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Issue 32 | Mar/Apr 2017

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from The editor

Monumental, not incremental change

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may be a relative newcomer to the Med-Tech Innovation readership, but I’ve been around the medical device sector for some time. I’ve often heard it said that there’s no real innovation in this market, more incremental progress. I choose a different perspective. Doing this job I get to see some amazing ideas brought to reality – ideas which very often serve completely unmet needs. Here’s one of my favourite stories. Last summer, Cambridge-based Owlstone Medical raised £4.9 million in finance to develop a breathalyser device capable of diagnosing cancer using ‘breath biopsy’ technology. Now, in my other life, I’m involved in the production of one of our sister titles, European Pharmaceutical Manufacturer. In the pharma world, stories like this can sometimes be the first and last time that you ever hear of a proposed new product. Nobody wants to issue a press release saying that the drug didn’t make it through the first phase of trials after all. But in just a few short months, the team at Owlstone have been back in touch to say that a biopharma company (4D Pharma) is already readying to use the breathalyser in the development of new treatments for cancer, as well as gastrointestinal, autoimmune, and respiratory conditions. To my mind, that’s a great example of the medtech sector breaking new boundaries in a very, very short space of time. It’s also the reason that I can’t wait to see how this year’s Med-Tech Innovation Expo unfolds. I’ve attended the show in the past as both an exhibitor and as a visitor – and this year I’m proud to be attending as part of the organisational effort. In my experience, this event has come to be known as a true springboard for new ideas. It’s never been about just making sales where the exhibitors are concerned; it’s about the chance of having that rare but pivotal conversation that spawns an idea, which in turn goes on to make a major contribution to healthcare delivery. Lastly, all that remains for me to say is that I look forward to seeing you at the expo. During the show, tweet me at @medtechonline if you have news that you think I should know about – it’s the perfect chance to meet up and discuss. Dave Gray, editor

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I N N O VAT I O N HOW TO CONTACT THE TEAM editor | dave gray +44 (0) 1244 680 222 david.g@rapidnews.com reporter | reece armstrong +44 (0) 1244 680 222 reece.armstrong@rapidnews.com group editor | lu rahman +44 (0) 1244 680 222 lu.rahman@rapidnews.com sales director | colin martin +44 (0) 1293 710 042 colin.martin@rapidnews.com sales manager | raymond fieldhouse +44 (0) 1244 952 363 ray.fieldhouse@rapidnews.com art | sam hamlyn +44 (0) 1244 680 222 sam@rapidnews.com 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 www. med-technews.com or e-mail: circulation@ med-techinnovation.com 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

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

www.med-techexpo.com


Contents : mar/apr 2017

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DIGITAL HEALTH The changing face of medical devices

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INNOVATION A vision of health: a real life story

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NHS How can medical device data work harder for the health system?

EXPO It’s show time! Through the doors at Med-Tech Innovation Expo

ACADEMIA Improving healthcare delivery with engineering

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3D PRINTING The possibilities are endless in medtech

INSIGHT What is frugal innovation? And what does it mean for medtech?

WEARABLES How are ergonomic trends shifting?

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Med-Tech Innovation DIGITAL NEWS HEALTH

a changing What does digital health mean for revenue streams in the medical device market? Vince Schaller, director, health practice, at healthcare branding group SGK writes.

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sk your doctor if it’s right for you.” That advice is still sound. But today, consumers are increasingly asking themselves, before they even schedule a doctor’s appointment, “What are the right choices for me?” Call it the increasing consumerism of health and wellness. Or, in the words of Kristin Hambelton, one of many CMOs who are bringing traditional marketing strategies to healthcare-oriented enterprises, call it the “Amazon Effect.” As Hambelton explains, “We want what we want, when we want it, and if we can’t get it from one place we’ll just keep looking until someone meets our needs.” NEW CHOICES, INCREASED COMPETITION, UBIQUITOUS INFORMATION Medical device manufacturers are facing a new reality: the empowered healthcare consumer. It’s a transformation driven in part by the proliferation of choices and the easy availability of product information and reviews - in other words, the “Amazon Effect”. But there are other powerful drivers as well. Consumers are paying far more attention to the health, nutritional, and fitness benefits of the brands they buy, using information they find on the internet, through social media, and on

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a growing selection of “clean label” products to guide their choices. Consumers are looking for continuous support for their health and wellness goals, not just a few words of advice at their yearly doctor’s appointment. That’s why mobile healthcare has become a top industry trend, with the number of users who have downloaded a health or fitness app doubling to 32% in just two years. The mobile health app category is expected to grow at a CAGR of 15 percent to reach £25 billion by 2020. Wearable devices are also booming, with the sports and fitness category expected to reach almost $15 billion by 2021. Wearable medical devices, such as heart rhythm monitors and pain management systems, are expected to grow from a global market of $3.3 billion in 2015 to $7.8 billion by 2020. BEYOND PRODUCT-CENTERED INFORMATION TO BRANDCENTERED RELEVANCE All of these trends point to one inescapable conclusion: consumers are eager to take control and responsibility for their own healthcare decisions. They still want their doctor’s advice, but they’re coming to appointments armed with a lot of information. And they’re actively evaluating their own wellness and seeking for ways to improve it every day.

Successful health and wellness brands know how to market to physicians, appealing to their expertise and their desire to deliver better outcomes for their patients. Now, they need to learn how to market to consumers, appealing to the most fundamental desire of all. To live well. Nothing could be more personal. Brands still need to build physician awareness and trust through productcentered information. But to win with empowered consumers, they must also provide brand-centered relevance, based on insight into consumer behaviors, perceptions and preferences. Like other consumer brands - such as CPG, automotive, fashion, and electronics - they need to learn how to create strong emotional bonds and brand identification to last a lifetime. GETTING IT RIGHT: A CASE STUDY Lifetime bonds are especially crucial for brands that ask users to make a major commitment in terms of money, time, or lifestyle. Consider a brand like Medtronic. From its beginnings with a wearable, battery-powered pacemaker, Medtronic has grown to become the world’s largest medical technology company - providing surgical, implantable, and wearable devices to treat nearly 40 medical conditions.


Med-Tech Innovation DIGITAL HEALTH

landscape Innovative products drive Medtronic’s success. Since 1949, Medtronic had been taking the rational message of clinical progress straight to physicians. But now there are more choices, and patients are asserting their rights to make the choice. Medtronic has learned how to engage patients on an emotional level. The new Medtronicdiabetes.com website is a prime example. It offers patients a wealth of information about the precision and responsiveness of insulin pump therapy, how the Medtronic pump system works, its advantages, insurance coverage, and how to make the decision between multiple daily self-injections or an insulin pump.

were simply texting a friend. And there are hundreds of skins available, so that users can transform their pumps into personalised fashion accessories, similar to choosing a cell phone case. RATIONAL CHOICES, EMOTIONAL CONNECTIONS Medtronic is just one example of a company that has learned how to connect with consumers by honoring their day-to-day concerns, interests, and hopes. Kaiser Permanente has significantly increased its enrollments and lowered costs by giving people information they need to take better care of themselves when seeing a doctor isn’t really necessary - and by creating an inspiring campaign around the theme that “Life Is Amazing”, and well worth the cost of protecting it.

This is just one example, and we’re sure to see many more in the coming years. Because consumers don’t want to be sold to. They want to choose. To believe their choices are rational, based on open and transparent information. To feel confident in their choices, based on the experiences and testimonies of people who have made the same choices. And to feel an emotional connection with the brand they’ve chosen, because it understands their desire for an exceptional life and is dedicated to helping fulfill it. So ask yourself: Is your brand right for them?

Just as important as these rational considerations, Medtronicdiabetes. com also provides emotional engagement with stories of real people overcoming their doubts about the technology, gaining peace of mind about its reliability, and coming to understand the benefits of better diabetes control. The message to patients is to “Live Your Exceptional Life,” without letting diabetes management get in the way of any activity. Patients will find images and videos that show how unobtrusive the system is, from sleeping with it to playing baseball. There’s even an app that allows patients to monitor their pump status and glucose levels from a smartphone, as unobtrusively as if they 7


Med-Tech Innovation NEWS

the basis for all that we do. “Moving to the Winnersh Triangle business park is a key part of our growth strategy for the future and will enhance our ability to network with many wellknown global businesses as well as the burgeoning local science and technology community.”

BD re-locates HQ, seeks UK talent Global medical technology company BD (Becton Dickinson and company), which is moving its UKI headquarters to the Reading area in Berkshire, is seeking new talent to join its 260 strong office. A major player in medication management, diagnostic and patient safety, BD says it is actively recruiting new associates with expertise in a range of different areas including business operations analysts, technical writing, market development, customer advocacy, sales, marketing, product management, graphic design, data analysis, engineering, and regulatory affairs. Following the acquisition of CareFusion in March 2015, BD UKI will be relocating from its previous office locations in Oxford and Basingstoke to the

Winnersh Triangle business park in early May 2017. The new office is in a strategic location, providing connectivity to and from London, Heathrow, and the wider south England network. Mike Fairbourn, vice president and general manager, UK and Ireland said: “Although the larger proportion of our people are moving with us to Winnersh from our existing

Oxford and Basingstoke locations, there are a number of exciting positions that we are looking to fill with motivated and talented individuals. This is an exciting opportunity for us to bring new talent into the company from the local Reading and wider catchment area. We provide an environment where our associates can develop and grow their careers and our purpose – advancing the world of health – serves as

BD’s new offices will be home for commercial operations for all of the company’s business segments as well as support functions, technical services and a centre where the company can host customers. On site at the business park are a fitness centre and spa, café, bar and restaurant, nursery, convenience store, bank, and 4-star hotel, with a 14 screen cinema a short walk away. Winnersh Triangle business park has its own train station with direct services to London and Reading, and provides direct road access to key motorway networks.

