, and manufacturing compliance. He’s worked with BSI’s notified body for 15 years. “It’s an additional burden on the company to keep buying individual standards. Moreover the standards are not static, new updates and revisions are released almost every other year.” As part of a team that has developed and sold three medical device start-up companies, Rinda had experience of the different methods of purchasing standards. He found that the large database model could be very expensive and so prior to investing in Compliance Navigator, Axonics Modulation Technologies was purchasing single standards. Rinda’s team experienced the drawbacks of the single standards model. Licences for single standards were available only on a single computer, and it was difficult for the start-up to justify the cost of multiple licences. “This was a problem,” says Rinda, “because determining the applicability of a particular standard, and appropriate test methods is a collaborative effort. The whole team had to be able to see the standard, particularly colleagues from engineering, and decide whether to

test to a certain requirement, or meet that requirement.” With such a brand new innovative product, the question of applicability was particularly difficult. Both cardiac and neuro medical device products have leads which are placed inside the body. As the patient moves, the leads need to move with them. So the lead is subject to the mechanical stresses of movement. As neuro is an area of innovation, neuro standards don’t specify the number of cycles needed to test bending of the leads and establish that they can move safely. The team needed access to standards in order to assess applicability, so even though a specific standard may not be applicable to a particular product line, they needed to be able to determine that this was indeed the case. Equally, there could be testing and validation methods described in some standards that were relevant to the R&D and compliance process for new products. For instance, standards in the neuromodulation space are not as mature as cardiac standards, because implantable systems are a relatively new product in this area. The team needed information from a wide variety of standards to help them develop test methods that would qualify the new products, and ensure they are safe from a patient perspective. As developers of an innovative new product, Rinda’s team also needed to know when standards were changing. A BSI roadshow offered Rinda the answer to these workflow issues when he saw a demonstration of Compliance Navigator. He followed up with a live demo and made a purchase. As Rinda said: “Everyone can now access and review the standards. And for applicability, I don’t have to buy single standard only to find out it is not applicable to the product I’m developing.” Compliance Navigator offers Axonics Modulation Technologies an enormous amount of standards covering many different aspects of medical device design, but without the cost burden of a large database. “It’s not expensive like the old fashioned databases used to be,” he said, “and that’s another

reason we like it so much.” The team was able to use Compliance Navigator to search, review and determine the most appropriate tests for developing new products. For example, they were able to review several different standards and found that the cardiac standards had the best and most detailed information on how to ensure the lead would be safe. The cardiac standards were used to qualify the implantable lead on the new neuro product and make sure it was safe for patient use. A couple of months after initial purchase, the entire company had moved to using Compliance Navigator. “There’s no-one who would want to go back to the old system now,” Rinda explained. Soon after mastering the basics, the team began to explore the additional features of the product, and were particularly impressed with the ability to group individual standards together and then share the different groups with different teams and colleagues according to the product they’re working on. After being tied to one computer that contained standards, the ability to share information with different team members is one of the strongest features, but most important is the notifications feature: “It’s a great tool, especially when we are in the middle of testing or the middle of regulatory review.”Axonics Modulation Technologies has experienced a direct time saving as a result of switching to Compliance Navigator. But more important is the accelerated workflow Rinda now sees: “If someone asks me something in a meeting, I can quickly check the information. Before, I would have to note it down, go away, check at the computer that has access to all the standards and report back at the next meeting, which might be a week later. Now I can provide an answer straight away. It saves a tremendous amount of time. So it’s not just the direct time saving of locating information quickly, it’s a much faster, accelerated workflow.” Rinda estimates a 50 – 60% cost saving on compliance in the R&D phase, by eliminating the time spent searching for applicable standards.

automation & robotics

Headed for the future The vision of Industry 4.0 presents a utopia interlinking all parts of an operation and where efficiencies, cost reductions and productivity increases can be achieved through integrated automation. Mitsubishi Electric has embraced the smart factory and Industry 4.0 concepts. Now, the group has distilled this guidance into a white paper, ‘Industry 4.0 – The road to digitalisation in future manufacturing’. Mitsubishi Electric marketing & operations group manager, Chris Evans, said: “When we start to consider Industry 4.0 it can be confusing. On one level we are looking at the convergence of business systems with the physical plant control but is this new? The real impetus behind Industry 4.0 comes not just from the link between the plant and the enterprise but once we have this link, not only can we have the means to improve performance but also to measure performance against an ideal model – the cyber physical system, if you will.” In-depth analysis and continuous improvement define the spirit of Industry 4.0 - but how do we get there and

is UK manufacturing ready to be smart? “If we built a plant from the ground up on a greenfield site, we could build a smart factory embodying the goals of Industry 4.0, using technologies available today,” Evans commented. “However the challenge with many manufacturing plants is that their automation systems have evolved over years, resulting in disparate automation platforms, poor network infrastructure, no data management strategy and little knowledge of how to get relevant information out. “You have to define exactly what the manufacturer is trying to achieve, its drivers and problems. Look at existing automation and what network infrastructure is in place, if any. Accept it will take time and investment. Look for quick wins that demonstrate returns against a moderate budget.” Mitsubishi Electric has undertaken smart factory

Industry 4.0 is synonymous with a vision of cuttingedge, futuristic manufacturing. Chris Evans, Mitsubishi Electric reveals how to create a smart factory and achieve Industry 4.0 goals

implementations at its own facilities. At its Kani Works switchgear production facility, a smart factory upgrade increased productivity and an operating rate plus a reduction in the number of stages in the manufacturing process. In its white paper Mitsubishi Electric defines the basis of Industry 4.0 and the overlapping principles of interoperability, information, integration, automation and autonomy. It defines the key features of Industry 4.0, looking at the importance of communications, cyber physical systems and cyber security. “Most plants in the UK haven’t had the luxury of being designed from scratch to meet the goals of Industry 4.0 but that doesn’t mean it can’t be done,” concluded Evans. “With strategic planning and a structured approach, any plant can reap the benefits of optimised, sustainable, safe production that is energy efficient, all within a fully connected supply chain. The road to digitalisation begins with the first step.”

