MTI Issue 44 by Med-Tech Innovation Magazine

www.med-technews.com Issue 44 | Sept/Oct 2019

@medtechonline

PLUS

Making compliance your friend Med In Ireland preview

MED-TECH INNOVATION | NEWS

TOGETHER IN PERFECT HARMONY HOW TWO FIRMS ARE BRINGING INDUSTRY 4.0 TO MEDTECH

MEDICAL DESIGN & MANUFACTURING INSIGHT

DOCUMENTATION WOES? TIME IS RUNNING OUT FOR COMPANIES TO PREPARE FOR THE IVDR… NSF INTERNATIONAL PROVIDES A WIDE RANGE OF SERVICES TO HELP COMPANIES DEVELOP NEW PRODUCTS AND BUILD IN COMPLIANCE AT AN EARLY STAGE. IVDR COMPLIANCE

NSF can help you identify the most efficient routes to compliance, based on your product portfolio and target markets.

REGULATORY AFFAIRS

What is the best strategy for your company? How do you tackle a submission to the FDA or to the Chinese authorities? NSF can advise on the options and their pros and cons.

QUALITY MANAGEMENT

Certification to relevant standards is critical. NSF can identify the gaps and help you fill them.

CLINICAL/ PERFORMANCE EVALUATION

Are your clinical/performance evaluations up to date and comprehensive? Our experts can help you update or improve your clinical/performance evaluation report.

AUDITS AND INSPECTIONS

In addition to helping companies to prepare for upcoming audits, we provide ongoing advice for the maintenance of your quality management system.

TRAINING AND EDUCATION

NSF is a leading provider of training courses and education, which can be tailored and delivered in-house according to your needs.

Call us now on +44 (0) 1751 432 999 or email Eudevices@nsf.org.

SPECIAL OFFER To help you prepare for the upcoming IVDR, get 25% off NSF’s European Union In Vitro Diagnostic Device Regulation eLearning. Use code EUREGS25 at checkout. Visit www.nsf.org/info/md-elearning for more information. If you would like eLearning for a larger group of people, contact us to discuss your requirements. NSF INTERNATIONAL | MEDICAL DEVICES | www.nsfmedicaldevices.org | www.nsf.org

CONTENTS regulars 6.

Regional news

The latest from Health Enterprise East and Medilink UK

opinion

How the sensor industry changed the game

13.

Regulatory update

NSF starts a brand new regular column

14.

On the cover

Two firms, one mission: Industry 4.0 for medtech

29.

Digital Health Age

Digital medication firm launching in the UK

features

MED-TECH

16.

INNOVATION | NEWS

Catheters and stents

Inspection, and why it matters

19.

Compamed

Heading to Germany? Here’s all you need to know

20.

Med in Ireland

Eight startups from over the water

22.

Adhesives

What is ‘skin-to-thing’?

27.

Innovation

Predicting heart disease using saliva

44.

STARTR

Our guide to the latest young up-starts in medtech

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from The editor The wheels are turning…

[

n interesting new report claims that 72% of medtech firms believe they’re stuck in a price war of their own making – be it intentional or unintentional. The report, which comes from global pricing strategy consultancy Simon-Kucher & Partners, finds the trend in price wars in medtech to be well above average amongst all industries – perhaps unsurprisingly given the various complex reimbursement models for medical devices the world over.

In other news, Hampleton Partners recorded an increase in medtech M&A activity in the first half of 2019 (11% more than the second half of 2018). And guess what… the main driver for this activity seems to be… you guessed it, digital health. Preventative medicine software, algorithms, and EHR/hospital management equipment make up a major slice of the pie.

Hampleton Partners says that there are currently 38 VC-backed digital health unicorns worldwide, worth a combined total of $90.7 billion. If VCs and financial What I found most interesting buyers are behind the about the report though majority of the M&A activity was a finding that 75% of in the market, what makes medtechs surveyed said up the rest? One assumes they were digitising their a significant portion will products in order to cut costs be from those major brand and increase revenue and medtechs seeking new profit growth. Digital health, capabilities for cutting costs. as anyone in the medtech Why do the R&D yourself – industry will tell you, will it’s slow, costly, and chances have a major part to play in are, there’s already a startup virtually every type of medical out there doing just what you device in the next couple of need, ready to get scooped years. But in addition to the up. obvious revenue potential (think added-value), it actually On an unrelated note, this represents a very short-term issue of Med-Tech Innovation investment and long-term News is my last as editor. savings, both for suppliers I’m leaving the business and HCPs. for pastures new, though

I’m pleased to say I’m still going to be working in the rewarding life sciences sector. It’s been a pleasure curating this magazine, and I hope you continue to find it useful in your endeavours. With many thanks and best wishes, David Gray

DIGITAL HEALTH, AS ANYONE IN THE MEDTECH INDUSTRY WILL TELL YOU, WILL HAVE A MAJOR PART TO PLAY IN VIRTUALLY EVERY TYPE OF MEDICAL DEVICE IN THE NEXT COUPLE OF YEARS

For faster digital transformation, look to a 2019 Gartner Peer Insights Customers’ Choice.

