MTI Issue 51 by Med-Tech Innovation Magazine

www.med-technews.com Issue 51 | Jan/Feb 2021

@medtechonline

MED-TECH INNOVATION | NEWS MED-TECH

innovation

PLUS Innovations in point-of-care diagnostics The double challenge of IVDR and a pandemic Requirements for devices to protect against cyberattacks

Having the X-factor

â&#x20AC;&#x201C; how human factors engineering can save lives

ADVANCING HEALTHCARE

The place to be for

Life Sciences

Top capacities to develop and deliver innovative products &Â services from bench to market in key areas. European leader in clinical research. Worldwide leaders trust us GSK, IBA, Zoetis...

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Favorable tax environment and R&D incentives. Biolog Europe, a facilitator in Supply Chain Management (SCM). Biotech hub connected with first-class clusters andÂ organisations worldwide.

CONTENTS regulars

COMMENT Ian Bolland highlights the challenges for life sciences in 2021

MAKING MEDTECH A round-up of the latest industry news

13.

OPINION Wilmington Healthcare explores key questions amid changes to NHS organisation and funding

16.

COVER STORY EU Automation explains how human factors engineering can be a life saver

33.

DIGITAL HEALTH

TÜV SÜD discusses what should be tested in the early design process of connected devices

34.

REAL WORLD MEDTECH Ian Bolland speaks to Dr Paul Rinne from GripAble about its remote rehabilitation offering

THE TEAM editor | ian bolland ian.bolland@rapidnews.com advertising manager | christine joinson +44 (0)1244 680 222 christine.joinson@rapidnews.com business development manager | richard york +44 (0)1244 952 367 richard.york@rapidnews.com

features 15.

IRELAND

MED-TECH

EIT Health looks at how Ireland’s thriving medtech ecosystem came to be

INNOVATION | NEWS

19.

3D PRINTING Sandvik explains the role of titanium powder and AM in medical implant production

23.

MED-TECH INNOVATION EXPO Inovus Medical provides a presentation teaser for Day 2 on the HealthTech Stage

24.

DIAGNOSTICS PixCell outlines the recent innovations in point-of-care diagnostics

27.

MEET THE START-UP

INBRAIN Neuroelectronics introduces its graphenebased brain implants

29.

REGULATION ICON outlines the challenges for firms getting ready for IVDR during a pandemic

vp sales & sales talent julie balmforth head of studio & production | sam hamlyn designer | matt clarke junior designer | ellie gaskell publisher | duncan wood

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from The editor Things can only get better… right?

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elcome to first issue of MedTech Innovation News of 2021. It feels natural to look ahead but while we hope for better things this year, we are definitely feeling the after-effects of 2020 and the COVID-19 pandemic. A different calendar year unfortunately does not mean there is instant change though life science companies have had their fair share in the UK and Ireland. Northern Ireland remains closely aligned with the European Union’s Single Market and Customs Union in an attempt to preserve peace on the island of Ireland, while changes to the UK’s trading relationship with the largest bloc on its doorstep were only cemented eight days beforehand when adverts telling them to “get ready” had been circulating the media for a couple of months prior. The early stages of this new arrangement is bound to provide its challenges, irrespective of preparedness. But over the last year or so, the industry has proved itself capable of rising to challenges when it helped mass produce PPE, ventilators and tests to combat a deadly organism that didn’t even exist only months earlier. The pharma industry deserves huge plaudits for developing and enalbing the roll out of vaccines as we all

intend to get back to the things we love doing – and I hope for those reading that includes attending the Med-Tech Innovation Expo at the end of September. It’s frustrating that we had to postpone it yet again, but we want to ensure you have the confidence that you can attend safely and exhibitors, speakers and visitors alike all get as much out of it as possible. We’ll need a helping hand in that. In particular, we all hope that at least one of the targets from government becomes a reality and that we can all return to normality. After so much unfounded optimism, to the point where it feels like things have got worse, it’s hard not to be sceptical. Regrettably it was nicely summed when the health secretary attended a GP surgery to see vaccines administered only to find out they haven’t arrived due to delay. At the time of writing, this has thankfully been an abnormality when it comes to the UK’s vaccine rollout. I’m keeping my fingers crossed and my arm is at the ready! Our first issue of the year intends to highlight some key aspects of the industry in recent months. This includes the diagnostics industry which has risen to the challenge when it comes to testing capability for dealing with

Coronavirus, it’s only right we highlight other areas they are involved in too, as well as more regulatory challenges coming the way of our medical device companies in the years ahead – particularly those that operate both in the UK and the EU. These are two of the big challenges that we all have to deal with and overcome, both on a personal and professional level. By now, we probably know someone who’s either been affected by this dreadful disease, or had their job or business has had to change because of the changing relationship between the UK and mainland Europe. I can only sign off by saying I hope you enjoy what we have to offer in 2021, and that this year is more prosperous and safer, individually and collectively, than the last one.

The industry has proved itself capable of rising to challenges when it helped mass produce PPE, ventilators and tests to combat a deadly organism that didn’t even exist only months earlier

Making medtech

DEEP TECH ECOSYSTEM UNVEILED IN BRISTOL

New September dates for Med-Tech Innovation Expo

apid News Group has announced its decision to reschedule Med-Tech Innovation Expo, the UK’s flagship event for the medical device industry, to 28 – 29 September 2021 at the NEC. The organisers have moved quickly to secure these new dates to enable the community to plan for the next period with confidence.

cientist and entrepreneur, Dr Harry Destecroix, has unveiled Science Creates, a deep tech ecosystem that offers specialised incubator space, a £15 million investment fund and a comprehensive network of strategic partners to nurture science and engineering start-ups and spinouts. Dr Destecroix, founder of Science Creates, said: “Where a discovery is made has a huge bearing on whether it’s successfully commercialised. While founding my own startup, Ziylo, I became aware of just how many discoveries failed to emerge from the lab in Bristol alone. No matter the quality of the research and discovery, the right ecosystem is fundamental if we are going to challenge the global 90% failure rate of science startups, and create many more successful ventures.”

No matter the quality of the research and discovery, the right ecosystem is fundamental if we are going to challenge the global 90% failure rate of science start-ups

Duncan Wood, CEO of Rapid News Group, said: “The latest information in the UK means the right thing to do is to reschedule the event to enable a further 13 weeks

of vaccinations to take place ahead of the event. “On current deployment projections this has the potential to have a huge impact on attendee’s ability to visit and of course the subsequent ability for our community to come together for education, insight, networking and to do business. As an organiser we recognise these connections are what makes live events work and this adjustment means we can be sure of creating more of these connections for the community whilst safeguarding the health and wellbeing of all attendees.”

Back to school: Friends set up advisory firm

Science Creates grew out of the original incubator, Unit DX, that Destecroix set up in collaboration with the University of Bristol in 2017 to commercialise companies like his own, Ziylo, which aimed to develop one of the first smart insulins to help people suffering with diabetes. In 2018, Ziylo was purchased by pharmaceutical giant Novo Nordisk in a deal potentially worth $800 million and Harry saw the opportunity to expand his incubator into an ecosystem that invests in and supports other exciting deep tech innovations.

ames Hardie and Mat Targowski have set up Sanollo, an advisory firm specialising in helping the latest medical technologies enter new markets. Sales have got off to a good start with three new customers and a pipeline of prospective customers throughout Europe, in India, Argentina, Malaysia and the USA. Hardie, whose background is in exporting medical devices, said: “We provide insight reports, market strategy, trial and distributor management approaches which allow companies to build the international side of their revenue. “Many UK businesses in the sector are focussed on the huge annual demands for product from the UK’s National Health Service and do not get involved in international markets.” Targowski, whose

background is in technology business development, added: “The COVID-19 pandemic has meant that we are currently operating without the usual international trade shows in Dusseldorf or Dubai, but there are still huge opportunities for UK businesses in the sector to extend their range. “Our collective skillset is enabling us to exploit a gap in the market and so far, aside from a scattering of older consultants in international trade, many of whom are retained by aspiring exporters, there is limited competition.”

Making medtech

up businesses to grow and flourish. Associate director Louise Flintoft said: “With the #ThinkBig initiative and our competition launch, we want to help healthcare and life science spin-outs and SMEs kick start or accelerate their development.

Life Science SMEs can win £5k of comms expertise

ealthcare marketing communications agency Onyx Health is launching a national competition for one business in the health and life science sector to win £5,000 of its communications expertise for free.

special to the market. This forms part of Onyx Health’s #ThinkBig campaign, which will be running throughout 2021 and is about encouraging life science startups and SMEs to fulfil their commercial potential.

The competition is aimed at innovative start-ups and SME’s in the health and life science sectors, who are at the industry’s cutting edge and can bring something extra

The #ThinkBig campaign includes budget-friendly packages, marketing activities and a program of educational events, designed specifically to support SMEs and start-

WEARABLE TO SUPPORT SOCIAL DISTANCING AND INFECTION CONTROL

assive industrial radio frequency identification (RFID) tag developer, OmniID, has extended its Sense range of IoT devices with the launch of three new devices incorporating Quuppa’s location technology. The Sense Shield is a wearable device that tracks and records the movements of the user and can be configured to sound an alarm whenever it is located two metres or less from another device. The Sense Shield has a range of public health applications including infection control in care homes, cruise ships, public transport and sports venues.