40 years in business for ITL

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2017 marks a milestone for contract medical device company the ITL Group as it celebrates 40 years in the industry. Founded in 1977, the contract design, development, manufacturing and consultancy group has established operations in Shanghai, China the USA, in addition to its headquarters in Ashford, Kent, UK.

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DISPLAYS

The firm began by developing gamma counters for radio-immunoassays, and today has a portfolio that includes in-vitro diagnostics (IVD), pointof-care devices, surgical robots, cancer staging and treatment, patient connected medical devices, and DNA sequencing as well as experience

in the development of consumables. Tom Cole, ITL Group’s CEO, said: “This is such an exciting time for us and it’s great to celebrate this anniversary with our loyal employees from all over the globe. We’re nothing without the expertise and dedication of our team so for the 40th anniversary what was most important to us was saying thank you to them.” “The industry has come a long way in the last four decades and we’ve seen significant developments in the processes and technology that we use, however what hasn’t changed is our ethos - to enhance lives through medical technology. We’re honoured to mark 40 years in the industry and are proud of all the life saving innovations we’ve helped realise during that time.”


Med-Tech Innovation NHS

making health data work harder Former neurosurgeon and ophthalmic surgeon Dr. Guy Wood-Gush, CEO of Deontics, welcomes positive moves to bring digital health into the frontline of care delivery, but fears the NHS may get left behind if it does not make its data work harder.

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igital transformation is rife across many markets. Retailers are exploiting huge amounts of data to deliver omnichannel customer experiences that are driving significant profits. Banks are recognising the potential of ‘fintech’ and are assimilating innovations such as blockchain to optimise their clicks and mortar operations. Governments are pressing ahead with digital by default strategies that prioritise customer selfservice. In health, similar transformation is underway. Doctors and care givers can come direct to your home using ‘Uber’-style apps. Patients and practitioners are engaging directly online and providing data that informs clinical research. Artificial intelligence and machine learning are developing at such a rate

that the traditional faceto-face doctor-patient relationship is likely to change significantly in the next few years. Yet despite the NHS’ strong history of innovation, it remains behind the times in terms of technology adoption, with pockets of development in evidence. The focus is on steady, linear development that will see hospitals prioritised for digital investment as recommended by US digital doctor Bob Wachter. Initiatives such as the Accelerated Access Review (AAR) and the Innovation and Technology (‘medtech’) tariff look to champion innovations that can make a difference to the patient experience. This will be welcomed by SMEs and digital health providers looking to work with the NHS, especially

given that, as former Life Sciences Minister George Freeman MP previously acknowledged, the NHS is slow to adopt new innovations developed outside the system. Take the new medtech tariff. This should accelerate uptake of new MedTech devices and apps for patients with diabetes, heart conditions, asthma, sleep disorders, and other chronic health conditions, and many other areas. By being accepted onto the tariff, it provides an opportunity for innovators to obtain the muchneeded credibility around their health technology products or services and make them attractive to health providers. It can also shorten the often lengthy procurement process that is associated with technology adoption within hospitals and other care settings.

OVERCOMING CHALLENGES But the gap from policy to frontline practice is huge. I’ve been working as an entrepreneur bringing new medical innovations to market for over ten years. For innovation adoption, in my experience the two main barriers are money, and people’s time. Money is a bigger challenge in the NHS given the current financial crisis. It is of course vital that taxpayers’ money is spent wisely. However, many ‘spend to save’ projects can fall by the wayside when immediate pressures come to bear. But time is also another important consideration. Decision makers in hospitals are busy, quite rightly, managing a fastpaced organisation that is dedicated to saving lives. Will innovation be top of the priority list for medical 9


Med-Tech Innovation NHS

directors, CCIOs, finance directors, or even the heads of technology, when dealing with day-to-day or monthby-month pressures? And when they do get the time to look at the innovations that are impacting health care delivery, will the customers – citizens such as you and me – have already voted with their feet, and be using apps to manage their health in the way they are used to with their finances? The resource and attention a busy hospital needs to run efficiently and safely is very intensive, and therefore it can be difficult to invest time in new IT projects. But problems that exist at the moment, such as variation in quality of care and outcomes, highlighted in the Carter Report, can be addressed by new technology. It is an issue that few consumers, faced with a plethora of choices on digital health, may care about unless health providers embrace the use of technology that meets the needs of the patient, the professional, and the health and care economy as a whole. CARROT OR STICK? Financial drivers can have a marked impact on

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efficiency of care delivery. Healthcare markets that are more financiallydriven, such as the US, are much more amenable to new technologies if that technology can meet patient needs and reduce cost. In addition, in the US there is huge pressure from payers to reduce costs, which is a very powerful dynamic. Everyone in the NHS is trying to save money, but it’s a bit more of a coherent force in the US. This is aided by the HITECH Act which takes on positive and negative incentives to adopt new technologies. The overall US market is set up very differently from the NHS, but there are clear lessons to be learned. The emphasis on making efficiencies focuses hospitals to think creatively about how to meet patient need and reduce cost – not improving one at the detriment of the other. Clinicians and support staff should be able to access 21st century tools to work smarter, quicker and safer to meet these inclusive goals. And these should be the measures central to achieving digital maturity that is rightly rewarded and celebrated in the NHS. It is

time go beyond just having the basics in place. We need to think now about what we want to achieve with health technology. MAKING DATA WORK HARDER Chief among those basics is the focus is on delivering electronic patient records (EPRs). But once these are in place, what do we do with them? The danger is that, without thinking ahead about what they enable, we introduce yet another system for hard-pressed healthcare professionals to have to contend with. Meanwhile patients who are managing their own health records get frustrated when they interact with healthcare settings that seem antiquated in comparison. Clinical decision support systems (CDSS) are one area that can be enabled by the sensible application of healthcare data and information, which to some extent can be realised through EPRs. The Government’s policy paper, Personalised health and care 2020, outlines the need to explore the potential for CDSS and the opportunity they present for “faster, more accurate diagnosis, patient safety, empowerment and experience, and to transform how remote channels can be used to deliver care”. However, it is also important to understand that CDSS can potentially be implemented quickly in advance of a lengthy EPR procurement and deployment cycle, which may be as long as four years to full implementation. This can allow clinical and cost gains to be realised quickly during this period.

This opportunity exists now. Fifty-five per cent of NHS trusts responding to the digital maturity selfevaluation agreed that “digital results are held in a structured format to enable clinical decision support”. However, only eighteen percent agreed with the statement that “digital systems provide automatic prompts for the next action required by multi-step care plans, pathways and protocols” – something that the latest generations of CDSS do with ease, and directly as part of clinical workflow. CDSS can take data and information and use it to create better outcomes and save money. We’ve made a conservative estimate that our technology can generate a return on investment of several hundred per cent over five years with a payback of less than one year. So, whilst there is a period of uncertainty following Britain’s decision to leave the EU, let us hope that the projected investment in healthcare technology does come to pass. Investment in technology and change management must continue to help reduce the projected NHS deficit by 2020, and address the errors currently costing more than £1bn in medico-legal costs each year. The medtech tariff and AAR are good signs; but such signs need to grow to realise the positive impact they can deliver. Digital disruptors are putting the patient at the centre of care. The NHS needs to take heed if it is to reap the benefits of digital health, and help sustain the NHS in these straitened times.


Med-Tech Innovation

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Med-Tech Innovation EXPO

SAVE THE DATE

Ricoh Arena, Coventry, UK

through the doors at med-tech innovation With this year’s show just around the corner, we’ve got a selection of highlights to get you in the mood for the best of the best in medical technology and innovation.

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nce again taking place at the Ricoh Arena, Coventry, this year’s expo promises to be the most exciting yet, with a host of new features and, of course, new innovation. The profile spans the entire supply chain for those involved in the development and manufacture of medical devices – from design through to scale-up, and from software through to IP protection. Like the medtech industry itself, the expo is constantly evolving with the needs of the market. As healthcare becomes increasingly a consumer concern, suppliers will inevitably be discussing the latest trends in wearable tech, the quantified patient and data for healthcare.

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This keen eye on trends is reflected too in the Med-Tech Innovation Conference, taking place at the heart of the show across both days. Organised in collaboration with Medilink UK, the conference is a must for those who need to keep a finger on the pulse of the industry. And with some of the biggest brands in the market slated to speak, the organisers are anticipating a full house. Darren Clark, chief executive at Medilink East Midlands said of the conference: “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.” This is the only event for the UK and Ireland where medical device stakeholders can meet with over 150 brands and suppliers to discuss challenges, trends, and make new business connections. The event also boasts the endorsement of some of the leading authorities in the industry, with names like Innovate UK, the GTMA and Medilink UK all showing their support.


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Med-Tech Innovation EXPO

Two parts are better than one Trelleborg Sealing Solutions says it will use stand 56A at Med-Tech Innovation Expo to demonstrate that it is “revolutionising” the healthcare and medical markets with its liquid silicone rubber (LSR) and two-component injection technology.