See why InterSystems is a data platform of choice at InterSystems.com/gartner

InterSystems was named a January 2019 Gartner Peer Insights Customers’ Choice for Operational Database Management Systems (OPDBMS). The GARTNER PEER INSIGHTS CUSTOMERS’ CHOICE badge is a trademark and service mark of Gartner, Inc., and/or its affiliates, and is used herein with permission. All rights reserved. Gartner Peer Insights Customers’ Choice constitute the subjective opinions of individual end-user reviews, ratings, and data applied against a documented methodology; they neither represent the views of, nor constitute an endorsement by, Gartner or its affiliates. https://www.gartner.com/reviews/customers-choice/operational-dbms ©2019 InterSystems Corporation. All rights reserved. InterSystems is a registered trademark of InterSystems Corporation. All other trademarks are property of their respective owners. 5-19

NEWS AND VIEWS FROM HEALTH ENTERPRISE EAST

regional news

LICE GREENHALGH, INNOVATION MANAGER AT HEALTH ENTERPRISE EAST EXPLAINS HOW INNOVATORS CAN BEST USE THEIR FUNDING WHEN DEVELOPING MEDTECH PRODUCTS

Use it, don’t lose it Innovators looking to kickstart their ventures can often be confused on the best source of funding, and it’s easy to understand why. Several types of funding are available, each with their own pros and cons. Innovators in the early stages may be suited to research grants from medical research charities and hospital charitable funds. For more established innovations, the National Institute for Health Research offer a range of funding schemes to suit innovators at varying commercialisation stages. Organisations such as Innovate UK, fund later stage, business-led projects. Other funding options include bank finance and equity investment via crowdfunding, angel investment or venture capital. These funding streams have one commonality – they require a clear plan on how the finances will be used to meet the aims of the project. Although securing funding is important, an often-overlooked, concurrent task is to construct a detailed plan on how best to actually use it. Of course, upon securing investment, you should celebrate such an achievement

– but now the hard work begins. The most effective strategy is to seek out expert opinions where needed but maintain a firm grip on the budget to ensure the project’s milestones are achieved. In order to successfully allocate financial resources across various streams of product development, there are numerous things to consider. For example, ensuring you use competitively priced service providers: we would suggest obtaining three quotes from independent organisations for prototype design and development, making sure you understand what services are being included, if there are any extras to think about and if you agree with their proposals. Logistics are also key: what timescales are these providers working to, will you have adequate time to evaluate the prototype and gain appropriate feedback before funding runs out? Are you able to complete a clinical trial with the product and what type of quality accreditation does the partner have? Regulation is also an important factor. Medical devices are governed by national and international regulations and therefore must be tested and certified prior to going to market. The regulatory landscape is complex, often varying between regions, further confounded by changes in EU regulation and uncertainties caused by Brexit. Our advice would be to invest in regulatory advice early on, to avoid costly mistakes later down the line. Another tip is to make use of a qualified health economist who will be able to perform quantitative evaluations of your innovation. This type of cost-benefit analysis will be

invaluable when building a robust investment proposition and sourcing further funding. These three streams of design and prototyping, regulation and health economics are key areas in which to seek expert advice. However, you may be able to save in other areas by using your own knowledge. For example, instead of commissioning a piece of market research, you could conduct a small survey using your own connections. This will enable you to home in on the real questions and uncertainties behind your innovation. A final area in which to invest time and effort is intellectual property (IP) protection, utilising your expertise in order to protect your ideas. Using the patenting process as an example, we advise that you sit down with a patent agent to discuss your innovation at an early stage, ideally prepared with a list of similar inventions. This will give them a better understanding of the space you are in and allow for a fuller discussion around the patentable features of your innovation. Although the fees can seem expensive, IP protection will strengthen your commercial position and thus increase the value of your offering significantly. A firm grip on the finances is no mean feat, it is also not something to pursue alone. There is a wealth of support available to medtech innovators, including the Academic Health Science Networks, the Knowledge Transfer Networks, innovation incubators and other local entrepreneur groups. Health Enterprise East offers support to its NHS member trusts as well as consultancy services to medtech innovators and companies.

THE LATEST ANNOUNCEMENTS FROM THE MEDILINK UK COMMUNITY BOOK NOW: MEDILINK EAST MIDLANDS BUSINESS AWARDS 2019

LINKING UP

Thursday 5 December 2019 @ 7:00 pm - 11:00 pm, Radisson Blu East Midlands Airport The Medilink EM Business Awards are a night of celebration to highlight the best of the best in the life sciences sector for the East Midlands. The awards are comprised of seven categories: start up, export achievement, delivering innovation in to health and care, innovation, outstanding achievement, deal of the year and one to watch. The evening will consist of a drinks reception with a three course dinner included, and the awards ceremony will be hosted by acclaimed stand-up comedian Jimmy McGhie, whose onscreen TV credits include Russell Howard’s Good News. It is set to be an exciting evening of celebration with over 150 industry professionals expected to attend. Book online via the Medilink East Midlands website.

SWANSEA UNIVERSITY RESEARCHER WINS £60,000 FUNDING TO AID BIOMATERIAL RESEARCH A researcher at Mediwales member Swansea University is the third person in the institution’s history to win funding from the Royal Academy of Engineering. Dr Jonathan Widdowson, 26, who is also the CEO of company ProColl, won the funding of £60,000 that will aid his mission to supply biomaterials to help researchers create innovations such as artificial skin and organs with the group’s vegan-friendly materials. This includes a material based on collagen, a major component of connective tissues in the human body, for medical breakthroughs that could have potential in fields such as cancer drug testing to (autograft) organ replacement. Dr Widdowson has reportedly discovered a way to produce nonanimal derived products with just two people involved in production to meet global demand. SEHTA MEMBERS TO BENEFIT FROM LAW FIRM PARTNERSHIP The South East Health Technologies Alliance (SEHTA) has announced a partnership with Hill Dickinson LLP, an international healthcare law firm, to provide a strategic and advisory function for its members. The Hill Dickinson team will engage with companies, including early-stage startups, to offer mentorship and to support SEHTA in a variety of industry-led events. As part of this partnership, the two firms recently launched a ‘Medtech Business Support Programme’, which offers SMEs the opportunity to have a one hour mentor surgery with either SEHTA for business support or with Hill Dickinson for regulatory support, or both. This is a non-monetary value support programme, as services are offered in kind. Deadline to apply is 31st July.