Dave Beeby, principal development engineer, additive manufacturing technology

IMPLANTS

and concepts at Renishaw, discusses the considerations for additively manufactured implants.

ALL IN YOUR HEAD

ne area of implant technology that has seen significant advancement in the last year is craniomaxillofacial surgery. This includes cranial plates, orbital floors, orbital walls, mid-face implants and mandibular bars and plates. AM technology can also be used to produce custom guides, which a surgeon can use to ensure an implant is correctly located. SOFTWARE CMF implant manufacture is traditionally based on physical models made of a patientâ&#x20AC;&#x2122;s head in plaster. For example, when producing a cranial plate, implants would be produced from a sheet of titanium. This sheet would be cut, wrapped around the model of the patient and pressed with a hydraulic press to form an implant capable of holding its shape. This process could take up to several weeks. Digitising the process can dramatically reduce the amount of time needed to produce an implant. The AM design process does not rely on physical models as the implant is designed in computer-aided-design (CAD) software, based on data from 3D patient scans.

DESIGNING FOR AM Additive manufacturing removes many of the geometric constraints of traditional machining, but does come with its own considerations. It is important that the implant design is feasible for additive manufacturing. This means that it must be possible to add the correct supports to prevent thermal stress warping the part and to ensure the part is buildable. Tailored software applications, such as ADEPT, a package for CMF implants, makes this easier. The software only allows the design of implants that can be manufactured, as it is programmed to take the design constraints of the process into account. The software means that the designer does not need to check for faults, giving the surgeon peace of mind that the implant is correct. Implant manufacturers can use QuantAM build preparation software to carefully control the laser parameters of the AM machine. This is ideal for medical applications, as the machine parameters must be validated. Surgeons and prosthetic teams can design implants for additive manufacture in the hospital. However,

implant designers can work with third party manufacturers to benefit from their expertise and experience including their processes and quality management system. The hospital that commissioned the implant can use the already validated processes of its partner company and rely on its ISO13485 certification. STRUCTURE During the AM process, layers of powders are joined together to form a component using a laser. Without as many spatial limitations as traditional methods like CNC machining, implants can be designed with a form to fit the necessary function for the patient, rather than to fit in with the manufacturing constraints of the production process. Another consideration when manufacturing custom implants is material choice and composition. The manufacturer must be sure that the resulting part has the necessary mechanical properties to meet medical device metallurgy standards. This includes achieving the lowest possible oxygen concentration and a high level of ductility to prevent the possibility of an implant snapping.

The manufacturer must also overcome any technical hurdles during process developments. With large, thin implants, there is a risk of warping. To achieve high accuracy and prevent warping, the manufacturer can develop a support strategy and optimise laser parameters to get the most accurate part. However, significant process development is necessary to ensure that the product is suitable and meets regulation. By working with an experienced implant manufacturer, surgeons and implant designers can benefit from the manufacturerâ&#x20AC;&#x2122;s expertise. Developing an additive manufacturing implant process from scratch requires intensive research and development. By partnering with an experienced implant manufacturer, hospitals do not need to perform this work and can instead concentrate on their core skills, ultimately delivering greater benefit to the patient.

MED-TECH INNOVATION | EXPO

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www.med-techexpo.com ADVANCING HEALTHCARE

3d printing

FLEXIBLE FRIEND

new technique combines precision printing of stretchable conductive inks with pick-and-place manufacturing of electronic components to make flexible, wearable sensors. Wearable electronic devices that aim to track and measure the body’s movements need to be able to flex and move with the body, yet integrating rigid electrical components on or within skin-mimicking matrix materials has proven to be challenging. This mismatch in flexibility concentrates stress at the junction between the hard and soft elements, frequently causing wearable devices to fail. One team of researchers believe the answer could be hybrid 3D printing, which integrates soft, electrically conductive inks and matrix materials with rigid electronic components into a single, stretchable device.

Is 3D printing the solution to design hurdles in wearable tech?

Jennifer Lewis at the Wyss Institute for Biologically Inspired Engineering at Harvard University has teamed up with J. Daniel Berrigan and Michael Durstock, at the US Air Force Research Laboratory to study the approach.

a modest vacuum through an empty printing nozzle (through which ink is normally dispensed) to pick up electronic components and place them onto the substrate surface in a specific, programmable manner.