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he benefit to the device manufacturer is a hygienic, robust and costeffective product design, often combining multiple components and functions into a single one, eliminating the risk and cost associated with a secondary assembly. Ursula Nollenberger, LSR Components product director for Trelleborg Sealing Solutions, said: “LSR lends itself perfectly to medical applications because it is inert, very pure by nature and very versatile in its use, suiting it to a broad range of application conditions. It is also ideal for a large variety of medical grades which facilitates specification choices, making it a preferred choice within the healthcare sector. “One of our most outstanding

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capabilities is the simultaneous injection of LSR in combination with technical plastics, 2C LSR technology. One of the key advantages of this is the ability to mould several components into a highly complex single part.” The simultaneous 2C LSR process is available in many hard-soft and softsoft combinations, including multicolour and multihardness options, and is extremely efficient for high production volumes. “Trelleborg’s 2C LSR technology allows medical device manufacturers much more latitude in their design solutions, for example utilising space more effectively, saving or cutting out weight, or integrating extra functions. This ground-breaking technique offers a wealth of options for integration and

miniaturisation, resulting in better and more effective solutions in the long run” continued Nollenberger. In life sciences applications it is particularly important to counter the prominent challenge of unwanted bacterial growth and inherent impurities either by way of inferior material properties or unsuitable production methods. Trelleborg claims that 2C LSR technology enables more hygienic design solutions by eliminating, for example, dead space through the use of a customised 2C solution versus a classic O-Ring sealed package. FUTURE PLANS On future plans, Nollenberger added: “We continue to push forward with tool, process and automation technologies to let us produce ever smaller parts, down to micro and now even nanogram weights, enabling the many ground-breaking and exciting technologies our customers are developing. Finding solutions to the so far thought impossible with LSR is what we thrive on.”

Turn up the volume UK silicones group Primasil (stand 61A) will be discussing solutions for high volume work at this year’s expo.

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raditional moulding techniques remain commonplace for components with design attributes on more than one dimension. But tooling can be expensive, and for non-automated processes, prices may be relatively high. That’s not all - traditional machinery may not be able to satisfy very high volume requirements. This can be problematic. While custom manufacturing processes may be developed for some parts, high development and prototyping costs make this prohibitive in many cases. Primasil says that automated punching may provide an answer. Components less than 3mm thick may be cut from silicone rubber sheet with a shaped steel strip. Not only are the tooling costs lower, but the automated process means the labour required is minimal. This, Primasil says, results in much lower part prices than when using traditional manufacturing techniques. Quality can also be automated, with inline cameras taking the place of manual inspection.

The Saint tourniquet is an example of this. Fabric tourniquets had been falling in popularity due to infection risk, so elastomeric alternatives were introduced. But these were overengineered, and too expensive for the single-use demands of the marketplace. The Saint uses a patented locking technology which allows singlehanded use. It also makes possible production using automated punching. With a much lower part price, these tourniquets are now reportedly being adopted in clinics around the world. The group points out that punching isn’t suitable for all components. The product must be flat with no detail on the upper and lower surface. Also, very soft materials will deform when cutting, so

the edges may not be perfect. Nonetheless, for certain applications, punching may bring high volume capabilities with rapid ramp up. Straps, gaskets, seals, washers, and self-adhesive backed sponge are just some of the components Primasil currently produces with automated punching machines. Many of these are then packaged in an ISO certified cleanroom, before being sent to medical device manufacturers or end customers across the globe. As a silicone rubber supplier with automated punching capability, Primasil reports that it is experiencing increasing demand for punched products as medical device OEMs are facing increase price pressure.


Med-Tech Innovation EXPO

Hard to navigate TLM Laser director Andy Toms reflects on the challenges of direct product marking in the medical sector, and the benefits that the FOBA HELP system can bring to manufacturers.

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here are a number of challenges around UDI. Manufacturers face the challenge of finding a physical space, on small implants such as plates or screws, to place the 2D code and the human readable content. 2D codes, such as a data matrix, need a certain physical space to enable them to be readable. On the other hand a UDI starts with a minimum of 14 characters. Based on current readability requirements, a UDI 2D code would have to

be at a minimum 5mm by 5mm. It is clear that this in itself may be a challenge on some devices or implants. Having achieved the requirement to produce the UDI code, it is essential to be able to validate these tiny marks before the product is transferred to the next production stage or indeed released to market. This can be an enormous challenge, marking very small devices with the accuracy of a tenth of a millimeter or less. Validating these marks is as critical as their placement. There is however a wellestablished automation principal which is to perform as many operations as possible whilst you have control of the part.

This concept has been embraced by FOBA within their holistic visionassisted laser marking process called HELP (Holistic Enhanced Laser Process). This combination of premark verification, followed by laser marking and then postmark verification in a closed loop is unique as it is among the only known fully integrated commercial products that delivers all the above in a simple fully integrated user interface.

parts to be scrapped. Although the HELP concept was driven by the increasing regulatory demands of the medical sector, any manufacturer who is producing parts with a number of variants and a requirement to marking them and

validate the content could benefit from the capabilities of HELP. As an example, safety critical aerospace or automotive parts would fall into this category. To discuss UDI challenges in more depth, visit TLM Laser on stand 42.

Having all of the required processes in a closed loop not only ensures compliance with the latest UDI regulations, but generates cost savings by eliminating false marking which in turn can cause expensive

From ideas to reality Product designer to the medtech industry, Maddison, will be looking to discuss design challenges and solutions with visitors to the show, from stand number 51. pecialised in helping clients to translate ideas into commercial designs, the group says its role is to guide customers to make the right design decisions, solve technical problems and ensure designs meet end users’ needs.

The example in the visualisation shows a capillary refill sensor recently designed for George Rice at Nottingham University. This is typical of the group’s projects: classed as a wearable, in close contact to the patient and performing an exacting role. The challenge, according to Maddison, is to juggle requirements on biocompatibility, performance and cost to create a solution which works (and often to do this within a tight budget).

The most visible aspect of the group’s work is the aesthetic impact of its designs.

Maddison designed and prototyped the sensor head so that the team could carry

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out trials to gather the evidence they needed to show the sensor worked. The group then created the visualisation shown by taking stock images and super-imposing the CAD (including a quick design of a ‘bluesky’ control module) to show how the system might work in practice.

they can also use to disseminate the value of research in ways which are immediately understandable to the general public, and images which communicate the value of IP to investors and

grant giving bodies. Maddison often uses these images in its user research to explain to patients and clinicians the context and detail of how a technology might be implemented.

The design firm also repeated this in other settings, such as adult ICU, paediatrics and A&E. This, Maddison says, created a valuable resource for the client: a vision the team can use to consolidate their thinking on what they are trying to achieve; something 15


Med-Tech Innovation EXPO

Putting a spring in your tech Celebrating its 70 anniversary next year, European Springs & Pressings will be demonstrating its capabilities in the spring coiling, wire forming and pressing industries. th

Put it to the test Failure to maintain consistent and traceable test processes throughout the product lifecycle is a recipe for disaster, according to Anecto Limited (stand 17).

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s a test laboratory itself, Galway-based Anecto knows only too well how important it is that all test processes utilised by a company deliver consistent, accurate and traceable test results. Anecto’s services include test method validation (TMV) and verification along with equipment qualification.

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tuart McSheehy, managing director at the group’s London factory said: “We’re hoping that Med-Tech opens up further opportunities, enabling us to add value to the medical world through our quality tailored service. “We are quite unique to other UK spring makers in that we cover a whole variety of disciplines. We have stamping, coiling, multi-slide, heavy coiling, high speed stamping and assembly facilities, as well as both high and low volume production capabilities.” McSheehy continued: “We manufacture tension, torsion and compression springs with diameters from 0.03mm to 65mm, pressings and multislides up to 130 tonnes and have an unlimited design spectrum of wire forms. “With clients ranging from major blue chip manufacturers through to specialist niche companies, we’re active across numerous sectors and where better than to showcase our product range and facilities than at Med-Tech Innovation?” The company, which has factories in London and Cornwall, a sales office in Belfast and a stocking facility in Yorkshire can be found on stand 87 during the show.

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TMV is a risk-based arm of quality control designed to demonstrate the validity of a test or inspection method. Using TMV, the process under examination must show at various stages that it meets intended requirements and produces usable results. According to Anecto’s lead engineer Philip Roxby, there are a number of occasions when test method validation is required. These are: Developing a new test method; Revising an existing test method; Establishing an existing test method in a new facility; Comparing the effectiveness of two methods. “Under any of these circumstances, employing Test Method Validation would be an advisable course of action. Test Method Validation confirms that a test method can consistently provide valid

and compliant results,” explained Philip.

Universal appeal Swanstone and Tommy Nielsen ApS will be showing the Universal 501 FSX machine and demonstrating the forming and sealing process from stand 99.

“It also introduces testing at various stages of the Product Lifecycle and ensures their accuracy while creating a solid foundation for traceable evidence practices throughout the lifecycle.” He says this means they have valuable experience in many relevant disciplines including: Developing test equipment; Calibration & maintenance; Designing tests; Medical device development; Manufacturing. “TMV and equipment qualification go hand-inhand. We can support equipment selection and user requirement specification (URS) development, equipment installation and operational qualification (IQ/OQ). These studies ensure equipment capability with the delivery of reproducible test results, which provides a concrete base for subsequent TMV, explained Philip” Among the challenges facing implementation of a test method is the inconsistency of much record keeping. Test Method Validation introduces templates for each test that can be followed to ensure consistency and compliance.

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he Universal machine can form and seal in one operation, as well as form blisters, then fill and seal at a later stage. The Universal machine is ideal for R&D and small to medium volumes. Swanstone has been the sole representative for Tommy Nielsen in the UK and Ireland for over 19 years. Alongside the Universal machine, Tommy Nielsen also caters for the high volume packaging market with machines such as the Minipharma and Pharmaline. The firm also promises to deliver “anything from general advice relating to packaging materials, CAD Design and standard equipment adapted for your individual requirements to spare parts supply”. Swanstone and Tommy Nielsen say they “enjoy maintaining personal contact during exhibitions, meeting new potential customers as well as keeping in touch with long standing existing customers” and “always look forward to new good quality leads and are positive that these new potential customers will benefit and enjoy their Tommy Nielsen experience for many years to come”.


Med-Tech Innovation EXPO

Linking up ISO13485-accredited group Datalink Electronics, will be discussing its role in contract electronic product design and manufacturing from stand 46 at the expo.