Dr Tony Kington, CEO of Omni-ID said: “We foresee some really exciting applications of our Sense devices. We’re particularly proud that our addition of Quuppa compatibility has enabled the rapid development of devices that can be applied in the global fight against the COVID-19 pandemic. The Sense Shield has potential applications in healthcare settings, cruise ships, sports venues and wherever an organisation needs to help people to maintain social distancing. Quuppa’s location accuracy is second to none, so our latest Sense products offer high performance in terms

“Right now, the healthcare sector is having to face up to new challenges and opportunities, such as the cancellation of events and restrictions on visits in clinical settings, which are forcing them to look to innovative solutions to engage and interact with their customers. “Whether you are a start-up or a more established business, we know money does not grow on trees, and marketing may seem like an unaffordable luxury. However, its role in business growth makes it an essential investment. That’s why we want to do all we can to support the life science sector during these uncertain times by offering £5,000 worth of our expertise in this competition. Get in touch to see how we can help.”

of communication distance, ruggedness, battery life, and accuracy.” The existing Sense BLE asset-tracking device has a version enabled with Quuppa. The third addition to the Sense range is a simpler version of the Sense Shield, which provides the same Quuppaenabled location accuracy for tracking assets, without the audible alarm. Omni-ID has also launched its ‘OmniSphere’ middleware IoT platform, which provides dashboards to display various sensor data including motion alarms, range measurement, push button alerts, temperature, GNSS coordinates and devices’ current and previous positions on a configurable map. The rules engine within OmniSphere enables alerts to be generated based on sensor data, for example, sending an email when a device enters or leaves a geofence, or notifying when a device’s temperature goes above or below a preconfigured threshold.

Design and manufacturing firm becomes employee owned

ngineering and process automation company, 3P innovation has become an employee-owned company as it aims to secure its long-term future. 3P was founded in Warwick in 2006 by a group of likeminded engineers with a passion for quality engineering, high performance machinery, innovation and collaboration. The company has grown rapidly, working closely with clients to create manufacturing solutions across a variety of sectors. In 2018, it moved to a new, purpose-built facility in Warwick and has since doubled turnover. Founders Tom Bailey and Dave Seaward decided the employees will be the best successors for ongoing and long-term ownership of the business, choosing an Employee Ownership Trust (EOT) as its succession model. Tom Bailey, managing director, said: “As the founders of 3P, both Dave Seaward and I feel a genuine obligation to our customers and employees alike to continue to provide a strong and secure platform for sustained growth and development of the business. 3P has always fostered positive employee engagement to ensure we work tirelessly in close partnership with our customers. It is our employees past and present who are responsible for the success we currently enjoy. Becoming an employee-owned business will ensure that these values remain embedded within the business for the long term.”

MEDILINK

Medilink Midlands CEO and board announced

edilink Midlands has announced that its board of directors has appointed Dr Darren Clark as chief executive officer and member of the board of directors. Dr Clark joined Medilink East Midlands in 2004 and has over 20 years’ experience in the life science sector, the majority gained in industry, at Pharmaceutical Profiles (now Quotient Sciences), with the remainder in academic research at the University of Warwick. He said: “What businesses need more than anything at the moment is reliability and assurance. As the newly appointed CEO, I have a deep commitment to strengthen our support to the Midlands life science community. “Looking forward, we will need to accelerate our strategic approach to ensure we serve all our patrons, members and the Midlands life science community as

a whole, to the best of our ability in these everchanging times. Great work has been done, but we must continue to drive the Midlands forward.” As the East and West Midlands come together as Medilink Midlands, a new board of directors has been formed by bringing together the former boards of Medilink East and West Midlands, with Prof Martin Levermore DL appointed chair of the board, who previously served as chair on the Medilink West Midlands board of directors. Prof Levermore said: “As Medilink Midlands enters its next chapter, I look forward to working alongside my fellow board members to enable bigger and better opportunities to all and shine a light on the regions remarkable infrastructure of life sciences, medtech, and healthcare organisations we boast, here in the Midlands.”

Digital health firm receives Deal of the Month A funding injection secured by a rapidly growing Welsh medtech specialist has been named as Deal of the Month. Cardiff-based Bond Digital Health has received £1 million from Wealth Club, the highnet-worth investment service, and £200,000 from the Development Bank of Wales. The money will fund further business growth,

product development and expansion into new global markets. Last year Bond received £700,000 in equity funding from the same two organisations and was later awarded more than £200,000 in government grants. Bond used the funding to expand its team, creating five new highvalue tech jobs to help develop its technology for the market.

Plastic bottles recycled to make face masks

n Ilkeston textile manufacturer has developed a sustainable washable face mask made from recycled waste plastic bottles in a bid to reduce the environmental impact of Coronavirus. Baltex has created the mask in response to reports that disposable masks have led to a surge in plastic pollution during the pandemic. The company, which designs, manufactures, and supplies a variety of technical textiles for markets including the medical industry, launched its Airox Face Mask, with an anti-viral finish, last year. It has now developed a 3D fabric with yarn made from crushed plastic drink bottles, creating sustainable masks. Designed to be comfortable yet strong enough for use during manual labour or sporting activities, the Airox Sport is already being used by staff in several companies

across the East Midlands. The fabric has passed tests for breathability, liquid repellence and buyer comfort while the specialist coating, called ViralOff has been accredited with reducing levels of Influenza A, BirdFlu, Norovirus and SARS by 99%. Managing director Charles Wood, said: “There have been huge improvements in the quality of yarns made from recycled products and the fabric we have developed is soft and extremely comfortable. “While it is perfect for wearing to the supermarket, the breathability of this mask makes it ideal for wearing while exercising or in workplaces where the labour is quite manual; it is already being used on the shop floor at several companies in the East Midlands. “While welcome news of a vaccine may mean we won’t need face

masks forever, we are expecting them to still be a requirement until at least Easter time. “Hopefully our environmentally-friendly masks will prevent both plastics and used masks ending up in landfill, or worse, abandoned in our streets, rivers and eventually the sea.”

Bond’s connectivity and data platform, Transform, collects and stores data from lateral flow diagnostic tests – the same type of rapid tests that are being widely used in the COVID-19 outbreak. A version of Transform is currently in-market, digitising and powering a Canadian client’s COVID-19 rapid antigen test. Barford Owen Davies provided financial advice and assistance to Bond Digital Health while Acuity Law and Bevan & Buckland provided legal and corporate tax advice respectively.

cleanrooms

FLATPACK TO THE Guardtech explains its offering during the COVID-19 pandemic and looks to the future for cleanrooms.

cleanrooms

“T

he world is changing. These are turbulent times. We’re in the midst of a pandemic that has turned our lives upside down and inside out in ways most of us would have thought unimaginable 12 months ago.” Guardtech commercial director Mark Wheeler has seen the business landscape shift immeasurably over the past 12 months and he and Guardtech Cleanrooms have been using their expertise to help businesses tackle the COVID-19 crisis in a variety of different ways. One of the greatest areas of concern has been the UK’s shortage of laboratories – as well as workspaces for COVID-19 testing and diagnostics. Largescale construction projects often require a great deal of time and money – and many institutions and businesses have seen their finances wrecked by the pandemic. At the time of writing the company is providing controlled environments, labs and COVID-19 testing units. “Many firms don’t have the resources to tackle the problem,” continues Wheeler, “but Guardtech Cleanrooms are offering solutions. We’re helping businesses. And our work is undoubtedly, albeit indirectly, helping to save lives.” Guardtech has used its expertise to create two immediate solutions – CleanCube portable cleanrooms and ISOPOD modular cleanrooms. WHAT IS A CLEANCUBE? A cleanroom built to the same quality standard as any of Guardtech’s large-scale modular builds, but within a mobile format. The CleanCube comes in three forms – box vans, shipping containers and modular buildings. Containers come as 20ft or 40ft units and the vans are either 3.5 or 7.5-ton vehicles and can be internally fitted out to meet the requirements of biosafety laboratories (BSL 1, 2 & 3), COVID-19 testing stations and COVID-19 diagnostic labs, as well as standard temporary ISO 5, 6, 7 and 8 cleanrooms. Wheeler explains that the development of the CleanCube began with a mission to assist clients that had the capability and resource to provide testing and diagnostics for tackling COVID-19,

but didn’t have the platform to deliver their services. “They approached us about the CleanCube range to see if we could give them an expedited product to get them up and running with a transportable testing facility in as little as three weeks, and we were more than happy to accept the challenge. The key with the build is a fast, off-site constructed module, built to the same high standard of a modular cleanroom, with no compromise on materials or specification, but creatively designed to make best use of a compromised footprint.” The company’s response to the COVID-19 pandemic stretches beyond CleanCube mobile cleanrooms and COVID-19 testing and diagnostics. Guardtech was initially involved with the ‘ventilator challenge’ – when machines were scarce at the beginning of the crisis. The Haverhill-based firm soon found themselves working with manufacturers producing ventilators, and those directly supplying vital components for them. Wheeler said: “This involved repurposing facilities in super-quick time and providing our engineering skills to critical suppliers. One project that sticks in my memory was with an aerospace company – we worked with them to upscale manufacturing, on a project which included a canteen conversion into a new production space for valves that were to be used in the Dyson ventilators, all within the space of a week. “One part of that project was to overcome the challenge of getting components to the first floor of the building. The client presented the problem on the Wednesday afternoon, we designed a bespoke lifting solution on the Thursday morning, ordered the components in the afternoon and on the Friday and Saturday the whole company were involved in fitting these bespoke product lifts – made from components that were sourced in an extremely narrow timeframe.” The next phase of COVID-19related projects that Guardtech became involved were focussed on upscaling British-manufactured PPE. “I’m sure everyone remembers the negative press about the woeful shortages of PPE in the NHS,” Wheeler recalls. “It all stemmed from an inadequate domestic PPE

