Page 1 Issue 45 | Nov/Dec 2019



Why healthtech is the one to watch Industry 4.0 – why is it a game-changer?




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CONTENTS regulars 4.


Lu Rahman notes the important role heathtech has in the future of medtech


Making medtech

A round up of the industry news



Wilmington Healthcare explains why diagnostics is the next big challenge for NHS cancer services


Cover story

Design Partners explains how it puts people at the heart of its device design


Digital Health Age

Lu Rahman explains why the time is now for digital health






Made in Ireland

Laura Hughes takes a trip to Med in Ireland


Take the tube

How a packaging solution from Rose Plastic has been designed to save space, create safety and simplify handling in hospitals



Delivery service

West Pharmaceutical Services, explains how drug delivery devices have revolutionised the patient experience



Time for change

Lu Rahman asks why is Industry 4.0 such a gamechanger?


Making innovation


Ian Bolland talks to Dr Elliot Street, Inovus Medical


The latest up-starts in medtech

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from The editor



Time for medtech to make its mark

I have to admit it was a bit of a shock to come back from maternity leave to find I was now expected to do someone else’s job on top of my own. While the extra workload could be seen as something of a downside, the upside is that I get to immerse myself in UK and Irish medtech – one of the most exciting markets there is - not just on a local level but also on a global scale.

This is something that is being recognised at all levels. The 2019 EY medtech report, Pulse of the Industry, highlights the upward trend the sector is experiencing. It does however, warn that its long-term growth may be weak due to a lack of investment in R&D as well as a lack of collaboration between industry providers, payers and patients.

According to Jim Welch, EY global medtech leader: “Medtechs have a unique opportunity to capitalise on digital transformation. As devices become increasingly connected, medtech companies have a builtin advantage. They also have strong alignment with other healthcare ecosystem stakeholders, so they are well-placed to develop new business models and create value in the future. What they don’t have are broad, in-house capabilities to develop personalised healthcare offerings. Increased investment in digital collaborations that What’s currently expand customer experience, making the sector even as well as data and analytics more exciting is the rise of capabilities, will continue to technology – digital products, move medtechs closer to connected products, patients.” healthtech products – making it one of the most advanced There are opportunities industries we have. ahead for the medtech sector UK and Irish life sciences, in which the medtech market sits, innovate on a regular basis. Whether it’s antimicrobial materials that help curb the spread of infection, the development of medical adhesives, or the way in which the packaging market addresses issues of sustainability, the medtech sector is at the forefront of healthcare solutions. I never tire of learning about the journey a product takes from design to manufacture and then to its eventual home in a clinical setting.


but consideration of what businesses are lacking and where investment needs to be is crucial to its success. It’s a familiar tale - too often businesses miss out on lucrative opportunities as they don’t have leaders with foresight, encouragement or confidence to create the exact framework for growth. It’s situation that isn’t peculiar to the medtech world. Business across the globe throw away financial growth on a regular basis. What does set the medtech sector apart is the ongoing investment shown by global players. There is no other market innovating at the same level, showing so much potential, or that has the backing of global industry, government and academia. The future’s bright…


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Making medtech

Lightpoint Medical recognised for technological innovation


ightpoint Medical – a technology specialist in precision-guided cancer surgery – has been awarded the Medtech Insight Award for Best Technological Innovation, in the Devices and Diagnostics category. The Chesham-based company, which is part of the ABHI’s US Accelerator programme, fought off competition from global industry. The award recognises innovative medical devices and diagnostics making meaningful contributions to advancing patient treatment.

Report highlights success of global medtech market


YReports has produced intelligence that focuses on the global medtech market, future outlook, growth opportunities, and key contacts. The research shows the development of the market in Europe and the US, among others. It also analyses industry development trends and marketing channels. The report provides an analysis of the competitive landscape and offers information on several companies including Medtronic, DePuy Synthes (Johnson & Johnson), Koninklijke Philips, Ge Healthcare, Siemens Healthineers, Cardinal Health Inc, Stryker Corporation, Becton, Dickinson and Company and Baxter.


Founded in 2012, Lightpoint Medical is an innovative medical device company that develops molecular imaging and sensing technologies, enabling surgeons to detect cancer in real time during surgery. The company’s SENSEI technology, a miniaturised intra-operative cancer detection probe, is designed for use in robotic surgery, providing surgeons with a reliable solution to fully remove cancer in one procedure, whilst retaining healthy tissue.

Digital solutions having huge impact on the medtech manufacturing, says Frost & Sullivan

This year, Cancer Research UK figures suggest there will be over 18 million new cases of cancer worldwide, and the disease will account for around one in six deaths globally. By 2030, the incidence rate is set to soar by more than 60%, with over 24 million new cases each year. David Tuch, CEO Lightpoint Medical, said: “It is an honour to receive this prestigious award and to have our technology recognised as a leap forward in cancer treatment to improve patient outcomes. Our miniature probe provides surgeons with the capability to accurately detect cancer whilst reducing complications and healthcare costs. It is a privilege to be presented with this award.”


he traditional medtech industry’s growth rate is expected to drop gradually beyond 2020, from 5.8% to as low as 5.3% in 2024. The digital transformation of the industry, aimed at twin objectives of providing complete solutions along the patient’s care continuum, as well as improving efficiency of medtech organisations’ internal operations, is expected to improve operating margins and boost overall revenues. Frost & Sullivan estimates the potential of digital transformation

Making medtech


MEDICAL DEVICE ALERTS HIT FOUR-YEAR HIGH he number of alerts issued by the Medicine and Healthcare products Regulatory Agency (MHRA) has hit a four-year high of 35 in the past year*, up from 32 last year and more than double the 17 alerts issued three years ago, says Cityheadquartered law firm RPC. RPC says the figures suggest that the need for medical device manufacturers to take out specific product recall insurance is rising, with full recalls increasing as a proportion of all medical product alerts. A number of alerts issued by the MHRA in 2018/19 involved a full product recall or an instruction to destroy remaining products. RPC says that businesses that recall medical devices can face a range of costs, including shipping, storage and disposal, refunding purchasers, and increased staffing costs. Insurers have in recent years begun to offer tailored Product Recall & Contamination policies to cover these costs. Peter Rudd-Clarke, legal director at RPC, commented: “Product Recall insurance should be considered as a key part of medical device manufacturers’ risk management.”

The firm adds that the Medical Devices Regulation 2017 that will fully apply in 2020 will toughen the requirements on medical device manufacturers to selfreport when problems with devices are discovered. The latest information from the MHRA suggests that medical device manufacturers are taking a low-risk approach, and are increasingly engaging with the MHRA where issues may exist with a product. This suggests that the public is benefitting from a tighter regulatory regime designed to improve the safety levels of products placed on the market. These increased reporting requirements are also likely to drive sales of specialist product recall insurance policies.

initiatives to add up to $241 billion, aiding the medtech industry to grow at CAGR of 6.3% between 2018 and 2024. “The availability of digital solutions such as analytics, AI, and augmented or virtual reality is having a huge impact on several aspects of internal operations in the medtech industry, including manufacturing, and on external areas of care delivery,” said Siddharth Shah, program manager, transformational health at Frost & Sullivan. “Newer opportunities such as gamification, patient engagement, device data analytics, and medical device

cybersecurity are expected to emerge as a result.” Frost & Sullivan’s latest research, Digital Transformation of the Medtech Industry, explores the factors driving the digital transformation of the medtech industry, key areas of transformation, growth opportunities, analyses of key players in the sector, and revenue forecasts through 2024. In terms of technological sophistication, regulatory support, and willingness to invest, Europe is one of the markets relatively more mature for the adoption of digital


RPC says that almost threequarters of alerts issued by the MHRA in the past year involved the two most critical classes of devices** – those implanted into the body, such as pacemakers, replacement heart valves and breast implants.