“With this technique, we can print the electronic sensor directly onto the material, digitally pick-and-place electronic components, and print the conductive interconnects that complete the electronic circuitry required to ‘read’ the sensor’s data signal in one fell swoop,” said first author Alex Valentine, who was a staff engineer at the Wyss Institute when the study was completed. The study is published in Advanced Materials. The stretchable conductive ink is made of thermoplastic polyurethane (TPU), a flexible plastic that is mixed with silver flakes. Both pure TPU and silver-TPU inks are printed to create the devices’ underlying soft substrate and conductive electrodes, respectively.

The team took advantage of TPU’s adhesive properties by applying a dot of TPU ink beneath each component prior to attaching it to the underlying soft TPU substrate. Once dried, the TPU dots serve to anchor these rigid components and distribute stress throughout the entire matrix, allowing the fully assembled devices to be stretched up to 30% while still maintaining function. A device composed of 12 LEDs attached to a flat TPU sheet created using this method was able to be repeatedly bent into a cylindrical shape without reduction in the intensity of the LEDs’ light or mechanical failure of the device.

“Because both the substrate and the electrodes contain TPU, when they are coprinted layer-by-layer they strongly adhere to one another prior to drying,” said Valentine. “After the solvent evaporates, both of the inks solidify, forming an integrated system that is both flexible and stretchable.” The printing process causes the silver flakes in the conductive ink to align themselves along the printing direction so their flat, plate-like sides layer on top of one another, like overlapping leaves on a forest floor. This structural alignment improves their ability to conduct electricity along the printed electrodes. The researchers combined the printed soft sensors with a digital “pick-andplace process” that applies

As a simple proof-ofconcept, the team created two soft electronic devices to demonstrate the full capabilities of the technique. A strain sensor was fabricated by printing TPU and silverTPU-ink electrodes onto a textile base and applying a microcontroller chip and readout LEDs via the pick-and-place method, resulting in a wearable sleeve-like device that indicates how much the wearer’s arm is bending through successive lightingup of the LEDs. The second device, a pressure sensor in the shape of a person’s left footprint, was created by printing alternating layers of conductive silver-TPU electrodes and insulating TPU to form electrical capacitors on a soft TPU substrate, whose deformation patterns are processed by a manual electrical readout system to make a visual “heat map” image of the foot when a person steps on the sensor.

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UDI

IDENTIFY

early four years after the FDA set out its framework for establishing a unique device identification system to identify medical devices through their distribution and use, implementation is well over halfway and there is little time remaining before its compulsory introduction. The system means that by 2020 most medical devices will need to include a Unique Device Identifier (UDI) in human and machinereadable form. In addition, device labellers must submit mandatory data about each device to the FDA/National Library of Medicine’s Global Unique Device Identification Database (GUDID), enabling the public and healthcare stakeholders to access and download device information.

WARREN STACEY OF LABELLING SPECIALIST PRISYM ID EXAMINES UNIQUE DEVICE IDENTIFICATION IMPLEMENTATION TO DATE, AND OFFERS BEST PRACTICE GUIDANCE FOR COMPLIANCE.

The implications for medical device companies are significant. Assuring UDI compliance requires a major review not only of an organisation’s labelling capabilities but also how it connects with all the other divisions that impact supply chain operations. Furthermore, the journey towards UDI compliance requires an enterprise-wide programme of change management to ensure the requisite infrastructure is in place. It’s a journey that for many manufacturers has proved to be a challenging one. So what lessons have been learned to date, and what best practice can we give to medical device manufacturers yet to implement UDI? UDI: ITS MEANING AND PURPOSE? The FDA’s introduction of the UDI system has a number of goals: •

To drive more accurate reporting and analysis of adverse events, ensuring problem devices can be quickly identified and rectified

•

To reduce medical errors by giving healthcare professionals key information about devices

•

To enhance market analysis with access to real-world data on device usage

•

To provide a standard identifier to help manufacturers, distributors and healthcare providers to manage product recalls efficiently

The FDA’s definition of a UDI and guidelines are complex and mean that, for many companies, managing the transition to UDI compliance can be a challenging process. Critically, the implications for labelling operations are significant and require all medical device manufacturers to examine their current infrastructure and, in many cases, adapt it to enable more holistic label lifecycle management. LABELLING AT THE CENTRE The introduction of UDI capabilities is a cross-functional challenge for medical device manufacturers. A survey conducted last year by PRISYM ID highlighted that UDI implementation caused reverberations in manufacturing, quality, operations and distribution. Likewise, UDI projects also tend to involve IT and regulatory teams, meaning that they permeate almost every department and system within an organisation. This naturally dictates a collaborative approach where implementation decisions cannot be made or managed in isolation. However, the biggest impact of UDI implementation is typically felt in Labelling and Packaging. 85% of respondents reported that Labelling, Packaging & Design were affected the most. This is underlined by data which reveals that companies experienced more issues around their labelling capabilities than any other area.