GOT THE TIME, BUDDY? Medilink EM Member Renfrew Group International and Aseptika have worked together on the design and prototyping of the Activ8rlives BuddyWotch, which has now been granted a patent by the European Patent Office. BuddyWotch is a medicalgrade wearable device, for use by patients with severe cardiovascular and respiratory diseases This solution will provide expert pathways for use by both patient/ carers and the healthcare team to inform, manage and report the success of self-care plans so that patients can remain independent at home, with a better quality and more sustainable model of care. Such solutions must be truly wearable, comfortable, ergonomic, attractive, and suitable for use with minimal training by consumers, often age-related. Achieving this whilst developing the packaging design, mechanical engineering and design for production has been the Renfrew Group team’s priority. The product, called BuddyWotch will continuously monitor, record and transmit the patient’s physiological signs of blood oxygen, heart rate, breathing rate and temperature for 24-hoursa-day, 7-days-a-week. With its integrated 9-axis accelerometer, BuddyWotch tracks in real-time the patient’s physiological signs and how these change over time as the patient goes about daily life. As well as acting as an alert in case of medical emergencies, this information is used to continuously calculate the patient’s overall health and to detect whether the wearer’s health is getting better or is declining rapidly. The BuddyWotch can be used to test the patient in a GP clinic using the 6-minute walk test – something usually only performed in a laboratory setting during sessions at hospital outpatient clinic appointments.

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Our comprehensively-equipped Inspirations Lab is based in Cranfield but, if you can’t make it to Bedfordshire, our applications teams can visit your site so that you can still make the most of this offer.

MOTION | POSITIONING

A sixth sense? Nigel Whittle, Head of Healthcare & Medical at Plextek, outlines where and how advances in health sensing and monitoring tech could help start to revolutionise our care.

e are all only too aware that early detection is absolutely key to improving the survival rates of serious illness and disease, never more so when it comes to cancer and other life-threatening conditions. But how can developments in tech and healthcare devices catapult this critical part of our wellbeing into useful reality? Whereas popular wearable health devices, such as Fitbits and Garmins, are very effective at monitoring a range of accessible physiological parameters including heart rate, body temperature, blood pressure, sleep, movement and even oxygen saturation levels; they produce a distinct lack of actionable information. It is only when this data is combined and cross-referenced that we are able to build a more complete profile of our overall health. This integrated approach to health monitoring and measurement can also provide more accurate alerts to anomalous physiological changes, which can potentially identify deteriorating health or the onset of a serious medical problem. However, while this is very valuable to flag up concerns, most serious clinical diagnostic procedures require deeper

analyses, such as biochemical analysis of blood chemistry, or identification of marker molecules that are predictive of disease. If we can start to access that information nonintrusively, the benefits would include monitoring of chronic diseases such as diabetes, or early detection of cancer, which could have a profound impact on disease outcomes. WHERE ARE WE NOW? When it comes to general health monitoring, we are already seeing where technology is making an important contribution. For example, MonitorMe from Sanandco, developed with the help of Plextek, is a simple physiological monitoring system, which reports directly to a health provider or care body. And while the popularity of existing consumer wearables has waned, going forward we will start to see more integration with the ability to offer more effective health advisory alerts and sync up to other clinical diagnostic apps. Sleep trackers have also suffered from the lack of actionable data, making them more of a gimmick in the eye of the consumer. The challenge here is to be able to provide meaningful and useful data, which can be integrated with other health measurement

systems because, for example, monitoring sleep patterns isn’t much use unless it can be linked to other symptoms, such as blood pressure or heart rate, which could then suggest an underlying condition. For more detailed health monitoring, there are also some exciting areas of innovation being explored. Plextek is assisting in the development of a non-invasive device for measuring fluctuating glucose levels in patients’ blood, which uses electrical field sensors. Accurate non-invasive procedures are the holy grail here and would have a profound effect on the lives of those with the disease. Owlstone Medical has developed breath biopsy technology to obtain deep biochemical information from excretion products. But it has now refined detection devices to identify Volatile Organic Compounds from samples of our breath that may indicate underlying diseases and have the capacity to revolutionise early diagnosis. Challenges in this field include the reliance on the detection of key biomarkers for the diagnosis and prognosis of underlying health issues. Innovative ways of measuring and monitoring these molecules through advancing technologies could well lead to improved

early detection rates for a whole range of diseases, impacting significantly on survival rates. LOOKING FORWARD As for the future, the next five to 10 years are likely to see the increasing integration of unobtrusive physiological monitoring systems, perhaps based around relatively few core integrators such as the Apple Watch or Amazon Alexa. The information could then be used to trigger alerts to potential illnesses and allow for detailed investigation. As a result, an increasing amount of diagnosis is then likely to be performed remotely, in parallel with the increased usage of medical diagnostic apps. In turn, this could go on to increase the remoteness of physicians from their patients, allowing them to reach more specialists worldwide and domestically reduce the burden on outpatient departments in hospitals, for example. Controversially, the opportunities to obtain early information could be outweighed by an increased burden generated by the ‘worried well’ and an increased capacity for detailed health monitoring could put additional strain on the health service in terms of front end diagnosis and an increased use of medical facilities.

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Innovation in Miniature

THE X FACTOR Oli Hudson, of Wilmington Healthcare, explores the impact of NHSX, the NHS’s new joint organisation for digital, data and technology.