supply chain – due to the fact that almost all PPE is manufactured abroad and imported. We were proud to get the opportunity to work on cleanroom design & build projects for facemask manufacturing in the UK and Ireland, supported by government funding to upscale PPE capacity quickly.” The company is involved in a largescale design & build project for a COVID-19 testing re-agent facility that will support the national testing effort, and it has provided more than 20 mobile testing facilities for PCR testing. ISOPOD modular cleanrooms ISOPOD is Guardtech’s new concept in modular cleanroom design & build controlled environments which can be selfassembled and are customisable to best utilise the host room they are installed within. “ISOPOD is essentially a flat pack cleanroom,” explains Wheeler. “They’re manufactured to the same quality standards, with most of the same components, as any of our high-quality modular cleanrooms, but in a simplified manner that facilitates either quick installation or self-assembly by end users. The units are customisable, configurable, extendable, can be relocated and are available in hardwall, softwall or hybrid formats.” THE FUTURE Wheeler admits that it’s currently difficult to make predictions, but he is backing the cleanroom industry to play a massive role in helping to shape best practice in a range of sectors going forward. “In today’s world, control is the new norm. Risk management, segregation, considered workspaces, controlled environments, filtration – these are all terms that are being adopted on a far wider basis than ever before and it is the responsibility of industries such as ours to lead from the front and share our vast experience with those that are new to this arena. “I believe that over time we will see a new wave of industries adopting upgraded production environments, seeing this step as a responsible way to protect staff in production environments and as an added safeguard against the risk of potential downtime.”

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How NHS changes will affect medtech: Five key questions Oli Hudson, content director at Wilmington Healthcare, explores some key questions for medtech amid a flurry of changes to NHS organisation and funding coming this year.

1. What does the latest round of NHS reform mean for medtech? Since the publication of the NHS document ‘Integrated care: Next steps to building strong and effective care systems across England’, we now know much more about how the new system-based financial model will work in practice. The document underlines the ‘whole-system’ approach, whereby a ‘single pot’ of funding which brings together current CCG commissioning budgets, primary care budgets, the majority of specialised commissioning spend, as well as a system’s share of National Transformation Funding, will fund a contractual network made up of NHS trusts, specialist trusts, primary and community care providers in various integrated groupings. In secondary care the document calls for the formation of ‘provider collaboratives’ at place level – a similar idea to the ‘integrated care partnership’, who will hold these contracts to serve particular patient groups. This whole-system approach to payment – founded on a ‘fixed payment’ to cover services rather than an activity-based approach that encouraged organisations to compete for commissioning monies – is intended to better reflect care models that use a ‘whole pathway’ outlook covering all sectors of care and encourage collaboration between them.

2. How will GIRFT affect these new pathways? The Getting It Right First Time initiative – originally established as a means to standardise hospital care processes, techniques, and purchasing to reduce nationwide variation – has been increasingly taking all these system developments into account when issuing guidance – which has a lot of influence in the clinical community about what should be used, on which patients, and in which circumstances. For instance, the recent report on ophthalmology intended to increase patient throughput of hi-flow services such as cataract surgery, spent a deal of time relating how success was also based on collaboration with primary care. 3. Who is responsible for implementing NICE device recommendations now? NHS organisations must follow recommendations in NICE Technology Appraisals and for some time have had a contractual requirement to take into account other types of NICE guidance, including NICE Medical Technologies Guidance and NICE Diagnostics Guidance. But with the move to systems and ‘population-based’ healthcare as spelt out in the Integrated care document, these contracts will no longer be held chiefly by individual NHS organisations, but by the so-called ‘provider collaboratives’ acting on behalf of a ‘place’ based population – for which they would then be responsible

for running, and funding, the pathway in the contract. 4. What’s happened to the high-cost devices exclusion list? Normally for each new tariff, high-cost devices steering groups meet to discuss items that could be added or removed from the high-cost, tariff excluded list. There is also a web portal for people to submit nominations for the lists, as well as a horizon scanning exercise to identify new items that might be expected to come onto the list. However, the steering groups for 2021/22 were not able to meet until late 2020 and neither the horizon scanning process or web portal have been run. As such, the steering group’s view was that – particularly in the context of the rollover of prices and the uncertain impact of COVID-19 – it would not be appropriate to make significant changes to the lists of high-cost drugs or devices for 2021/22.

Nonetheless, the mandate policy and the consultation outcome report will be published this winter prior to its April launch. It will confirm the final criteria, the technologies that it will cover and additional implementation support. After the policy is launched, a team from the Accelerated Access Collaborative (AAC) will regularly review NICE guidance on medical technologies and diagnostics to identify which medical devices, diagnostics and digital products will gain mandate support. CONCLUSION Expect more on changes to medtech funding processes – and to the decision-making units responsible for their market access, adoption and purchasing in the weeks to come. Some devices previously acquired through specialised commissioning have now had their budgets transferred over to integrated care systems for 2021/22.

5. What about the medtech funding mandate? This has been suspended until April 2021. A move to support innovative medical devices by providing funding and speeding up access to patients, originally the plan was to launch it in 2020 until COVID-19 meant the National Tariff payment system – which supports the medtech funding mandate - was suspended. Now, the tariff has been more or less supplanted by the systembased approach.

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IRELAND

HOW IRISH MEDTECH CAME TO THRIVE Dr Paul Anglim, partnership development lead for EIT Health Ireland-UK, takes a look at how Ireland’s thriving medtech ecosystem came to be, and why it continues to go from strength to strength.

n understanding Ireland’s success in medtech, it’s important to look at how Ireland turned around its manufacturing slump to become a hotspot for nine of the world’s top ten medtech companies. The origins of its prosperous medtech sector can be traced back to its highlyskilled manufacturing workforce and strategic government support. When the manufacturing industry suffered a downturn in the 1980s, both the Irish government and those running the sites wanted to safeguard and grow the field of manufacturing. For them, it was time to embed R&D and innovation into medtech. MAKING IRELAND AN ATTRACTIVE PLACE FOR R&D Over the next few decades, the Irish government’s strategy went beyond offering physical space and taxation grants, with the development of strategic funding agencies and initiatives. In 2015, the Science Foundation Ireland’s CÚRAM Centre for Research in Medical Devices launched Ireland’s first stem cell manufacturing centre at NUI Galway. With the goal of positioning Ireland as the leader in medical device technology development, the SFI CÚRAM focusses on delivering affordable transformative solutions for chronic diseases. Other collaborations between the government, health services and leading universities have further cemented R&D in

industry and Ireland’s healthcare system. Take, for example, the establishment of the Health Innovation Hub Ireland (HIHI) at University College Cork in 2016. Backed by Enterprise Ireland and the Health Service Executive, the HIHI incorporates partnering institutes Trinity College Dublin, NUI Galway, Cork Institute of Technology (CIT) and associated hospital groups to lead on ground-breaking research and harness new healthcare technology, services and products. The development of clinical and patient-focussed research has paved the way for Ireland to lead on the exchange of technology ideas. According to IDA Ireland, government grant assistance is responsible for 70% of medtech companies in Ireland engaging in research and development activities. The goal to entrench R&D in the medtech sector is fast becoming a reality. INDUSTRY AND GOVERNMENT ALIGNMENT As the medtech industry looks to drive growth, alignment between governmental agencies and key associations have played a major role in making this possible. The IDA has made Ireland an attractive place to do business. The break-up of the IDA into three separate organisations in the mid-1990s enabled it to focus on driving high-quality foreign direct investment in Ireland. The USbased medtech company Stryker’s 2019 investment of more than €200 million in R&D at its Cork facilities is just one example of the IDA’s success in brokering landmark deals.

Underscoring its support of industry, the IDA recently announced that it is set to deliver a targeted COVID-19 fund, investing a total of €200 million in medical technologies and pharmaceuticals. In addition to the IDA, the Irish Medtech Association has been vital in championing the needs of multinationals corporations and SME member companies to the Irish government. Sitting within Ibec, the Irish Medtech Association has a clear grasp on what the actual needs of industry are, how to represent them to governmental bodies – and how to ensure Ireland remains a key location for companies to base their operations. A BURGEONING ENTREPRENEURIAL MINDSET There has also been shift in perception on what is means to be an entrepreneur. People want people to be successful. The entrepreneurial mindset is common among university students of today – and there’s an abundance of universityled programmes to develop innovative ideas. NUI Galway’s BioInnovate Fellowship programme has paved the way for a plethora of successful medtech start-ups. Supported by Enterprise Ireland, BioInnovate delivers needs led innovation based on a proven Stanford BioDesign framework, identifying where recommended solutions would have the most impact. Bioinnovate, like other university-led fellowships, is physically housed in the same place as earlier stage programmes, enabling innovators to meet, network and share new ideas. In these spaces, the entrepreneurial mindset is the norm, and new innovators emerge in Ireland’s medtech sector. IRELAND AS A THRIVING MEDTECH ECOSYSTEM Taking into account the support from government agencies, industry, clinical and academic institutions, the existence of Ireland’s 300-plus community of medtech companies can be better understood. It is in this dynamic environment that EU-backed organisations like EIT Health, a network of leading health innovators, have decided to expand their presence in Ireland.