udi

WITH ME Building and implementing an appropriate labelling system was cited as the single biggest issue, with 23% of respondents encountering difficulties. Alongside this, almost a fifth (19%) found getting a UDI onto the device label their biggest challenge, while 9% reported issues adding a UDI to device packaging. This data shows that, when asked to name their biggest issue around UDI compliance, more than half of all respondents cited issues related to labelling. Making the move to UDI compliance requires manufacturers to ensure device labels not only include a device identifier (DI), production identifier (PI) and associated barcodes, but also include 13 additional pieces of information. These requirements represent a major shift and necessitate a labelling system that can capture these data sets accurately and efficiently and configure them to the appropriate label design. Ideally, the labelling system would be able to communicate seamlessly with systems that support the submission of data to GUDID. This separate process requires the submission of data covering a total of 62 fields – with data not only coming from the label itself but from various locations right across the organisation. LABEL LIFECYCLE MANAGEMENT The impact of UDI regulations on labelling operations is a major reason why Label Lifecycle Management (LLM) is now regarded as a must-have capability for global medical device manufacturers. LLM encompasses the full range of disciplines, processes and controls that go into the preparation, production and audit of every single label. Unlike traditional labelling systems that focus purely on the final output – the label itself – an LLM system focuses on data, supporting the end-to-end

FIGURE 1

management of labelling across its entire lifecycle. It gives companies full visibility of all their data assets as well as editing tools and vision control to help maintain data integrity. Crucially, an LLM system assures robust data validation and reinforces it with transparent audit tools that can supply objective evidence in the event of internal or regulatory inspection. These capabilities are crucial if organisations are to meet the regulatory requirements of UDI. CONCLUSION It’s therefore no surprise that medical device companies are increasingly looking to improve their labelling systems to ensure operations are UDI compliant. There is a growing trend towards the implementation of ‘vision’ systems that automate label inspection, post-print. Indeed, the most progressive

organisations are deploying endto-end LLM systems that give them a 360° view of all their data via a centralised global platform that interoperates with existing systems right across the enterprise. LLM solutions give manufacturers the reassurance of complete label integrity – a single version of the truth – across the entire label lifecycle. Moreover, they provide a secure, reliable and scalable platform for efficient UDI-compliant labelling. With more than half of all survey respondents citing label-related issues as the biggest challenge in the journey towards UDI implementation, it makes sense for the remaining medical device manufacturers who have yet to implement UDI to ensure they have the optimal labelling solution in place as they approach the final 2020 FDA deadline.

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Surmodics controls all critical aspects of manufacturing at our Ireland facility, including: Design & Prototyping • Dedicated R&D, rapid prototyping, concept-tocommercialization development Balloon Development • Expertise in forming, extrusion and top assembly; proprietary braided technology Proprietary Catheter Technology • Ultra-thin-walled, coiled/braided catheters for robust torque and kink-resistance Surmodics Surface Technology • The industry’s leading hydrophilic, drug-delivery and hemocompatible coatings Manufacturing • World-class, purpose built manufacturing facility with full vertical integration in controlled and validated cleanroom environments Quality & Regulatory Support • FDA, CE and Japanese approvals, ISO 13485 compliance, post-market surveillance

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innovation

DUBLIN

MED-TECH INNOVATION | NEWS MED-TECH

innovation island Med-Tech Innovationâ&#x20AC;&#x2122;s guide to Med In Ireland and the Irish market

“It’s little wonder the world’s medtech leaders are heading to Ireland to conduct R&D, and step up their manufacturing game”

innovation island Ireland boasts one of the most successful clusters of healthcare technology in the global medtech community. On 19th October, the region’s medtech leaders will congregate at the RDS, Dublin, for Med In Ireland, organised by Enterprise Ireland (EI). Med In Ireland is a high-profile showcase for the entire spectrum of the Irish medical technologies sector. Leaders in medical devices, sub-supply, precision engineered components, diagnostics, connected health, healthcare providers, and research and development will exhibit to an international audience. With such a large market share, it’s little wonder the world’s medtech leaders are heading to Ireland to conduct R&D, and step up their manufacturing game. It’s great news for the country too. According to EI, there are now 348 medtech firms based in Ireland, the majority of which are indigenous. The sector currently employs 29,000 people, with that figure forecast to rise over the next three years. Significant investment via the Science Foundation Ireland has boosted R&D the region, which is an academics’ paradise in terms of access to futuristic technologies.

IRELAND

But perhaps the biggest indicator of success for the Irish medtech sector is the recently unveiled Cúram Centre for Research in Medical Devices. Based in Galway, the Cúram centre opened its doors last year, following years of work to bring it together.

Its purpose? To bring together collaborators to research and develop devices for treating chronic illnesses, including diabetes and heart disease. And with major names like Boston Scientific, Cook Medical and Stryker Instruments among its supporters, the centre seems bound to foster a wealth of new technologies. Whether you’re planning on attending Med In Ireland, or simply want to know more about the fascinating work being done in the region, Med-Tech Innovation has compiled this special focus on Ireland, with interviews and reports from some of the key exhibitors at Med In Ireland 2017.

Venn Life Sciences

www.vennlifesciences.com

Experts in Drug Development & Clinical Research Over 25 years bringing Clinical Research to Life Clinical Pharmacology

Data Management

Drug Candidate Selection

Biostatistics / Data Analysis

In-licensing & Technical Due Diligence

IVRS / IWRS

Non-clinical / Pre-clinical development

Methodology Consulting

Regulatory Affairs

Clinical & Medical Monitoring

Pharmacokinetics

Clinical Resourcing

Pharmacometrics & PK / PD modelling

Quality

CMC Protocol Development Feasibility Investigator Initiated Studies Patient Recruitment Project Management Medical Writing Training