HSX which is designed to drive digital transformation within NHS health and social care, enabling patients and staff to benefit from the latest digital systems and technology, was officially launched in July. NHSX, which unites teams from the Department of Health and Social Care (DHSC), NHS England (NHSE) and NHS Improvement (NHSI), will help to deliver key aspects of the Long-term Plan. These include population health strategies, which will necessitate the collection and analysis of in-depth population data, to help the NHS better understand local health and social care needs, and plan and budget accordingly. DATA SHARING Sharing NHS patient data with industry to help improve care has been the subject of much controversy in recent years. However, in July, it was announced that NHSX had assumed new controls in this area. The details were revealed in guidance from DHSC, which said that NHSX would become “a national centre for expertise” to provide advice to the NHS on sharing patient data. The guidance also reiterated the DHSC’s ban on trusts striking their own exclusive deals. Other areas that

NHSX will be involved in will include supporting the uptake of digital initiatives such as Local Health and Care Records (LHCRs), which will be informed by the work of the five Local Health and Care Record Exemplars (LHCRE) that were announced by NHS England last year. These joined up patient records have significant implications for the MedTech industry since they will integrate information provided by devices and equipment, ranging from ultrasound scanners to pacemakers, with a patient’s full health and social care history. DRIVING INNOVATION Sharing patient data at an earlier stage, particularly between primary and secondary care, is key to ensuring that innovations are effective and delivering good outcomes. In line with this, NHSX will support organisations such as the Accelerated Access Collaborative (AAC) which was set up last year to help the NHS fast-track innovative drugs, devices, diagnostics and digital products. Since its inception, the AAC has already selected and supported 12 ‘rapid uptake products’ to increase their use within the NHS. These include a cost-saving device called Urolift for lower urinary tract symptoms of benign prostatic hyperplasia. NHSX will also

assist Academic Health Science Networks (AHSNs) which are playing a central role in the AAC by supporting the local uptake of technologies and helping to identify the next generation of innovations that can be considered for future adoption by the AAC. NHSX’s work in this area will be particularly valuable for innovative MedTech devices that are designed for use on small cohorts of patients and involve new surgical techniques. In the past, it has been notoriously difficult to generate a robust evidence base for these kinds of products, particularly when patient data has not been joined-up. However, NHSX aims to ensure that, for example, positive patient outcomes for a MedTech device used in secondary care can be viewed seamlessly alongside any complications that may have arisen at a later stage and been managed in primary care. These joined up patient records will enable more comprehensive datasets and assist the aims of both the AAC and AHSNs. They are good news for MedTech companies, since they will enable them to demonstrate positive outcomes at scale across whole care pathways. This is of paramount importance for proving the value of a product, particularly if it is more expensive than its competitors.

NHSX will also work with the AAC in jointly leading the new National Artificial Intelligence (AI) Lab, which was recently announced by Health and Social Care Secretary Matt Hancock. AI will support clinical decision-making on surgical pathways since it will enable clinicians to better determine what type of surgery to perform for particular patients and the risks associated with it. Elsewhere, NHSX is also working with NHSE on the procurement of interoperable IT systems, which are essential for delivering integrated care. In August, NHSX and NHSE published a list of accredited suppliers of electronic patient record solutions, designed “to give purchasers in the NHS more confidence in their route to digitisation”. CONCLUSION Although NHSX is a new initiative and its work has only just begun, it is already instigating significant changes to help the NHS realise its digital transformation goals, particularly with regards to data. This has huge implications for the MedTech industry since it will enable companies to build a solid evidence base to demonstrate the value of their products across the whole care pathway for specific cohorts of patients. This will be crucial in helping them to differentiate their products in a highly competitive market.

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IN THE FIRST OF A NEW REGULAR SERIES FROM NSF INTERNATIONAL, HOWARD BROADBRIDGE, PRINCIPAL – CLIENT RELATIONSHIPS, EUROPE, ARGUES THAT IT’S NEVER TOO EARLY TO MAKE FRIENDS WITH COMPLIANCE.

REGULATORY UPDATE

PRODUCT DEVELOPMENT

MAKING COMPLIANCE YOUR FRIEND

ringing a medical device or in-vitro diagnostic product (IVD) to market from early concept to full commercialisation is a complex task, whether it be within a start-up or a corporate giant. Apart from needing input from different areas of expertise, it requires the developers to consider the multiple factors which will influence the process and ultimately shape the product and the way it is presented to the customer or end user. These may include engineering (device and software), sales and marketing, finance, quality assurance and manufacturing – but will definitely require input from a regulatory perspective. The key question is: when’s best to address the regulatory issue? The answer to the question posed above is that it’s never too early. Whatever the product, it will need to comply with the regulations of the jurisdiction in which it is marketed, whether it be FDA, CFDA, MDR or IVDR. The earlier compliance is built in, the lower the likelihood of a product coming up against a regulatory hurdle at a stage in the development process when design changes would be far more costly. A simple example would be the use of certain chemicals within a product. Via the MDR, the European Commission will soon regulate the use of certain chemicals within medical products due to their toxicity if they

come into contact with human tissue. For instance, phthalates are known to be endocrine disrupters and a full risk-benefit assessment is required if they are used. A decision to remove them at, say, design transfer stage would be disastrous for the product development process, causing long delays and potentially a loss of budgeted revenue. For IVDs, there are stringent new requirements for performance evaluations laid down within the IVDR which will be applied fully in May 2022. These must demonstrate that the product will provide clinical benefit for the IVD to be regarded as compliant. Undertaking the evaluations as early as possible in the development cycle will avoid the manufacturer going back to the drawing board – and again, incurring additional costs and delays. Robyn Meurant, Executive Director at NSF commented: “Regulation is there to ensure the patient benefits from the use of an IVD. Understanding patient and user needs from the beginning of design and development means you can have an IVD that is both wanted (meaning easier to sell) and should face fewer regulatory barriers (meaning faster to market)”. Although it is not something marketing managers would normally focus on when developing strategy (indeed,

regulatory affairs is often regarded by some as a hindrance), compliance with standards can also be turned into a valuable product feature. A manufacturer can use thorough and consistent adherence to product standards and regulations to differentiate its product from others in the market. By developing products that have compliance built-in and nurturing a culture of regulatory compliance within an organization, a manufacturer can build the trust of both end-users and other links in the supply chain such as distributors and importers. This can not only encourage sales growth, but will also protect margins by avoiding costly quick fixes when a compliance issue is highlighted in an audit. It will also contribute to protecting human health by reducing risk. I have described how building in compliance can speed up commercialization of an idea, avoid unnecessary, costly re-designs and be used as a product differentiator. Adaptation to a changing regulatory landscape can become second nature, making it easier to react. So, in the end, regulatory compliance can be your friend, rather than being seen as an irritating intruder, hell-bent on disrupting the launch of your beautiful new product.