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he group works with leading companies, universities and startups in order to help turn their technology and research into products “at the forefront of the medical devices industry”. Services include feasibility studies, design, development, prototyping, certification support, production and full product life-cycle management. Some of Datalink’s areas of specialism in the medical sector include: • Respiratory control and monitoring including a xenon dosing equipment

used for anaesthetising babies with birth difficulties, as well as cardiac arrest adult patients • Wearable medical electronics, e.g. noninvasive and minimallyinvasive vital signs and continuous glucose monitoring for home and hospital use • Mixed-gas respiratory monitoring systems • Drug-delivery systems including a needleless syringe with an accurate integrated optical dose measurement technology • Medical control systems, e.g. a selfbalancing two-wheel powered mobility vehicle

Some of these products, Datalink points out, can be categorised as members of the Internet of Things – dubbed the next industrial revolution. The design department works with manufacturing personnel throughout the design process to check that products can be manufactured and tested for the appropriate production volumes. Datalink says it also has good working relationships with a number of test houses and notified bodies.

Having both design and manufacturing capabilities means that clients can move rapidly from prototype design to production manufacture, with a constant feedback on the suitability of designs for

manufacture, claims the firm. Datalink is accredited to ISO13485 for the design and manufacture of medical products and ISO9001 for more general electronic products.

Breathe easy Festo, exhibiting on stand 45A, will showcase piezo technology for medical devices.

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round 600 million people worldwide are afflicted with chronic obstructive pulmonary disease (COPD). Mobile oxygen system devices improve the mental and physical ability of patients as well as their quality of life.

Japanese company Musashi Medical Laboratory supplies easy-to-operate regulators in smartphone format for these oxygen system devices, thus significantly improving comfort and handling for patients. Compact piezo valves from Festo provide a quiet oxygen supply for the devices. Musashi Medical Laboratory took a new approach to designing the oxygen conserver: the group separated the flow regulator from the oxygen bottle so that it can be held conveniently in the hand for operation. Its size and weight are comparable to those

of a smartphone, and it can be comfortably carried directly on the patient’s body in a shirt or trouser pocket. The regulator is compact and light, not least, Festo claims, because of the proportional valve VEMR which regulates the supply of oxygen via the tubing. Another advantage of the piezo valve is that its switching operations are inaudible. The device is matched to the patient’s respiratory rate. A sensor ensures that the regulator detects inhalation. The right amount of oxygen is then mixed with the

respiratory air. During inhalation, the sensor detects a pressure drop and transmits a signal to the regulator which in turn opens the proportional valve VEMR. Oxygen then flows from the oxygen bottle – not uninterruptedly as with other devices, but only for as long as the patient is inhaling. As soon as inhalation has been completed, the valve shuts off the supply of oxygen. Oxygen consumption is thus much more efficient. The oxygen bottle doesn’t have to be refilled as often and the patient’s independence is increased as a result. Festo says that

thanks to the energyefficient piezo valve, the device’s operating time is considerably extended before the battery has to be recharged. As well as the VEMR piezo valve, Festo is also launching a new light-weight VEMD mass flow controller. With integrated piezo technology the VEMD mass flow device provides proportional control of gas flows. Little energy is required to maintain an active state and no pulsewidth-modulated signal is required making the device particularly quiet.

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Med-Tech Innovation EXPO

Star quality software Vivaldi Software, stand 13A, will be discussing Vivaldi QMS, a platform developed to meet the precise and complex requirements associated with numerous quality standards for medical devices.

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he platform includes a suite of tailored programs designed to make co-ordinating and controlling documents, processes and training records even easier. Documents such as work instructions, SOPs and templates can be securely managed and controlled, according to the group. Vivaldi Document Control offers management of versioning, archiving, flexible assessment and review processes, easy automatic distribution, permission management and access control, as well as document protection. Also from Vivaldi is Process2Flow, a solution for risk management, audits, CAPAs, deviations, medical device master record and incident management.

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Vivaldi QMS offers management of process records, with automation and a 360-degree overview, and Process2Flow allows users to view all registrations associated with their medical devices. In addition, Vivaldi Training Manager enables the collective management of training courses, qualifications, employee training recordscompetences and targets.   Users can also evidence the skills against performing a task or job role, according to Vivaldi Software. The group explained that the software

is useful in helping medical device manufacturers to alleviate concerns about validation. As part of the ISO13485 QMS package, Vivaldi says it will facilitate the validation of Vivaldi Quality Management System. The options for this include selfvalidation, where the group can provide customers with the script templates for performing the validation themselves, or third party validation, where customers may have a validation partner or wish to use a Vivaldi Software validation partner who will validate the system against the specific requirements.

Life in 3D Tri-Tech 3D will bring 3D printing solutions for hospitals and doctors to its exhibit on stand 100 at this year’s expo.

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reclinical studies are an essential step in protecting patient safety, meeting regulatory requirements and evaluating a new device’s potential to solve an unmet clinical need. Existing models used to evaluate device performance, such as animals and cadavers, present significant limitations: they can be expensive or difficult to obtain, require a controlled environment, and often don’t represent the targeted pathology precisely. Due to these limitations, Tri-Tech 3D explains, tissue and anatomical disparities can obscure design deficiencies, leaving them to be discovered later when they’re costlier to correct. What’s more, planning, procurement and biohazard controls introduce considerable costs and lead times early in the product lifecycle, but now there are ways to gain certainty by validating device performance on models that represent a range of clinical cases. It is possible to simulate blood flow, embed sensors, and mimic a variety of tissue properties, test

anywhere without the complex logistics of procuring test specimens and securing a controlled environment, in turn mitigating cost overruns by reducing the likelihood of repeated in-vivo evaluations. 3D printed models are far less expensive, so you can get your device on solid footing before making that investment, the group explains. Tri-Tech 3D is a supplier of Stratasys 3D printers, printers which it reports are used to help hospitals “accelerate medical progress and improve surgical success”. Multi-material, multi-colour printing can be used to create anatomical models and parts allowing hospitals and physicians to deliver personalised medicine to patients. This kind of personalisation, the group argues, can reduce risk, improve success rates, increase

efficiency and minimise waste. Stratasys 3D printing could also help doctors recreate patient anatomy and develop custom guides and moulds to shape patient-specific procedures. Allowing physicians to complete more design revisions in less time, means less time to verification and validation. Stratasys technology also provides hospitals with the capability to improve lab and operating room efficiency by creating custom tools and fixtures that meet specific manufacturing needs. Its systems allow doctors the freedom to produce customised tools for research and clinical care, helping to eliminate manufacturing constraints and make processes more agile. Tri-Tech 3D offers the complete range of Objet PolyJet and Stratasys FDM 3D printing technologies.


Med-Tech Innovation EXPO

What a line up Laser Lines says it will bring one of the first Stratasys F370 3D printers in the UK and will be running live demonstrations on stand 60A.

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he multi-material F170, F270 and F370, together dubbed F123, “mark a significant advance for devices at their anticipated price”, claims Laser Lines.

A new, faster drawerloading system makes replenishing materials simpler, while the bundled GrabCAD Print shortens the printing process, says Laser Lines.

The group says that the printers offer faster output in a wider range of materials. The group adds that they are almost silent in standby and “whisper-quiet” in use.

GrabCAD Print enables the user to print direct from native CAD files, meaning it is not necessary to convert to STL files – as well as offering remote print monitoring through its mobile app. The addition of a USB port offers users the ability to load files without requiring access to a network. A license for Stratasys’ Insight application also comes with the F370.

The F170 features a 10x10x10 inch build chamber, whilst the F370 extends this to 14x10x14 inches, and supports engineeringgrade thermoplastic. Despite the variations in the chamber, the printer’s physical size is the same in either model.

With wifi and ethernet connectivity across the range the printers

offer plug-and-print operation. “After over twenty years of research and development, Stratasys has delivered a truly compelling offering here,” said Laser Lines sales director, Mark Tyrtania.

and each has a draft mode that helps reduce the cost of producing test models.

“It’s an exciting development, and one in which we’ve been involved since the beginning, when Stratasys asked what we and our customers wanted to see in its next generation products. What it’s come up with is the perfect fit.” As well as ABS-M30, ASA and QSR support material (plus PCABS in the F370), the printers can use PLA,

Use your intellect Intellectual Property (IP) systems are essential in helping medical technology innovators reach their business goals. Not only can companies protect their innovations, they can help to minimise wasted R&D on technology that is already known, and can also ensure that they have freedom to operate in a new area.

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s a provider of IP services with a large, multi-disciplinary team, Potter Clarkson says it helps clients achieve commercial success by maximising value from their IP, through a wide

range of IP services which include patents, designs, trade marks, branding, freedomto-operate, licensing, NDAs and conflict resolution. For a medtech product the IP system can be used in many ways throughout the product life-cycle. The early stages focus on the identification of potential IP and advising on optimum protection, and can also be held with collaboration and licensing issues and NDAs. With the support and guidance of a crossdisciplinary medtech

team, which includes patent and trade mark attorneys, IP solicitors, paralegals and support staff, all experienced in working in the healthcare and medical technology field, Potter Clarkson says it can assist in filing patent and registered design applications. In addition, competitor intelligence can be provided, along with taking any required steps to challenge any IP rights that could inhibit commercial freedom, both in the UK and abroad.

latest figures from the European Patent Office (EPO) show. Medical technology is the top technical field for patent applications filed at the EPO, the group reports, with more filings in this

sector last year than all the pharmaceutical and biotech applications combined. Potter Clarkson will be on hand on stand 50 at the expo.