NORTHERN IRELAND

European Network of Offices

62 Donegall Pass, Belfast BT7 1BU, Northern Ireland. Tel: +44 (0) 28 90 804 095

IRELAND

19 Railway Road, Dalkey, Dublin, Ireland. Tel: +353 (0) 1 537 3269

THE UK

1 Berkeley Street, London, WIJ8DJ, United Kingdom. Tel: +44 (0) 28 90 804 095

THE NETHERLANDS

Hoofdstraat 15, 7902 EA, Hoogeveen, The Netherlands. Tel: +31 (0) 524 712 456 Lage Mosten 29, 4822 NK, Breda, The Netherlands. Tel: +31 (0) 765 480 666

GERMANY

Marie Curie Str.2, 53359, Rheinbach, Germany. Tel: +49 (0) 2226 9098 40

FRANCE

63, Boulevard Haussmann, 75008 Paris, France. Tel: +33 (0) 140 21 19 00

contact us For more details on Venn Life Sciences and an up to date list of our offices please visit www.vennlifesciences.com or email us at marketing@venncro.com

ireland’s medtech industry in numbers

mapping the market €12.5bn IN GOODS EXPORTED GLOBALLY

EXPORTS TO OVER 100 COUNTRIES

29,000

EMPLOYEES

€205m

SPENT ON RD&I BY MEDTECH COMPANIES IN 2015

348

MEDTECH COMPANIES

IRELAND

234

INDIGENOUS COMPANIES

OF THE WORLD’S TOP 25 MEDTECH FIRMS

50% Source(s): Med In Ireland (Enterprise Ireland) and Ibec (Irish Medtech Association)

OF COMPANIES ARE IN B2B

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Source your Innovation advantage

Irish Medtech companies are helping global healthcare and medical leaders to win with world-class innovation. Flexible, customerfocused and part of Europeâ&#x20AC;&#x2122;s most innovative Medtech cluster, an Irish partner could be your source of competitive advantage too. For expert assistance identifying your ideal Medtech partner, visit: irishadvantage.co.uk/medtech

Behind every great medical device, there’s a great clinical trial. MTI editor Dave Gray spoke to Colette Donaghy,

clinical operations manager, Venn Life Sciences, to find out what goes into making a device trial successful.

TRIED AND TESTED

lead studies in disease of the left main artery being conducted anywhere in the world. The project began when Venn’s COO was approached by one of two lead investigators, Professor Robert-jan van Geuns at the Erasmus University in the Netherlands. Both he and Professor Keith Oldroyd, who is based in the Golden Jubilee Hospital in Glasgow, realised at a very early stage that they needed help to conduct this large-scale investigator initiated study. The study involved a comparison of two drug-eluting stents; the newer of the stents uses a different coating that allows the drug to dissolve differently in the patients’ heart. Additionally, the newer stent reduces the length of time that patients must take blood thinners to reduce the risk of foreign body reactions. Typically, stents of this type would require the patient to take blood thinners for 12 months – which increases the risk of bleeding events and complications from any further surgeries that may be required during that time. The new stents reduce that time down to just four months. Donaghy explains: “This study was not being run by large pharma or a large medtech company. This was

the responsibility of the two interventional cardiologists above who wanted to look at this particular use of the newer stent in a real-world environment.” The sponsor of the trial is the Golden Jubilee National Hospital, National Waiting Times Centre Board in Glasgow. The first challenge was the administrative task of setting up the study in different countries. To do that requires knowledge of the regulatory pathways in each country. Venn has experts around the world capable of undertaking this kind of work. Donaghy says that this specialist knowledge is invaluable when trying to conduct trials on an international scale. “In each country we had to go through the relevant ethical review bodies, who looked at the study, checked that they were happy for it to be conducted, and that there would be no negative impact for the patient.” The other challenge for the client was setting up contracts. Venn needed to set up a contract with each institution, and in some cases with each investigator. The group uses a corporate legal adviser, which is essential in securing an agreement which

protects both Venn, and the client. “There’s a lot to do when setting up an international clinical trial. Each country needs to be set up individually and the sites trained in the study processes. And if that’s going to be happening in different countries, then you need people who can speak the language.” Venn has sites in Russia, Poland, Germany, France, the Netherlands and the UK. The trial is ongoing, and Donaghy says that there is significant interest from clinicians in the eventual findings and the primary outcomes at 24 months. “This study will be followed up for the next five years. We will monitor major adverse coronary events and they’ll be classed into categories – e.g. bleeding, thrombosis, stent replacement, etc. We will monitor this over a period of five years, allowing us to look back and see why those things happened. “Currently the client is highly satisfied that we delivered the trial within the timelines that we were given, and that we managed to get full recruitment. This is one of the largest investigatorlead studies in this area that is being conducted anywhere in the world.”