INDUSTRY 4.0

WORKING TOGETHER IN PERFECT HARMONY

itsubishi Electric and Riverside Medical Packaging have once again teamed up on a project to enhance efficiency. The new Shawpak thermopackaging machine developed by Riverside Medical Packaging allows manufacturers to replace a 20m long packing line with a single unit under 2m in length. A compact integrated control system developed by Mitsubishi Electric is key to optimising the machine’s performance while keeping within a small target size envelope. Based in Derby in the East Midlands, UK, Riverside Medical Packaging is specialised in contract manufacturing and machine development for the healthcare industry. From facilities specifically tailored for the manufacture of medical packaging and products, the

company develops intelligent and innovative solutions for producing, packaging and sterilising single use medical devices.

The reduced footprint of the new machine can release a large amount of valuable floor space in clean-room production environments, offering significant cost and productivity advantages to operators. “The Shawpak helps customers reduce the cost of maintaining a cleanroom production environment and to maximise their return on investment,” said David Shaw, CEO at Riverside Medical Packaging. The Shawpak has a compact size and flexible layout that enables it to be configured in many ways to suit individual requirements. Thanks to a rotary format, Shawpak machines start at 1.5m long and can occupy less than 2m2 of floorspace. Ivor Rowe, technical manager at Riverside, said: “A comparable FFS machine can be anywhere from 7m to 20m in length depending on the packaging process requirements, occupying a working space of up to 40m2. As a result, a given cleanroom space can fit six times more packing machines with a Shawpak design, increasing both productivity and throughput.” The Shawpak models are compact thermoforming sealing machines that can be loaded manually, or for increased speed, by an integrated robot. The key innovation is the forming, packing and sealing process which is now carried out on a drum, rather than a linear conveyor system. The rotary motion of the drum and the precision indexing of the sealing film are synchronised using Mitsubishi Electric servo control, while the product and package manipulation uses suction. The

product to be packed is loaded on top of the drum and the finished packet is ejected into a discharge conveyor underneath. The webs of packaging material (such as PET or polyethylene sheets) plus the forming, sealing and cutting stations are positioned around the drum. In developing the machine, the management team says it was confident that the market for such a product existed, but knew that the automation package would be a key part of the development. “As this was a completely new concept for us, we needed an automation solution provider that could supply not only the PLC, servo and indexing systems, but also a cost-effective robot integration package,” said David Shaw. “Having developed the initial concept, we turned to Mitsubishi Electric to help us develop our vision for a highly compact design into a fast, efficient, robust and reliable machine,” he continued. “We relied heavily on Mitsubishi Electric to realise this project.”

Mitsubishi Electric was involved in the development of automation for the Shawpak machine right from the initial planning stages, developing the strategy and addressing the project’s challenges. These included delivering the extended functionality in the restricted space. Stephen Thornton, key account manager at Mitsubishi Electric, said: “The size of the control panel in the Shawpak is not only much smaller than in a traditional FFS machine, but one of the most compact we have ever seen. For this reason, we suggested using the MELSEC L-Series PLC to provide a compact solution with optimal performance.” The PLC is configured with a MELSEC Simple Motion module and MELSEC-WS safety modules, and connects to a Mitsubishi Electric GOT2000 operator terminal. There is also the option of a MELFA articulated arm robot for loading, which makes it possible to improve productivity while maintaining a controlled environment in the cleanroom more easily. This, too, is controlled via the PLC. All components are connected via a CC-Link open control network

INCREASED VERSATILITY AND FLEXIBILITY The new rotary design of Shawpak increases versatility and flexibility during packaging operations. Different forming drums with cavities of various dimensions can be supplied. These can be easily removed and replaced to pack objects of different sizes and shapes on the same machine. In addition, the new concept ensures that every piece of packaging material is used, reducing the amount of waste from cut packaging material experienced using other designs. Speaking about the relationship with Mitsubishi Electric, Rowe said: “The creation of such a machine would have not been possible without the support from Mitsubishi Electric and its range of automation solutions. We look forward to continuing to work together on Shawpak and future projects that will provide solutions for the packaging industry.”

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CATHETERS AND STENTS

INSPECTION TIME

isual inspection of catheters and stents continues to play a key role in quality control, as Ash Technologies explains. High definition imaging technology combined with inspection and measurement software has enabled digital microscopes to become an essential tool in quality control, inspection and production for the medical device industry. IMPROVING STENT INSPECTION There are a number of common defects which occur during the manufacture of stents, such as cracks, pits, score marks and scratches. It is essential that these defective stents are repaired or rejected from production. High resolution imaging, high magnification, large field of view and lighting are important factors for stent inspection. With Full HD 1080p at 60 frames per second, the Omni provides the perfect resolution to see defects and reduce any lag effect which can disorientate the operator. Lighting is also critical in achieving a sharp image. Diffused LED lighting reduces reflection on the stent surface and greatly improves the image clarity. The Omni digital microscope has a large magnification range and large field of view, which makes it easier to switch from an overview of the stent to a closeup view of a particular area. This in turn saves time as the operator can quickly identify a problem area and focus in on it. One of the challenges when visually inspecting a stent is its cylindrical shape. A convenient way to manoeuvre the stent is by using a rolling stage. This allows the operator to easily rotate the