More and more medtech companies are recognising the benefits of IP, as the 19


Med-Tech Innovation GALLERY

Capillary Film Technology and eg technology (stand 48) collaborated on the development of PICA, the Precision Immunoassay Capillary Analyser, including the associated disposable cartridge. The cartridge incorporates sample introduction, reagent storage and CFT’s low-cost, fluoropolymer microcapillary film.

As a UK based contract manufacturer of medical tube components, Polyflon is showcasing its precision thermoformed, micro-moulded and machined medical tube tips for single use minimally invasive devices and surgical instruments, all class 7 clean room produced, on stand 57A.

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Med-Tech Innovation GALLERY

Showcasing its scientiďŹ c injection moulding (SIM) expertise, Trend Technologies (stand 11) is a subcontract manufacturer of precision injection moulded components and subassemblies for medical device customers in the UK, Europe and globally.

Asahi Intecc, stand 93, is a Japanese medical device manufacturer specialised in making exible cables and tubes with high torsional rigidity. The group has in-house wiredrawing, wire-forming, coating, torque and assembly technologies.

MedNet (stand 56) has launched a new range of high quality introducer sheaths. Featuring a tapered smooth dilator, the introducers reportedly enable atraumatic insertions. The valve design provides leak free hemostasis with or without the device in place, while allowing easy catheter movement. With a soft suture tab that rotates, the radiopaque sheath reportedly also provides excellent kinking resistance

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Med-Tech Innovation EXPO

A clean sweep Showcasing its range of monobloc, hardwall and softwall cleanrooms on stand 59A, Connect 2 Cleanrooms will be on hand to advise on contamination control for the production of medical devices and components.

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he medical device industry is one of the largest industries in healthcare, driven by innovation and new technologies, the group says. Over the last decade there has been an unprecedented growth in innovative and improved technologies, which has led to the development of stateof-the-art medical devices and catalysed growth and advancement in the healthcare industry. Sean Fryers, marketing manager at Connect 2 Cleanrooms explained the importance of the expo: “Attendance at the Med-Tech Innovation Expo is an excellent opportunity for Connect 2 Cleanrooms to gain an insight into exciting new technologies and devices within the medical industry. Not only does it help increase our customer reach, but also allows us to link with industry peers, via networking seminars, learn about the ways to develop our products and integrate with the healthcare industry.” Connect 2 Cleanrooms’ ISO 14644-1:2015 classified controlled environments protect critical processes for medical plastics manufacture around the world and are suitable for: Medical device manufacturing Drug delivery systems Medical device packing Life sciences Biotechnology Stem cell research

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Re-charge your batteries

Growth spurt

Haredata Electronics will be displaying power solutions and battery charging technology from Friwo, stand 24.

Med-Tech Innovation exhibitor Wickham Laboratories (stand 91) has recently completed an approximate 40% expansion of its existing laboratory footprint.

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aredata stocks a range low voltage external, fixed and interchangeable plugtop and desktop power supplies and battery chargers as well as internal open frame power supplies and lithium-ion battery packs which are suitable for use with medical devices. In addition to medical chargers, the group offers lithium-ion battery packs that are assembled inhouse using Samsung cells. Along with the configuration of cells, Haredata says it is capable of implementing complex battery management systems (BMS). This includes a range of communication systems and parameter queries such as keeping a check on voltages and currents, the state of charge or depth of discharge as well as the internal and ambient temperature of the batteries. This makes it possible to indicate the “health” of a battery pack, its charge status or implement cell authentication to only allow approved battery packs to be used. These battery packs are available with medical

approval 62133 and are CE, UL, RoHS and UN38.3 Transport Regulation approved. The firm’s new medically approved range of ‘FOX’ power supplies are available in 6, 12, 18 and 30 Watts with voltages ranging from 5 to 48V, and also available is a 5V USB power supply which is DoE2016 ready and approved to IEC 606011 standards. The FOX power supplies have a low leakage current ≤10µA and a medical protection class of 2 x MOPP. Haredata says that having interchangeable input plugs on a power supply means that each power supply can be supplied with a range of suitable input plugs for major global markets in the USA, UK, EU, Australia and Asia. This, the firm explains, helps manufacturers ship their products into global markets, allowing for the ordering of a single power supply unit with multiple input plug options. These power supplies are also available with a wide range of DC connectors that can be fitted specific to individual requirements.

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ickham reports that this expansion was initiated due to a marked increase in demand for safety testing under the current regulations and provides an opportunity for expansion of the company’s medical device service offering. The medical device testing currently available through Wickham Laboratories, and its verified partners, includes a wide range of biocompatibility and general safety tests including ISO 11135-1/11737-2 for sterility testing, ISO 117371-1 for bioburden determination and the ISO 10993 suite of tests for haemocompatibility; cytotoxicity; implantation; sensitisation, skin irritation and pyrogenicity; acute, sub-acute and chronic systemic toxicity. For medical devices that require varying degrees of biocompatibility and safety testing, Wickham Laboratories says it offers personalised assessments and advice on each device’s individual requirements. The group also operates an in vitro R&D division dedicated to the development and validation of a variety of scientifically sound alternative testing methods.


Med-Tech Innovation EXPO

Little gem In time for Med-Tech Innovation, timing and battery technology specialist Jauch Quartz has launched a new quartz crystal series specifically for wireless applications.

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he new JXSxx -WA series is available in standard packages 2016, 2520 and 3225 and at 14 frequencies which are required to generate a stable reference clock for many RFtransceivers.                               Typical frequencies like 24.0 / 26.0 / 32.0 / 37.40 / 38.40 or 40.0MHz are often used by RF-ASICs that support wireless standards like bluetooth low energy (BLE), bluetooth smart, ZigBee, ISM, LoRa, LPWAN or other standards used in wireless applications within the world of IoT.

Due to their high frequency stability and their very low ESR, Jauch says that the crystals meet the requirements that are essential for IoT and other wireless applications. Typical applications include: • Internet of Things (IoT) and industrial (IIoT) • Bluetooth/bluetooth low energy/bluetooth smart • ZigBee, ISM, wifi/ WLAN, LPWAN and more • Telecommunication • Wearables The international enterprise, established

in 1954, is a key player in the timing segment and, with the addition of MEMS timing, is also active in the market for primary and secondary batteries.

Jauch has production facilities at the company’s HQ in Germany. This means that oscillators can be promptly configured with the group’s own

equipment and locally shipped from Europe. A battery assembly line for technically-demanding battery solutions is also on-site.

Case closed When Cipher Surgical needed to find a partner in enclosure design for its new OpClear control unit that was destined for use in hospital operating theatres worldwide, it approached CamdenBoss (stand 13).

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he OpClear unit helps maintain a clear lens and clear vision for surgeons using laparoscopes during operations by directing an “on demand” jet of CO2 across the lens to remove blood, peritoneal fluid, particulate matter and prevent condensation or fogging. This allows surgeons to maintain a clear view throughout

often lengthy operations thus maximising time that the laparoscope can be used without interruption for removal and cleaning. The result is enhanced safety and minimisation of frustration from having to stop working or continuing to work with reduced vision. Designed for use in hospital operating theatres worldwide, the

OpClear control unit needed to meet the very strict requirements of electrical safety – ISO 60601-1 – and EMC requirements ISO 60601-1-2 as well as meeting IC (Industry Canada) and US FCC (Federal Communications Commission) emissions standards. This was further complicated by the RFID system employed in the OpClear unit that allows automatic recognition of any product attached to the control unit as well as the usability aspects laid out in ISO 606011-6. As part of the project, UK group CamdenBoss says it helped develop a case that met the exacting requirements

of medical environments without compromising on the design for ease of manufacturing and serviceability.

material selection and manufacturing expertise for products used in such demanding conditions.”

Justin Buch, operations director for Cipher Surgical said: “CamdenBoss were chosen due to their expertise in the design and manufacture of bespoke enclosures for medical instruments and, in partnership, Cipher Surgical has been able to create a new system that meets the technical requirements, maintain great aesthetics and achieve a product that is easy to assemble. CamdenBoss is also a supplier of choice to manufacture the enclosure parts for their control in

He added: “The CamdenBoss design team worked well in the overall project team comprising Cipher Surgical and its other development and manufacturing partners, helping us achieve first time passes on all aspects of the control unit testing against the very demanding standards. CamdenBoss’s design team also attended cross-partner company working meetings to discuss the system design and contributed to resolution of issues as they arose through the development cycle” 23


Med-Tech Innovation EXPO

Hot property

Ask the academics

Ian Grey is a partner at intellectual property firm Venner Shipley (exhibiting on stand 83). Here, he discusses some of the key IP considerations for medical devices.

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n addition to meeting regulatory requirements, intellectual property should always be a primary consideration from the initial concept to the commercial use of a new medical device. As any prior disclosure can undermine subsequent attempts to seek intellectual property protection, it is important to ensure that that everyone involved in the development of a new medical device understands the need for secrecy from the initial concept stage. Although IP rights created by employees in the normal course of their work are owned by the employer, if you are collaborating with others, then the ownership of any IP generated as a result of that collaboration should be established in writing and steps take to ensure that non-disclosure agreements are in

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place. Existing intellectual property can provide a valuable source of information and so a search and analysis of previously published patents should be carried out to gain an understanding of what has already been developed. It is also necessary to establish whether any third parties have rights which they could rely on to stop you from marketing your product by carrying out freedom to operate searches. You also need to consider how best to protect your own intellectual property, including the filing of patents to protect the inventive concept, trade marks to protect the brand and trading name and registered designs to protect the shape and appearance of the device. A patent is usually the most valuable form of protection for a new medical device. A granted patent can provide an owner with a

Amongst the many innovations on display at the expo will be ErgoRaiser, a modular limb designed to meet the comfort and support needs of both patient and practitioner, created by The Design Unit at De Montfort University.