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HAVING THE

X-FACTOR

HOW HUMAN FACTORS ENGINEERING CAN SAVE LIVES

ow many times have you tried to plug a USB in the wrong way round? Since both sides are usually similar on the outside, chances are that you have tried to force a USB in upside down at least once. The consequences of this mistake are usually negligible, but in healthcare, poor design can have serious repercussions. We all know how to plug in a flash drive, so why do we still slip up? Usually, it’s because we are concentrating on something more important. Imagine the same happening in a busy emergency unit where healthcare providers are carrying out life-saving procedures. They’re short on time and working under pressure. One of the paramedics is trying to resuscitate a patient who just went into cardiac arrest — he charges the defibrillator, presses “on”, but instead of shocking, the device switches off, causing the team to waste precious time. What went wrong? And how could the same issue be prevented in the future? Human factors engineering can help answer these questions. TO ERR IS HUMAN When the heart stops beating, every minute that passes reduces the chance of resuscitating the patient by 10%. In the example above, the paramedic should have pressed “shock” instead of “on”, because in several defibrillator models, the on and off switches are the same. When the defibrillator is accidentally turned off, it takes an average of two to three minutes to restart, meaning the user has 2030% less chance of resuscitating a patient. Blaming the paramedic does not prevent other healthcare professionals from making the same mistake in the future. Chances are that improving the defibrillator’s design is a much more effective step.

Neil Ballinger, head of EMEA at manufacturing parts supplier EU Automation, explains the role of human factors engineering in optimising medical devices.

Human factors engineering (HFE) is the discipline that tries to identify and address problems with equipment and systems design. Its goal is to optimise the interaction of workers with their technical tools and work environment to improve safety, effectiveness and ease of use. HFE considers how products are used in a real work environment, by fallible humans. It uses the principles of cognitive behaviour to

Human Factors Engineering

We can redesign processes and tools to prevent mistakes or, if they do occur, make corrective actions more easily assess how workers will respond to a particular scenario, considering variables such as physical demands, mental workload and team dynamics. It also studies how environmental conditions such as PPE, noise, inadequate lighting or distractions can impact a worker’s ability to perform a task. The underlying principle in HFE is that we can’t redesign humans — slips and lapses are common even in the most scrupulous, best trained worker. However, we can redesign processes and tools to prevent mistakes or, if they do occur, make corrective actions more easily. To achieve this, HFE uses a combination of equipment usability tests, standardisation policies, checklists and environment redesign. NO MORE BLAME GAMES Compared with other high-risk industries, the applications of HFE principles in healthcare is quite recent. One of the first publications to tackle the question of equipment and systems design in the sector is the 2000 IOM report ‘To err is human: building a safer healthcare system’. The report was revolutionary in its approach to medical error — instead of blaming healthcare providers, it focussed on the inadequacy of tools and systems. The report also highlighted the need to create a culture of safety, where workers can report potential hazards without fearing criticism or retaliation. Yet 20 years later,

the standard approach is still to try and avoid all human error, and when this inevitably occurs, the first reaction is to blame the provider. Compare this with the aviation sector, where the principles of HFE started to be applied as early as the 1970s. Most major airlines have non-reprisal and non-retaliation policies, meaning that pilots and air traffic controllers can safely report when they are about to make a mistake, without having to fear for their jobs and licences. This allowed the industry to create systems that prevent or mitigate human error. The result? Today there are more than 30,000 flights a day, but planes crashes are rare. EXPECTATIONS VS REALITY One of the biggest problems in medical device manufacturing is that there is often a huge gap between how design engineers think a device will be used, and how it is actually used in the field. A 2007 usability study of two common models of defibrillators found that when the scenario required two subsequent synchronised cardioversions, 50% of the users had the device in the wrong mode the second time, although all of them were familiar with the model they were using. This happened because the device changed mode during the first shock without notifying the user. Researchers notified both manufacturers, and one of them replied that the appropriate corrective action for that case was explained in the device labelling.

But as every person who has ever pulled instead of pushed a door knows, labels are not always effective. When every second counts, paramedics don’t have time to calmly read the device label. The manufacturer’s response signals a huge gap between how work is imagined and how it is actually performed. This issue is not by any means exclusive to defibrillators, the same can happen with a variety of medical devices. For example, transcribing the wrong values from a glucometer into the electronic medical record is still a very common mistake in intensive care units. This could be easily fixed by implementing connectivity between the glucometer and the central electronic medical record. In this case, systems designers didn’t consider the fact that nurses need to transcribe these values manually multiple times, which can inevitably lead to mistakes. The good news is that system fixes are sometimes easier to implement that you might think. For example, older devices that lack connectivity can be retrofitted with smart sensors to communicate with the central system. When technology is designed to be used by real humans, in real work environment, it becomes an ally rather than a source of potential hazards. Though we’re still using trusty old USB devices, newer connectors, like the ones you use to charge your mobile phone, have been designed using human factors engineering to work both ways. We’re starting to see the same in medtech.

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MED-TECH INNOVATION | NEWS

3d printing

THE FUTURE OF MEDICAL IMPLANTS? Harald Kissel, R&D manager at Sandvik Additive Manufacturing, shares insight into how titanium powder and AM are revolutionising medical implant production.

n 1891, Professor Themistocles Glück performed the first hip replacement using a ball and socket made from ivory. Medical implant technology has since progressed, and recent developments in additive manufacturing (AM) and materials technology have even made bespoke 3D printed implants possible. The adult human body has 206 bones, which all have an important function of providing structural support and protecting our vital organs. Because of the important jobs bones are tasked with, a damaged bone can have severe consequences to a patient’s health and quality of life. LIMITED TREATMENTS If a bone has been severely damaged to the point where it cannot heal and function correctly, a medical implant must be inserted. This is particularly true for serious accidents that destroy areas that are complex to treat, such as the skull or spine. Typically, creating an implant that suits the patient’s needs requires multiple medical appointments. At a time when a damaged bone could be causing the patient pain, reduce their mobility and affect their lifestyle, this long wait for an implant can be incredibly uncomfortable. Despite the wait seeming long to the patient, the design process has actually been sped up to relieve

them more quickly - but this does result in a sub-optimal implant that isn’t tailored to their bodies. For skull injuries, this could even mean the patient is fitted with a mesh implant, which can be weak and lack precision. DISRUPTIVE TECHNOLOGIES Fortunately, AM and titanium powder have now allowed the production of made to measure medical implants that are biocompatible and fit to the body seamlessly. The advancement of 3D printing has even made it possible to fabricate carbon copies using anatomical data of our own skulls. Titanium has excellent properties as it can resist corrosion while simultaneously demonstrating strength, low weight and biocompatibility. AM using titanium powder allows complex bespoke implant designs to be produced at speed, in shapes no other manufacturing technology can deliver. The precise placement of the metal powder allows the production of a lightweight structure that reduces material waste. AM is seen as a disruptive technology in the medical sector, providing life-changing solutions to patients. The custom designs are made using a computerised tomography (CT) scan, an imaging technique that uses x-ray measurements taken from many different angles to produce a tomographic image of the body. The technique is hailed as a way to see

AM using titanium powder allows complex bespoke implant designs to be produced at speed, in shapes no other manufacturing technology can deliver

inside the body without surgery and goes beyond any other medical implant design method. Sandvik manufactures its own Osprey titanium powders in its powder plant, located in Sandviken, Sweden, which was awarded the ISO 13485:2016 medical certification in the summer of 2020. The powders are now approved for use in the additive manufacturing of medical applications. GROUND-BREAKING RESEARCH The fully automated production process at Sandvik’s plant ensures reliable titanium powder quality. In-house metallurgical capabilities allow Sandvik to conduct alloy development, alloy research and tuning of materials to the intended application. Sandvik is taking part in an innovative research projects in the medical 3D printing sector with The Swiss M4M Center in Switzerland, a public private partnership initiated by the Swiss government. The project aims to build up and certify a complete end-to-end production line for medical applications such as implants. This will progress medical 3D printing to a point where bespoke implants at the forefront of technology can be designed and manufactured quickly and cost-effectively. Sandvik is contributing its material expertise to facilitate the initiative. The joint venture aims to revolutionise medical devices and benefit the lives of thousands of people. While ivory is no longer used as a medical implant material, the options available to patients have since remained limited until now. Fortunately, 3D printed implants are becoming a viable option for patients with lifechanging injuries. Developments in titanium powder and AM have brought bespoke implants into reality, giving patients with damaged bones exceptional implant designs at speed.

3D PRINTING

HOW 3D PRINTING CAN REVAMP PERSONALISED SURGERY Gautam Gupta – vice president and general manager, medical devices, 3D Systems, explains how 3D printing technology is used to design patient-specific tools and guides to help improve surgical outcomes.

ealthcare is one of the most dynamic fields of technology. The speed at which innovation is occurring — from the way surgeries are performed, to the development of new therapies — is moving ever more rapidly. Unfortunately, despite all these advances, findings by the World Health Organisation suggest that globally, surgery still results in high rates of illness, disease, and death. Unsafe surgical care procedures cause complications in up to 25% of patients. Almost seven million surgical patients suffer significant complications, one million of whom die during or immediately following surgery. 3D printing has been recognised for its ability to enable the creation of personalised surgical plans and tools, thus helping improve patient outcomes. 3D Systems was an early innovator in the field through the introduction of our VSP surgical planning solutions whereby we combine

expertise in medical imaging, surgical simulation, and 3D printing to enable personalised surgery allowing surgeons to perform the surgery digitally before entering the operating room. PATIENT-SPECIFIC MODELS & TOOLS IMPROVE ACCURACY AND EFFICIENCY To create patient-specific models and tools, the clinician must first begin with scans of the patient’s anatomy. Today, D2P - an FDAcleared, CE-marked software - is available that relies on automatic segmentation tools driven by deep learning enabling medical practitioners to create accurate, digital 3D anatomic models from medical imaging data. D2P also includes a volumetric VR solution enabling instant views of patient scans in a 3D environment facilitating conversations between medical staff and their patients. The segmented anatomy, in combination with a pre-surgical

plan and an appropriate quality management system, allows for the design of patient-specific anatomic models, surgical instruments, and implants. This can be accomplished using organic 3D design software such as Geomagic Freeform that includes advanced design tools for working with complex, organic shapes like patient anatomic structures. This software facilitates user-friendly interaction with objects to create precise, patientmatched medical device designs for instruments and implants. These devices can then be 3D printed in biocompatible materials like titanium alloy or a variety of polymers for use within the sterile surgical field. Pre-surgical planning in combination with patient-specific surgical instruments allows the surgeon to focus on giving the patient the best possible outcome. In clinical applications where VSP is used today, the solutions have been shown to improve