IRELAND

enn Life Sciences is an integrated drug development and clinical research organisation with offices in Dublin, Belfast, France, Germany, and The Netherlands. Clinical operations manager Colette Donaghy is responsible for the planning, delivery, and execution of the group’s clinical trials. With significant experience in the medical device arena, Venn faces the usual challenges posed by the wider medtech market. Donaghy believes that the UK & Ireland uptake of new drug innovations still lags behind the rest of Europe. “We have a very good healthcare system, and improved access to new medicines and innovations help enhance patient care. But the long process of getting these new products readily available can mean that companies will choose to test their products in other countries where this is not an issue. Yet despite these challenges, Donaghy says that Venn continues to attract innovators from around the globe. In fact, the group recently collaborated in a clinical trial in cardiology which turned out to be one of the largest investigator-

33 33

One Irish company, Clindox, is using its web-based clinical trial solution to help an Indian

MAKING CONNECTIONS

bstructive airways diseases have become a major issue in India due to rapid urbanisation, the pressures of modern living and a lack of understanding of the issue among the general population. According to the Indian government Ministry of Health, an estimated 35 million people people in India have asthma and

22 million have COPD (chronic obstructive pulmonary disease). The Chest Research Foundation (CRF) was initially set up in November 2002, becoming a Public Charitable Trust in 2011. Part of its remit is to investigate respiratory diseases in India, with a focus on regional variations and causes - and to provide a

clinical evaluation of drugs for the treatment of these diseases. The respiratory trial in question involves 13,000 subjects, 250 investigators, 50 data managers and 8 different languages/ dialects - an exercise of significant scale. Mats Forsgren, CEO of Clindox, explained the company’s involvement: “We’re based

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research foundation conduct a clinical trial programme in areas where there’s no access to the internet. A webbased clinical trial, without an internet connection – so how does that work?

in Dublin but have a development team in India and have been looking at expanding our sales into the territory. This was a perfect opportunity to showcase what our system can do, but due to some unique challenges we’ve had to do some development work too.” Clindox believes that the clinical trial world has been slow to take up technology. Trial software systems have been around for years but typically the expense has made many smaller to mid-sized companies stick to paper-based trials. Companies like Clindox have been working to change the perception that trial systems are too slow to set-up and cost-prohibitive. For The Chest Research Foundation, this would ordinarily have been a paper-based trial, comprising 13,000 handwritten interviews on paper. This would have involved all of the data managers manually collating the info from eight different languages in order to crunch the numbers and then make sense of it. By working with Clindox, the CRF had an opportunity to speed up and simplify this process, but there were some challenges to overcome. The lack of internet connection in many of the regions, and the multiple language requirements were two major obstacles. Key to this project was the development of Clindox’s CRFweb App which can be used by investigator or patient on Android or iOS. It enables data to be entered where an internet connection isn’t available. The collected data is then seamlessly synchronised later when a secure connection is available. The group has also recently launched its ePRO (electronic patient reported outcome) module that enables the subjects to answer questionnaires at home without risk of them accessing other functionality or data. The module also facilitates a multi-language capability, which helped to address the language capability issue in India. For this study, the Chest Research Foundation investigators visit their subjects on site/at their home and record the information on their android device using the CRFweb app in the appropriate language. When they get back to the office, the data is automatically uploaded and the data manager has the information and analysis/ reporting facilities at their fingertips. Although the CRFweb app is being utilised in this case in an environment where there is limited internet access, Clindox says it has first world benefits too. Data security is paramount in clinical trials. The app allows the investigator to opt to collect data from a subject offline without any concerns about data security, through public/private wifi etc., then later, when back in a secure network environment, the system can automatically connect and upload the data. Clindox reports that this trial is going live at the time of publication, and as such the time saving for the Chest Research Foundation will be hard to quantify until the project is complete, but the groups says “the benefits are already obvious and significant”.

Ronan Benson, senior industrial designer at Galway-based medical devices design and manufacturing

group Synecco explains why you can’t afford to ignore integrated smart technologies.

ONLY SMARTIES HAVE THE ANSWER

ore and more of the products we interact with everyday are becoming smart devices. It could be your inhaler, your pill dispenser or even your clothes with integrated smart textiles. A wealth of user data will soon be available and the utilisation of this data will define the future of personal healthcare. Therapies and prescriptions will soon be monitored through smart devices. Furniture could detect developing pressure sores, wearables could monitor heartrates or implantable devices could be tracking and treating chronic conditions. Cloud based healthcare will improve outcomes and reduce inefficiencies in the system. Your doctor will connect with your local healthcare centre which will monitor and track your health and lifestyle through a myriad of new devices which are currently under development. Compliance will be traceable and your wellbeing will be monitored continuously. The goal will be to keep people healthier for longer and away from acute hospital care. As populations age in the developed world, these strategies will be essential in preventing our health services from being overwhelmed. In this new interconnected world, user data will be a valuable commodity, but it will also bring with it a suite of regulatory and security concerns. Personal medical data is very sensitive and its encryption, storage and use will bring up a host of questions for both the industry and the individual. In other industries, the value of user data is well known. Entities like Apple, Alphabet and Amazon know the massive potential that connected health represents and they are moving into this space rapidly. Right now, it’s easier for MedTech companies to access a sophisticated data system in the cloud than it is for the data companies to access the human body, but this won’t last long. Soon, this access will become commoditised if MedTech doesn’t figure out a way to ringfence it from a regulatory and IP standpoint. Unless the medical device industry has a

robust data monetisation strategy, companies such as, Amazon or Google will monopolise the medical industry’s data. Traditionally the medical industry is slow to adapt to new trends, however a catalyst for change is due to be implemented in May 2018. The General Data Protection Regulation (GDPR) is a regulation by which the European Union intend to strengthen the data protection for all EU citizens. The GDPR is the most important change in data regulation within the last 20 years. EU General Data Protection Regulation Any information related to a data subject (i.e. a user) that could identify that person is covered under these new regulations. It could be a name, a photo, posts on social media or medical information. The GDPR not only applies to organisations located within the EU but also to organisations located outside the EU who provide goods or services to EU citizens. Under these new rules, organisations must show full trackability on any data possessed on an individual. If found in violation of the new act, an organisation could face a penalty of up to 4% of total worldwide annual turnover of the preceding financial year. Now is the time to embrace user data and implement strategies to manage and utilise it appropriately. Challenges and opportunities For many organisations the challenge is not how to deal with user data, but is instead how to move into this new space. If your business is based around plastic components with no integrated technology, connected health can seem intimidating. How do you approach it? What do you monitor? Do you hire specialist staff or outsource the necessary expertise? Collaboration is the key and Ireland is overflowing with expertise in every aspect of smart device and traditional medical device development. Getting these differing skillsets working together with a common purpose will be essential in maximising the potential of connected health.