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he Design Unit is a creative group of academics who hold a strong track record of business success in the medical device sector.

monopoly in the invention covered by the patent for a maximum period of 20 years. This means that you can take legal action against third parties who use the same inventive concept without authorisation. Patents are also licensable and assignable and if you are seeking investment or eventually hope to sell your business, then the existence of a patent portfolio can help to increase the value of your company to investors. The UK, as well as a number of other countries, also offers favourable tax incentives to companies that derive income from patented inventions.

Building on the university’s academic knowledge and expertise, the group deliver innovative and cutting edge designs by working with a broad range of businesses and organisations. Their research and collaborative projects have been delivered to both the public and private sector bodies. The Design Unit has a comprehensive suite of rapid prototyping equipment with a focus on:

• The development of medical products for high volume manufacture. • The identification of methods for manufacturing high value products in low production volumes. • The ErgoRaiser was created in partnership with Spectrum Healthcare. It is designed to be simple to use, have minimum maintenance costs and have excellent infection prevention properties. To find out more about ErgoRaiser and how The Design Unit can explore ways to improve product design, performance, and user engagement, visit the team on the Medilink UK stand.


Med-Tech Innovation EXPO

Linking up Earlier this year, Med-Tech Innovation exhibitor STERIS (stand 47A) announced the new brand for its sterilisation services, STERIS Applied Sterilization Technologies (AST). Now, the group is also introducing the new name for its laboratory offering: STERIS Laboratories.

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TERIS Laboratories combines the services provided by the STERIS Pharmaceutical Laboratories locations in Europe, Africa, Asia and Central America and the Biotest Laboratories location in the USA. As a provider of microbiological testing and validation support, the laboratories will continue to support both the global and

local needs of their customers. The comprehensive offering includes laboratory testing, technical support and contract sterilisation. The firm, which offers expert advice on microbial control and material modification, says it is “committed to developing long term partnerships through understanding, quality and confidence”.

Golden opportunity The Centre for Process Innovation (CPI – stand 47) will be discussing a range of emerging and enabling technologies including printable electronics, sensors, photonics, nanotechnologies, formulation science, new materials and biotechnology.

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he global healthcare and life sciences sectors are in the midst of significant change, presenting both opportunities and challenges for the companies operating within them.

and service models, CPI says. Emerging technologies such as bio-technology, nanotechnologies, novel materials, photonics, big data and the internet of things can be utilised to address these challenges.

The UK’s population is predicted to grow and the demographics of the population will also change significantly. People are living longer, placing increasing pressure on our health and social care systems to deliver a higher standard of care to more patients.

In wearables monitoring and diagnostics CPI is working with industrial, academic, and clinical partners to develop novel monitoring devices and systems that measure parameters such as blood pressure, blood oxygen levels, breathing rate and hydration levels to provide an assessment of patient condition.

By closely integrating universities, the clinical research base, industry and the NHS, there is an opportunity to alleviate these pressures through harnessing new technology, innovation

CPI also has expertise in biological and biochemical sensors, which have a wide range of potential

applications within the healthcare sector. Biosensors can be utilised in in-vitro diagnostic (IVD) devices to test samples from the human body for infection, and to diagnose medical conditions and monitor drug therapies. Using CPI’s capabilities in printed electronics, where the flexible nature of the technology allows for conformable electronics and sensors, non-

invasive methods of screening can be developed to make the experience much more comfortable for patients. The group also has experience in working with companies to develop and commercialise photonic medical devices which treat a targeted range of life threatening diseases. In terms of packaging,

the centre says it can help companies create smart solutions for medical products which monitor supply chain traceability and counterfeiting, and prove compliance and authenticity. Printed sensors embedded within packaging have the ability to monitor indicators such as oxygen levels to identify product tampering and whether a drug is fit for consumption. 25


Med-Tech Innovation EXPO

One stop shop Contract electronic manufacturer Tioga is offering a broad spectrum of electronic assembly, from prototyping to complete product manufacturer and full ‘turn-key’ solutions in small to medium volume quantities at the expo, stand 50.

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ioga’s manufacturing facility is based in Derby in an old listed railway building. This site has been custom converted into an extensive electronic assembly plant now covering

47,000 square feet. After securing the full site and purchase of the building in March 2014 Tioga has recently acquired a

second manufacturing site based in Corby covering 30,000 square feet with extensive test

capability, which will see the firm enter the MoD and Aerospace markets. The firm says it offers total product management solutions to clients, which can encompass design, engineering support, global procurement and supply chain management, manufacturing, test, configuration, warehousing and distribution. Tioga covers all areas of electronic and electrical

assemblies and meets quality standards ISO 9001:2015, ISO 13485:2016 and complies with the manufacturing standard IPC-A-160 Rev F, Class 3 and IPC 7711/7721. The firm’s focus is on front end engineering and producing quality documents for our production processes, producing high quality assemblies with zero defects. Warwick Adams, managing director said: “I’m delighted with

the progress we have continued to make. With the investment we truly believe we have made Tioga an extremely professional, capable and competitive contract manufacturer offering all the facilities our customers expect at this level. With our focus firmly now on the future of Tioga the business can move forwards with solid customer partnerships and continue to provide an excellent, quality service”.

Breaking the mould Midas Pattern Company (stand 48A) will be on-hand at the expo to discuss the rapid manufacture of large, low-volume, highquality polyurethane mouldings and prototypes for medical, bio-medical and laboratory instrumentation enclosures.

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he company has extensive knowledge of the regulations relevant to this sector, has invested in the latest technology and understands and can meet the requisite material specifications.

In addition, Midas paint finishes are not only of the highest quality but extremely durable and resilient to cleaning chemicals. All Midas mouldings are supplied fully finished,

painted, screen-printed and assembled ready for installation. Midas offers two tooling systems which it says are easily modified. FASTrim is a low-cost system for producing

large prototypes in as little as 10-15 days. The second system, MRIM, is a composite tooling system offering low setup costs for high-quality mouldings in volumes from one to 2000 per annum.

Innovation by design Product design group IDC (Industrial Design Consultancy) says it will be demonstrating some of its most exciting medical product developments IDC on stand 50.

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DC says that its medical devices include a personal ECG heart monitor, new technology for surgical instruments such as video laryngoscopes and surgical glue devices, personal MS monitoring equipment, and wearable

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technology for nerve damage patients. Quality has always been an important part of IDC’s design process; working with a focus on both ISO 13485 and ISO 9000. The company has firmly established

its reputation in the medical sector, with many award winning medical products and also offers other far reaching benefits through its Shanghai office which opens opportunities in the vast Chinese medical device market.


Med-Tech Innovation EXPO

Join the elite Elite Electronics Systems will be exhibiting on stand 17, showcasing its manufacturing divisions: PCB assembly, cable and harness assembly and full system integration.

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he group says its three pillars are people, plant and processes. Central to this ethos, Elite says, is a highly skilled workforce that receives continuous training and knowledge in areas such as IPC 610 and 620 Class 3 Standards. The firm operates with over 70,000 square feet of manufacturing space, and says it

invests continuously in new technologies and equipment. Attention to detail at every stage in the process from quotation, purchasing, pre-production, product-assembly, test, inspection and delivery is critical. The achievement of the medical standard ISO 13-485:2012 and ISO 9001:2015, as well as J

Standard 001 assembly standard. Elite is also a UL-approved manufacturing facility. The group provides a range of services to support manufacturing. These include design for manufacture, design collaborations, supply chain management, testing solutions, and a cradle to grave service.

PLANT

THREE PILLARS

PEOPLE

PROCESSES

Design for life AME Group (stand 9A) will be discussing medical device design challenges, saying it can offer an end-to-end solution with design and prototyping services under one roof.

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he firm’s current work includes the development of a device that allows heart patients to be screened in just 90 seconds. The Rapid Rhythm device facilitates quicker electrocardiogram (ECG) tests compared to traditional methods and requires fewer training hours for medical professionals. As part of a userfocused design process for Rapid Rhythm,

AME conducted onsite interviews at GP surgeries and heart wards to observe patients and health professionals. This enabled the team to understand how they engaged with ECG test equipment, identifying problems with existing products and opportunities for innovation.

insight in the product development process, and as such the creative team undertakes extensive research to give the final product a competitive edge. The aim is to understand user requirements, and current and emerging trends. AME says “the user inspires and informs the design direction to enhance AME says it the effectiveness of understands the integral the product outcome, role of consumer whilst trends influence

The group offers a range of in-house rapid prototyping Informed by the findings processes to produce one-off verification gathered through prototypes, fully research the firm can facilitate the conceptual finished appearance models or low volume design of a physical production solutions. product, its packaging Prototyping techniques design, graphics or help verify a device to brand. Processes here ensures it meets the might include creative workshops to generate required specification and regulatory intellectual property, requirements. This concept development helps reduce risk, and to explore potential avoid the potential design solutions and sketch models to assess costs associated with a products appearance production changes further down the line. and ergonomics. and drive the product strategy”.

Once complete the product is validated and detailed by AME engineers using various physical and virtual techniques. The firm says it also helps clients to create robust manufacturing strategies and identify suitable partners for mass production.

For low volume production, AME says that its facilities provide a cost-effective manufacturing solution. In the case of Rapid Rhythm, the AME team manufactured a small quantity of devices to validate the product in the field prior to volume manufacture.

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Med-Tech Innovation ACADEMIA

learning curve The University of Surrey has launched a new programme called Innovation for Health, designed to “help change the delivery of healthcare in the UK”.