3D PRINTING

3D printing has been recognised for its ability to enable the creation of personalised surgical plans and tools, thus helping improve patient outcomes surgical accuracy and outcomes -- saving time in the operating room which benefits both the surgeon and the patient. Designing the optimal surgical plan also includes considering the procedure in a less invasive way, helping to reduce the length of stay, and ultimately overall healthcare costs. This can be illustrated by a case that allowed 3D Systems’ biomedical engineers to collaborate with Dr. Oren Tepper, attending surgeon, Division of Plastic and Reconstructive Surgery, Montefiore Medical Center, in planning and conducting ground-breaking surgery on a young girl who was born with an undersized jaw that inhibited her breathing. Traditionally in such cases, surgeons have been unable to perform the surgeries required to reshape a child’s jaw due to the pain and risks associated while the patient is very young. However, VSP technology-enabled Dr. Tepper to successfully correct the child’s jaw much earlier than is typical, at one month old as opposed to six-years-old, sparing her additional years of living with a tracheostomy. REVOLUTIONARY APPROACH AT THE POINT OF CARE Since our VSP surgical panning solutions first became available, the patient-specific models, tools, and instruments have been 3D printed at a 3D Systems location, and shipped to the surgeon. While efficient, healthcare providers have become increasingly reliant on innovation to improve patient care. With the advent of the global pandemic, supply chains and timely

delivery of healthcare was put to the test, and additive manufacturing demonstrated its power as an enabling solution. As the number of COVID-19 cases increased, healthcare workers needed increased volumes of PPE to treat patients. Additionally, the need for ventilators was growing exponentially and production lines came to a halt as raw materials were unavailable. It was very apparent how the pandemic disrupted supply chains and additive manufacturing (AM) was highlighted for its ability to rapidly adapt with new designs to produce the necessary items. When it came to manufacturing of nasopharyngeal swabs, for example, AM enabled rapid innovation via multiple design and material iterations to launch a product that could be massproduced cost-effectively. As the pandemic brought into focus, any sort of distance between where the patient-specific models, tools, and instruments are created, and where the surgery is performed has a direct impact on patient treatment. If these capabilities could be located within the healthcare institution – at the point of care - the planning and delivery time could be condensed.

Center (Nahariya, Israel), which includes a 3D printing lab. This is the first — and currently, only — centre in Israel that has an inhouse end-to-end surgical planning workflow, in which physicians have the know-how to use 3D Systems’ surgical planning applications and 3D printing. Despite only just starting to use this workflow in their daily practice, Professor Saruji said: “We already see the great progress in our patient outcomes. The errors are dramatically reduced, and the surgical ability of the surgeon is constantly improving. Also, having those capabilities in-house helps us to reduce procedural cost.” 3D printing is accelerating healthcare innovation, yet at the point of care, I believe this technology is still in its infancy. As the technology becomes more userfriendly for medical professionals, more hospitals will be able to implement end-to-end solutions for personalised surgery. This will disrupt existing healthcare models, improve the quality of care, and crucially, save more lives.

This is already occurring at some of the world’s elite hospitals where clinicians can create customised solutions for patient care by using AM solutions available to them on campus. For instance, Professor Samer Saruji leads the Craniomaxillofacial Surgery unit at Galilee Medical

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Med-Tech Innovation Expo

CONNECTED SURGICAL TRAINING – A NEW ERA FOR SURGICAL EDUCATION

On day two of Med-Tech Innovation Expo, Dr Elliot Street from Inovus Medical will present on bringing surgical training models to market. Here, the company provides some industry insight, and a flavour of what visitors to the HealthTech stage can expect.

novus Medical CEO, Dr Elliot Street said: “The recent global pandemic has shown us the importance of technology in allowing professionals to connect even when separated physically and geographically. At Inovus Medical we have addressed the need for trainers and trainees to be connected in a way never before possible, ensuring high fidelity surgical training can continue in the face of physical, geographical and financial barriers across the globe.” Simulation based training for surgical procedures has been gaining steady traction over the course of the last decade, proving to be an effective and safe learning environment to perform and record simulated ‘full surgical procedures’ as well as basic skills tasks. With the more recent advent of ‘digital surgery’, the delivery of training in the live theatre environment is changing significantly. The result is a suite of emerging technologies that are allowing surgical training to be ‘connected’ in a way never previously possible. There are several factors driving these tectonic shifts in surgical training, none starker than the COVID-19 pandemic which has decimated the traditional delivery of surgical training courses through lockdowns and social distancing measures. Elective lists and the traditional ‘training cases’ in which trainee surgeons would gain their real-life experience have either halted entirely or been drastically reduced in number. These changes

have compounded the underlying issues of lack of access and underwhelming functionality of existing simulation options. As a result, the majority of trainee surgeons in the UK and across the globe are experiencing short falls in their training with increasing risk of skills fade, as such, they are turning to technology to fill the gaps. Traditional simulation technology such as VR systems have been readily available on the market for some time to offer simulated experiences. Their shortcomings for the modern-day training environment are, however, many. The need to hone skills in a risk-free environment is driving an emergent demand for ‘take home training’. To replace the traditional training shortfalls, this take-home training must provide realistic haptic feedback and the ability for connected learning with outcome focussed reporting. Affordability is a major factor in delivering on this new need for training and can only truly be achieved through novel technologies such as Augmented Reality (AR) where virtual and real environments are combined to meet these training demands. With support and funding through SBRI Healthcare, funded by NHS England, healthcare simulation company Inovus Medical has incorporated both connected learning and haptic feedback into its product development as a means of offering surgical trainees the opportunity to train from anywhere in the world be it; in a simulation centre, hospital or at home allowing them to

connect with their trainer through an online training portal and experience highly realistic simulated training. The system developed by Inovus, LapAR, utilises real feel soft tissue models and real laparoscopic instruments to provide unparalleled functionality. Inovus Medical has used a novel approach to develop what it calls ‘functional Augmented Reality’ by merging real feel simulated soft tissue models with digital anatomy and ensuring seamless interaction between both the digital and real environments. The company has developed a proprietary method for triggering and managing intraoperative complications such as bleeding vessels and bowel perforations. The technology also allows tracking of decision making and tracking surgical performance combined with an online portfolio to show progression in skill over time. The LapAR platform allows surgeons to practise a range of procedures across the specialities of general surgery and gynaecology. Instrument tracking technology enables capture of instrument handling and performance metrics with performance data displayed in an online platform. The system is already in use across the UK, North America and Asia Pacific and is proving to be the perfect tool for delivering surgical training in the COVID era and beyond. Med-Tech Innovation Expo will take place on 28-29 September 2021 at the NEC, Birmingham.

Diagnostics

THE KEY TO PANDEMIC MANAGEMENT: UNLOCKING THE SECRETS OF THE BLOOD Yaara Ben-Yosef, regulatory & clinical affairs manager at PixCell Medical, examines the innovations in point-of-care diagnostic solutions during the COVID-19 pandemic.

hroughout the COVID-19 pandemic there have been several tests, treatments, and methods claiming to manage the disease. One key source of information that has proven consistently valuable is the blood. Floating in our bloodstream, along with red blood cells, white blood cells, and platelets, is a treasure trove of information about our health. Gathering and interpreting this data is of great importance, allowing doctors and epidemiologists to fully understand the impact of the disease. THE SCIENCE – CBC One of our most heavily relied upon haematological tools is the Complete Blood Count (CBC) test, the most frequently ordered blood test in the US and globally. This test evaluates the cells that circulate in the blood, including red blood cells (RBCs), white blood cells (WBCs), and platelets (PLTs), providing critical information on a patient’s health status. The CBC is used routinely in initial screenings upon admission of suspected COVID-19 patients, as the RT-PCR test

has a non-negligible false negative or false positive rate, and adjunctive tests assist in assigning degrees of urgency to patients. The CBC is used to monitor the progression of disease and host response and can provide a reliable indication of how severe the disease will become in each patient. POINT-OF-CARE TESTING The current method of processing a blood test is familiar to most of us - the patient presents themselves at a clinic where blood is drawn by a technician, after which the sample is sent to a centralised laboratory while the patient awaits the results. As the need for rapid blood testing has grown, diagnostic instruments must become portable and easier to use. While results from clinical laboratories remain a crucial component of our healthcare system, they should be complemented by tests performed at the point of care. Decentralising the testing process for suspected or quarantined COVID-19 patients is necessary to properly evaluate, monitor and treat the disease. Decentralised diagnostic solutions must be readily deployable, easy-to-use, compact, and accurate so that they fit “pop-up” treatment centres, field hospitals, and isolation wards. A concern throughout the pandemic is that hospitals will not be able to function due to shortages in resources and medical staff. Medical personnel

have become infected by the virus at exceedingly high rates – according to the International Council of Nurses, as many nurses have died during this pandemic as in World War I and an estimated 10% of cases are among healthcare workers. It is therefore critical to introduce technologies that help minimise the risk of contamination, including diagnostic devices that can be operated within isolation wards rather than needing to carry samples through the hospital to the lab. In some cases, infectious patients can have their own point-of-care (POC) device in their hospital room and can perform the CBC testing on themselves by taking a simple finger prick of blood and using the device to run the test. This conserves resources and lightens the load on hospital staff, as patients are monitored daily – and can potentially perform these tests autonomously. These tests provide accurate and rapid information, allowing doctors to make timely clinical decisions and personalise treatment plans for each patient. Point-of-care CBC testing can lead to more efficient, effective medical treatments and improved quality of medical care, allowing for more frequent and consistent testing cases of COVID-19. These tests can also help lower the risk of hospital personnel contamination, alleviate hospital overcrowding by reducing the time it takes to treat patients, and efficiently allocate resources to the most severe cases.

