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Issue 31 | Jan/Feb 2017












when The chips are down The lab-on-chip competition with the big pay out

Serving the UK and Ireland’s £27bn medical technology industries

PLUS Why you need usability testing Staying safe in the cyber world

Inside the device that healed her heart is our relentless attention to detail.

When Anna was diagnosed with a ventricular septal defect, a septal occluder made with Fort Wayne Metals Nitinol wire closed the hole between the chambers of her heart, enabling it to pump normally. Nitinol wire for septal occluders has to be nothing short of perfect. It must withstand high compressive force during deployment, recover to its original shape, and maintain fatigue and corrosion resistance to function reliably inside the heart for a lifetime. If you’re looking for the highest grade medical wire for your device, give us a call. We’ll put our relentless commitment to quality to work for you.



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from The editor IoT: it’s much more than wearables

[ UK manufacturing is off to a great start, despite the ongoing uncertainty surrounding Brexit. In fact, the sector contributed to a 1.1% rise in total production between November and December 2016, according to the Office for National Statistics. Commentators have even said that the figures represent the highest levels of optimism since June 2015. The strength of the UK economy at the close of the year has been attributed in part to a strong final quarter for the manufacturing sector. So how does the UK maintain this momentum in order to weather the storm of Brexit? IoT technologies may just hold the key. We know that in medtech, IoT has become big business. From connected wearable devices, to hospital cyber security, the opportunities are mounting for innovative companies and startups to take a bite of the apple – indeed, even Apple itself is rumoured to be making a bigger play in the connected medical arena. But IoT has massive potential for manufacturers too.

In particular, despite the initial outlay on upgrades to equipment, the opportunities for cost savings are hard to ignore. In the same way that connected devices may soon be able to predict heart attacks before they occur, new manufacturing technology can alert the supplier/service organisation before the machine develops a fault.

But you’re not going to get the full enjoyment benefit, not to mention potential energy savings on your utility bills unless you methodically upgrade all systems throughout your house. This can, in some cases, be as extensive as fitting a new boiler, re-wiring the house, purchasing new appliances. It’s going to be costly, but the end-result looks great.

But it’s not just about improving operational efficiencies. Machine suppliers can offer added value to their customers by leveraging the data generated by the machine into a more consultative service.

It’s the same for manufacturers. If your IT infrastructure is seriously out-of-date, you may have more work to do in the short-term.

This can result in efficiencies, product quality improvements and perhaps even new part design capabilities.

As we race towards Med-Tech Innovation Expo I’ll be looking out for news from our readers and contributors as they take steps to make their processes smart.

Investing in smart manufacturing and IoT comes with a warning, however. Simply retrofitting a couple of smart components is not always going to be enough to get the real benefit. Look at smart homes, as an example of this. You can buy an Amazon Echo speaker, and a few expensive lightbulbs, and bingo! Technically, you now have a smart home.

And on that note, I’d like to conclude this editorial by saying thank you to those in the sector who have given me such a warm welcome to Med-Tech Innovation since I took the helm in December. I hope I can continue the longestablished standard of bringing quality, useful content to this futuristic market.


I N N O VAT I O N HOW TO CONTACT THE TEAM editor | dave gray +44 (0) 1244 680 222 reporter | reece armstrong +44 (0) 1244 680 222 group editor | lu rahman +44 (0) 1244 680 222 sales director | colin martin +44 (0) 1293 710 042 art | sam hamlyn +44 (0) 1244 680 222 publisher | duncan wood Rapid Medtech Communications Ltd. Carlton House, Sandpiper Way, Chester Business Park, Chester CH4 9QE Subscription: Med-Tech Innovation is free to qualified readers in the UK and Ireland. Register to receive copies at or e-mail: 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 herein or for any opinion expressed. ©Rapid Medtech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher.

ISSN 2046-5424 4

It’s Show Time 12-20

We kick off Med-Tech Innovation Expo 26-27 April 2017


NEWS ROUNDUP The rugby head guard with medtech credentials


FOUR GOOD REASONS To engage in usability testing

Contents : Jan/Feb 2017


TAKE THE TUBE Top processing tips for medical tubing


Q&A MTI sits down with ConvaTec to discuss the group’s acquisition of EuroTec Beheer




GALLERY This year’s expo in pictures

TALKING TECHNICAL Expo exhibitors on product development with precision technology

CRYSTAL VISION Owen Mumford gazes into its crystal ball




ON THE COVER The lab-on-chip competition making headlines

THE HOSPITAL OF THE FUTURE Industry and academia team up

STAY SAFE How to handle cybersecurity in medical devices



The Medical Technology Event Med-Tech Innovation Expo is the UK and Ireland’s leading showcase for medical technology and innovation – it is the only event that serves the whole of the £27bn UK and Irish medical technology sector. Med-Tech Innovation Expo brings together stakeholders from the medical and healthcare sectors to source products, explore new ideas, understand emerging technologies and talk to over 150 companies representing the supply chain from the ideation stage, through design and validation to manufacture. The centrepiece Med-Tech Innovation Conference, produced in association with Medilink, enhances the show floor experience with a world class programme.

Register now to see the entire spectrum of medical technology under one roof

Med-Tech Innovation NEWS

World first as rugby head guard gets medical device classification Contego Sports, a sports technology company based in Galway has launched what it says is the first rugby head guard that has been scientifically proven to provide impact protection and is now classed as a medical device. The company says the N-Pro – which is the world’s first head guard to be CE-marked under the medical device classification – reduces impact force to the head by up to 75% compared with other head guards on the market. N-Pro is a Class I, Rule I, medical device. In order to secure medical device classification, a product needs to meet three scientific parameters: Safety – that the product is safe for the user and other players; usability – that the product can be easily used and is fit for purpose and effectiveness – that the product works. The N-Pro uses Defentex impact management technology and is designed to dramatically reduce the G-Force energy transferred to a player’s head during linear and rotational impacts major factors in sports-induced brain injury.

Speaking to the Irish Independent, Contego Sports chief executive, Mark Ganly says he was inspired to set up the company to reduce rugby injuries when he heard of rugby player  John Fogarty who had to give up the sport due to concussion. He told the newspaper: “Six years ago, I read an interview with John Fogarty in the Sunday Independent. The human aspect of the story caught my attention as Fogarty was the same age as myself at the time - and he had a young family. The Fogarty story planted the seed with me and my wife and we started talking. At that point,

our careers were separate - and so we talked about how we might combine our skills to make a head guard product.” The device has caught the interest of Martin Raftery, chief medical officer, World Rugby. He told the Sports Industry Group: “Player welfare is World Rugby’s number one priority and we welcome any commitment to injury prevention research. We have watched the development of the N-Pro with interest over the last three years. We will monitor its use and look forward to seeing feedback.”

Smithers opens dedicated facility for medical device testing Smithers, a specialist in rubber, plastics and composites testing and a provider of chemical analysis, primary pack and shipment testing for medical devices, has opened a dedicated facility for its medical device testing services in Shawbury. The new facility expands on existing capabilities and will focus on highvolume routine medical device tests ranging from product development to post-market surveillance, in line with the new compliance requirements related to European legislation for drug delivery devices. 

 “The new laboratory is our latest investment in support of client demand in the medical device space,” said Sam Sheppard Fidler, vice president and general manager, Smithers Rapra and Smithers Pira Europe.

“The expansion affords more capacity for high-volume testing, enabling us the potential to triple the number of tests we can perform.”

 The laboratory team is welcoming customers and prospective clients to visit the new facility and see first-hand how high volume routine medical tests are expedited. Types of testing that will be handled at the new Shawbury facility include (but are not limited to): • • • • • • • • • •

Leakage Ease of assembly Actuation assessment Simulated use and ease of use Dose accuracy Tamper evidence assessment Verifications of product claims Visual inspections Dimensions Connection compatibility

Leading the team in the new lab is Chris Berry, Ph.D., manager, medical device physical testing. Dr. Berry has worked for Smithers for nine years and served previously as principal scientist at the Smithers Pira Packaging and Technical Services laboratory located in Leatherhead. As testing volume increases, Berry plans to bring additional employees on board over the course of the next 12-18 months. 7


TTP spin-out created to commercialise micropump technology The new spin-out from TTP Group will develop, license and manufacture second generation ‘Disc Pump’ technology used in medical devices TTP Group has announced the launch of TTP Ventus. The new spin-out has been formed to commercialise the second generation of The Technology Partnership’s (TTP) proprietary micropump technology, Disc Pump, which was showcased at MD&M West in February. The micropump platform, named Disc Pump, is “enabling disruptive new products across medical and industrial markets”, according to TTP. The technology has been designed to enable silent operation combined with exceptional pressure and flow. Disc Pump’s small size and light weight make the technology suitable for wearable products in particular. The second generation of Disc Pump delivers twice the flow rate for the same input power, doubling the efficiency of earlier designs. It maintains the technology’s silence, controllability and size, and incorporates an improved electrical connection.