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nnovation for Health combines both teaching and research into an academic programme aimed at training the next generation of graduates who can proficiently work across the traditional boundaries of health and engineering sciences. Building on its existing health-related engineering programmes, in the first phase the University of Surrey has developed five new undergraduate courses including Data Science for Health, Electronic Engineering for Medicine and Healthcare, Medical Engineering, Biomedicine (Electronic Engineering) and Biomedicine (Data Science).   Each course will be taught in the new £12.5 million ‘Innovation for Health’ building, which was officially opened by Sir Mark Walport, Chief Scientific Adviser to the UK Government. The new facility will enable students from engineering, biomedical and health sciences to learn alongside each other, giving insight into each other’s specialities and engaging in hybrid research driven projects.   The development of a ‘Learning Laboratory’ and associated academic activities will help prepare students for the changing healthcare landscape, which is increasingly being shaped by advancing technologies.   Professor Max Lu, president and vice chancellor of the University of Surrey, said: “The Innovation for Health programme is another example of the University’s ambition to drive innovation for the benefit of our society.   “In addition to providing opportunities for cross-disciplinary collaboration to develop integrated solutions for future healthcare, this programme will also equip our students with the skills and cutting-edge technology, so that they will not only be job ready but also will be able to lead change in

MTI EXPO, April 26-27, Stand 17 28

their profession. The research projects that will take place in this new facility will lead to innovative devices and therapies to improve people’s lives.” Sir Mark Walport, chief scientific adviser to the UK Government said: “I am delighted to be here for the launch of ‘The Innovation for Health’ programme and for the opening of this splendid new facility here at the University of Surrey.   “Dealing with the well-known challenges of health systems in an affordable way is a crucial central health innovation mission of the future.”   Working with Surrey and Borders NHS Trust, the Alzheimer’s Society and a number of other partners, researchers from the University of Surrey are combining the university’s 5G test bed with robotics, wearable technologies and remote monitoring systems to enable carers to observe the behaviour of persons they are caring for with dementia without needing to be at their specific location.   In addition to this, researchers in collaboration with other partners including NHS24 and Docobo, are trialling a new e-SMART project. This project involves giving patients a mobile phone with an app like programme to help them identify and record their chemotherapy symptoms twice a day. This information is sent securely to a system that assesses these symptoms and triggers an immediate alert to doctors or nurses if the patient requires assistance. The mobile communication also offers patients real time information and advice on how to manage their symptoms at home without the need to travel to hospital.


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:

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Med-Tech Innovation INNOVATION

A vision of health How my son’s fight for his sight inspired an engineering innovation with global impact - by Douglas Anderson, founder of Optos. Over the last two decades, huge strides have been made in the medical imaging of our eyes. In the early 90s, the use of standard techniques meant it was only possible to view less than 5% of the retina in a single image during routine examinations. This has since dramatically improved, with modern technology now capable of imaging approximately 82% of the retina, making the identification of threats to eyesight much easier. I have been lucky enough to have played a key role in bringing this technology, made possible through innovative engineering, into widespread use across the healthcare industry. In 1991, my five-year-old son, Leif, suffered a detached retina that caused him to lose the sight in his left eye. Learning that if the detachment had been spotted earlier, his eyesight could have been saved

was devastating. The inability of then current tests to identify early-stage eye problems, coupled with professionals’ lack of experience in assessing often uncooperative children, were major factors in the missed diagnosis. As an industrial design engineer by trade, this motivated me to kick-start the development of a new machine that would tackle those issues. Creations under the optos brand would later go on to catch a similar defect in my son’s right eye, subsequently saving his sight. There were major problems with retina-scanning technology when I set out to find a solution. The first was its field of vision. Its width was very limited compared to what is available now, making it extremely difficult to effectively analyse the entire retina and catch the signs of illness. I discovered this after many

studies of Leif’s eye by a clinician of international standard who said that it was only possible to get “a glimpse” of his retina. The second was its usability. The technology, a binocular indirect opthalmascope, was a tricky tool to use, uncommon outside of a hospital and requiring specialist expertise. In order to be effective, this tool also required patients to stay still with dilated pupils for substantial periods of time, making it very hard to get accurate recordings for patients like my son. After all, it is tough to get a five year old to sit still for an extended period of time! This combination of low capability and poor usability meant referrals to specialists only happened once symptoms were well developed. Any new design would have to overcome these issues, delivering an image of the entire retina in an easy and fast way. I had no background in ophthalmology and so was reliant on knowing the product requirements, as well as my training in design planning processes. I found and directed a team of more than 20 engineers with different expertise to develop the technology. It took us two and a half years to develop an ellipsoidal mirror that directed the scanning point of a laser onto the pupil in such a way that the laser was then refracted onto the majority of the retina, allowing it to be mapped. Yet this idea – called a scanning laser opthalmoscope – was initially discarded, as it appeared too difficult to manufacture. We looked instead at how to improve existing technology, but found that any solution was a

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to the customer, delivering a new revenue stream for the practice. Yet part of this agreement – but not a contractual one – was to use the device for all examinations. While an expensive strategy not without risk (it required a major change in work flows for practices), it worked. Imaging was done by a technician before the consulting room was even reached, meaning the actual consultation was a thorough analysis of the retina.

ABOVE | Leif age 5 INSET | Leif and Douglas

compromise to either its usability or functionality. These were also thrown out as the time as the effort required for them was not worth the small incremental benefits they would deliver. So we returned to the ellipsoidal mirror design, which was the only one that promised a stepchange in capability. It took a further eight and a half years of engineering to bring the design – the Panoramic200, or P200 - to market. To do this took painstaking management. We broke down every single task into numerous sub-tasks that took no longer than a week to complete, ensuring a continuous stream of updates were seen by stakeholders and a sense of progress was felt regularly. We also focused whole-heartedly on the risk areas of the project, ensuring that these were overcome first and time and effort not spent on work that would not come to fruition. Development may not have been fast, but it was assured and was not at risk of collapsing. Once the product was ready for market, we had to convince a cost-averse audience to take on a product worth £100,000, when typical equipment was worth between £1,000 and £10,000. This market also did not grasp the value of the product. It was necessary to consider unusual strategies to get a product into the market as, once in use, its benefits would ensure continued uptake. The capital investment was the major hurdle, so we removed it entirely. The P200 was offered free, with money made instead from a $20 charge for each use. This was usually passed on

This strategy has been a huge success as the P200 has been used in over 60 million exams across 11,000 practices. 400 clinical trials have been completed or are in progress using the equipment. What’s more, the technology won the prestigious Royal Academy of Engineering MacRobert Award in 2006, known for spotting the ‘next big thing’ in engineering and recognising outstanding innovation combined with commercial success and tangible social benefit. As described by the award judges, Optos “developed a revolutionary diagnostic instrument by dint of eight years’ determination, creativity and perseverance”, ensuring “many people owe their sight to the timely use of this outstanding example of clinical engineering.” Such recognition culminated in the purchase of Optos by Nikon in 2015 for £259 million, the biggest ever spend on medical imaging by the company. Most importantly, however, 16 years later it helped save the sight in my son’s right eye as the same condition re-surfaced, catching it early enough to be treated. While I would not want to relive the personal trauma of my son’s early sight loss, it is gratifying that it inspired a solution that has since helped millions of people and prevented other similar incidents. It also goes to show that the most successful and impactful ideas often stem from personal experience. It gave me a focus and uncompromising drive for success, fuelled by the understanding of the true impact that a better solution could deliver, even though I had no background in ophthalmology. After all, engineering is, at its heart, about finding solutions to real world problems; I am very pleased to see that this solution solved a problem not just for my son, but for millions of others around the world.

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www.first-sensor.com 31


Med-Tech Innovation 3D PRINTING

INNOVATING FROM END-TO-END Everybody knows 3D printing is big business in medtech – but do you know the full extent of the role it has to play? Ian Matthews, design engineering team manager, R&D at Owen Mumford explains.

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cross the manufacturing lifecycle, 3D printing promises to speed up processes and deliver products to customers faster. The market for 3D printing in healthcare is estimated to grow with a CAGR 17.5 per cent from 2016 to 2023, according to a research report by Credence Research. On its own, however, this technology is not a quick fix when it comes to designing and developing new medical devices. Alongside this approach, experience of the physical properties of different materials under various designs can be combined with advanced software modelling to improve the finished product. By taking an end-to-end design approach, companies can reduce the time taken to prototype device designs but also improve the quality of the finished product too. IN THE BEGINNING As part of the design for a new product, 3D printing techniques can be used in different ways depending on the stage. At the beginning of the design stage, Polyjet printing can be used to support iterative development. This approach provides high resolution and speed of development, which suits the early stage of design. However, Polyjet-produced parts can be relatively brittle compared to production quality designs. Alongside this, Fused Deposition Modelling (FDM) uses an additive manufacturing approach that is suitable for prototyping and production. Due to its physical form, FDM provides greater consistency when evaluating device function; however, it can be coarse and rigid in form, which can make it less suitable for external presentations.