Alerts issued by the MHRA in the past year concerned a range of devices, including a heart monitor which risks battery packs exploding due to overheating; a blood and IV fluid warming device, which could leach unsafe levels of aluminium into the bloodstream of users, and knee joint replacements which risk early failure due to loosening parts. Peter Rudd-Clarke added: “The need for specialist product recall policies is only going to increase for medical device manufacturers over the coming years. The 2017 Regulation takes effect next year which may lead to recalls at an earlier stage of the product lifecycle if there are questions over a product’s performance.” “A product recall can represent a huge cost to a medical device manufacturer, and much of it is not covered by a standard product liability policy.” * Year-end June 30 2019. Source: MHRA ** Medical Device Directive Class IIb and Class III devices

transformation solutions. “While widespread adoption of the digital solutions still remains a challenge, it is expected to improve significantly, driven by demand from users of the tech-savvy generation and a rising pressure within the industry to improve margins and efficiency,” noted Shah. “Some pioneering health systems are already seeing returns on investment from the implementation of their digital solutions, making their future receptivity to medtech solutions positive. Support from regulatory bodies will only help further this goal.”


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Regional News

Health Enterprise East celebrates 15 years of medtech innovation 12 November 2019 marks the 15th anniversary of Health Enterprise East and therefore a natural time for reflection. In some respects, the world has changed significantly since 2004 – a time when Twitter didn’t even exist – yet the fundamental challenges facing the NHS are highly familiar. While the NHS has certainly undergone some major structural reforms, these have yet to filter through to changes in the way patients experience care. The desired shifting of the burden of care to the primary and community sector has yet to manifest itself, and as a result people continue to flock to A&E, with waiting times in England reportedly reaching their worst level since the four-hour target was introduced. Has the NHS in fact done little more than rearrange the deck chairs on the Titanic? In some ways the challenges of 2019 are arguably harder than they were when HEE was first established: there is no longer any slack or spare capacity in the system. Not only does the NHS have to continually do more with less, but an increasingly savvy public is demanding a greater role in management of its healthcare needs. There is a role and

an opportunity for medtech innovators here. Over the last 15 years, HEE has evaluated over 2,000 medtech ideas, so it’s clear to me that there is no lack of innovation and creativity. The true challenge remains adoption. The good news is that the NHS is becoming more adept in this area and has been working to improve the medtech adoption ecosystem. In 2013, the introduction of the Academic Health Science Networks (AHSNs) brought a focus on the adoption and spread of evidence-based innovation. Before then, it was simply no-one’s ‘job’ in the NHS to implement good ideas across the system. More recently, research and innovation has been put at the heart of the NHS Long Term Plan, which seeks to build a pipeline of proven innovations which meet the needs of patients and the NHS, as well as to improve uptake and spread of these innovations. Crucially, the NHS has also begun to recognise the value of collaborating with industry. For example, the joint project between Moorfield Eye Hospital and Google’s DeepMind Health brings health technologists and clinicians together to co-develop a new approach to diagnosing eye disease. Another exciting venture is the 100,000 Genomes Project, a collaboration between NHS England, Genomics England, biotech company Illumina and 85 acute trusts. The aim is to work together to gain a better understanding of the triggers for rare diseases, a research effort which no commercial

organisation or health body could successfully undertake on its own. Nevertheless, SMEs continue to find it hard to get a foot in the door of the NHS, lacking the economies of scale that major corporates can provide. The NHS is trying to address these problems, and support for medtech SMEs is available via schemes such as the AHSN Innovation Exchanges and the SBRI Healthcare programme. However, adoption typically remains slower than many would like, hampered largely by regulatory, financial and cultural barriers within the NHS procurement process. HEE’s aim for the next 15 years is to continue to champion those SME medtech innovators whose ideas have the potential to make a huge difference to patients but who need support to make it all the way. With 125 commercial licences and six newly-created companies under our belt, as well as around 40 projects currently in the pipeline, at HEE we feel optimistic about the future. Here’s to another 15 years!

Crucially, the NHS has also begun to recognise the value of collaborating with industry 9





Medilink East Midlands has teamed up with the East Midlands Academic Health Science Network (EMAHSN) for the Medilink East Midlands Business Awards: Delivering Innovation in to Health and Care. This recognises an impacted efficacy, patient outcomes and NHS system costs. The four finalists are: Neater Solutions, expert in the design, manufacture and supply of equipment that gives people greater independence, dignity and choice in their lives; NuVision Biotherapies, a regenerative medicine company established to deliver high quality and affordable wound care biotherapies to treat patients worldwide; OCB Media, specialist in the design, production and delivery of e-learning for the healthcare sector. Services include instructional design, digital asset development, learning management systems and associated technologies; The Spirit Health Group, provider of products and services that improve the lives of patients while delivering real value solutions for healthcare organisations. The awards will be presented on Thursday 5 December at the Radisson Blu, East Midlands Airport.

HGF EXPANDS IN SCOTLAND Medilink member, and intellectual property specialist, HGF, has moved. The expansion and increased team in Edinburgh gives the company additional technical expertise into new markets, such as engineering and electronics. The initiative follows a company’s collaboration with Patronus IP, which extended reach across Germany and Austria. HGF has also opened an office in Dublin, which adds up to the total of 22 offices in the UK and Europe. Dr Jamie Thomson, patent director at HGF, commented: “I am delighted to see our Scottish team growing so fast. Since 2015, we’ve grown from two to six attorneys and increased our support staff as our client base has grown. We needed to increase our office space to accommodate our everexpanding team. This has also allowed us to extend our offering to all technical fields.” Paul Sanderson, CEO of HGF, commented: “HGF understands the importance of growth, our continued expansion reflects our commitment to providing the highest quality service both now and, in the future”.

MEDILINK NORTH OF ENGLAND OFFERS PAVILION AT ARAB HEALTH Medilink North of England will be running Northern Powerhouse missions to Arab Health 2020. The event brings together industry professionals from across the world and provides opportunities to connect with buyers, suppliers, distributors, and clinicians who share your passion for healthcare. Attendees have the chance to discover new insights and break into new markets while showcasing their medical products and services on the world stage. With other 159 attending countries, Arab Health 2020, will be a vital event for healthcare professionals, who want to bring their businesses closer to the Middle East and North Africa region and strengthen their international presence. Medilink North of England is offering a UK pavilion at the exhibition, along with logistical and administration support. or call 0114 232 9292.