stent and inspect all areas for defects. IMPROVING BALLOON CATHETER INSPECTION The manufacture of balloon catheters is a complicated process that can occasionally result in defective products. Common defects which occur during the manufacturing of balloon catheters include gel spots, “fish eyes” and foreign particles. Due to the safety critical nature of balloon catheters it is essential that all defects are eliminated before being shipped. Balloon defects can often be difficult to identify and categorise with traditional inspection tools. However digital microscopes provide an effective solution to inspect and measure balloon catheters. Polarised lighting is very useful for detecting surface defects in materials like balloons. The polarisation interference patterns uncover common defects such as gel spots and ‘fish eyes’. This technique involves using a polarising filter on both the lens and sub stage light. The lens polarising filter is rotated to produce the interference patterns. MEASUREMENT OF MEDICAL DEVICE PARTS Omni’s integrated measurement software can be used to carry out measurements of stent struts and to add text if something needs to be labelled. Technical drawings of medical device parts can be imported as DXF files and used to create overlay templates with tolerance limits ensuring continuity of quality control from the design of the part. Measurement overlays of specific part dimensions can also be created to enable a qualitative inspection against on-screen templates. These overlay templates can be configured with part-specific

camera and lighting parameters to ensure reproducibility and standardisation of inspection conditions. A repeatable inspection process ensures produced parts are of consistent quality. The automatic edge detection feature in the Omni measurement software ensures that measurements are repeatable thus reducing variability between operators. Digital microscopes are also appealing for the medical device industry, due to their efficiency. The Omnis can maintain calibration whilst zooming, so there is no need for time consuming recalibrations between changing magnifications. All data captured using the Omni digital microscope can be saved to the network for efficiency or stored on internal and external memory as required. Advantages that digital microscopes can offer medical device inspection processes: Improved ergonomics: Operators can inspect and analyse samples while sitting or standing comfortably for longer periods of time. Improved workflow efficiency: Reduces the number of steps and tools involved in inspection and analysis through integrated, easy to use inspection and measurement software applications. Documentation of inspection: Offers traceability and documentation of inspection and analysis through image capture for reporting and quality control purposes. User control: Offers improved traceability and control if many different users work with the same microscope. Key applications for digital microscopes within the medical device industry include: • I nspection of the surface of a medical device to detect defects •M easurement of medical device parts

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COMPAMED

COMPAMED TO FOCUS ON FUTURISTIC HOSPITALS

ON 10 JULY 2019, THE COMPAMED INNOVATION FORUM TOOK PLACE AT THE HELIOS CLINIC IN KREFELD AND FOCUSSED ON HIGH-TECH SOLUTIONS FOR HOSPITALS.

he forum, which acts as a taster of the themes and conversations taking place during the annual trade show in Düsseldorf, aims to create a “direct dialogue between the manufacturers and developers of technical solutions and the end product users”, according to the organisers. Not compact enough, not flexible enough, too expensive, cannot be integrated sensibly into operational procedures on the wards; these were some of the shortcomings of current medical tech identified as part of the forum. The first introductory discussion of the day suggested that high-tech medical technology in particular often seems to have been developed at cross purposes to the real needs of medical professionals. Franziska Niederschelp from the Helios Clinic presented the digitisation measures that have been implemented and the progress within the Helios Group. In the future, said Niederschelp, voice assistance systems for doctor’s letters and file management will play a particular role. A further focal point is the patient data gained from medical devices, laboratories and wards, which has to be bundled automatically and combined digitally.

Anaesthetist Dr Jens Ebnet raised awareness of the particular demands medical technology faces in acute situations. As lack of acceptance may give rise to risks, it is necessary to sufficiently involve specialist doctors in the development of automated, data-processing medical devices. Using Swordcath, his own development of an intuitive system for inserting blood catheters, as an example, he also criticised regulatory hurdles and the lack of political support for small and mid-sized companies. Meanwhile in her talk, Maren Gessler from the Helios Centre for Research and Innovation in Wuppertal explained that there are options to support and fund innovative concepts and ideas. The second session centred on technologies that may offer innovative opportunities for application in diagnostics and therapies. Swiss company CSEM has developed an optical method of reliably monitoring blood pressure. The method uses the light of a conventional smartphone camera via an app. Eike Kottkamp from InnoME explained the advantages of single-use sensor products: in fields of use that do not require high precision measurements, single-use sensors are attractive alternatives to elaborate and expensive sterilisation processes and open up new fields of application, for example under wound dressings. Dr Dirk Janasek from ISAS e.V. presented an innovative procedure for reliable haemophilia testing. Michael Görtz from the Fraunhofer Institute for Microelectronic Circuits and Systems explained how sensor implants are able to continuously monitor functions such as blood pressure, intraocular pressure and cerebral

pressure and support therapy measures. Among other topics, Dr. Heike Kreher from Micronit explained how microfluidic chips used in rapid tests can identify a subtype of leukaemia, for example, and open up timely therapy measures for patients. Another major theme was the development of products that are already market-ready and successfully in use – including in Krefeld. The spectrum ranges from intelligent home-alert systems, WLAN connections for medical-technical devices, an in-house logistics system that automatically prepares the medication doses for inpatients, an infrared-based system that discretely monitors the rooms of patients who are at risk of falling, innovative visitation trolleys for hospital staff and robotics systems that support paraplegic patients. The lively and productive discussions in between the talks emphasised the tremendous need for communication between users and manufacturers. Almost 800 exhibitors from 40 countries are expected to attend Compamed 2019 in halls 8a and 8b at Messe Düsseldorf. Compamed takes place at the same time as the world’s biggest medical trade fair, Medica 2019.

med in ireland

SUPER

ed In Ireland, organised by Enterprise Ireland, is returning for 2020 with a stellar lineup and an impressive exhibition space. More than 800 executives from the global medical technology and healthcare sectors will attend the one-day event this October. The event provides an opportunity for international visitors to experience the future of medtech, in a country acknowledged as a global medtech hub. To give readers a flavoUr of the expertise on offer, Enterprise Ireland shines the spotlight on just eight of the medtech startups making waves in the country.