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The technology platform has been recognised by the Institute of Physics, winning its inaugural Business Innovation Award in 2012. To exploit the potential of the Disc Pump platform TTP invested in developing a second-generation design and in establishing its own manufacturing facility. TTP Ventus is now being launched, establishing a new business focused on the development, licensing, and manufacture of the Disc Pump platform. James McCrone, managing director, TTP Ventus, said: “Disc Pump offers a unique combination of silent operation, ultra-smooth flow, instantaneous response, compact form-factor, and high performance. Our mission to work with entrepreneurial partners, both large and small, is to bring disruptive new products to market. We share TTP’s culture of technical excellence, innovation, and customer focus and are able to draw upon its 250 world-class scientists and engineers to accelerate the integration and development of our partners’ products.”

Med-Tech Innovation

Solenoid Valves for Micro Dispensing ● High speed operation, up to 1200 Hz ● Operating pressures up to 120 psi ● Wide range of seal materials ● 12 or 24 vdc The Lee VHS valves are designed for high speed, precision micro-dispensing of fluids. They are available with outlet ports for push on tubing, 062 Minstac fittings or with an integral jewelled orifice in three different diameters and are designed for a life of 250 million cycles. Innovation in Miniature

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Med-Tech Innovation TUBING

take the tube Steve Maxson of Graham Engineering Corporation shares his top tips for processing and workplace safety for fluoropolymer medical tubing.


ecently Graham Engineering Corporation has received a number of inquiries from medical tubing processors with an interest in venturing into the world of fluoropolymers. Materials such as FEP, PFA,


PVDF and ETFE are known for their excellent physical properties and hold promise for many medical applications, such as micro tubing for intravenous (IV) catheters and insulin infusion, single lumen and multi-lumen tubing

for endoscopy and cardiology devices, and heat shrink tubing used as a manufacturing aid for catheter reflow purposes. Our American Kuhne extrusion systems have been employed for such applications. There are some important considerations that we have identified regarding extrusion equipment and safety related to processing fluoropolymers. Components that come in contact with molten resin such as the die head, tooling, adapter, breaker plate, and screw should be made of corrosionresistant metals with high nickel content like Inconel 625 or Hastelloy C276. For corrosion protection of the extruder barrel, I recommend a tungsten carbide/nickelbased bimetallic barrel liner such as X800. For small medical extruders,

32 mm and smaller, the entire backing material of the bimetallic barrel is solid Inconel and the liner material is X800. The typical fluoropolymer screw is a singleflight design with a 3:1 compression ratio. In some cases a lowshear Saxton-type distributive mixer is included at the end of the screw. Although Inconel and Hastelloy are corrosion resistant, these specialty metals have low torsional strength compared to common screws that are made of 4140 or 4340 heattreated steel. For instance, Hastelloy 625 has a yield strength of approximately 52,000 psi (359 MPa), about half that of 4140 steel at 28-32 Rc. Inconel 625 is a little stronger than Hastelloy C276 but is not as corrosion resistant. Care must be taken to avoid screw breakage

Med-Tech Innovation TUBING

Figure 1 when using an Inconel or Hastelloy screw while processing other high temperature polymers that are not corrosive such as PEEK, Polysulfone (PSU), and Polyetherimide (PEI). For example, a 25mm extruder with a 5HP motor geared for 100RPM screw speed is very likely to snap a screw made from Hastelloy 625 during a cold start situation.  Fluoropolymers have high melting points. For instance, PFA has a melting point at about 581°F. The barrel set points for FEP are in the 600-740°F range; therefore the extruder barrel heaters should be made from cast bronze and rated up to 900°F. Due to the high operating temperatures, a special dual-layer barrel safety shroud should be used over the barrel to protect the operator from burns (See Figure 1).

Fluoropolymers are also highly susceptible to melt fracture (“shark skin” appearance) on the surface of tubing, caused by excessive shear in the die tooling gaps as output rates are increased (see image). The typical approach to avoiding melt fracture is to utilise larger tooling gaps, which means making the tubing with a larger drawdown. Tooling drawdowns of 3:1 to 20:1 are common for many polymers, whereas processors of fluoropolymers have used drawdowns of 50:1 or greater. Proper safety measures are important to consider when processing fluoropolymers. According to the “Guide to the Safe Handling of Fluoropolymer Resins” published by the Fluoropolymers Division of the Plastics Industry Association (formerly SPI), gases, vapours and

fumes released during the extrusion of fluoropolymers may be harmful to human health. Vapours and fumes released during extrusion and while cleaning the die head can cause flu-like symptoms (chills, headaches, fever) that typically pass within 24 to 48 hours. The corrosive gases should be captured immediately and removed with an exhaust ventilation system that includes extraction hoods, ducting, and a fan. Extraction hoods should be placed above the die head and, for large-diameter tubing, an additional extraction hood over the area where the tubing is cut to length. Sealed packages of fluoropolymer resins should only be opened in well ventilated areas. Consult the resin supplier’s MSDS for specific recommendations.

There are some important considerations that we have identified regarding extrusion equipment and safety related to processing fluoropolymers.


Med-Tech Innovation EXPO

Let’s start the show Darren Clark, chief executive at Medilink East Midlands offers an early glimpse at this year’s Med-Tech Innovation Conference, taking place at the heart of the show.


or the fifth consecutive year, the MedTech Innovation Conference for 2017 is being run in collaboration with Medilink UK, and we are delighted to be associated with such a prestigious event. Establishing itself as the leading national healthcare technologies conference, this is the event to attend for anybody wanting to stay up to date with trends and developments in the medtech industry, which is experiencing exponential growth, with more companies and more employees, than any other area of the life sciences sector. This conference, which combines experiences from those at large global corporations, with insight from national bodies such as the National Institute

for Health and Care Excellence (NICE) and the Association of British Healthcare Industries, is set to be the best yet. Day one will open with a session from the Office for Life Sciences. With Brexit looming and the Industrial Strategy green paper consultation in full swing, there has never been a more critical time for the industry. This once in a lifetime event will impact every single organisation involved in life sciences; find out about the government’s new hands-on approach to ensure the UK continues to be a world leader during this first session. We will also be joined by Tim Hodgetts CBE, medical director at Defence Medical Services. Tim will be providing a fascinating insight into how the Ministry of Defence rapidly adopts game-changing innovation in its work ‘repairing our seriously wounded’ and how this can be applied into the national health arena. For anybody involved in getting a product into the NHS, talks from Device Access UK, ABHI and Academy for Healthcare Science are not to be missed. Get updates on a new industry driven credentialing system which will affect any company engaging with the NHS, and hear tips from Michael Branagan-Harris, CEO, Devices Access UK, who says that achieving national adoption for your product or service isn’t the impossible task it may seem. Whether you’re an established business or you’re just starting out, what better companies to hear from than technology giants such as Philips, Microsoft, Stratasys and 3M. Bill Cruise, vice president, Western Europe 3M and chair of Medilink UK, will open


the conference on day two with some thoughts on current industry drivers, and share the experiences of one the world’s most innovative organisations. Sean O’Shea will provide Microsoft’s vision of the digital transformation of the healthcare sector, and additionally how smaller companies can take advantage of the opportunities to partner with Microsoft. The theme of digital health continues with Patrick Strauss, CEO, Illumitas and subject matter expert on the Internet of Things (IoT), exploring strategies for developing IoT in healthcare. Patrick will be followed by Keith Errey, from Isansys, explaining how vital it is to use technology to its full advantage to completely understand medical data. Other exciting speakers in a packed two day programme include Tom Clutton-Brock, chair of NICE Interventional Procedures Advisory Committee, voted one of the top 100 most influential people in healthcare; Giovanni Accardo, business unit director at Boston Scientific, who will give an insight into their revolutionary strategy to transform the acute healthcare pathway; Professor John Fisher CBE, director of the EPSRC Centre for Innovative Manufacturing in Medical Devices; and Dan Clark, professor of clinical engineering at The University of Nottingham and expert member of medical technology advisory Committee, NICE. On behalf of myself and the team, we hope that your visit to Med-Tech Innovation Expo 2017 is a successful one, and that the conference we have put together is of great value to all who attend.