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Why diagnostics is the next big challenge for NHS cancer services The next decade will see a new wave of advanced biotech capable of assisting enormous strides forward in cancer care, with potential for safer, more effective treatment, improved survival and a better quality of life for patients says Oli Hudson, content director at Wilmington Healthcare


he pharmaceutical picture is exciting, and the principle of ‘personalised’ or ‘precision’ medicine is one that is increasingly expected to revolutionise cancer treatment – but its success depends on a parallel development in companion diagnostics. In short, this field involves bioanalytical methods designed to assess whether a patient will respond favourably to a specific medical treatment or not and the science in this field is advancing rapidly. Pharma now needs to collaborate with diagnostics manufacturers, testing laboratories, health informatics, commissioners, and regulators in order to provide a viable, safe and cost-effective treatment pathway. In addition, the role of the patient is paramount, and a large-scale data gathering exercise is required to establish which patient populations will benefit from which therapies. It is likely that industry will need the help of healthcare systems to map patient populations and get a better sense of what will work on whom, and for which conditions. DIAGNOSTICS IN THE NHS With this as the background, cancer diagnosis has been put front and centre by the UK government, and in England the 2019 NHS Long-Term Plan has set in place two ambitious targets. By 2028, the proportion of cancers diagnosed at stages

one and two should rise from around half to three quarters of cancer patients. Then, from 2028, 55 000 more people each year should survive their cancer for at least five years following diagnosis. These two targets are intended to reinforce each other: we know that many cancers become more survivable if captured early, at stages one and two. And in order to capture them early, we need early diagnosis. To make this a reality, the long term plan has put in place two key pieces of infrastructure. The first is cancer alliances, groups of cancer clinicians that will drive the development of cancer pathways at a local level; the second is the emergence of rapid diagnostic centres. Currently existing in pilot form, rapid diagnostics centres are multi-disciplinary and can cover much of the data gathering work mentioned above. They provide a single point of access to a diagnostic pathway for all patients with symptoms that could indicate cancer, and a personalised, accurate and timely diagnosis of patients’ symptoms. They combine all existing diagnostic provision and use networked expertise and information. Success will depend on corralling many disparate resources in the NHS – including GPs, who form a big part of this as they, supported by the local alliance’s clinical network, will refer patients with suspected symptoms to RDCs.

These can be non-specific – for example, lung cancer at an early stage can resemble a common cold, and the greater provision provided by RDCs and their networks can help pick this up. As you can see from the map, they are currently clustered around the vanguard areas of London and Manchester, but by the idea is for the cancer alliances to take this forward so that all areas of England will be covered by 2023. This is especially important as speed of diagnosis and cancer survival varies widely by healthcare community. Access to diagnostics services and therapies, and the outcomes from them, can depend on where you live. Research by Wilmington Healthcare has shown that lung cancer is a particularly variable type. Most diagnoses are at stage 4, by which stage the cancer is much less survivable. How likely a patient is to come forward before that is affected by a variety of factors such as an area’s deprivation, population, and quality of screening services. If NHS diagnostics is enabled in the way the government wants, and is matched with the rollout of precision medicine, this will begin to happen less, with patients more likely to be given an effective therapy. CONCLUSION The roll-out of high quality and fast diagnostic services across the country, and the concomitant development of personalised medicine with

companion diagnostics could be transformative; but it will also require close and co-operative working between the NHS, the pharma and diagnostics industries. If they can get this right, progress against the disease could be considerable, and if the long-term plan’s targets are met we can consider this a great leap forward. And, as the industry has suggested, while cancer may lead the way in this process, there is scope for personalised medicine and companion diagnostics to transform the way we treat other conditions such as asthma, diabetes, arthritis and Alzheimers’- and even some mental health conditions.


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In focus

How to be compliant


oncerned about what the new EU MDR 2020 regulations mean to you? Volker Watzke, Domino Printing Sciences, offers advice on how to become compliant as quickly and efficiently as possible The deadline for ensuring compliance with the European Union’s Medical Device Regulations (EU MDR) is looming. These new regulations are aimed at improving the traceability features and safety management of medical devices for sale within the EU. With less than nine months to go before the deadline, the countdown is on for medical device manufacturers to ensure they are compliant. WHAT IS REQUIRED FROM THE EU MDR? The EU MDR will come into force on 26 May 2020, replacing the EU’s current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/ EEC). Manufacturers of medical devices for sale within the EU must adhere to strict guidelines to ensure their products are safe to use. From 26 May 2020, all medical devices will need to be assigned a unique device identification (UDI) code. Devices which fall under Class III and Class IIa/b will need to have their UDI recorded,

indexed, and registered on a central EU database called EUDAMED – the European Database for Medical Devices. Manufacturers of Class III and Class IIa/b products will be responsible for sharing product data according to Annex VI Part B of the regulation. Manufacturers of Class I products will also be required to collect and save product data but need only share this information if requested. The introduction of the EU MDR obligates medical device manufacturers to invest in technology to enable the fast and accurate application of traceability coding to products and packaging at the individual item level. Failure to comply with these procedures may mean that devices are withdrawn from sale, with device manufacturers no longer able to supply their products to other EU member states. WHERE ARE WE NOW? The technical specification for EUDAMED is expected to be released by the end of 2019. So far, manufacturers have the benefit of a technical bulletin, available from the European Commission, which provides information on how data should be submitted. The technical bulletin is addressed to the different needs of each manufacturer. Manufacturers will have approximately five to six months from the release of the technical specification of EUDAMED and the final date of registration. It is, therefore, advisable to begin collecting data as soon as possible. Manufacturers will need to collect data on each product according to the Annex VI, Part B of the EU MDR, and begin preparing the data for sharing on EUDAMED. As well as preparing all data in advance of the May 2020 deadline, manufacturers should ensure that they have the right partners who support them

through the process. To ensure that their devices comply with the new regulations, manufacturers should speak to their code issuing agency and notified bodies for advice. At present, some large medical device manufacturers are utilising up to 25% of their employee base in bringing their procedures up to standard. Small and mediumsized manufacturers are unlikely to have the capacity to dedicate so much of their workforce and should consider options for external support. ISSUING AGENCIES In June 2019 GS1 became the first issuing agency for EU MDR compliant codes, meaning that 2D Data Matrix and GS1128 codes can be used going forward. It is expected that other issuing agencies will follow suit, with potential for the use of HIBCC and ICCBBA coding in the future. NOTIFIED BODIES As part of existing EU Directives (90/385/EWG) and (93/42/EWG) manufacturers audit and check their products on a regular basis to ensure compliance. Notified bodies support manufacturers in this process to ensure that new and existing products can be sold. Of the 57 notified bodies across Europe dealing with current legislation, only 38 have applied for accreditation to the EU MDR. At the time of writing, only four notified bodies had achieved the new accreditation. A GLOBAL EFFECT The EU MDR covers all items sold within the EU, but this does not mean that only EU member states need to fulfil the requirements. All manufacturers that wish to sell their product in the EU need to ensure that they satisfy the EU MDR requirements, or they may see their products removed from sale.