COROFLO Coroflo has developed a groundbreaking breastfeeding monitor, the Coro, which can accurately measure exactly how much breast milk a baby is consuming. The Coro is the first breastfeeding monitor in the world that can give mothers accurate, precise, and real-time data about milk supply. Coroflo has already received Richard Branson’s seal of approval and raised €900,000 in

CAREFOLK The platform developed by Carefolk is for people who care, quite literally. Designed for both healthcare professionals and carers, the platform provides access to six products that can be used independently or together on the platform, integrating and talking to one another to create one perfectly formed system. “We’ve built a multi-tenancy integrated care platform that

NEURENT MEDICAL While you might not have heard the term rhinitis, if you have not suffered from the condition yourself, you almost certainly know someone who has. The term describes an inflammatory condition on the inside of the nose that results in congestion or rhinorrhoea, and affects roughly one in five people across the world. Based in Galway, on Ireland’s west coast, Neurent Medical is

seed funding at a €4m valuation. “One of the main obstacles to successful breastfeeding is a concern about low supply, with some mothers uncertain about how much milk their baby is getting,” explains CEO, Rosanne Longmore.

seamlessly integrates care teams, single care professionals, community and social services, and families,” CEO Owen O’Doherty explains. “The platform also contains ‘Carefolk Community’, which allows caregivers to connect and share.”

developing a minimally invasive solution for the condition, which has the potential to revolutionise the way in which patients are treated, offering a better quality of life for millions of people. “It’s a disruptive device play in a pharma world,” says co-founder and CEO Brian Shields, who established Neurent Medical with David Townley in 2015.

med in ireland

TIPPYTALK Founded by Rob Laffan, father of a five-year-old girl with non-verbal autism, TippyTalk helps other nonverbal children to communicate. The technology translates pictures into text messages, which are sent to the phone of a family member or caregiver. The app helps a person who is non-verbal to communicate and express a

desire, want, need or feeling. “We are the next generation of augmented alternative communication (AAC) for people who are nonverbal,” Rob explains. “Once upon a time, the only way to communicate using AAC was face-to-face but our platform allows users to communicate with anyone, anywhere, at any time.”

INCEREB Incereb is developing a range of paediatric, neonatal and foetal sensors for EEG monitoring that can be applied in minutes, with minimal training. Previously, attaching EEGs to a baby’s head to determine brain function would take time and training, and would be uncomfortable for the child. Incereb set out to change that. “Having worked in neurophysiology for almost 20 years, with almost 8 years in paediatrics and neonatal ICU,

HEALTHBEACON Managing medication can be tricky, even for those who only need to take one tablet per day. When self-injection and dynamic schedules are involved, managing medication can be a huge barrier to successful treatment. With a 96% patient acceptance rate, HealthBeacon – described as a ‘sharps bin’ for those who self-inject at home – is the result of some tinkering and a lot of effort, according to founder Jim Joyce.

“After going a few rounds as mad scientists, we found a practical solution that helped patients take their medications on schedule,” he explains. “We could see the data impact immediately as we increased a patient’s probability that they would remain on treatment and by remaining on treatment we could drive better outcomes. Now that we had an impactful product, it was time to build a company around it.”

CONNEXICON MEDICAL Connexicon Medical specialises in the manufacture of tissue adhesives and sealants for topical and internal applications. Its product, Indermil Flexifuze, is a liquid topical tissue adhesive used to close wounds that can

VIVASURE A more established start-up, having been around for five years, Vivasure makes polymer implants and delivery systems – primarily focused on minimally invasive vessel closure in cardiology, interventional radiology, and vascular surgery.

it was obvious that many NICU devices were simply adult devices scaled down for use on tiny babies,” says founder Jim Roche. “Incereb is the first EEG device of its type to be designed specifically for use on neonates in the NICU. It’s faster to apply, accurate, kinder to the baby, and makes EEG brain monitoring in the NICU available 24/7/365” The Incereb design has already celebrated a number of successes in the US and entered the South American market last year.

stay in place for five to eight days, acting as a physical barrier to microbial penetration. Part of a fastmoving and competitive market, the company has raised over €1.15m in funding to date.

In 2016, its first European product – a vascular closure device – saw investors back it to the value of over €16 million. The company aims to meet clinical requirements with a particular focus on arterial and venous closure devices, based on its patented PerQseal technology.

ADHESIVES

WHAT DO DEVELOPERS OF SKIN-CONTACT DEVICES NEED TO KNOW ABOUT THE DEVICE-TO-SKIN INTERFACE?

EDITH BIANCHI, GLOBAL BUSINESS DEVELOPMENT AT MED-S2T SOLUTIONS EXPLAINS.

Got skin in the game?

As technology transforms our life and our health, healthcare trends are changing. More and more wearable devices are being developed by leading innovative companies, with great aspirations to lead this revolution. Traditional medical devices are now being replaced by smart and versatile wearable devices used in various applications. This revolution is driven by some major trends such as aging population, chronic illness increase and the desire to improve life-quality and wellbeing. Another major driver of wearable technology is the Internet of Things (IoT). It is allowing collected data from ‘things’ to be connected to the cloud, where Artificial Intelligence (AI) can be used to identify trends and enable decisions to be made accordingly. This technological evolution has been integrated into the medical field and is known as the Internet of Medical Things (IoMT). This shift can potentially transform

medical field as we know it today. By using IoMT, we can generate and analyse the collected medical data in a way that was not possible otherwise. Such connected devices are enabling and enhancing possibilities of home-care as well as access to medical experts anywhere. In a world with aging population and massive health expenditures, IoMT may be the very desired means to cope with many of the subsequent challenges. This holds a tremendous value to improve patient personalised care and outcomes. It also carries the potential of creating an efficient way of health monitoring, promoting wellbeing, allowing real-time interventions, progress treatment and adherence and improving the management of chronic disease. Analysts are estimating the IoMT market will continue its growth trend and simultaneously the worldwide wearables market is forecast to continue its upward trajectory.