Med-Tech Innovation Expo | 26-27 April 2017 Ricoh Arena, Coventry, UK


Qosina will exhibit on stand 41

Making Connections Qosina, a worldwide supplier of thousands of stock OEM components to the medical, bioprocessing and pharmaceutical industries, will be exhibiting for the third consecutive year at Med-Tech Innovation Expo in 2017. “The Med-Tech Innovation Expo is an important trade show for Qosina as it affords us the opportunity to meet with our customers from the United Kingdom in person,” said Scott Herskovitz, vice president of sales and marketing at Qosina. “Many of our clients attend this show, so we take full advantage of engaging with them to help us better understand the unique market requirements. Qosina is proud to be a supplier to the medical device industry leaders that are based here and pleased that this show gives us the opportunity to grow the relationships.”

“In today’s market, there are significant external forces that could influence our business,” said Herskovitz. “Now more than ever, it is important for us to understand what pressures our U.K. customers face and how we can better serve their needs as they respond to the ever-evolving changes in the medtech industry.” Qosina is headquartered in Ronkonkoma, New York, USA and offers free samples of its medical components, which include tubing connectors, luers, clamps, clips, check valves, stopcocks, hemostasis valves, tuohy borst adapters, swabs, spikes, syringes, tubing, bioprocessing accessories, compression fittings and the newly added ISO 80369-3 compatible ENFit products. Qosina also offers low minimum orders and just-in-time delivery.

medical devices needles and probes

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Med-Tech Innovation EXPO

On stand 12A, rose plastic will be introducing QuadroPack Tipline optimum protection for long surgical instruments and applications.

Ensinger, exhibiting on stand 50, will show components made of hightemperature plastics for medical and pharmaceutical applications.

On show on stand 50, IDC’s medical devices include a personal ECG heart monitor, technology for surgical instruments such as video laryngoscopes and surgical glue devices, and wearable technology for nerve damage patients.


Med-Tech Innovation EXPO


Med-Tech Innovation EXPO

Connect 2 Cleanrooms, stand 59a, designs and manufactures panel (monobloc) cleanrooms plus hard and soft wall cleanrooms in-house and delivers quality cleanroom solutions to meet the ISO 14644-1 standard required.

On stand 53a, Laser Micromachining will showcase the capabilities of its UK facility which provides product development and manufacturing services - laser machining, laser welding, 3D printing, laser tools and metrology.


Med-Tech Innovation EXPO

STERIS Laboratories, stand 47A, provides microbiological testing, chemical testing, and validation support services through its network of laboratories in Europe, Asia, Africa, and North America.

On stand 97, Oliver Healthcare Packaging will demonstrate that mounting cards can offer a good alternative to thermoformed tray solutions.

TLM Laser, stand 42, will display a holistic vision-assisted laser marking process called HELP (Holistic Enhanced Laser Process). This combination of pre-mark verification, followed by laser marking and then post-mark verification in a closed loop, provides a solution for producing and checking UDI information.


Med-Tech Innovation EXPO

Laser Micromachining will exhibit on stand 53a

Make it look easy Nadeem Rizvi, managing director at Laser Micromachining explains how product development can be made easier with precision micro-technologies.


he med-tech and bio-tech sectors are evolving rapidly with new advances continually being utilised for novel products. Companies bringing new devices to market can now access a wide range of precision micro-technologies from a single UK manufacturing facility at Laser Micromachining (LML). LML will be exhibiting at Med-Tech Innovation to showcase the following services which LML offers: l High l l l l

quality laser machining of all materials Direct, laser welding of thin metals 3D printing of custom parts Precision metrology of micro-parts Supply of bespoke laser tools

LASER MACHINING Critical functions of devices in the medical and bio-tech usually rely on the precision patterning, drilling, cutting or milling of materials such as polymers, metals, thin films or glasses (see figure 1). Figure 1: Laser machining of fluidic devices in polymer.

This material processing also has to be accomplished without melting of the material or damage/distortion to the device and this is possible with the correct choice of laser and the right processing method. LML has more than 12 years of experience in providing such high-quality machining solutions. 18

In addition to obtaining the correct feature geometry with micron-level accuracy, the laser process also has to be repeatable and reliable. The ability to take an initial demonstration into functioning prototype parts and then ultimately through to full device production is an important consideration when developing a product manufacturing route and LML has a proven capability in this regard. LASER WELDING Materials, mainly thick metals, have been welded together using lasers for many decades for macro applications but micro-products pose particular challenges which cannot be solved by using existing laser macro-welding techniques. This is mainly due to two factors: (a) medical and biotech parts usually use ultra-thin materials and (b) damage, especially undue heating or melting, has to be avoided due to the delicate nature of the products. Using a new generation of fibre lasers it is now possible to produce in situ welds on sensitive components without thermal distortion or damage to surrounding materials (see figure 2). With this pulsed fibre laser method, dozens of dissimilar thin metals can be laser welded with excellent weld strengths. The laser welding is carried out directly in air with no assist gas or any filler material being required, making this approach highly flexible and very convenient.

Figure 2: Laser welded thin steel foils.

Figure 3: 3D printed cassettes for laserproduced medical sensor devices. Using a combination of laser machining and laser welding, LML can now provide far more extensive solutions for product developments in the med-tech and bio-tech sectors, giving product designers many more innovative options with which to accomplish the functions which are required in complex devices. 3D PRINTING The overall additive manufacturing sector is growing at astounding rates and many new techniques are being brought out for manufacturing 3D parts from different materials. Although 3D-printing of micro-parts is not as mature, there are significant benefits to the micro-product designer in being able to get small complex parts made and LML now provides this service as part of the product development cycle. Since all micro-products have to interface to the real (macro) world at some stage, the housing of lasermade micro-parts is an important consideration. LML can now bring these elements together so that the laser-made, laser-welded parts can be designed and made to fit into various types of cassettes, cartridges or housings as shown in figure 3. Although the 3D printed parts may not be the ultimate high-volume solution, there is a strong benefit in assessing the entire product idea at an early stage of prototyping and LML can make this happen efficiently and in a flexible manner.

Mitsubishi Electric will exhibit on stand 54A

We are there, when reliability is of top priority. Image source: Robotronic AG

Our innovative sensor solutions make medical devices even safer and more efficient.

Rise of the machines Mitsubishi Electric will demonstrate a new compact ‘Direct Teach Pendant’ for small robots and a quality improving pick-to-light system for manual assembly tasks at the expo in Coventry this year.


amous for its efficient and reliable small articulated arm and SCARA robots, Mitsubishi Electric is now offering its latest development programming flexibility; a hand-held Direct Teach Pendant. It enables the operator to physically teach a standard, or clean room robot, movements and action sequences without a complex software interface. The RV2 Robot Direct Teach function enables operators to quickly and easily vary the capacity, volumes and types of products being produced or tested by a robot, making it ideal for both medical and laboratory applications, says the firm. From reliable robots to more consistent, error-free humans, Mitsubishi Electric will also be demonstrating its latest ‘Guided Operator Solutions’ system at the show. The system is dedicated to preventing mistakes in manual parts picking and assembly tasks and is enabling device manufacturers to actively improve their quality processes whilst also reducing operating costs.

To control picking sequences the system uses a combination of indicator lights, touch sensors, light curtains and door mechanisms that can be applied to parts bins. High resolution HMI screens are used to display assembly instructions and provide operator feedback, while PLC control allows for a scalable solution depending on the application’s complexity. The use of a PLC also allows for easy integration into existing automation and IT platforms, providing vital data for quality improvement and management systems. For the operator it makes each new assembly task far easier to complete quickly and accurately. Both applications are designed to improve production processes and assembly tasks for the medical, pharmaceutical and life science industries. Visitors to the show will however be able to form their own opinions based on direct experience, as there will be an interactive display on the Mitsubishi Electric stand (54a) for people to have a go at teaching a robot, and see Guided Operator Solutions components in action. 19

Med-Tech Innovation EXPO

comtec will exhibit on stand 50

A way with words Comtec - a specialist translation services provider, conveniently based in the Midlands - is exhibiting at Med-Tech Innovation Expo for the first time this year. Here, Comtec’s director, Sophie Howe (pictured) shares what attracted her to this event, what she hopes to learn from it, and where translations fit into the Med-Tech landscape.