Waving the flag for UK healthtech: The ABHI UK pavilion at MEDICA WHY HEALTHTECH WILL BE A KEY FOCUS FOR THE ABHI

ealth technology (healthtech) is a key partner to healthcare services around the world. It enables improved efficiencies and effectiveness across the hospital setting, with investment in the latest devices, digitisation and diagnostic technologies delivering significant benefits to patient care, cutting waiting times and alleviating workforce burdens. Representing the industry in the UK is the Association of British Healthtech Industries (ABHI). Its role as a membership body is to support the healthtech community to save and enhance lives. With 300 members, including both multinationals and small and medium enterprises (SMEs), its companies provide a range of products and services into the healthcare system, from syringes and wound dressings, to surgical robots and digitally enhanced technologies. MEDICA 2019

And so, a key piece of ABHI’s work is to cultivate a positive environment that encourages growth for the sector. This happens through international activity, which includes hosting UK pavilions at some of the world’s largest health shows, dedicated healthtech trade missions to key markets and business


MEDICA, Dussledorf, attracts over 5,000 exhibitors from 70 countries and plays host to tens of thousands of visitors every year. The ABHI UK Pavilion will be located in hall 16.

development support through its US Accelerator programme. This year, ABHI will once again be leading a pavilion of health technology companies at MEDICA 2019. With thousands of visitors expected to visit the pavilion every day, MEDICA is a prime opportunity for UK companies to meet their global partners in one place. Added to this, the ABHI’s publicity work provides UK exhibitors with great exposure before and during the show. Through exhibiting with ABHI, companies have full access to a central support stand, meeting areas, working offices and an internet café. There will be dedicated one-to-one sessions with representatives from the UK’s Department for International Trade, invitations to exclusive networking drinks receptions and, for the first time, individual access to several of ABHI’s senior leadership team. The latter provides UK exhibitors with access to ABHI’s knowledge, expertise and support on topics ranging from digital health, regulation, policy and market access. Paul Benton, managing director, International, ABHI said: “The UK has long been a leader in healthcare. We have world-class universities, dynamic companies and the biggest single-payer health system on the planet, all adding up to what is an incredible ecosystem of innovation and medical excellence. It is why overseas companies want to partner with our UK manufacturers and it is the reason the UK carries significant weight when it comes to exploring international markets. It is, in short, a stamp of quality and we are proud to be at MEDICA once again to showcase many examples of this.” This year, the ABHI UK pavilion – will highlight ground-breaking UK digital health technologies, giving an international platform to the digital transformation breathing new life into the medical world. These include:

• MIRA Rehab, whose medical software turns physical and cognitive exercise into video games. Using motion tracking sensors, MIRA (Medical Interactive Recovery Assistant) is designed to make physical therapy easier and more fun for patients while helping clinicians track their patients’ progress through means of telerehabilitation. By ‘gamifying’ exercise, the device is helping to change the way physical therapy is delivered, which can be a long and arduous process for those in need of rehabilitation. • Another revolutionary new device being showcased on the ABHI UK pavilion is the world’s first ‘smart’ peak flow meter that connects to a smartphone. Utilising smartphone sensor technology, the device can predict a potential attack up to seven days in advance, allowing asthma patients to better manage their condition. The smart device, created by Smart Respiratory Products, allows patients to understand their peak flow (the measure of how quickly you can blow air out of your lungs) through a mobile app and is set to aid the 235 million asthma sufferers worldwide. • Oxford MEStar – an Oxford University bioengineering spinout company – will also be joining the ABHI UK Pavilion to showcase the world’s first digital faecal occult blood testing devices to enable early bowel cancer identification. Originally formed by scientists from the Institute of Biomedical Engineering at Oxford University, Measure Bowel Health is the company’s first product in a series of digital handheld diagnostic tests. It is the only digital faecal occult blood (FOB) testing device of its kind and uses patented technology originating from research carried out over ten years at the Universities of Glasgow and Oxford, to detect the early signs of bowel conditions including cancer.



ABHI leadership team to share industry knowledge at MEDICA 2019 RICHARD PHILLIPS, DIRECTOR, POLICY & COMMUNICATIONS.

UK companies at MEDICA 2019, should speak with Davies to become part of this national conversation around digital adoption.

Phillips joined ABHI in June 2015, with over 20 years’ experience in life sciences. With strong connections into the NHS and its leadership structures, he has a great understanding of policy, NHS strategy and the opportunities for UK companies to engage with the system and accelerate the adoption of their technologies and services. With healthtech’s reach increasingly widening, the role of policy, and how government measures impact business, has arguably never been more significant. Brexit is one area, and Phillips has managed ABHI’s interactions on the issue since the UK voted to leave the European Union – advocating for the continued supply of products to patients no matter than outcome. Elsewhere, Phillips provides regular expert commentary on the direction of NHS travel. The NHS Long Term Plan, for example, details a number of areas where companies can engage with the system to support its vision. Companies at MEDICA 2019 would benefit from spending time with him to see where their health technologies align with government priorities at both regional and national level. PHIL BROWN, DIRECTOR, TECHNICAL AND REGULATORY.

Brown has over 30 years’ experience of working with novel technologies and liaising with national authorities, the European Commission, trade associations and standards bodies on issues related to regulation and ethics. With deep knowledge of healthtech regulation in the UK and Europe, Brown is currently working with UK

businesses to support their transition to the Medical Device Regulation. The process has come under increased scrutiny of late, with issues of capacity, particularly with regard to notified body accreditation, and wider system preparedness causing concern for many companies.

unfolding environment of digitallyassisted heath care. Davies is currently working with companies to develop and advocate ABHI’s position in regards to the ability of the UK health and care system to support and rapidly adopt new technologies and services.

Brown is in regular dialogue with the MHRA and partners at both national and international level to find measures that will mitigate against the risk of companies being unable to place products on the market after May 2020. The situation is of course further complicated by the UK’s future relationship with the EU.

He says: “Digital technologies have the ability to support a more efficient and effective health system, with significant benefits to patient care. Access to well curated data sets is critical for industry to apply their skills, knowledge and resources, unleashing the potential low of life saving and enhancing innovations. We are therefore working with the NHS, and the health system more broadly, to develop the necessary security, regulatory and ethical infrastructure that will enable the development and adoption of such innovations.”

Regulation is business critical. Without full compliance, companies cannot operate. Those exhibiting with ABHI at MEDICA 2019 are therefore strongly advised to spend time with Brown to assess their readiness for the impending changes to the system. ANDREW DAVIES, DIGITAL HEALTH LEAD

Davies has over 25 years’ experience in the health technology sector, having worked within a number of household names before joining ABHI. His experience has covered roles in UK and international marketing, market access and business development across both capital and consumable equipment. Recent years have seen Davies head-up ABHI’s Market Access function, ensuring that system processes are aligned to safely adopt the latest in healthtech. As of July 2019, Davies’ role was refined to focus solely on digital health; a position which sees an emphasis on promoting the opportunities where UK healthtech companies can play a part in the

UK companies at MEDICA 2019, both big and small, should speak with Davies and become part of this national conversation around digital adoption. Taking place from 18-21st November in Dusseldorf, Germany, MEDICA attracts over 5,000 exhibitors from 70 countries and plays host to tens of thousands of visitors every year. The ABHI UK Pavilion will be located in hall 16.

The ABHI pavilion will highlight ground-breaking UK digital health technologies


MSM Designing Empowered Healthcare Experiences Industrial Design | Engineering | User Experience Human Factors | Prototyping

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med in ireland


aura Hughes, MPN editor, describes her recent trip to Med in Ireland and learned why the country is considered a hub for the medtech industry.

the potential to access a €500 million Disruptive Technology Fund. This fund provides an opportunity for small and medium sized companies to collaborate with multinationals and research centres to develop new products and technologies. These systems play a key role in making Ireland the medtech hub it is considered to be.

Ireland is home to 18 of the world’s top 25 medical device manufacturers, as well as being the second largest country for exporting medical devices in Europe. Ireland is therefore often thought of as a medtech hub. Government initiatives such as Enterprise Ireland (EI) and STEM programmes such as those by Irish Manufacturing Research, where the organisation works with both primary and secondary schools to encourage the younger generation to be interested in manufacturing and medtech attempts to ensure the current success of the sector within Ireland will continue for many more years to come.