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Looking at Polyjet and FDM together, these techniques can develop prototypes faster. By knowing the difference between these processes and their specific benefits, engineers can produce the right kind of parts with less rework. When showing products publicly, Stereolithography (SLA) can provide prototypes with a high quality look and feel. Whilst generally used for high resolution, aesthetic samples within the early stages, using SLA can also be great for high-profile opportunities where customers will get to experience the prototype. However, using SLA can be expensive compared to production of plastic parts using other processes. At Owen Mumford, we have developed other approaches that can make use of injection moulding and soft tooling to look at prototypes in higher volumes. This “middle stage” between initial prototype and full production can help medical device manufacturers prepare for summative trials and also provides an idea of representative manufacturing challenges. Injection moulding is not a 3D printing technique in itself; however, by designing 3D moulds to contain different injected plastics, 3D printing can support companies in testing the use of different plastics quickly. This approach can be linked to experience with different physical forms and understanding of how devices react over time. By using materials in this way, manufacturers can reduce the time taken to bring a product from prototype to production. This approach can then be supplemented with soft tooling. By using this approach, higher volumes of prototype devices can be created for larger sample size testing and usability

studies. This step can get devices into the hands of potential users and show up potential issues around variability that one-off devices and 3D printed prototypes cannot. GOING INTO PRODUCTION While 3D printing can help companies get their designs formalised faster, this should supplement experience and functional design skills. By using knowledge of how moulded parts may react differently to those created using 3D printing, engineers can organise the production strategy to benefit the company. For example, material wear and behaviour over time is very different across various plastics. Knowing how different materials will behave over time based on common usage patterns can help avoid issues that would otherwise affect performance during usage studies or clinical trials. This real-world experience is especially valuable around impact loading. While 3D printing can inform design choices, these parts can’t accurately represent how the production device might behave. Simulation of designs using computers can help to point out potential issues that can then be removed before fullscale production begins. Using knowledge of different materials can have a profound effect on the performance of parts and assemblies within devices. Without this experience, companies will find that development takes longer and more iterations will be required. 3D printing makes it possible to advance medical device design while also reducing cost. However, by looking at the design process as part of a continuous and joined-up process, companies can speed up their time to market and see faster returns on their investment.


OR F E T A D A ! Y R A I D R YOU

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Med-Tech Innovation INSIGHT

Is frugal innovation revolutionising medtech? In a world of endless innovation and technological progress, who can we really call a pioneer? Rajendra Velagapudi, senior vice president, business excellence, Cyient writes.

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onsider Dr. Sandek Ruit. An ophthalmologist from the Tilganga Eye Centre in Nepal, Dr. Ruit has restored vision to tens of thousands of people across the country. How? By working with lab technicians to develop an inexpensive acrylic lens - called the intraocular lens – which costs almost £80 cheaper than its imported counterpart, he and his team have been able to reduce the average cost of cataract surgeries to just £92, compared to an estimated £2400 in the West. The Centre produces and sells approximately 350,000 intraocular lenses across the globe annually at a cost of roughly £3.20 each, and Dr. Ruit also trains foreign surgeons to replicate the procedure in their respective home countries. He and his team embody the ‘frugal innovation concept’, having restored eyesight to thousands at a very affordable cost. Put simply, frugal innovation is the process of reducing the complexity and production costs of a product in a scalable and sustainable manner. It can be achieved through redesigning products, implementing new business models, and re-configuring value chains, although ultimately consumers should always be the beneficiaries of such a development. By reducing the cost of product significantly, it immediately becomes available to tens of thousands of users who could barely afford the product earlier. The industry that stands to gain the most from the concept is medical technology, which historically has been the preserve of high-income, developed nations. Currently, 76% of the world’s medical devices are being used by only 13% of the global population, with many inapplicable in

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Put simply, frugal innovation is the process of reducing the complexity and production costs of a product in a scalable and sustainable manner. developing nations due to a lack of skills, training, and environments in which to utilise the technology. Most are not designed to cope with the harsh environment, humidity, and dusty conditions typical to the developing world; in sub-Saharan Africa for example, 70% of the medical equipment purchased is idle according to the World Health Organisation. As recently as 2014, between 70 and 75% of medical device sales originated in developed economies at a growth rate of 4-6%, but in the past few years original equipment manufacturers (OEMs) have begun to focus on some of the world’s developing economies – and with good reason. Some of the world’s fastest-growing economies, including the BRIC countries and others in Asia and Latin America, are exhibiting even faster growth rates of 10-18% year on year. As a result, medical device OEMs are beginning to realise the importance of developing different products for different markets. By extension, this is helping drive frugal innovation as OEMs turn away from premium product production towards value-based devices, which they manufacture in emerging

countries and tailor to the economic, infrastructural, and environmental conditions of the product’s target market. It’s a trend that some of the biggest names in medtech are beginning to cotton onto, including GE, Siemens and Medtronic, to mention a few. GE for instance has experienced great success in emerging economies with its ‘MAC I’ portable ECG machine, which at a price of £429 costs just 16p for each use. Medtronic meanwhile is working on cost-effective implantable devices such as pacemakers, which it is seeking to market at between five and ten times lower than the current cost. These exciting developments have the potential to revolutionise healthcare in emerging economies, where the infrastructure is not as advanced, and provision not as affordable, (as a percentage of disposable income) as in developed economies. We’ve talked at length about the underlying aspects of this concept, but putting it into action is an altogether different matter. Engineering service providers (ESPs) in particular have a pivotal role to play in the widespread adoption of frugal innovation. By encouraging companies in the medtech sector to pursue collaborative business models, ESPs can now create agile ecosystems that are significantly more conducive to innovation than the clearly defined but often rigid confines of OEMs. Implementing a programme of frugal innovation is not without its challenges, nonetheless. Its success depends heavily on different stakeholders creating the conditions for it to thrive. Major technology companies, for


Med-Tech Innovation INSIGHT

example, need to nurture a culture of innovation within the industry and encourage OEMs to experiment with their products in order to find optimal solutions for developing markets. End-users should also be co-opted into the product design process to ensure that medtech products are effective and easy to operate. And large OEMs should be encouraged to collaborate with innovators (who are often small service providers) to move these potential medtech innovations from the design phase through to production. This represents a difficult challenge, but not the biggest one – that continues to be prohibitive government legislation across the globe, which isn’t currently sufficient to regulate the medtech industry and guarantee the quality of the products on the market. By instituting definitive regulations to safeguard against this, governments can ensure that frugal innovation doesn’t end up as a means to merely cut costs at the expense of product quality.

Engineering service providers (ESPs) in particular have a pivotal role to play in the widespread adoption of frugal innovation.

And herein lies the issue. Rapid technological advancement in recent years means that developed nations need no longer be the sole beneficiaries of innovation in medical care. OEMs of all sizes now possess the means to pursue frugal innovation and produce new forms of medical equipment at a far lower cost than ever before. Provided sufficient legislation and regulation is implemented to protect product quality, the concept possesses the potential improve the lives of citizens across all parts of the globe.

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Med-Tech Innovation WEARABLES NEWS

the human factor How are medical device ergonomics changing with the arrival of the wearable revolution? Howard Jones, product designer at i4 Product Design explains.

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s a product design consultancy, one of the many challenges we have when developing new products is ergonomics. Most products by their nature require human interaction in some form, from button accessibility to 24 hour a day wearable technology. How products work with people and how we can potentially improve people’s interaction with a product, can make a significant difference to a product’s success. At i4 we work with appropriate ergonomic data sources and apply this wherever necessary through carefully calculated CAD measurements, test models and user groups. One sample project that featured ergonomic requirements was a novel wearable product that would act upon a specific area of the user’s head. The target global market for the product was very wide and as such involved complex requirements. There are several approaches to creating a product that can be made to fit a wide variety of headsizes; solidstate (but flexible), slide and pivot features and modular parts to name a but few. Each have pros and cons including among others; restrictions with material choice, manufacturing methods and user functionality As with most projects, we started with initial sketches and sketch visuals to clarify direction and market acceptance; taking into account size/weight/balance of components such as outer case, PCB, and other electrical components. Having reached an overall appearance that the client was pleased-with we then applied appropriate ergonomic data to achieve a real-world fit that could be tested. Often some of the more specific ergonomic measurements are

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not recorded in standard documents, and need to be accrued either by a specialist ergonomic lab or via more simple in-house methods, depending on the accuracy required. It’s worth noting that if this information isn’t readily available it can add additional time to a project. In this case the client was made aware of the level of complexity involved with fit at a very early stage and the project plan customised to suit. Our approach to adjustment was to use a flexible solid-state unit (an assembly of parts, but fixed), as it was deemed more appropriate for the target market, product type and manufacturing price point. Incorporating adjustment wasn’t found to be the optimum solution in this case. Added complexity and timescales from creating additional parts, along with increase in size to accommodate wall thickness around adjusters would’ve increased the overall dimensions (something we were keen to avoid). We pursued with creating CAD geometry that allowed for variance in both head size and comfort of fit, using material choice and geometry to give us the flexibility we required. Once we had CAD geometry that we were satisfied would meet the ergonomic data and manufacturing feasibility, we utilised our 3D printer to create a series of accurate prototypes for functional trials. When developing a wearable product such as this, the subjective nature of “what was a comfortable fit?” becomes an important consideration, so this needed to be tried on people. Lots of people. Calculated trials of three subtly different designs were arranged, consisting of an appropriate section of people. A user questionnaire was compiled in order to gain effective and consistent qualitative and quantitative feedback in addition to visual data. From this we were able to incorporate

the findings and make any necessary adjustments in response. The product is due to be launched in 2017 where we will be able to release further details and images of the product. Two previous i4 medical device design projects which are now on the market that underwent a significant ergonomic evaluation were the Optos Daytona and California desktop retinal scanning devices. The Daytona retinal scanner is used on healthy people within a high Optometrist environment. The scan by this device only lasts for less than one second and is used by the full range of age groups. The user interface for the device was drastically different from the California model which is used by Ophthalmologists in evaluation of eye conditions in unwell individuals where scans can take up to 20 minutes (with a Fluorescein Angiography). As seen in the images above, the Daytona is an approachable product with little need for stabilisation of the head. In contrast, the California requires significant adjustment, both of the direct patient interface (brow and chin bar) as well as the scanner head itself (X Y Z adjustment). The first image depicts how the design has evolved from the 200Tx which was very much the status quo head positioning and still persists with Optos’ competitors. Ergonomics/human factors are increasingly being recognised as pivotal to the overall safety and efficacy of a product and to the extent that regulators have issued their own guidance documentation. The FDA released their draft guidance documentation back in 2011 with the MHRA slower off the mark only releasing their draft document earlier this year for comment.


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MTI Issue 32  

MTI Issue 32