e have longstanding relationships with a wide range of manufacturers in the medical sector and have built up an experienced team of specialist medical translators to support them on global projects in more than 200 languages. It has been a pleasure to be a part of those companies’ success in international markets, and naturally we would like to help others do the same. It’s an area that my team and I are seeing a lot of interest in and growth, and therefore Med-Tech Innovation Expo was a logical fit for us. We plan to further develop our medical translation services this year, so where better place to do this? We are also members of Medilink UK and they provided the catalyst for getting us involved: we will be sharing Stand 50 with them and other members. For me, MTI Expo, is a great opportunity to get a finger on the pulse of the med-tech sector – sorry for the medical pun! I’m interested in finding out more about the challenges


manufacturers face when exporting and growing their businesses overseas, and these insights will help us ensure our medical translation services are closely aligned with the sector. Translations are often viewed as ‘another thing to do’ on the endless ‘to do’ list for a company launching a product into an international market; but success, or failure, could rest on the quality of their translations. There are key quality, compliance and patient safety considerations, but also user experience factors to bear in mind. Our clients report increased acceptance of products when user information and marketing material is translated into native languages. It also increases the usability of products and patient safety. Regulatory changes are a considerable challenge for all healthcare and medical organisations. When driven by a plethora of local authorities, FDA (USA), CFDA (China), EU’s MDD, etc., it can be a minefield. I’ll be interested to hear from people visiting MTI Expo about how they manage

their translations in respect to this, and also different language requirements country-by-country. Having worked closely with companies in this sector, we established an efficient and effective translation process, and I hope we can help others develop strategies for dealing with this everchanging landscape. Given the stringent regulations around medical product information, when choosing a translation partner it is essential to find a specialist provider: one that can demonstrate clearly their best practices for quality assurance. My advice would be to expect at the minimum specialist medical translators; access to local in-market experts to capture specialist knowledge; quality standard procedures in place; and the use of Translation Memory or terminological databases to ensure accuracy and consistency. I think it’s an exciting time to be expanding into international markets, especially for the UK and Irish med-tech sectors. Although Brexit will have an impact - no doubt many at

MTI Expo will have opinions on this - there are great opportunities to be had. Translations fit across the entire product development lifecycle, from international R&D projects, through market research, patient focus groups, clinical trials, to compiling product literature, supporting training materials, software, labelling, and post-market feedback collection. Therefore, translations are a very important component of any international expansion strategy, and really should be on the agenda early in the planning stage. At Comtec we do work to very tight deadlines at times, but ideally any manufacturer that is planning to launch overseas should start having conversations with translation service providers sooner rather than later. MTI Expo is certainly a good opportunity to talk to my team and I about this, and get a timeline for your translation projects.

MEDILINK UK Medilink UK is the UK’s largest network of life science and health technology organisations, with a total of 1,500 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:

new product development and Magazinemarket research ●

or im altor● selecting and reaching your target market, whether it’s in the UK or abroad ere which means ● Clinical research and NHS procurement ortant ● Sourcing funding and finance or im altor

Medilink UK Awards 2017 26 April, Ricoh Arena, Coventry

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Med-Tech Innovation 2017: LOOKING AHEAD

crystal vision Oli Gould, design engineering team manager at Owen Mumford shares his observations for what lies ahead in the next twelve months. According to a new report published by business intelligence firm Visongain1, the global medical device market is expected to reach £320 billion this year, a significant increase from the total of £256 billion reached back in 2012. This growth suggests that the industry will see great opportunities for expansion in the next twelve months. How will wider trends in healthcare affect demand for medical devices, and how can companies in the medical device industry try to take advantage of this increased demand?


Prediction #1 Additional funding will support growth in the industry There will be increased support for development in the medical device sector from the government. For example, the UK Government will be investing an additional £2 billion per year in science and engineering between 2017 and 2020, supporting and encouraging growth in the fields of research2. According to the UK Prime Minister, Theresa May, this is part of a plan to position the UK as “the global go-to place for scientists, innovators and tech investors.” Alongside this move by the government, private companies are also investing in training and development for engineering skills, in order to close the skills gap that currently exists within the industry. The move provides a clear signal of intent that science and engineering will be at the forefront of the country’s future, with an evergrowing demand for skilled employees. In line with recent apprenticeship funding (projected to raise up to £3 billion a year by 2019-20), the government is offering support to encourage the development of science and engineering in the UK.

Med-Tech Innovation 2017: LOOKING AHEAD

Prediction #2 inued shift in nt There will be a co proach design how companies ap using 3D printing

and 3D ive manufacturing Advances in addit al device dic me vast in the printing have been ratching the we are still only sc arena already, but er. off n technologies ca surface that these efficient ing provides a costAdditive manufactur ts from uc od a wide range of pr ts, way of producing en on mp co d customised ing highly complex an tak is It . es vic de t runs of t single parts or shor uc od pr minant role in the an increasingly do ocess. pr ing tur fac nu ma development and to a wide ‘3D printing’ refers However, the term for design, s that can be used range of processe aknesses. we n strengths and each with their ow different 3D printing As the costs around nue to drop, more technologies conti periment t the chance to ex ge ll organisations wi oaches. e with various appr and gain experienc and e opportunities to us With this, growing ing ag ur co en ally increase, innovate will natur is Th nt. me re develop more use and mo and ntial for 3D printing se es is nt moveme pporting su in ing to scale up additive manufactur ng more idi ov pr in d lopment an new product deve ges. efficient design sta

Prediction #3 A growing focu s on the individ ual and personalis ed care Whilst there is still a long way to go, a positiv shift towards pe e rsonalised care is underway, as offerings are sh ifting from mas s generalisation to mass custom isation and prec ision. The end goal is to im prove treatmen t adherence, self-managemen t and efficacy, m aking the initial outcome positive. Whilst there is no ‘one size fits all’ appr oach, personal ised care will become more ac cessible in both diagnostic and therapeutic area s. This will prov ide patients with better fitting de vices that can im prove how and when they rece ive treatment. With a growing demand for sm aller and more convenient met hods of treatmen t, personalised care will focus on how to mon itor and deliver treatment in lin e with patient lif estyles. This includes analys ing the best met hod for patients, how th e end user inte racts with their devices over tim e, removing op tions that cause confusion and implementing ne w features that make treat ment easier. To gether, this will improve a patie nt’s self-manag ement system. This combinatio n of product de sign and psychology can help adherence to treatment regimes over tim e. This makes tre atments more successful for pa tients, for pharm aceutical companies and for healthcare pr oviders as well.

Prediction #4 Medical devices will get more connectivity Like many traditional products, manufacturers are looking at how connecting medical devices to the Internet can help in treatment programmes. Using Internet-based services can help with adherence to treatment regimes, while consumption of device consumables can also be tracked. Automatic ordering of replacement parts such as pen needles or other consumables can then be added. According to The U.S Food and Drug Administration, devices can go to market when there is a reasonable assurance that the benefits to patients outweigh the risks. These new connected devices have to be secure against unauthorised access or tampering. Medical devices must be protected against attacks, as the potential harm could be far higher. For this trend to be successful, manufacturers and healthcare providers must collaborate to identify cybersecurity risks and stop them from being exploited. With a growing industry, there inevitably comes an increasing level of competition. Medical device manufacturers will need to display how they can manage cost-effective design and development processes to deliver better products to tighter regulatory policies, especially in the emerging economies. By using knowledge and experience from today’s advanced technologies across design and manufacturing, medical device companies can improve their speed to market in 2017 and quickly respond to new changes and trends in the global marketplace.

References 1

Visiongain – “The Global Medical Device Market Will Reach $398.0BN In 2017 Predicts New Visiongain Report” available at https://www.‘The-globalmedical-devices-market-will-reach-398-0bn-in-2017’predicts-new-visiongain-report 2 – “PM announces major research boost to make Britain the go-to place for innovators and investors” available at government/news/pm-announces-a-2-billioninvestment-in-research-and-development 23

Med-Tech Innovation DESIGN

FOUR GOOD REASONS TO ENGAGE IN USABILITY TESTING Usability testing in a market research context can reveal deep insights into user experience and positively influence device design. Creative Medical Research’s Alper Hulusi considers the key benefits of usability testing for medical device manufacturers.


UNDERSTAND USABILITY IN AN EVERYDAY CONTEXT To understand usability, it’s critical to gain a deep understanding of how patients and healthcare professionals interact with devices from day to day. Market research agencies carry out a range of appropriate research methods (such as ethnography) to gain this information. For example, users may receive training on the device as they would in a real-life situation, and provide feedback via an interview. They might ask patients to provide a video diary so that usability can be tracked over a longer period and also observe them handling the device in their own environment. The skill of the market researcher is to extract the key insights that manufacturers need to improve the user experience and ultimately, the commercial success of the device.


IDENTIFY UNMET AND ILL-MET NEEDS FROM THE USER PERSPECTIVE By getting closer to patients through focus groups and interviews, market researchers can understand what truly drives people to seek out a certain device or to improve their adherence to it. For example, a CGM device may be technically very sophisticated, offering a wealth of potentially life changing data, but if it is bulky or catches on clothes then it may be hard to convince people to make the switch. In the ‘new era’ where patients may choose to self-fund, this is very useful information. For example, we may learn that making a device more discrete by making it available in a range of skin tones (as opposed to white) will have a big impact on the likelihood of someone buying it.