Before the exhibition began keynote speeches were delivered from industry experts, and Chris Coburn, chief innovation officer, Partners HealthCare led a panel discussion focused on the advancements in medical technologies. There were representatives from Ireland, Dubai, the United States and Belgium to ensure a global perspective was presented.

On Thursday 19 October more than 800 delegates headed to the RDS in Dublin for the biennial invite-only Med in Ireland event. The event was hosted by EI, a government organisation aiming to develop and grow Irish enterprises across the global market. Last year, EI invested €23 million in Irish start-ups and supported a total of 132 startup companies. EI also supports businesses throughout all stages of their growth and connects them to international customers. In addition to EI, medtech companies in Ireland also have

Ireland’s outstanding health eco system was mentioned by Liam Kelly, chief executive officer, Teleflex. Kelly discussed how unique Ireland is because different organisations often work together, including competitors collaborating in some cases in order to keep medtech local. He explained how research and development centres are able to easily engage with hospitals in Ireland and during my trip I was able to experience this firsthand. I visited BioInnovate, one of the world’s largest medical device hubs which is only a short walk away from the Health Innovation Hub Ireland (HIHI). The HIHI is based in the hospital and works together with BioInnovate to solve problems and improve patient care. One of the many success stories to result from the two organisations working

together is Embo medical, a medical device company who is developing the first true one-shot vascular embolisation device. Ireland places a strong focus on encouraging innovation and so the Cleveland Clinic joined with EI to present an innovation award during the Med in Ireland event. This year’s winner was Cormac Farrelly for his approach to target challenging embolisations. Charles Steiner, technology development director, Cleveland Clinic Innovations described the technology as a “game changer” and commented how it had the potential to offer both a near term and long term impact to patient care for all of us. As his prize Farrelly will have the opportunity to visit the Cleveland Clinic to develop the device with clinicians, and additionally, Farrelly and the other two finalists will be awarded €15,000 in funding from EI. With Ireland’s solid infrastructure in place which supports both individual innovators of medtech devices and medtech companies, alongside multiple organisations working together in attempt to keep medtech local, it doesn’t appear that the momentum of medtech within Ireland will be slowing down anytime soon.

I don’t see the momentum of medtech within Ireland slowing down anytime soon. 19

Cover story



ugene Canavan, from awardwinning design & innovation company Design Partners, explains the importance of putting people at the heart of medical device design Human factors engineering (HFE) is about designing for people. It seeks to recognise human capability – both cognitive and physical – and design solutions around individuals making the most of that capability. Design Partners product development ambition is to elevate human potential, making life, work and society better and safer by combining design, engineering and HFE. Embedding and integrating human factors into our design and engineering capability is key to this ambition. When defining medical device and healthcare solutions, documenting usability is a regulatory


requirement. This aspect is focused on risk reduction, safety and ensuring the solution is optimised for use. Deployed correctly, HFE will be present throughout a product development life cycle to meet regulatory requirements, but the true value of an integrated HFE process to a development team is much greater. BENEFITS OF HFE People; The process is about optimising human cognitive and physical capability, so it’s appropriate that users are considered first. Understanding the end user is essential to make the most of their capabilities. The HFE process maintains a user perspective throughout, from early engagement with users and key opinion leaders, by way of methodologies such as interviews, workflow analysis and contextual enquiry field work. Inherent in the process is understanding user populations, their respective tasks and workflows, in the context of the their working environment. Ambition; Have you ever wondered during a project if you are doing the right thing? Is the ambition of the project compromised? Is this the

right solution for the market? When development projects present technical or mechanical challenges prototyping is a common activity at defined points in the project. The HFE process is no different, as testing early and often with users helps optimise and de-risk the human element. User testing confirms the ambitions and goals of the project are being met. De-risk; The true value of the HFE process is to consider and optimise for the human component within a system. Understanding this human component in real-time gives a product development team insight that is actionable and implementable. User safety is a central critical element of this. HFE usability standards HE75 and ISO-62366 are designed to be used in conjunction with the medical device risk management standard ISO-14971. The HFE process actively manages risk related to usability and workflow. Cost containment; Understanding the human component in real-time across the development cycle ensures you are solving the correct problem. It’s easy for a project team to go off on a tangent

Cover story

and work diligently until reaching a dead end. In our experience project teams and management highly value the reassurance, insight and data that usability testing delivers, keeping the project team on track, focused and motivated. Failing early is positive, failing late will be costly –in both time and resources. THE PROCESS A product development process will generally have five or six key phases, starting with research design to set the project up for success with a clear definition of product requirements. This is followed by conceptualising to answer the product requirements, followed by iterative development to perfect the solution and eventually, detailed design, where a full specification for production is defined. A characteristic of projects moving is that exploration is wide at the beginning but becomes more focussed, narrowing to an optimised solution. The HFE process follows a similar path as every stage of the product development life cycle will have usability-centred input and output. While there may be an HFE lead in the project team or an outsourced HFE consultant, HFE activities should engage the full cross functional team at each stage, to maximise its benefits and promote the integration. Having HFE as a standalone function, may serve to meet the regulatory requirement, but will negate the true benefits HFE can bring to the product and the project team. Placing the end user at the centre of new product development rather than the technology, allows a true

understanding the their needs, behaviours and environment; critical to creating meaningful product experiences. This is achieved by employing research mythologies such as VOC interviews, contextual enquiry or ethnographic studies. Having the cross functional team engage in user research is key to building an understanding of the user, which creates novel, relevant and user–centric device solutions. Usability research feeds the concept phase and provides real insight into technology development and the complete product ecosystem. The outputs from the concept stage can be used for formative usability tests. A well-defined formative test protocol with clear criteria for success is essential, with testing early and often this does not need to employ large numbers. Formative testing should become more rigorous and focused, with participant numbers increasing as the project progresses. The outputs from formative testing should be concisely documented, be actionable and implementable. The formative process is designed to verify project direction and provide insight-rich data for iterative refinement. This maintains an end user perspective throughout the problem-solving stages of the project. Formative usability testing builds to a conclusion, moving into summative testing following design freeze. The execution of a summative test is a validation of the usability work completed in the project and a demonstration that the system is de-risked for use. The summative test is a representation of actual use

in the marketplace, including training with supporting materials expected to accompany the product launch. This is the most important and expensive phase of the HFE process so it is essential that the test protocol is robust and executed by an experienced moderator. When unexpected issues do arise, it is critical that the moderator uncovers the reasoning behind the issue. Retrospective interviews with the participants are key here as they capture user perspectives and account for usability aspects that may not have been considered in the test protocol. The subsequent summative report is the conclusion of the HFE process. This report is the primary evidence to regulatory bodies that the solution is optimised for safety and intended use.