On many occasions, IoMT devices are presented in a concept of a wearable device used for applications such as monitoring, diagnostics, neuro-stimulation, smart infusion pumps for drug delivery etc. When developing such products, our starting point is the patient, in the focus of our product decisions. In most cases the device would be attached to the skin and many times would be used repeatedly. The patient’s ‘skin’ interface to the ‘thing’, has been coined by Med-S2T as ‘Skinto-Thing’. This crucial element is often overlooked by medical device developers, left for a later stage of design. However, it may be the determining factor of implementation of the entire device or technology. The challenge of adhering the device to the skin with medical grade materials in a conformable and cost-effective way, is critical to the success of such wearable devices.

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The fixation materials industry often describes such solutions as ‘stick-to-skin’ but it is a fairly narrow definition in my opinion.

Such a tailored solution requires a multidisciplinary approach and a firm understanding of clinical characteristics, biocompatible materials, human factors and usability as well as the ideal range of capable and reliable manufacturing technologies and suppliers. Most of R&D engineering team’s focus is rightfully directed to the device itself, to the computing and cloud technologies, to the electronics and to the gateway apps for collecting and analysing the data. Yet, engineering teams must be aware of S2T (Skin-toThing) challenges and assume responsibility to understand the requirements and process in developing an optimal Skinto-Thing solution. The intended wearing location, duration, target population and many other considerations, should dictate the solution, its components, materials, design and production technologies, and these would be better defined if initiated during early stages of development.

The fixation materials industry often describes such solutions as ‘stick-to-skin’ but it is a fairly narrow definiation in my opinion, even if not intended as such. It gives the impression of a simple sticking element while in fact, the challenge of a safe removal of materials as well as an appropriate and conformable attachment to the largest organ in our body – our skin – is not so straightforward. These challeges may be even greater when often the user will be an infant, an elderly patient suffering from health issues such as diabetes, cancer patients and other populations requiring special considerations. Anyone who has ever worn a bandaid on their finger for few hours, can witness the impact of breathability issues and meceration resulting in a wrinkled, whitish appearance to the skin in the treated area. It is obviously much more of a challenge when having a device attached with its weight, dimensions, location and the breathability barrier it creates. When professionally addressing the development of such skin interface device fixation, one should also be aware of the combination and stack-up of different layers of the patch as well the potential interaction between the different materials and manufacturing technologies. These may all have an impact on

the properties and biocompatibility of medical grade materials. This is a challenge which canot be simply adressed by reading the material data sheet. As described in Use of International Standard ISO 10993-1, “Biological evaluation of medical devices, the risk assessment should evaluate not only the materials used in the device, but also the processing of the materials, the manufacturing methods (including the sterilisation process), and any residuals from manufacturing aids used during the process. It takes a multidiciplinary approach and iterative process in order to achieve an optimal and cost-effecive solution with an optimal material selection, design and manufacturing process. A well defined solution and development process will assure an optimal solution which users would be able to easily adopt. It would also mean better time-to-market which is so crucial to any developed innovation. The awareness of ‘Skin-toThing’ and the understanding of its appropriate development process, will certainly make a tremendous contribution to the successful usage and healthbenefits of current technological breakthroughs in the medical device, fitness, healthcare and pharmaceuticals industries.

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INNOVATION

A HAND-HELD DEVICE TO PREDICT HEART FAILURE BASED ON SALIVA HAS BEEN DEVELOPED WITH THE AIM OF HELPING MILLIONS OF POTENTIAL SUFFERERS TAKE PREVENTATIVE MEASURES.

SPIT IT OUT

multi-partner deal has been signed to bring the technology to market. It contains nano-sensors on the tip of the diagnostic stick to measure heart disease biomarkers from saliva to predict the risk of heart disease, failure or heart attack, then warn users via an app. The collaboration is being led by an Australian start-up based in Melbourne called ESN Cleer, with RMIT University and the Innovative Manufacturing Cooperative Research Centre (IMCRC) researching and developing the device for pilot manufacture, with expectations it will hit market by 2021. ESN Cleer CEO, Leopoldt de Bruin, said the collaboration represented some of the best minds in medical device innovation, design and manufacture. De Bruin said: “We’re really pleased to be able to bring these strands together in addressing such a major global health challenge. “Of the 400 million people who suffer from cardiovascular

disease globally, only 16% of cases are due to genetic traits. This underlines how much room there is to improve on screening and prevention, which is where this device could have such an impact.” Cardiovascular disease currently accounts for nearly one-third of all global disease deaths each year. It is hoped the device will be able to predict cancer risk in the future. Research co-director of RMIT’s Functional Materials and Microsystems Research Group, Professor Sharath Sriram, said this was the first portable heart disease test with such high levels of accuracy. The sensing technology, developed at RMIT’s MicroNano Research Facility, was validated in the lab to measure biomarker concentrations a thousand times more precisely than levels in human body fluids. Sriram said: “This marks a big step forward in technology for screening.

conducted after a heart failure episode. Such reactive testing is too late, leaving people with debilitating illness or leading to deaths.” “Prevention is always better than cure, which is where this technology comes in, adding accurate prediction to the mix.” The IMCRC funding, which matches contributions from ESN Cleer, is enabling a $3.5 million project investment into addressing the challenge of manufacturing and large-scale production of the diagnostic swabs. David Chuter, CEO and managing director at the IMCRC: “Utilising advanced materials and adopting high-precision, automated manufacturing processes will allow the swabs to be high value and at a competitive cost.”

“Often, blood tests are only

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DIGITAL HEALTH AGE