The skill of the market researcher is to extract the key insights that manufacturers need to improve the user experience and ultimately, the commercial success of the device.



INFORM YOUR MARKETING STRATEGY This benefit of usability testing relates to the above point and is imperative for marketing managers. Market research can help companies understand which of their marketing messages best resonate with patients and healthcare providers and provide invaluable insight to inform communications and collateral. For example, which taglines/statements are the most compelling? Which terms are seen as too technical or too simple? How do similar statements perform in different markets?

Med-Tech Innovation Q&A

opportunity knocks In January, British medical device manufacturer ConvaTec announced the acquisition of Dutch rival EuroTec Beheer, manufacturer of ostomy appliances for a purchase price of €25 million. Med-Tech Innovation sat down with Symeria Hudson, president, global franchises and innovation at ConvaTec to find out what the deal really means


IMPROVE COMMUNICATION Getting the product right is of course a priority for manufacturers, but a robust communications strategy is also important. By engaging in market research, manufacturers will gain great insights into their brand that will ultimately improve relationships with customers. For example, patients and HCPs might express their wish for loyalty schemes and more regular product updates along with their preferred methods of communication (e.g. email, website or social media). TO SUMMARISE Whether we are researching devices, supporting materials or communications, usability testing is a key aspect of product development strategy. No matter what usability methodology is used, the benefits of usability testing are the same: to gain actionable insights that medical device manufacturers can use to improve their product and portfolio offering.

WHAT’S THE BACKGROUND TO THE ACQUISITION? EuroTec represents a significant strategic opportunity for us in the France/Benelux region and the acquisition is an important step in continuing the positive momentum of our ostomy franchise. EuroTec will increase our sales and market share growth in the region. The business has a proven and successful direct to consumer model. WHAT’S NEXT IN YOUR GROWTH STRATEGY? ARE THERE MORE ACQUISITIONS ON THE HORIZON? We will actively consider acquisitions of, or investments in, complementary businesses or product lines that would enhance our business or product portfolio but our main focus is on growing our franchise revenue through launching new, innovative products, entering new large markets and investing in direct to consumer. WHAT CAN WE EXPECT TO SEE IN THE MARKET SOON? In ostomy care, our approach to innovation leverages our strength in providing the best adhesive technology in products for our users. We strive to create solutions that enable people with stomas to live life to the fullest, ensuring that our products fit into their lifestyle – and not the other way around. For example, if you have an ostomy, it’s remarkable how a change to a part of your body can begin to control so much of your life. We strongly believe that having a stoma doesn’t have to dictate who you are and what you do, and we make sure your needs are taken care of — so you can stop thinking about your condition or your stoma every second and focus on what’s really important. HOW DO CUSTOMERS PLAY A PART IN THE PRODUCT DEVELOPMENT PROCESS? The needs of our consumers inform an approach that includes providing superior products and support services, enabling ostomy patients to thrive and live the life they want. Over the past few years, we have redefined the way in which we engage with our consumers, and gathered insights into the consumer experience that have helped us shape and develop a new service and support platform for people living with an ostomy called me+. The me+ program is designed to support consumers

EuroTec represents a significant strategic opportunity for us in the France/Benelux region and the acquisition is an important step in continuing the positive momentum of our ostomy franchise along their care journey, and elevate their experience of living with an ostomy. Through the program, ConvaTec provides support to clinicians and caregivers, as well as personalised solutions for people living with an ostomy, through ongoing resources, tools, honest information, emotional support and products. Our product innovation is also focused on addressing consumer needs and concerns, which include leaking, odour and skin issues, in order of importance. With our recently launched Esteem+ Flex Convex one-piece ostomy system, we completed a significant programme of new product launches in ostomy care, providing a full and comprehensive one-piece as well as two-piece portfolio. We are continuing to optimise our portfolio, building and improving on our adhesives and coupling technologies as well as closures and filters, to name a few examples. FINALLY, WHAT DOES CONVATEC BRING TO THE TABLE, BEYOND THE PRODUCTS THEMSELVES? By combining our product offering with a robust service and support program, it is our belief that people living with an ostomy are more likely to have good outcomes and a better experience of ostomy care. Through our commitment to education, community and advancements in product design and technology, we’re helping every person take back control and live life on their terms. 25

Med-Tech Innovation ON THE COVER

it’s in their blood Epigem, a high-tech British micro engineering company, has issued a blood challenge to students from the Durham University-led SOFI CDT (Centre for Doctoral Training in Soft Matter and Functional Interfaces).


r Tim Ryan, Epigem’s managing director, and Niamh Kilcawley (pictured), Epigem’s Marie Słodowska-Curie fellow and early stage researcher, presented the problems to the students late last year. This is part of Niamh’s work into developing microfluidic devices for the diagnoses of rare anaemic conditions, such as sickle cell anaemia and thalassemia. Epigem and Durham University have a long-standing relationship and this latest stage will contribute to Epigem’s work in ‘Relevance’, an EU-backed project which will improve prognostic, diagnostic and therapeutic approaches on red blood cells production, function, and clearance. Epigem is a polymer micro engineering company specialising in the life sciences, development and manufacture of microfluidic devices, micro optical components and film processed printed electronics. It has strong contacts with universities across the north east of England, such as Northumbria and Durham.

MTI EXPO, April 26-27, Stand 17 26

Epigem’s work on EU programmes ‘Relevance’ and ‘Commitment’, and collaboration with the SOFI CDT is providing the CDT students (comprising physicists, chemists and mathematicians) with an early opportunity to learn how to undertake research in multi-disciplinary, complex problem-solving teams. The students are gaining an appreciation of how industry operates, from the perspective of both small companies such as Epigem, and larger companies which are sponsoring SOFI. Dr Ryan said: “Few students have an opportunity to make a difference to the lives of millions of people. However, this project will contribute to helping patients with, for example, rare anaemias, and I’m sure the students will make a real difference.” Professor Lian Hutchings from Durham University said: “This is a fantastic opportunity to collaborate with a local company, provide the CDT students with first-class training and at the same time gain a better understanding of the needs of industry. Epigem is a truly innovative company and our links with it are generating powerful outcomes.” SOFI CDT is a £10 million collaboration between Durham University and the Universities of Leeds and Edinburgh, funded by the Engineering and Physical Sciences Research Council (EPSRC), each of the Universities and a consortium of industrial partners, with the aim of training the next generation of scientific leaders for high impact industrial careers.

Med-Tech Innovation ACADEMIA

building the hospital of the future A medical technology company and a University are reaping the benefits of a collaboration which has resulted in the development of an innovative piece of hospital equipment.


ollowing an exhaustive development process which saw biomedical test equipment specialist Rigel Medical work closely with industry professionals to ensure its new patient simulator, the PatSim200, met their needs, the company turned to Teesside University to assist with the design of the machine. Mark Beckwith, (pictured) a senior lecturer in industrial design in the University’s School of Design, Culture & the Arts, has more than 25 years’ experience in new product development and has previously collaborated with Rigel to design a number of different medical products. He was able to use this expertise to meet Rigel’s brief and design a product suitable for use in a hospital environment with the ability to be modified as new variants of the machine come to market. Only a few weeks after being launched, the device is already attracting interest from markets in the Far East, USA, Germany and the UK. Rigel, part of the Seaward Group, employs 170 people at its headquarters in Peterlee, County Durham, and is also based in Tampa, Florida.

In fact, a British Medical Journal study found that one in four operating room errors are due to equipment problems – errors which could be avoided by simple device checks before surgery. While much of the industry’s focus is on innovations in healthcare equipment, it is important to remember the test devices which interact with and safeguard this equipment. It obviously is not practical or reliable to test the accuracy of these monitors on patients or volunteers. So a patient simulator device plugs directly into monitoring equipment and, through electrical signals, simulates various types of vital signs from ECG to IBP. All of these tests can be performed relatively quickly by inhouse engineers, independent service operators, or by the manufacturer’s own service engineers under the hospital’s contract. To ensure that the new device met the needs of end users, Rigel took a clean-sheet approach to the development of the PatSim200. Designers and engineers spent hours shadowing biomedical engineers to understand what they wanted from a vital sign simulator.

The PatSim200 is Rigel’s simplest, fastest and most costeffective patient simulator yet. It puts medical equipment through its paces by mimicking the most common vital signs of patients, such as body temperature, blood pressure, heart-rate and respiration. These tests are vital for highlighting faults with medical equipment in hospitals and healthcare facilities, ensuring that the monitors are accurate in real patient situations. Faulty or inaccurate equipment poses a large risk to healthcare managers, as problems with patients can be missed or misread and costly inquiries can ensue.