CHARACTERISTICS OF AN EMBEDDED AND INTEGRATED HFE PROCESS Early and continued application of the HFE process increases the likelihood of meeting user needs, bringing commercial advantage and creating better performing solutions. An embedded HFE process will have the following characteristics. • End-user perspective and needs are maintained through the process • Design decisions are informed by end-user interaction tasks and needs •HFE activity is tied to the overall development process • HFE activity is tied to the design controls and risk management • Usability problems are addressed as they arise and not at the end • HFE process provides for an iterative optimisation process • The results of HFE activities are actionable • The HFE plan is defined and is linked to the project design history file (DHF) HFE is a regulatory requirement but applied well, it is also a strategic product development and cost containment tool essential to commercial success. Let’s harness the power of HFE to provide solutions that elevate human capability.







here has it seems, never been a better time to be in digital health. And for medtech players involved in the design and manufacture of healthtech products, there are significant opportunities on the horizon. With the NHS continuing its drive for increased innovation, the conditions are being created to help manufacturers take advantage of the growth of healthtech in the UK. Of course, making innovative healthcare solutions is nothing new to the medtech sector, so what’s changed? Earlier this year the NHS revealed its Long Term Plan. Its aim is to speed up the route by which innovation reaches the patient. Crucial to the plan is the role of the Academic Health Science Networks (AHSNs) – the link between academia, industry and the NHS – who have been guaranteed funding until 2023 to get innovations to patients as quickly as possible. Also playing a fundamental role is the Accelerated Access Collaborative (AAC). Set up in 2016, the AAC ‘brings industry, government and the NHS together to remove barriers to the uptake of innovations. This enables NHS patients to have faster access to innovations that can transform care’. The remit of the AAC has now stepped up with an over-arching function across the entire UK health innovation network, ‘providing more joined-up support for innovators and setting the strategy for innovation in the


health system’. The AAC identifies and supports innovation that it feels will have the ’biggest impact on patient health outcomes and NHS services’. These include medical technologies, digital products and diagnostic products. Using a range of platforms, such as HealthTechConnect and UK Pharma Scan, businesses can register their products – if the AAC sees significant potential they will receive guidance from the AAC on how to get to both market and NHS patients, as quickly as possible. The public perception of digital products is positive also. A recent report from Stada Health highlighted that more than half the people in the UK have a positive attitude towards the future of health and 50% of them would consider the use of technology in healthcare situations. MTI News writer Ian Bolland spoke to Roger Scarlett-Smith, executive vicepresident of Thornton & Ross, where the report was unveiled. He said: “The findings of this study demonstrate that we have every reason to feel optimistic regarding the future of health in the UK…Health education and literacy in the UK – particularly among the younger generations – are key to addressing any remaining concerns so that we can look to the future of health with confidence. “This, combined with the digital transformation enabled by realtime data measurement, means


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MORE THAN 1BILLION PATIENTS TO BENEFIT FROM 5G CONNECTED HEALTHCARE BY 2020 More than one billion patients worldwide are expected to benefit from improved healthcare services by the end of the next decade (2030), as 5G mobile connected technologies transform hospitals and doctors surgeries, according to a new report by Huawei and independent research and consulting firm STL Partners. 5G connected remote patient monitoring, wearable health

we are in a better position than ever to positively impact our health – rather than responding to illness, we believe the future is likely to revolve around sustaining wellbeing. The insight gathered through this report enables Thornton & Ross and the Stada Group to be at the forefront of understanding the consumer behaviour that will drive this health model.” It’s an exciting time to be part of the digital health landscape. According to the ABHI – which represents the healthtech industry, the sector now employs 127,400 people in 3,860 companies, with a combined turnover of £24bn. For a relatively new sector, these are impressive figures. As a comparison, according to figures from the British Plastics Federation, the UK plastics sector has a turnover of £23.5bn, employing around 170,000 people.

devices, virtual HD doctor-patient consultations and connected ambulances are all expected to be common-place and improve healthcare around the world by 2030, according to the report. Victor Zhang, senior vice president, Huawei, said: “Hospitals and doctor’s surgeries around the world are coming under increased pressure due to ever ageing and increasing populations.

of tomorrow here. That British businesses shape the technology of tomorrow, and British values drive progress for the benefit of everyone. And, I believe, one of the ways we do that, is by embracing innovation in healthcare. By opening up our health service to innovators, wherever we may find them: business, academia, or from anywhere around the world.” Pulling together innovation and creating the conditions for healthtech to grow and thrive, is welcome news for the medtech manufacturing sector. The fact that healthtech has the ability to make significant, long-term contributions to the future of the UK, speaks for itself. Is there any other industry currently in the spotlight in the same way?

For Matt Hancock, the secretary of state for health and social care, ensuring the success of the healthtech sector is crucial to the future of the UK. He said: “So, for me, making sure that Britain remains at the forefront of healthtech, biotech, genomics, AI, scientific research, and healthcare innovation, isn’t just about ensuring we have a worldclass NHS – as important as that is. It isn’t just about ensuring we have a strong economy – as important as that is.

Of course innovators are just one part of the process. As healthcare sectors in both the UK and Ireland see demand rise from both clinicians and patients, the economic benefits reach further into the manufacturing supply chain. Designers, materials suppliers, sensor specialists along with the growing number of pharma companies looking to take advantage of the booming digital health sector, are just some of the examples of the expertise fuelling the healthtech economy.

“It’s about making sure that Britain wins the 4th Industrial Revolution. That we create the high-skilled, well-paid, tech jobs

Ireland is also a tour de force within the healthtech arena. According to Enterprise Ireland, “the country’s world-leading

“However, over the next decade, 5G connected wearable devices, remote patient monitoring and HD patient-doctor consultations, and even surgery, will transform the healthcare industry; potentially freeing up $94bn which can be reallocated elsewhere.”

position in the medtech sector has been nurtured through a combination of state planning and partnership with multinationals, that now positions the healthcare and life sciences sector as one of Ireland’s strongest and most important business industries. It employs some 38,000 people in around 350 companies. That makes Ireland the largest employer of medtech professionals in Europe per capita. Ireland is also the second largest exporter of medtech products in Europe, with annual exports of €12.6 billion to over 100 countries globally.” In 2017 the Irish government outlined the future of healthcare which placed a strong focus on healthtech: “Digital health solutions can support more efficient processes, empowering patients in managing their care and accessing their own medical records, as well as facilitating the provision of services in more appropriate care settings closer to the patient’s home.” Only a few years ago we joked about the digital doctor seeing us now but thanks to time, pressures on healthcare waiting lists, clinicians’ and patients’ desire for better care, and how it’s delivered, the digital health sector holds longterm promise for both the UK and Irish economies.

Is there any other industry currently in the spotlight in the same way? 23

Medilink UK Medilink UK is the UK’s largest network of life science and health technology organisations, with over 1,600 members and a database of over 48,000 contacts.

Our experts can provide specialist support in: ●

We encourage innovation in the sector and nurture collaboration between academics, clinicians and industry. With offices based across the UK, members of Medilink UK have access to opportunities and events on both a national and a regional level.