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Vascular device developers must focus on three critical areas of performance: delivery systems, mechanism of action or treatment, and surface technology. MTI spoke to Surmodics, a company which, through recent acquisitions, is determined to offer whole vascular device products that excel in all three areas.

under the skin

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output machinery, and Surmodics’ customised packaging and labelling allows customers to brand their products for market differentiation. Surmodics “Our customers range from start-ups to global has made a strategic corporations. To satisfy their needs, significant we have expanded our facility for large-scale, investment lean manufacturing, with four class-eight rooms in its newly Over the past year, we have more than doubled acquired Irish cleanroom and tripled semi-controlled space to manufacturing enable product development and high capacity facility manufacturing of all Surmodics technologies. “Surmodics’ expertise includes a proprietary ultra-high pressure braided balloon technology, as well as conventional low-profile, non-compliant, semi-compliant and compliant capability. By combining this capability with our specialty ultrathin-wall braided catheter technology, we’re able to offer customers a broad range of highly differentiated total product solutions from one manufacturing location,” said Greaney. Regarding catheter technology, Greaney said: “Our proprietary coiled/braided shaft technology is truly unique: ultra-thin walled, yet with unsurpassed performance in kink-resistance, torque-control and radial strength. We also offer precision-engineered hemostasis valve technology with exceptionally low insertion and withdrawal force for medical devices ranging from .035” to 34 Fr”. Greaney continued: “Our Ireland facility uses Surmodics’ industry-leading surface technology, including our patented Serene hydrophilic coatings that leverage advanced UV curing processes to facilitate rapid covalent bonding to a wide variety of catheter substrates. Specific to drug-delivery capabilities, the facility is certified to handle small molecule compounds such as paclitaxel and sirolimus. Surmodics’ research and development teams are advancing a pipeline of drug coated balloons targeting a range of peripheral indications, including SFA, BTK and AV Access.” While Surmodics’ headquarters in Eden Prairie, Minnesota, remains a center of excellence for surface technology development, to serve customers with European manufacturing, the full range of coating products, performance testing, surface characterisation and chemistry analysis performed at its headquarters is also offered at its Ireland facility. “Our Irish facility has a history of close partnership with customers, collaborating at all stages of product design cycle to insure market needs are met. That’s very much in keeping with the Surmodics corporate culture, and it’s why Surmodics has invested to make Ireland its global manufacturing centre of excellence,” said Greaney.”

IRELAND

Surmodics is best known as a developer of coatings for vascular devices. Since 2003, when the group developed the surface technology for the first drug-eluting stent, it has developed lubricious, haemocompatible, and drug-delivery coatings for over 150 devices in all major intravascular categories. The recent introduction of its Serene hydrophilic coating marked another milestone: a highly lubricious yet durable coating that displays both low friction and low particulates. The group is now aiming to offer highly differentiated, complete vascular devices. Two recent strategic acquisitions are helping Surmodics realise this vision. In 2015, Surmodics acquired Creagh Medical, an innovative developer and manufacturer of balloon catheters located in Ballinasloe, Ireland. With its subsequent acquisition of US-based Normedix, Surmodics attained comprehensive design, development and pilot manufacturing capabilities for custom catheter solutions. With the Ireland-based design, development and high-volume manufacturing facility, significant investment has already been made to combine all of Surmodics’ capabilities under one roof. The facility controls all critical aspects of product lifecycle design, development and manufacturing. Dedicated R&D teams design, engineer, and performance-test a wide range of vascular devices. Rapid prototyping, leveraging multiple processes and technologies minimise cost and accelerate development. From concept through production, Surmodics says it maintains strict design controls, development traceability, and a strong linkage between design and manufacturing for efficient validation testing and predictable scale-up to manufacturing. Thomas Greaney, executive vice president for medical devices at Surmodics, told MTI: “Our Ireland facility is much more than a manufacturing site. As our customers drive to commercialisation, we also support them with an experienced regulatory team adept at anticipating and removing potential barriers to timely regulatory approval in global markets. Products manufactured in our Irish facility have FDA clearance, CE mark and Japan approvals, in addition to many other country registrations.” Surmodics’ manufacturing process begins with multi-layer micro-extrusion of thermoplastic catheter components and balloon tubing to the tightest of tolerances. The group claims to have perfected multiple balloon forming processes to achieve demanding performance expectations. The complete catheter top-assembly uses high

Shimmer Sensing is a specialist in clinical-grade wearable sensing systems. In a world where disruptive med-tech start-ups and global fortune 500 companies alike are pursuing wearable tech, Martina Donohue, marketing manager at Shimmer spoke to MTI’s Dave Gray about the rapidly evolving landscape.