Med-Tech Innovation ACADEMIA

“Human vital signs are complex signals. Particularly when we’re talking about ECG waves, they are also very small. So at the heart of a good patient simulator design is a solid low-noise analog circuit design, with independent outputs for each signal,” says Andrew Teasdale Principal Systems Engineer at Rigel Medical. “And because human vital signs vary just as much as people do, there is an incredible array of variables and parameters to consider, which means a powerful microcontroller is needed to store, process and output the signals. “The on-board software to make all of this work is very complex, but the product needs to be as simple as possible for the operator to use. And as any design engineer will tell you, achieving true simplicity is not a trivial task.” The PatSim200 incorporates a large colour display, with a home menu that displays all the currently running vital sign parameters. This means that biomeds no longer need to move around multiple menus. The device also skips the traditional splash image so the user can get straight to work.


“Are there aspects of your design which could be prone to obsolescence? Will it be obvious to users if your product becomes inaccurate or faulty Does it require external testing and calibration? All of these factors can have implications for patient safety. “We’ve listened to the feedback of our customers and built features that address their needs. “For instance, biomeds can spend minutes scrolling through test options, whereas they might only use a handful of tests regularly. We took inspiration from everyday items like digital radios, meaning that now users can recall their five ‘favourite’ sequences at the press of a button.” Rigel engineers also took note of compatibility needs for users. The result is that PatSim200’s cable ports are compatible with most hospital legacy IBP and temperature cables, making it Rigel’s most versatile simulator yet.

Rigel also analysed biomed workflows to optimise out unnecessary operations and button presses. As a result, the PatSim200 comes with a consistent and intuitive user interface, which speeds up the testing process – a key priority for the end users.

From agreeing the project parameters and brief with Rigel Medical, the PatSim200 project involved six months’ design, development, and prototyping work for Mark Beckwith. Following the consultation with the biomedical engineers it was established that the device needed to be robust, ergonomic and portable. It also needed to incorporate a rechargeable battery and micro-USB connector to make recharging easier,

“Designers and engineers often don’t see their products in use on the hospital floor, but it’s important to be aware of how the device works in the real world,” adds Andrew. “Biomedical engineers perform a lot of tasks over the course of the day – our job is to streamline that process for them and save them time.

As well as taking into account the internal components, key to the design was the ability for the device to be modular. This would enable the PatSim to be adapted to meet the varied needs of biomedical engineers. Because it was being used in a hospital setting the device would also need to be easy to clean.

Med-Tech Innovation ACADEMIA

“This was a slightly more technical brief as, because of the need for the device to be modular, it meant I couldn’t use traditional clamshell moulding,” says Mark. “Once I was given the technology, I looked at the aesthetic of the design to ensure that it was saleable and good to look at.

“There’s many aspects of this project with Rigel that I’ll be able to take away. It’s been quite challenging with a number of issues that I’ve had to overcome, particularly regarding modularity of the device, and these sort of details are key to how I work with students.”

“The second part of the project was ensuring that it could be manufactured economically and easily assembled in the factory. I looked at how many devices Rigel were planning on selling, as the manufacturing process would be very different if they were only planning for a handful to be produced. ”

Andrew adds: “Healthcare technology is becoming increasingly advanced, which makes it more important than ever to ensure patient safety by regularly testing medical equipment.

Maintaining academic links with industry is a key part of Teesside University’s philosophy.

“Test equipment doesn’t save lives, but is a key part of ensuring quality patient care In the biomed field, we know that engineers and their test equipment don’t save lives. But they are a key part of ensuring quality patient care.

The university, based in Middlesbrough, won a Queen’s Anniversary Prize in 2014 for outstanding work in the field of enterprise and business engagement. At the heart of its strategy is working with employers to make sure its courses are relevant to the needs of industry.

“Our partnership with Mark and Teesside University has been extremely fruitful over the years and the PatSim200 is the latest example of this. It marries high-quality product development with great design and we’re delighted with the end result.

The benefits of these partnerships are twofold. As well as enabling companies like Rigel to access cutting-edge academic expertise, the University’s industry partnerships also inform the teaching of academics, ensuring that students are kept abreast of the latest technology and are job-ready when they graduate.

“The device is already proving to be extremely popular with biomedical engineers and attracting interest from a number of new markets.” For more information on design courses at Teesside University visit

“Doing live projects like this is a vital part of my teaching,” adds Mark. “When I first started working we were designing use a drawing board and pens. A lot of changes have occurred over the years and it’s extremely important that I’m aware of them and real-life experience is the best way to do that.


Med-Tech Innovation SECURITY


ike any other computer system, medical devices are vulnerable to security threats and this has the potential to affect the safety and effectiveness of the device. The trend of making devices more connected - to the Internet, hospital networks, and to other medical devices – increases this vulnerability. Additionally, by the end of May 2018 all hardware and software that processes personal data concerning the health of EU citizens must comply with the General Data Protection Regulation. The maximum fine under the GDPR is 4% of the total worldwide annual turnover of the preceding financial year for that company. Many medical devices record real-time data that, when uploaded to a doctor along with a patient name or other type of patient identifier, become Protected Health Information (PHI) that is governed in the United States by HIPAA. Even if this data is not uploaded to a healthcare provider and PHI is present on the medical device, the design of the medical device must be such that it is not possible to access the PHI through wireless networks, or through hacking into the device or associated software or databases should the device become lost or stolen. Criminal penalties under HIPAA, tiered in accordance with the seriousness of the offense, range from a fine of up to $50,000 and/or imprisonment for up to a year for a simple violation to a fine up to $100,000 and/or imprisonment up to five years for an offense committed under false pretences and a fine of up to $250,000 and/or imprisonment up to ten years for an offense committed with intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm. In addition to confidentiality considerations, the Medical Devices Directive requires all risks be reduced as far as possible. In practice this means that designs are consistent with the generally accepted state-of-the-art and compliant with international standards. If threats to the integrity or availability of data could lead to patient harm, then they must be addressed. This means the application of a systematic, risk based approach to information security as covered by ISO 27001. To address the subject, we must first define what we mean by information security: SECURITY OF INFORMATION CAN BE THOUGHT OF IN THREE DIFFERENT WAYS: • Confidentiality: Protecting information from unauthorised access. • Integrity: Protecting information from modification by unauthorised entities. • Availability: Making the information available to authorised personnel. The priorities of these three focus areas may be different for a medical device manufacturer and healthcare provider, e.g. Integrity and availability are more important than confidentiality. This differs from other industries such as finance and requires an approach that is integrated with Risk Management as defined in ISO14971 and required by ISO13485. WHAT ARE THE THREATS? The threats can be considered to fall into two groups. Firstly, an attacker may take control of one or more devices with the deliberate intent of harming a patient. Motives for this could range from “ransomware”, i.e. organised


stay safe Peter Brady, CEO, Ascensys Medical highlights the threats and potential solutions to cyber-security in medical devices criminals aiming to blackmail healthcare providers or device manufacturers, a new form of terrorist attack, industrial sabotage or simply an individual with the intent to cause harm for whatever reason he or she might have (In Australia, 49-year-old Vitek Boden conducted a series of electronic attacks on the Maroochy Shire sewage control system after a job application he had made was rejected by the area’s Council – he was able to take control of the sewage management system and caused millions of litres of raw sewage to spill out into local parks, rivers and even the grounds of a Hyatt Regency hotel. He is currently serving a two year jail sentence). The second threat is the presence of some unauthorised program – which could be a virus, worm or any other program that compromises the effectiveness or safety of a medical device. Here the intent might not be to cause harm to a patient, but it might lead to that all the same. The table overleaf summarises the human threats to information systems, their motivations and likely consequences. SOLUTIONS Dealing with these security issues is something the medical device industry is late to address, particularly when compared with the commercial world, and perhaps for good reasons – patching an operating system may well invalidate extensive software validation efforts and lead to increased costs. However, in the commercial world preventing an attack might be considered successful if the attacker’s intent is blocked, even if the program under attack is

Med-Tech Innovation SECURITY

Origin of threat

Possible Motivation


Hacker, cracker

Challenge Ego Rebellion Status Money

• Hacking • Social engineering • System intrusion, break-ins • Unauthorized system access

Computer criminal

Destruction of information Illegal information disclosure Monetary gain Unauthorized data alteration

• Computer crime (e.g. cyber stalking) • Fraudulent act (e.g. replay, impersonation, interception) • Information bribery • Spoofing • System intrusion


Blackmail Destruction Exploitation Revenge Political Gain Media Coverage

• Bomb/Terrorism • Information warfare • System attack (e.g. distributed denial of service) • System penetration • System tampering

Industrial espionage (Intelligence, companies, foreign governments, other government interests)