To find out more about Medilink UK and the regional offices, visit

New product development and market research Selecting and reaching your target market, whether it’s in the UK or abroad Clinical research and NHS procurement Sourcing funding and finance




Take the tube


edical products need packaging that is easy and safe to handle. This is particularly true for implants that have to be inserted into the patient’s body while remaining sterile. Thomas Braun, manager marketing Rose Plastic Medical Packaging says: “One major challenge for packaging medical implants is certainly the requirement to package implants safely and securely. That is, to not only protect them from mechanical damage and ensure that no abrasion occurs, but also to provide an effective double sterile barrier. While the safety of the implant has to be ensured, the usability also has to convince by safe, simple and fast handling during the packaging process and also at the end user.” With this in mind the company has developed TubeinTube which is designed to guarantee sterile and contact-free handling and transfer of the implant. It can be safely transferred from the non-sterile to the sterile area of the operating room. This double sterile barrier packaging consists of two transparent tubes which are inserted into each other. Each of the tubes is secured by an air-tight closure; in the case of the inner tube, this also ensures that the implant is firmly seated. The outer tube has a tamperevident closure; if left unopened, it ensures that the implant is undamaged and sterile. It is easy to open using the attached tab. The packaging geometry

ensures that the inner tube with the implant sits securely and firmly in the outer tube - yet is easy to remove. “By providing an effective double sterile barrier, combined with easy, intuitive handling during surgery and perfect suitability for wellorganized storage with minimal space requirements, we feel that TubeInTube helps solve the challenges facing medical implant packaging,” says Braun. Rose Plastic also feels that another advantage of the product is its costeffectiveness and that compared with more conventional packaging solutions, it creates less packaging waste. This reduces the transport volume, simplifies disposal and minimizes the space required for the implants, an important factor in many clinics. This means that significantly more implants can be clearly stored in the same amount of space. TubeInTube is suited for implants such as bone screws in various sizes, but can also be customized and further developed to accommodate numerous other implants, taking individual requirements into account. “The packaging concept is suited for all kinds of cylindrical or elongated implants, as screws, nails or plates and can be adapted to customers’ needs,” says Braun.

Rose Plastic is at the forefront of medical packaging and is aware of the challenges the industry faces. It is also aware of what the future holds for this key element in the medical device supply chain. Braun says: “Of course, the megatrends in the packaging industry do not stop at medical packaging. The concepts of smart packaging, digitisation and automation are always present and place high demands on the packaging of the future. In addition, there is the demand for packaging solutions that can save both space and waste. With our packaging we are well prepared for these requirements and will continue to develop innovative packaging with high customer benefits in the future.” Braun explains the position as follows: “Since the company was founded, Rose Plastic Medical Packaging has earned a first-class reputation in the industry through a high degree of innovation, qualified consulting and customer-specific solution competence. We take a very close look, analyze processes and then find new solutions that, for example, increase handling and safety. In addition to medical technology, our industries also include the dental, healthcare and laboratory sectors”.


Drug delivery devices




kinny jeans are a bit like marmite for the British reader and peanut butter and jelly sandwiches for the American reader: you either love them or hate them. Whilst the current female fashion in the jeans department is for tight jeans which sit on the ankle, many jeans trends have dictated the way we purchase this wardrobe staple over the past few decades. From bell bottoms in the 1960s, flares in the mid1970s, drainpipe jeans in the 1990s through to the skinnies of today, we are all subjected to trends, whether we choose to follow them or not. The same is true in healthcare in that we see distinct trends in the way medicines are offered to patients and patients have distinct preferences for their disease management; most importantly patients have never been more firmly rooted in pharmaceutical development considerations. From implants revolutionising the choice of

contraceptive dosing - to pens for top-up insulin injections at the dinner table - significant steps forward have been made in health management thanks to patient preference. Such steps have been supported by pharmaceutical companies to help improve patient compliance and for their medications to stay ahead of the competition. A PLETHORA OF APPLICATIONS We are familiar with medical devices enabling choice for health management, from the availability of slow-release hormonal implants (such as Implanon) for managing contraception through to devices for monitoring and treating diabetes, such as Dexcom’s constant glucose monitor and Eli Lilly’s Trulicity autoinjector for treatment. In the area of cancer treatment, the first small volume wearable, OnPro, which is used to automatically administer Neulasta (to treat neutropenia), has also capitalised on the use of device technology, enabling most patients to spend the day after strong chemotherapy in the comfort of their own homes. So, across a range of therapies, we see monitoring and drug delivery devices improving a patient’s disease management. GREATER DEMANDS It is important to note that the small molecule and commercial biologic therapies are dominated by pens and autoinjector devices, but the demands of new biologic molecular entities are asking for more. Newer biologics need packaging which is less likely to cause an interaction with the drug. In addition, they often need higher volumes,


Figure 1: Second generation SmartDose 10mL wearable device

higher viscosities, sophisticated functionality and a range of delivery profiles. Couple the demands of the molecule with that of the payer (better health outcomes) and the patient (home administration and less frequent injections), and it becomes clear that alternative delivery solutions are very much in demand. Whilst pens and autoinjectors are still produced in their millions annually, growth in this sector is due to therapies such as Eli Lilly’s Trulicity which, while still using an autoinjector, offers a decreased injection frequency. Larger syringes of up to 2.25 mL and cartridge-based systems are also driving autoinjector designs, which ultimately offer a patient a wider treatment choice, and release formulators from the confines of having to formulate the drug to <1mL. CARTRIDGES - THE WAY FORWARD? Prefilled syringe systems remain the primary packaging option for drug containment, but we are seeing growth in cartridges as the primary container, which can only be a growing market as drug delivery volumes increase. The trend of moving from intravenous to sub-cutaneous route of administration is also driving the need for cartridgebased systems.

Drug delivery devices

One such system is Westâ&#x20AC;&#x2122;s SmartDose drug-delivery platform, which offers options for subcutaneous delivery of up to 10mL doses via a prefilled cartridge system, as seen in Figure 1. Such a system enhances the patient experience while removing costs from the healthcare system by removing the patient from hospital. For a patient to be able to manage their own care in their own home, at a time of their choosing, is empowering. Alexion recognises the need for patient choice as they recently disclosed that they are planning to offer a subcutaneous version of their new Ultomiris drug, which will be offered in a SmartDose device. As we look at the way regulators have approached the approval of new combination product therapies, they require a more holistic approach to the data, so emphasis is placed on how the drug and device work in harmony to reach drug delivery goals. Combine this approach with the fast track, early approval of products, and the decision of how to deliver the drug is forced earlier into the development cycle. EARLY DEVELOPMENT Devices are now entering clinical studies and early emphasis on this, as well as human factors and clinical data, are putting developers in a good position for a smooth regulatory approval, even if final dose and format is unfinalised. Having a holistic mindset by incorporating the

delivery device as early as possible into the development process may well decrease the risk of delays through the whole development cycle. As competition around market share is fierce, speed to market is key, whether you are developing a small molecule, a vaccine, a biologic or a biosimilar. Another important consideration with reducing risk in the drug development process is that of understanding where the greatest risks lie and mitigating them upfront. From device feasibility and closure integrity testing, stress and human factors tests, scaling from clinical studies to commercial quantities and training for call centres and failure investigation, there are many potential pitfalls along the way. Add in the need for a deep regulatory understanding and it is obvious to see why delay risks are plentiful, no matter who the developer. INTEGRATION Integrating these process parts and partnering with a supplier who can handle the outsourcing requirements, as well as guide you through the steps is a sensible decision to make early in the drug development process. Westâ&#x20AC;&#x2122;s Integrated Solutions program provides such a service, offering great expertise in combination product development. West has the first and only commercially available large volume wearable device approved as a combination product with Amgenâ&#x20AC;&#x2122;s Repatha.

As we see a broader range of companies successfully bring their molecules all the way to commercialisation, the need for partnering with experts in their own niche field will only become more important. Integration of external suppliers and being open to supplier partnering can benefit many types of companies, whether you are a smaller company showing great drug formulation and development expertise, but you are device lean, or you are a larger pharmaceutical company with in-house expertise across the complete development chain, but you cannot support specific project timelines.