YOU WEAR IT WELL

IRELAND

he group develops, manufactures and markets a full range of clinical grade wearable wireless sensors including: wearable electrocardiogram (ECG), electromyography (EMG), galvanic skin

response (GSR), and body worn motion sensors for the clinical, research, and OEM markets. With data becoming progressively more important, finding ways to accurately capture, communicate and synthesise the data for actionable decision making can be challenging. Shimmer is developing smaller, more discrete sensors with multiple sensing capabilities. But working in the wearables field, while rewarding, is not without its challenges, as Donohue explains: “Most studies in wearables view the long-term outlook for wearable medical devices with strong growth into the

future. In the last few years there has been exceptional technological innovation in wearable electronics, sensors and wireless platforms, but there are challenges ahead as the industry moves from simply reporting real-time data to tracking, diagnosing and ultimately treating healthcare issues. “Average activity trackers will have to become smarter by measuring other biometrics beyond steps and movement while maintaining a cost-effective model. Other challenges lie in the area of continuous monitoring, for example in ECG. Stringent regulatory requirements may delay time to market for some solutions. In the smart wearables segment - i.e. those that have hardware with multiple applications and platform integration as opposed to basic wearables which have limited functionality the issue of regulatory challenges is raised as more medical grade wearables begin to be used by professionals to diagnose or influence the course of care. “And in the medical community, challenges in protection around privacy and access of data are becoming much more prevalent. Security and data privacy around wearables could act as a competitive edge for some companies, especially

for the enterprise and medical–grade wearable segment.” All of these challenges, Shimmer believes, build the case for a more active participation by key stakeholders such as governments or state healthcare agencies to provide funding for development and deployment of a cost effective approach. “Much more value will be placed on clinically relevant wearables in the future that can address unmet health and wellness needs,” said Donohue The wearables market is defined by its creativity, with innovative new technologies emerging at pace. And Ireland is no exception, says Donohue: “There are many reasons why Ireland is so successful in medtech, but the key reason that we believe Ireland has come out on top, is a the relationship fostered between the medtech industry, Irish SMEs and leading Irish academic centres of excellence. These cohesive relations allow for a structured and common approach to solving healthcare issues in the industry, such as treatment efficacy, all while maintaining a focus on cost reduction. “The essential investment in R&D and innovation this region has seen over the last five years has delivered huge job creation and a speciality skill set unique to Ireland. The success stories

that we see today compound the need for further collaboration to produce much needed novel technologies.” One of the most fascinating applications for wearable devices is in clinical trials. Real world evidence is increasingly sought after in proving the efficacy of drugs and devices. Donohue says the potential here for firms in the wearables sector is huge. “Many factors are driving clinical trials towards the use of wearable sensors. The cost of sensors is coming down and the science of interpreting the data is improving rapidly. Just as important, sensors can provide quantitative measures of the effectiveness of interventions (clinical endpoints) as well as early identification of adverse events. “At the most basic level, measures of activity levels and sleep quality are such fundamental indicators of health that we believe every clinical trial will need to monitor them in the not too distant future. Beyond that, it is possible to monitor a wide variety of clinically important parameters. We believe that wearable sensors will generate the primary endpoints on almost every clinical trial within 5-10 years.” Shimmer Sensing will be showcasing its full range of wearable enabling technology form its stand at Med In Ireland.

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“Investment in this region has delivered a speciality skill set unique to Ireland”

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STARTR Our guide to the latest young up-starts in medtech

PAPER CHASE

London medtech startup drfocused says it has developed a mobile-based solution to help reduce the amount of time doctors have to spend on paperwork. Co-founder of drfocused and A&E doctor Kit Latham said: “Doctors spend a staggering 30% of their time on paperwork and on top of that, the software they use at work usually slows them down, rather than helping them to work faster – it’s an expensive problem and it frustrates hard-working clinicians.”

WRAP UP WARM

A new scarf has been developed by French startup Wair which apparently filters out pollution. Showcased at CES 2017, the scarf raised over €30,000 during its crowdfunding campaign. The scarf uses a multilayer filtration system that stops microparticles such as pollens, gasses and bacteria. Wearers can also use the company’s Supairman app to assess the pollution rate where they live.

FILTERING THROUGH

MediSieve – a device that filters blood and could one day be used to remove certain diseases. Treatment with MediSieve’s magnetic filter device offers new hope for malaria patients whose cases are severe or resistant to existing medicines as it involves no drugs or chemicals. Initial trials show that the 3D printed magnetic blood filter could extract up to 90% of infected cells from a person with malaria in under four hours.

PHOENIX FROM THE FLAMES

Consumer tech giant Jawbone was recently reported to be entering liquidation. But it may not be the end of the brand, which is reportedly hatching plans for a startup business in the medtech space – to be badged Jawbone Health Hub.

HOW VERY PREDICTABLE

Scottish newcomer snap40 says it has developed a way of using predictive analytics to help identify those at risk of health deterioration. Users wear a medical device to continuously monitor health indicators, the data of which is continuously sent to the snap40 predictive analytics software platform. The group has just been awarded a £1 million SBRI healthcare development contract

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Visit Our Stand at Med In Ireland 19 October 2017, RDS Dublin