Competitive advantage Economic espionage

• Defence advantage • Political advantage • Economic exploitation • Information theft • Intrusion on personal privacy • Social engineering • System penetration • Unauthorized system access (access to classified, proprietary, and/or technology-related

Insiders (poorly trained, disgruntled, malicious, negligent, dishonest, or terminated employees)

Curiosity Ego Intelligence Monetary gain Revenge Unintentional errors and omissions (e.g. data entry error, programming error)

• Assault on an employee • Blackmail • Browsing of proprietary information • Computer abuse • Fraud and theft • Information bribery • Input of falsified, corrupted data • Interception

prevented from performing its intended function. In the case of a medical device, such as an infusion pump, this might not be the case. So, the need for effective (and cost-effective) strategies for dealing with security threats is critical. A sensible approach is to turn to international standards for guidance because they are the consensus amongst industry experts on what constitutes best practice. The information security standard, ISO 27001 tells us that starting with an Information Security Management Systems (ISMS) is the most effective way to begin to protect our business and its information assets. The ISMS is analogous to a Quality Management System (QMS) as provided for in the ISO 13485

standard that medical device manufacturers are familiar with but with the goal of managing information security in a systematic way rather than quality. The ISMS provides protection from major failures of information systems and information security incidents. Implementing an ISMS also allows for operations to resume in a swift manner when security lapses occur. It is not unusual for companies to be put off implementing an ISMS due to potential costs and a lack of understanding of its relevance. It’s also common for companies to believe that they already have certain operations in place for potential cyber-attacks and lapses in security, but these are generally applied in an ad-hoc manner and usually lack a systematic review process. The cost of implementing an ISMS is typically orders of magnitude less than the cost of security breaches. Information security risk controls typically fall into two broad areas: prevention and detection. Prevention strategies will aim to build robust and secure systems that are extremely difficult to penetrate. Detection strategies will include ongoing monitoring to detect the presence of malicious code, either directly or indirectly (e.g. through the side effects of its presence), or to detect if any unauthorised control of a device has been achieved. As previously mentioned, in the medical devices sector there is a potential for harm to patients and operators and this introduces a new dimension to information security. Risk Management in medical devices seeks to minimise risk of harm to patients and personnel. Where hazardous situations can be caused by information security breaches, either through data integrity corruption or from lack of availability of data when it is needed, then an ISMS is the best mitigation because it provides a systematic approach to the management of information security. 31

Med-Tech Innovation DEVICE SAFETY

BREAST IMPLANT BARCODES A ‘WORLD FIRST’ IN HEALTHCARE Breast implants and medicine in the UK are to be printed with barcodes to help improve patient safety. Med-Tech Innovation and Medical Plastics News group editor Lu Rahman writes.


t is hoped the initiative will help avoid cases such as the PIP scandal in 2010 where thousands of women received faulty silicone implants. The barcode technology used in major industries such as aerospace and retail is being introduced to the NHS in England to improve patient safety. Barcodes are being placed on breast implants, replacement hips, medication and surgical tools.

On average, nurses spend one hour a day on every shift searching for stock

The £12 million Department of Health ‘Scan4Safety’ project is already helping staff to quickly and easily track each patient through their hospital journey. From the unique barcodes on wristbands patients receive when they enter hospital, to the barcodes used to record their medication and the equipment used in their treatment, each code can be scanned to show which member of staff administered each treatment, at what time and where. By using barcodes, anything that might develop a fault years later, for example a screw used in a knee operation or breast implant, can be traced. The details, such as when it was used and the surgeon who carried out the procedure, can be found quickly and easily. This technology will also help to eliminate avoidable harm in hospitals, including errors such as patients being administered the wrong drugs and surgery being performed on the wrong part of the body. Early results from six pilot projects show Scan4Safety has the potential to save lives and save up to £1 billion for the NHS over seven years. Secretary of state for health Jeremy Hunt said: “Scan4Safety is a world first in healthcare – and a vital part of this government’s drive to make the NHS the safest and most transparent healthcare system in the world. Using simple barcodes that major industries rely on every day will help to transform standards of care – before, during and after patients have treatment, at the same time 32

as freeing up resources for care by reducing waste.” Scan4Safety is being piloted in 6 NHS trusts in Derby, Leeds, Salisbury, Cornwall, North Tees and Plymouth. These sites have reported that the scheme is reducing unnecessary waste and effectively managing medical stocks, saving valuable staff time and giving the patient more information about their treatment.

Tim Wells, consultant cardiologist at Salisbury NHS Foundation Trust, said: “The recent implementation of the Scan4Safety project in cardiology provides us for the very first time complete traceability of products such as implantable medical devices used with our patients. “Knowledge is power - not only does this provide us with a level of data and insight that can be used to better challenge clinical practice and variation, helping us to reduce inefficiencies and improve patient experience and outcomes - more importantly it ultimately helps to safeguard our patients from avoidable harm. In the event of a product recall, we can now easily and quickly track an affected product to the right patient. “On average, nurses spend 1 hour a day on every shift searching for stock – by using the barcode technology, NHS staff can keep track of hospital goods and order them automatically when they need them.” Scan4Safety removes human inventory errors, and registers ‘use-by’ dates on medicines and equipment so that stock can be managed easily and patients given the most appropriate medicines. Scan4Safety can also be used to see how effective different equipment is, for example, if one type of hip replacement wears out more easily than another, improving patient outcomes and helping to make the health system more effective.

Med-Tech Innovation MATERIALS

WEARING IT WELL Dow Corning is making a big play in the wearables sector with its ‘soft skin’ adhesives


ccording to Grand View Research, the global market for wearable medical devices is expected to reach £22.21 billion by 2022. Dow Corning, a specialist in silicon-based technology, sees the role of specialised adhesive technologies as a key driver of this growth – especially in skin-adhered medical devices, a major segment of the wearables market. Selecting the right adhesive for each device type – based upon factors such as duration of wear, skin condition, and device size and weight – can have a significant impact on patient compliance and, ultimately, treatment efficacy. Advancements in silicone-based adhesive technologies are intended to offer expanded flexibility to support new device designs while meeting patient needs for comfort and ease of use. “Wearable medical devices represent one of the fastest growing sectors in the healthcare industry, which is being fueled by several trends,” said Marie Crane, healthcare marketing leader, Dow Corning. “While wearable monitoring and treatment devices can deliver important benefits to patients, caregivers and the health system as a whole, their effectiveness depends on compliant usage – and compliance is closely linked to comfort. This is where Dow Corning’s tailored silicone solutions for skin-adhered devices, including Dow Corning MG 7-1010 Soft Skin Adhesive, our highest adhesion level of soft-skin adhesive to date, make a big difference.” Four major trends are driving the growth of wearable medical devices, including skin-adhered diagnostic and therapeutic devices. 1. Population ageing: Seniors typically have more medical issues than the younger population and can face difficulty travelling to the hospital or doctor’s office to receive care. Wearable medical devices allow more elderly people to benefit from convenient, remote monitoring and treatment at home.

2. Chronic Conditions: The Centers for Disease Control and Prevention (CDC) reports that as of 2012, about half of all adults had one or more chronic health conditions. Heart disease, stroke, cancer, type 2 diabetes, obesity and arthritis often require ongoing monitoring, which can be provided with wearables. Importantly, wearable devices can also help with prevention by enabling patients to track their health and make healthier choices. 3. Self-management: Patients’ increasing interest in managing their own health and fitness is another major factor in the growth of wearable devices. Skin-adhered devices can provide a wide range of self-management functions, from back therapy guidance and ambulation monitoring to smoking cessation and sweat analysis for evaluating exercise results. 4. Cost Control: Ongoing pressure to reduce spiraling medical costs can be alleviated by replacing some in-patient or out-patient clinical care with remote monitoring and treatment. Skin-adhered devices can wirelessly relay critical data to clinicians and automatically deliver medication, for example, via a programmed on-body injector. While skin-adhered diagnostic and therapeutic devices provide answers to the challenges of these megatrends, their efficacy – and market success – depend directly on patient compliance. Avoiding irritation during wear and discomfort during removal of skin-adhered devices, particularly when patients have delicate or sensitive skin, is an important compliance factor. This is why many device designers are turning to silicone pressure-sensitive and soft-skin adhesives. Dow Corning says its advanced silicone adhesives – with different levels of tack, adhesion strength and other parameters – offer biocompatibility, water repellency and design versatility.