DIAGNOSTICS

How automation has unlocked a new era in surveillance Arvind Kothandaraman, general manager, specialty diagnostics at PerkinElmer, examines how automation in the lab enables molecular surveillance.

or decades, automation has played an important role in shaping how people across industries and job functions do their work. Its current and future impact, however, will be especially profound in the lab. While artificial intelligence (AI), machine learning (ML) and robotics have been in laboratories for years, these automation technologies have become increasingly important in the age of COVID-19. In 2021 and beyond, diagnostic labs will continue to embrace automation, particularly in a move toward widespread surveillance. In turn, the advances made by labs will contribute to a broader effort in the global scientific community that leads to new methods of detecting disease, developing therapeutics and discovering preventative measures. AUTOMATION 1.0 Since its earliest applications in the lab, automation – particularly mechanical automation – has helped improve the jobs of laboratory personnel. Apart from being highly repetitive, many lab procedures can be arduous and error-prone when performed manually. For this reason, it’s not uncommon to see a high rate of burnout among the population of lab employees who are responsible this work. However, when technicians have the option of working with self-contained, fully automated instruments and workflows, the result is often increased lab throughput and a minimal amount of manual labour associated with this work. Furthermore, because manual testing also tends

to be susceptible to person-to-person and laboratory-to-laboratory variation, mechanical automation has long been used to maintain sample integrity and reduce error. In addition to the mechanical automation that is commonplace in diagnostic laboratories today, there is an expansive landscape of software offerings that automate the back-end work of diagnostic labs as well. To avoid the time-intensive tasks associated with testing analysis – along with more operational aspects of lab management – software platforms backed by AI, ML or robotic process automation can accelerate these processes and oftentimes within specific parameters established by lab leaders. The advent of the cloud and cloud-based platforms go a step further towards eliminating the burden of traditional lab management and monitoring. Decades ago, the lab environment that we know today might have been unimaginable. As automation is likely to continue exceeding our expectations, it will move beyond making lab work more efficient, effective and safer, and may change the nature of lab work itself. AUTOMATION 2.0 AND NEXTGENERATION SURVEILLANCE As society continues to confront COVID-19, automation tools and technologies are enabling a new era of diagnostic testing and screening – helping labs monitor for community and population-level occurrences of infectious disease. For example, a research lab at Rutgers University in

New Jersey harnessed automation to develop a test that dramatically expanded COVID-19 testing in that state. While at the time, a typical hospital was able to process 20 to 30 samples a day, this technology showed potential for processing tens of thousands of samples in the same time span. In the coming years, similar advances in mechanical lab automation will help diagnostic labs keep pace with everincreasing testing demands in real-time – especially as more routine screening programs are adopted. In terms of other laboratory software, automation will continue to show impressive strength in data analysis. By aggregating and analysing the treasure trove of information that current testing programs have created, automation will help generate insights that help researchers better understand how disease develops in the human body, and how it spreads. Only when armed with this knowledge can pharmaceutical companies begin to develop the drugs and therapeutics with potential to control and ideally cure diseases. One day, automation may even move beyond the retrospective approach to diagnostics and more into the field of predictive analytics. While it remains to be seen just how far automation will go in the field of diagnostics, one thing that is certain is that these technologies here to stay. Laboratories that continue to embrace automation in all its forms are those that will thrive in 2021 and beyond.

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MEET THE STARTUP: INBRAIN NEUROELECTRONICS Graphene Flagship spin-off, INBRAIN Neuroelectronics, is developing graphene-based brain implants to treat brain disorders.

n Europe, there are 165 million people living with a brain disorder, and one in three are predicted to suffer with some neurological disorder during their lifetime. Each year, the cost of treating brain disorders equates to 35% of Europe’s total disease burden — that’s almost €800 billion.

very large and unable to accurately stimulate the affected area or record brain activity in detail. As a result, despite the enormous potential of neuromodulation to treat a range of brain disorders, current efforts have proved largely ineffective, with many causing significant side effects.

INBRAIN is a spin off from the Graphene Flagship, one of the largest European research initiatives, and its partners the Catalan Institute of Nanoscience and Nanotechnology (ICN2) and the Catalan Institution for Research and Advanced Studies (ICREA), in Spain. Established in 2019, INBRAIN uses technology developed by Graphene Flagship partners ICN2, ICREA and the University of Manchester to develop smart devices for patients with neuronal disorders, like Parkinson’s or epilepsy.

Graphene´s properties enable the electrodes to be miniaturised while still performing excellently. Graphenebased implants can support many more electrodes than traditional electrode arrays, and therefore are capable of high-resolution recording and stimulation. This results in mapping of brain activity with unprecedented spatial and temporal resolution and, at the same time, brain stimulation with unique precision.

INBRAIN’s technology is built around graphene electrodes which decode with high fidelity neural signals from the brain and then can produce smart therapeutic responses specific to the clinical condition of each patient. Clinicians have long used electrode arrays to monitor and to stimulate brain activity. But, the performance of commercially available technologies, based on metals like platinum, drops significantly when miniaturised. Existing clinically-used electrodes are therefore

Graphene-based implants can support many more electrodes than traditional electrode arrays

A smart and low-invasive neural interface, INBRAIN’s device can be used over large areas of the cortex without interfering with normal brain function or can be integrated into probes reaching deep structures of the brain. Powered by artificial intelligence and using big data, the implants can read and modulate brain activity, detect specific biomarkers and trigger adaptive responses to deliver optimal results in personalised neurological therapies. “The high-density bi-directional graphene dots in our brain interfaces collect real-time high-resolution brain signals and identify relevant biomarkers,” explained Carolina Aguilar, CEO of INBRAIN Neuroelectronics. “We link these to symptoms to generate a therapeutic solution. This entire process can be done through machine learning algorithms that eventually make the process automatic, delivering a true neuroelectric therapy free of the side effects associated to the current therapies.

“As we collect more securitised and anonymised data, we can create better and smarter algorithms and therefore more effective therapeutic solutions.” INBRAIN’s technology has been validated in in-vitro and in-vivo biocompatibility, as well as toxicity tests. It has been used successfully in studies on small animals and will be further validated through tests on large animals to ensure they are safe and superior to current solutions using metals. To achieve this ambition a team that has been put together, combining technical expertise and business acumen. It includes Graphene Flagship figures Jose Garrido, Kostas Kostarelos and Anton Guimera, neurotechnology experts from Philips, Medtronic and other start-ups such as Bert Bakker and Michel Decre, and neurotech business knowledge thanks to former Medtronic global director Carolina Aguilar. The team continues to grow with key neuroengineering talent in Europe. INBRAIN is currently working to ensure patient safety and to comply with necessary pre-clinical work and clinical regulatory milestones. The company plans to start its first in-human studies this year.

Regulation

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IVDR

What you need to know Alison Dennis, head of life sciences at Taylor Wessing, explains to MedTech Innovation News the differences between IVDMDD and IVDR. What are the mechanics of the new IVDR regulation? The IVDR will be fully applicable in the EU from 26 May 2022. The basic mechanics of the regulation are the same as for the Directive: both follow the New Approach. IVDs are now split into classes (A to D), as opposed to lists, and the highest classes will require notified body certification. The assessment for all IVDs will be against 20 general safety and performance requirements (GSPRs), with the need to balance risks against benefits in the safety and effectiveness of the IVD. The manufacturer will draw up detailed technical documentation against those GSPRs. This will be reviewed, where applicable, by the notified body. The technical documentation will also need to detail the post market surveillance system (PMS) that the manufacturer will have in place to continually monitor and assess the safety and effectiveness of the IVD in actual use. The Regulation requires that all actors in the supply chain (known as economic operators, EOs) take a role in ensuring that devices

are properly regulated and are safe. Because each EO requires information from further up the supply chain and is required to provide information to other EOs, this means that a network of agreements must be put in place. Where are IVD firms going to have to change practices? The most major change in regulatory practices for IVDs is the requirement for notified body certification. Under the Directive only 10-15% of IVDs require notified body certification, whereas under the Regulation it is estimated that this could be as many as 85%. IVD firms must learn how to meet the requirements of notified bodies and should prepare for regulatory activities to delay market entry for new IVDs compared to current timelines. The second biggest change is the requirement for more, and more rigorous performance evaluation data. Data will not only be required but will then be scrutinised by a notified body for the majority of IVDs. Companies will need to generate data if they do not currently hold or cannot otherwise obtain adequate data supporting the safety and effectiveness of their IVDs. This data-gathering will then need to continue through structured and proactive engagement in post marketing surveillance (PMS) activities. Manufacturers based outside the EU will require an importer based in the EU. Because the importer’s name and contact details must accompany the IVD for most IVDs it is not practical to have multiple distributors each acting as importer. Manufacturers from outside the EU are having to establish an EU entity that acts to “place the devices on the market.” Are IVD firms prepared for regulatory changes? Notified bodies are currently reporting low