Med-Tech Innovation HOW TO: CLEANROOMS


Compressed air is a very common, useful and non-disruptive power source for various types of process equipment, however the introduction of an external air source into a controlled environment is a potential source of contamination. Crowthorne Hi-Tec Services (CHTS) explains.


egular testing and validation of production environments is an accepted practice but, to date, similar testing of compressed air lines that run into clean rooms is not. Crowthorne Hi-Tec Services (CHTS) validates a large number of clean rooms that contain compressed air systems but is only scheduled to test compressed air in about 15% of these environments. If you introduce air into a controlled environment that is not of the same standard, then you have degraded the facility and therefore the quality of the environment. Apart from internal QA/QC practices there are a number of industry standards that set out parameters for the quality of compressed air. BS ISO 8573 ‘Compressed Air and Purity Classes’ is the foundation standard but users should note that compressed air standards are not rated in a comparable manner to that applicable for the background production environment; particle sizes and densities differ and this is an important factor. Other relevant standards are

HSG 39 ‘Compressed Air Safety’ and BCAS (British Compressed Air Society) Guidance Note 102. In addition, the regular maintenance of compressed air equipment forms part of wider legislation covering a range of lab and production equipment.

• Particles • Bioburden

As part of a controlled environment quality system, compressed air systems should be tested from a number of different perspectives:

Crowthorne customers who schedule the compressed air testing service, receive a five point plan to ensure that their compressed air utility provides pneumatic power and nothing else into their controlled environments:

• Product safety: Loss of environment integrity could prejudice product safety; CHTS has come across a persistent bio-burden contamination issue arising from the use of organic thread sealant in a compressed air unions rather than PTFE tape. • Personnel safety: Ensuring that compressed air systems are clean and safe makes an important contribution to your labs health & safety compliance. Dampness or water vapour can cause particle agglomeration causing blocking of safety valves and pressurised oil or oil vapour can act as an incendiary risk. • Quality integrity: In controlled production environments, compressed air may be viewed as a Critical Process Parameter which should be controlled as part of an overall quality regime. Compressed air can contain a number of contaminants. A basic test will look at: • Water vapour/ Dew point test • Hydrocarbons and oil mist


Testing regimes can then be customised to take into account the risk of contaminants particular to a specific plant or process.

• Basic testing to determine to what standard the compressed air is working to. • Assistance and guidance to determine the correct level at which the system needs to work to maintain environment integrity. • Identification of remedial action if necessary • Development of a maintenance programme and periodic testing accompanied by avalidation report. • Assistance and advice on extending and/ or amending the compressed air network All compressed air testing carried out by CHTS takes place using calibrated equipment that has been the subject of independent autoclave sterilisation before it is connected to a customer system, again with a view to retaining the integrity of the clean room environment.

Med-Tech Innovation PEOPLE

Cambridge Design Partnership appoints new partner Cambridge Design Partnership’s head of drug delivery becomes a partner at the Cambridge-based product design and innovation consultancy. Uri Baruch is a senior mechanical engineer and expert in drug delivery devices. For more than four years, he has led the drug delivery sector at Cambridge Design Partnership (CDP), delivering a wide range of design projects including an awardwinning needle safety device, an emergency auto-injector and pen injector packaging designs for delivery devices and inhalation products. These led to successful submissions to both FDA and EMA in several submission categories. Baruch has a Master’s degree in engineering from the Israel Institute of Technology (IIT) where he specialised in MEMS (microelectromechanical systems) design and materials engineering. He’s worked across a number of industries including aerospace and defence, medical devices, automotive and inkjet. He has extensive knowledge in design for manufacturing and process design and was involved in setting up and transferring several production lines around the world. Commenting on his appointment,  Baruch said: “My appointment to partner shows the importance of drug delivery to CDP and the

global healthcare marketplace. The healthcare landscape is changing in all of the world’s key geographies due to a combination of rapidly ageing populations, increased patient load on healthcare infrastructures and financial pressures on providers. “CDP is already innovating in this space with a number of the world’s leading manufacturers who are seeking to address these challenges. Among areas we can discuss, we’re looking at the managing high viscosity formulations in drug products, how device connectivity can support dosage adherence and continuing to increase usability and compliance across all new device developments.

“I look forward to spearheading the further expansion of our Drug Delivery capability and team in the UK and in our US office in Palo Alto to support this work.” CDP partner and founder, Mike Cane said: “Uri will lead the expansion of the important drug delivery device sector at CDP. He’ll be building on the success that our dedicated team has enjoyed so far, with a series of initiatives to enhance the services that we provide to our global customers. We are pleased to announce his appointment.” 

Obituary: Stuart Hall, technical director, Telsonic UK In January, Telsonic UK announced the sad death of technical director Stuart Hall, who passed away suddenly on the 7th January 2017 at the age of 54. Stuart had been a key member of the Telsonic UK team for over 24 years, fulfilling a number of roles before becoming technical director. Stuart was highly respected as an individual, widely recognised for his technical expertise by colleagues and customers alike, and always a pleasure to work with, said the firm. The statement from Telsonic read: “Stuart will be deeply missed and we send our heartfelt condolences and sympathy to his family.”


Med-Tech Innovation BREAKTHROUGH

irish medtech firm to help cut down on chemotherapy The firm has scored a €2.1 million investment to commercialise a test that helps HCPs make decisions about whether breast cancer patients require chemo


ncoMark, a University College Dublin (UCD) spinout company, is focused on the development of novel panels of cancer biomarkers, to aid treatment decisions and allow more tailored patient management, ultimately improving the quality of life for cancer patients. This investment round will fund the commercialisation of OncoMark’s lead product, OncoMasTR, which it plans to launch in 2018. OncoMasTR is a novel prognostic test for early-stage breast cancer that will reduce the number of breast cancer patients receiving unnecessary chemotherapy. The OncoMasTR test is based on a panel of genetic ‘drivers’ of breast cancer. The original research that resulted in the identification of the panel was led by Professor Adrian Bracken, Smurfit Institute of Genetics, Trinity College Dublin and researchers at the UCD Conway Institute, led by Professor William Gallagher. The OncoMasTR technology was subsequently exclusively licenced by both universities to OncoMark. OncoMark was previously awarded €2.7 million, through the Horizon 2020 SME Instrument Phase 2, to clinically validate the OncoMasTR test. This new funding round will allow the translation of the test from clinical validation to regulatory approval and full commercialisation. OncoMark, which was co-founded by Professor William Gallagher and Steve Penney as a spin-out from UCD’s School of Biomolecular and Biomedical Science, is headquartered at NovaUCD, the Centre for New Ventures and Entrepreneurs.


Des O’Leary, chief executive officer, OncoMark said, “In the absence of accurate tests, the majority of early-stage breast cancer patients are treated with chemotherapy despite many not benefiting from the treatment. This exposes individuals to severe side effects and results in significant costs to healthcare systems worldwide. Approximately 70% of patients do not require chemotherapy after initial surgery, but it has been difficult to identify these individuals. The OncoMasTR test is designed to enable a more personalised approach to patient care, helping clinicians to determine which patients should not receive chemotherapy, ultimately improving their quality of life.”  He added, “We are delighted to announce the successful achievement of our fundraising targets which will, in addition to the Horizon 2020 funding, allow us to complete the commercialisation of the OncoMasTR test, with product launch scheduled for mid-2018.” He concluded, “OncoMark currently has 14 employees, a significant increase prior to the OncoMasTR project, and I expect our staff numbers to increase further in the years ahead.” Orla Rimmington, partner, Kernel Capital, said, “OncoMark aims to prevent early stage breast cancer patients’ exposure to ineffective treatment and needless toxicity. Kernel Capital are delighted to have led this investment in OncoMark, with its genomic assessment test, based on pioneering research led by Professor William Gallagher.” Dr Tom Kelly, head of division, Industrial, Life Sciences and Consumer,

Pictured (l-r) at NovaUCD are; Dawn Walsh, Kernel Capital; Des O’Leary, CEO, OncoMark; Professor William Gallagher, director, UCD Conway Institute and co-founder, OncoMark; Deirdre Glenn, manager, Life Sciences Sector, Enterprise Ireland and Kevin Healy, senior manager, Corporate Banking Ireland, Bank of Ireland.

Enterprise Ireland said, “The thriving Irish medtech sector continues its story of success and the development of innovative products such as OncoMasTR contributes significantly to Ireland’s reputation as a leading global cluster for medical technologies. Companies like OncoMark are the future of the Irish economy. They have used Ireland’s extensive innovation ecosystem and worked with the Enterprise Ireland commercialisation team to bring the fruits of academic enquiry to market and profitably. We will continue to support companies like OncoMark in delivering medical solutions that impact positively on the lives of cancer patients worldwide.” The €2.1 million funding round included; Kernel Capital, through the Bank of Ireland Kernel Capital Venture Funds, the Irrus Investments syndicate, the Galway HBAN MedTech syndicate, private investors and Enterprise Ireland.

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MTI Issue 31  

MTI Issue 31