up-take in applications for certifications under IVDR. This indicates that IVD firms are not yet ready for the regulatory changes. Translating our experiences with MDR, it is likely that a substantial number of SME IVDR manufacturers have not progressed far with preparing for the extensive regulatory changes represented by IVDR. Although there is a transition period, this will not apply to IVDs which do not require a notified body under IVDMDD but will do so under IVDR, which is the majority of IVDs. It is therefore imperative that IVD manufacturers prepare for and submit applications to a notified body as soon as possible. What do IVD manufacturers need to consider ahead of the deadline? • What their new IVD classifications will be • Whether notified body certification is required • Whether they have adequate data to answer fully the GSPR requirements • How to gather additional data needed via a performance evaluation to support their IVD application and to do in sufficient time to make an application to a notified body to obtain a certificate before 26 May 2022 • Working on designing their technical documentation • A new PMS system to meet the requirements of the IVDR by 26 May 2022 • Setting up agreements with EOs to include obligations on information flows up and down the supply chain for regulatory purposes. What is the effect on firms in the UK and Ireland? The IVDR will apply in both the Republic of Ireland and in Northern Ireland. If IVD manufacturers have UK notified body certificates under IVDMDD that these are transferred to a notified body in the EU and that any AR is also transferred into the EU, or alternatively Northern Ireland.

REGULATION

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How to manage the impact of COVID-19 on IVDR timelines Angela Brown, global head and senior director, regulatory affairs and Nicole A. Cowan, director, project management, IVD operations & strategy, examine how IVD manufacturers can meet 2022 deadlines despite the COVID-19 pandemic.

he COVID-19 pandemic created an evolving regulatory landscape with protocols and guidelines changing to keep pace with the virus and its impact on the healthcare system. Further, this pandemic affected the medical device industry regarding device design timelines, manufacturing capabilities and distribution logistics. Particularly, the in vitro diagnostic (IVD) market had to shift quickly with SARS-CoV-2 tests requiring rapid development, leaving global supply shortages and labs struggling to meet demands. Amid these disruptions, IVD developers face the challenge of complying with the new IVD Regulation (IVDR). The IVDR brings significant changes to the IVD industry with CE certification by a notified body (NB) now becoming the rule rather than the exception. Due to the pandemic, IVD manufacturers must comply with the 26th May 2022 deadline have come up against many challenges such as the lack of NB onsite audits due to travel and quarantine restrictions. While the industry is pushing for changes — such as the ability for NBs to conduct virtual audits and an extension to the 2022 IVDR deadline — regulatory authorities have resisted. Coupled with the IVDR, the end of the Brexit transition and guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) has further impacted IVD manufacturers.

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Understanding the recent guidelines, alternative solutions and best practices in selecting and managing NBs can allow continued availability of safe medical devices and assist in preventing medical device shortages.

IVDR BOTTLENECK GROWS AMID TRAVEL RESTRICTIONS The new classification system is an enormous change, as broadening the scope of the rules means that approximately 90% of IVDs will now be required to be reviewed by a NB, placing an additional burden on and creating a bottleneck for NBs. For example, under the previous directive, companion diagnostics were considered low-risk and self-declared without assessment by an NB. Now, classified as a higher-risk, Class C device, they will require increased expectations for clinical evidence and a greater scrutiny of data. The establishment of new classifications provide additional challenges to the NB reviewing process, amplifying the need for companies to go through the certification process early. Given the length of time needed for products under the new regulation — even more so for high-risk diagnostics — to be certified by an NB, companies will need to act as soon as possible before to achieve compliance.

Nicole Cowan

conduct virtual audits has the potential to ease the bottlenecks the industry is experiencing due to hurdles currently preventing on-site visits.

COVID-19 has further exacerbated the existing bottleneck. Before this pandemic there was already a decrease in the IVDR designation of NBs, possibly caused by the rise in expectations and responsibilities, the need for more experts to achieve designation and the investment required to train new staff. However, since the pandemic, no onsite assessments took place between mid-March and mid-July, neither for MDR nor for IVDR, causing delays in the designation process.

A STRATEGIC PLAN With IVDR still in its infancy, developers should anticipate further guidance documents and delegating acts to be published, which may cause additional changes. Despite growing challenges, it is unlikely that the implementation of the IVDR will be delayed. IVD manufacturers must start prioritising product portfolios and conducting their assessments now to ensure compliance. While some products can remain on the market via extended compliance with IVDD during a grace period (which lasts until 26 May 2024), for products currently in development and early in the product life cycle, manufacturers should ensure they are working towards IVDR requirements for EU approval.

With less than two years to the date of application, only four IVDR NBs — compared to 21 under the In Vitro Diagnostic Directive (IVDD) — are operating. Debates over other changes continue, such as loosening requirements for on-site audits. Allowing NBs the freedom and flexibility to

To maintain market share, manufacturers will need to overcome the shortage of NBs, as well as address new clinical data and technical file requirements. Establishing strategic partnerships can help in creating a global market strategy to ensure compliance in time for the deadlines.

Sensors and Electronics

Breathing Easier THE ADD-ON TO HELP MANAGE RESPIRATORY CONDITIONS Ian Bolland spoke to David van Sickle, co-founder and CEO of Propeller Health – a company dedicated to the management of chronic respiratory disease.

he company was founded with the aim of making respiratory diseases easier for patients to manage conditions such as COPD and asthma. Van Sickle previously had an academic career studying the conditions in different areas around the world, including working at the Center for Disease Control and Prevention in the United States. Acting as a medication adherence intervention, van Sickle explains how it works, saying: “We essentially created a piece of hardware that connects the existing inhalers to the networks so we can passively monitor the use of those daily medicines and identify when people aren’t using them, or when they have and encourage them use their medication more regularly. “Because there’s a sensor on the device we’re understanding when they’ve taken it on time or missed a dose and we can remind them to come back around on that morning or evening medicine. There’s also the sensor that goes on the medicine that’s used as needed – the rescue medicine – and that’s essentially giving us this vital sign of whether they’re doing well or not. Ideally, we never hear from that, we don’t want people to have symptoms and they shouldn’t be having them very often. “We’re able to essentially identify people who aren’t doing well and need help controlling the disease and bring those people to the attention of their physician, as well as giving themselves feedback in an app that they need to be doing more to avoid or mitigate exposure that are causing symptoms – or they need to be sticking more regularly with that daily medicine, or that there’s something else going on that needs to be investigated.”

The sensors are battery operated portable Bluetooth devices designed to last approximately 18 months. A challenge for the company in terms of the design of the sensor, was to figure out a common architecture with multiple different mechanical embodiments. “What we use is a variety of different types of sensors; whether it’s pressure sensors, capacitive touch, acoustic monitoring, etc. It’s all designed to passively, but accurately, identify when somebody has picked up and is using that medicine. So, we make these small, little attachments that go onto a person’s existing medication.” The active social life of medication devices, such as inhalers, means that any sensor has to be low cost and robust, and remain easy for a patient to use. The development of the sensor is done in house – with Propeller’s hardware team covering everything from prototyping, manufacturing, supply chain management and regulatory aspects. In sum, van Sickle views

Propeller as a hardware-enabled software business. “We have to essentially build those pieces of hardware because we want that data to exist and it’s really in the software life that the value of that data is created. The hardware has to be built so we can bring those data to life, essentially.” Towards the end of 2020, the company struck an agreement with Novartis – a partnership which co-packages Propeller’s sensor with a new medicine for uncontrolled asthma in the EU – which provides a new way for Propeller to gets its product into the hands of more patients. Van Sickle sees it as a way of distributing digital health to more people in a cost-effective way. The digital health, sensors and electronics elements of medtech is something he sees as becoming increasingly intertwined. “When we started back in 2010 it wasn’t common for people to have wearables or to have things like Fitbits. Even smartphones weren’t nearly as popular as they are now. I’d highlight a couple of things. One is the social dynamics. People have become a lot more used to devices that are tracking things like health and activity and wellness. There’s just been a general trend for people to monitor their own health and wellbeing through things like watches and other kinds of wearable devices.” Future plans for the company include an increased presence in the UK. “We’re working on a couple of programmes to bring Propeller to different parts of the NHS and we’re really excited about what that will mean with people and severe asthma and so forth.”

DIGITAL HEALTH

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2020 ‘REVISION’ WHAT’S IN STORE FOR 2021? Jim O’Donoghue, president, S3 Connected Health, examines how last year’s events have impacted digital adoption, and how it will continue to unfold.

espite its devastating impact on health systems worldwide, it’s unquestionable that the pandemic has acted as a catalyst for positive change. Nearly 47% of UK clinicians are now using telemedicine (17% in 2019), 69% are e-prescribing (61% in 2019), and over half (52%) are utilising medical apps to treat patients (29% in 2019). Change isn’t just happening among healthcare providers. In Britain, face-toface consultations dropped by 60% as a consequence of COVID-19 restrictions, with 10 million UK patients actively avoiding in-clinic care during the pandemic, for fear of contracting the virus, according to our research. Now, with the Coronavirus vaccination programme gathering pace, the question is: will we go back to relying on in-person care, or is remote care here to stay? And, with providers and patients now more technologically adept, what other medtech trends can we expect to see in 2021? CHANGING PERCEPTIONS The need to facilitate remote care to prevent infections via doctor-patient meetings has undoubtedly accelerated the adoption of digital health, but it’s also set a precedent for how care can be delivered after

the pandemic. Many patients only turned to telehealth last year with a view to avoiding in-clinic care, but this doesn’t mean they don’t recognise its long-term value: our research actually shows 71% of people are willing to use digital healthcare in the future. Due to the pandemic, UK patients now realise in-clinic care doesn’t have to be the go-to solution. In fact, 23% believe that a virtual-first approach would improve the overall quality of care. It’s not about scrapping in-person health services completely, it’s about leveraging remote care when possible: for example, 34% of Britons feel remote-by-default care would lead to improving the healthcare experience, while 33% believe a more prominent use of digital services would save healthcare professionals (HCPs) precious time. While 2020 forced patients to embrace remote care as a necessity, they’ve come to appreciate its benefits regardless of the pandemic. Consequently, the groundwork has been laid for virtual-first healthcare becoming widely adopted from this year. CONNECTIVITY WILL DRIVE BETTER CARE OUTCOMES As we strive to modernise healthcare systems to solve the challenges posed by the Coronavirus, connectivity will be the engine of successful innovation. In order to drive efficiencies, save precious resources, and improve outcomes, healthcare

services will be increasingly designed around connected devices. For instance, implantables and wearables will enable greater remote healthcare provision, allowing many conditions to be observed, and potentially treated, in patients’ homes. Symptoms can be tracked and monitored through AI-powered data analysis: meaning, clinicians can promptly spot any worsening of conditions, and identify and implement the right interventions without the need for face-to-face observation. Meanwhile, connected devices will improve service delivery and take healthcare processes to new levels of efficiency in-hospital, too. Where care must remain tied to clinical settings, connected devices can help HCPs optimise resource allocation and delivery; think distribution of staff, medication, or equipment like ventilators. This way, patients can continue accessing the care they need despite COVID-19 challenges and enjoy a better quality of care beyond the pandemic. AI ENHANCING INTEGRATED SERVICES Artificial intelligence (AI) will play an increasingly important role in enhancing connected health services. Fresh from fast-tracking COVID-19 vaccine research and detecting infections through thermal screening, AI will be increasingly used to streamline day-to-day tasks at

healthcare facilities. AI’s ability to quickly and accurately analyse data will be leveraged to support clinical decisions, complementing human expertise, enhancing care delivery, and affording clinicians time to focus on more complex or urgent cases. 2021 will be about unlocking the value of technology like wearables and AI through connectivity, yet these will only realise their full potential of improving health outcomes if they are part of re-designed care pathways. MEDTECH WILL PAVE THE WAY FOR A BRIGHTER, POST-COVID FUTURE In 2021 and the years to come, technology and connectivity will empower healthcare organisations and professionals to provide better care across therapy areas, while maximising resources, relieving stress on pressurised systems, and ultimately ensuring better patient safety and wellbeing. This is a significant time to be working in medtech; from the inflection point triggered by COVID-19, we have entered an era of innovation that will bring overwhelmingly positive change for the future of healthcare.

DIGITAL HEALTH

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ON GUARD: PROTECTING DEVICES AGAINST CYBERSECURITY RISK Richard Poate, senior manager at TÜV SÜD, discusses some of the requirements that should be tested in the early design process of connected devices.

HEALTHCARE’S CYBER TRANSFORMATION Connected medical products with remote access are becoming a growth area, but these systems can become a target for cyberattack. This is because often not all the risks associated with a remote connection, and the usability of them by third parties, are taken into consideration. There are therefore multiple regulatory, ethical and business reasons to ensure that all digital healthcare and medical devices are thoroughly tested and secure. This includes compliance with global regulatory requirements, such as the In Vitro Diagnostic Medical Device Regulation (IVDR) and the Medical Device Regulation (MDR) in the EU; as well as the regional requirements of the US FDA, Health Canada, China National Medical Products Administration and the Japan Ministry of Health and Welfare. However, there are still no harmonised standards for the cybersecurity of medical devices. While global regulators play catch-up with this situation, there are some cybersecurity standards which are focussed and provide guidance for medical devices: • MDCG 2019-16 – Guidance on cybersecurity for medical devices, which is one of the most important guidelines for MDR implementation. • IEC/TR 60601-4-5 – Safetyrelated technical security specifications for medical devices (currently under development)

• I EC 81001-5-1 - Application of risk management for IT-networks incorporating medical devices (currently under development) •U L 2900-2-1- The USA Food & Drug Administration’s cybersecurity aid for industry and regulators. Cybersecurity must be based on a well-structured development and testing process. For example, after any major software changes a vulnerability scan or penetration test should be repeated, at least partly. Manufacturers must also consider security-related tests regarding the change, as well as conduct regression tests which show that the change did not have a negative effect on the cybersecurity of the device. While there is currently no law that requires testing to be done, most guidance documents indicate that it should be conducted. Therefore, due to global regulations and privacy laws, skipping it is not an option. It is therefore up to manufacturers to prove due dilligence – that they have taken appropriate actions to bring safe products onto the market. The EU’s MDCG 201916 document provides manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and IVDR regarding cybersecurity. When assessing risks in accordance with Annex I of the MDR, it is important to include security issues in the risk assessment. During the

risk management process, the manufacturer should foresee or evaluate the potential exploitation of those security vulnerabilities that may be a result of reasonably foreseeable misuse. FIRST LINE OF DEFENCE While there are some standards and industry guidance available globally, they are not complete and ratified, neither are they mandatory. However, these do represent a first line of defence, and as a first step designers and manufacturers should think “secure by design” and take a proactive approach to cybersecurity, recognising that attacks are “when not if”. It is also vital to keep up to date with standards and regulations to ensure that they are working to the “state of the art.” Likewise, by following developments of testing frameworks, this will provide a guided, robust and costeffective solution, alongside participating in appropriate standards workshops (for example CEN-CENELEC events for European Standards) While digitisation and increasing connectivity bring enormous opportunities, unforeseeable risks and serious vulnerabilities can be exploited by new forms of cybercrime. Security that is tolerant of implant, wearable, mobile-connected, and public-network-using devices is therefore

paramount. It is important to remember that there are no ‘bad user behaviours’, only scenarios that the designer or manufacturer has failed to identify. Neither should patients be expected to shoulder any additional burden for security as it is a manufacturer’s responsibility to ensure up to date compliance with all standards and constantly review the ‘cyber resistance’ status of devices. The Internet of Medical Things (IOMT) has transformed healthcare. However, as medical devices become increasingly connected they also become more vulnerable to cyberattack, exposing the people who use them to hazards that did not previously exist. Ongoing investment in cybersecurity is therefore crucial to keep up with both technological developments for competitive advantage, alongside effective measures to combat hackers. All digital health and medical devices must be thoroughly tested and secure, as well as comply with global and regional regulatory requirements.

GET A GRIP Ian Bolland caught up with Dr Paul Rinne, CEO and founder of GripAble to discuss its remote rehabilitation offering and how the outlook has changed for adopting similar technologies.

r Rinne founded the company when he was a PhD student at Imperial College London, where, as a neuroscientist, he was researching neuroplasticity, in particular how the brain recovers post-damage.

actually, where is the opportunity with something like mobile? It really should be built in an incredibly intuitive and quick way. If you look at some of the top products outside of rehabilitation, it’s built on being as simple as possible.

The approach to developing GripAble was, as Dr Rinne explains, ‘bottomup’ rather than being handed “fancy” robotic technology to work with, but to start with a patient’s needs and find the right technological solution. Motion capture systems and virtual reality were examples of technology that have been entertained in this field but didn’t have the desired effect due to time constraints or usability and doesn’t encourage mass adoption. A core focus for Dr Rinne was ease of use.

“GripAble looks to not create a new pathway, but to improve on a current one. Right now, there is a device that measures grip strength, it’s found in the majority of clinics around the world that do anything to do with upper limb and arm recovery. It is a simple case of squeeze as hard as you can, and it gives you kilos of force of what that individual can squeeze. We do the same with GripAble.”

He said: “Hopefully it will improve, and we want to work with VR systems – I really remember a quote that hit home for me from a stroke patient and it was: “Paul, every day I wake up and feel I’ve got a worse hangover. That’s my feeling from this stroke. The last thing I want to do is put goggles over my eyes and go into a 3D world.”” The GripAble device is a joystick that uses inbuilt sensors to measure a patient’s strength, by measuring grip strength and release. The gyroscopes and accelerometers in the device track range and motion in wrist and lower arm movements as start points. “I was really trying to strip back on the complex nature of things and go:

From the first sketches of the device, it took seven years until a first product was manufactured. This included two to three years of clinical prototyping, validation and working with clinicians and patients to pinpoint the product’s applicability, and the GripAble team saw the opportunity surrounding the upsurge in adoption of mobile technology in everyday life. Despite the inevitable delays brought about because of the COVID-19 pandemic, the device completed its journey from concept to manufacture in the summer of 2020.

“Mobile apps and mobile technology coming through was the big leap forward, as this is something that can be used in the clinic, the patient can then take it to the bedside but most importantly they can take it home.

“We went through 100 different shapes to get the right shape for the patient, the correct way for modular add-ons to be clipped on so that individual finger training and various things that are coming.

“With COVID-19, the big drive and the big push for everyone approaching us is the need of something for home use. That’s the big shift for us. Now providers and therapists are actively seeking solutions that can be left with the patient and that can be taken to their home.

“The most important thing for me was moving away from any sort of computers or anything that was fixed to a set location.

“Before, you were forging that market and no-one was really pushing for it, now that opportunity to help people at home has vastly increased for us.”

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