SmartDose is a registered trademark of West Pharma. Services, a subsidiary of West Pharmaceutical Services Neulasta, Onpro, Pushtronex and Repatha are registered trademarks of Amgen ULTOMIRIS is a registered trademark of Alexion Pharmaceuticals Trucility is a registered trademark of Eli Lilly and Company


Industry 4.0




It’s a smart world, and medtech is no exception. As an industry driven by quality and regulation, we’re seeing devices that improve the patient experience, allow clinicians to monitor conditions remotely and more effectively while gathering data and reducing healthcare costs. This transformation at the point of care is not without demands. Increasingly complex medical devices, the use of innovative materials and the implementation of the most advanced technology, adds a new level of expertise to the design process – and this can come at a cost to the manufacturer. The global population is getting older. Healthcare systems are working to keep people alive and for longer. The demand on the manufacture of medical devices – be it implants, or hearing aids or the latest connected devices – has never been greater. Not only have medtech developers had to push healthtech to a new level but they have had to optimise the way in which they manufacture - and this while keeping one step ahead of market demands and competitors. 4TH INDUSTRIAL REVOLUTION Industry 4.0 has been described as the fourth industrial revolution. Why is it so important? The concept is often described as creating a smart factory, a process that brings together the physical and the digital / virtual. In real terms this means that manufacturers can create an environment that facilitates optimum workflow. Machines communicate with machines creating a dynamic, rather than linear, environment. We’ve grown used to hearing about the internet of things and how mobile tech and the cloud will benefit business. But this is really something different. Referred to as the industrial internet of things (IIOT), this change in the manufacturing process promises far-reaching benefits on the factory


floor, allowing the creation of goods and products in a way we haven’t seen before. From the use of automation and robotics to software-defined production processes, connection the manufacturing environment with the internet and its own machines, means we have a way of making things like never before. Importantly for medtech, the development of sensor technology and microelectronics has helped transform what is made and the way it’s made. Innovation moves at a pace within the healthcare sector and the manufacturing sector is expected to keep up. Across the globe healthcare systems are under huge pressure to deliver first-rate care at maximum value. The key to achieving this is not just through innovative medical technology but through the way it’s made. The IIOT allows this to happen. THE END OF THE PRODUCTION LINE? Industry 4.0 throws the concept of the linear production line on its head. A particular job can seek out the machine that allows it to achieve competition in the fastest and most efficient way possible. The system also benefits smaller product runs and is highly beneficial for the customisation of medical devices. ISSUE OF QUALITY One of the most obvious ways in which Industry 4.0 can bring benefits to the medtech manufacturer is by improving quality. Medical technology manufacturer, Raumedic, recently partnered with software provider Guardus Solutions, to design the manufacturing execution system (MES) for existing and future machinery. The aim of the solution was to make significant improvements in quality management. Individual products can be tracked all the way back to the raw material and can also be digitalised, cross-linked, managed and documented from the time of their

development to their delivery. The MES covers the entire product cycle. “The use of digitalised processes will not just open up undreamed of possibilities. Above all, it will boost the value that we can and will generate for our customers,” said Martin Schenkel, head of operations at Raumedic. “Medical technology and pharmaceuticals are sensitive business areas that have extremely high quality requirements,” CEO Martin Bayer said. AND COMPLIANCE? Regulatory compliance is a vital element of medical technology manufacturing. The beauty of the Internet of Things is that records are always available for the relevant regulatory bodies. Zenith Technologies specialises in implementing digital technologies to manage, control and optimise drug and medical device production for maximum operational efficiency and regulatory compliance. The company was recently acquired by Cognizant, a manufacturing technology service. The acquisition boosts Cognizant’s capabilities for designing, implementing and managing endto-end operational and information technology systems for connected biopharmaceutical and medical device manufacturers. The combined Cognizant-Zenith Technologies expertise will deliver a range of Industry 4.0 capabilities, from factory design consultation, machine sensor and controller instrumentation, supervisory control, and data acquisition, to manufacturing execution systems, batch automation, enterprise resource planning integration and managed services. GETTING READY FOR INDUSTRY 4.0 While it’s all very well for us to be singing the virtues of smart factories and the benefits advanced automation can bring to the medical technology manufacturer, it of course comes at a

Industry 4.0

cost. Initiatives which help drive the implementation of new technology are therefore, highly welcome. In the UK, nine companies based in the North West are the first to benefit from a government programme that will boost manufacturing productivity and growth through the adoption of digital technology. The businesses are part of the £20 million Made Smarter Programme, which will help them to grow by adopting new digital technologies. Based in Greater Manchester, Cheshire, Lancashire and the Liverpool City Region, the companies are set to introduce 12 advanced manufacturing methods including Artificial Intelligence (AI), Industrial Internet of Things (IIoT), 3D printing and robotics.




But what about the businesses that can’t access this can of help? Creating a smart manufacturing environment isn’t going to happen overnight. The first thing to do is make sure you get what you want and what you need. Work out your end goal or highlight any problems your current manufacturing process may have and start from there. Don’t buy into a host of digital solutions that aren’t the solutions you need. How much connectivity does your process really need? The best approach Industry 4.0 is to think small and scale up. One of the key drivers for making Industry 4.0 really work is to have your whole workforce on side. Too often employees rail against the idea of automation or smart machines for fear it could lead to job losses. Making sure the whole business understands the benefits that a connected production process brings, means it’s more likely to be a success. Automation technology supplier Festo, has created guidance on Industry 4.0 that’s worth a read.



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Regulatory update


hether as a sophisticated test to identify cancer markers or a costeffective method of detecting malaria in a low or middle-income country, in-vitro diagnostic devices (IVDs) are an essential component of making a diagnosis and choosing a safe and effective treatment. They represent a key platform in the delivery of health care and disease prevention globally. An often-overlooked issue with these important products is data integrity. Many misconceptions are held, especially by IVD manufacturers who have often missed the ongoing scrutiny of premarket assessment for CE marking. The new EU IVD Regulation 2017/746 emphasizes comprehensive and competent notified body premarket assessment that will require approximately 80% of all IVDs to be CE marked. It will also require notified bodies to carry out annual inspections of manufacturing sites. The quality and integrity of your technical data is what will bring conformity. Many IVD manufacturing sites and technical files will be facing tough scrutiny for the first time - so make sure the culture of quality is strong, and your data is attributable, legible, contemporaneous, original and accurate. DEFINITION OF DATA INTEGRITY AND THE ALCOA PRINCIPLES According to the WHO, “Data integrity is the degree to which data are complete, consistent, accurate, trustworthy and reliable and that these characteristics of the data are maintained throughout the data

lifecycle. The data should be collected and maintained in a secure manner, such that they are attributable, legible, contemporaneously recorded, original or a true copy and accurate.” ALCOA is the commonly used acronym for “attributable, legible, contemporaneous, original and accurate.” The ALCOA principles have been acknowledged as fundamental for maintaining data integrity. Implicit in these principles is the need that data are also complete, consistent, enduring and available. HERE ARE SOME COMMON ATTITUDES TO DATA INTEGRITY. FACT OR MYTH? WHAT DO YOU THINK? Data integrity refers to falsified data in the pharma industry. When we talk about data integrity, people tend to think about falsified data associated with the pharma industry. This of course is a criminal activity, but it is not the only way in which data integrity can be compromised. Data integrity is more frequently inadvertently breached in day-to-day activities. So, the statement is true, but the issue is not exclusive to the pharma industry or to the falsification of data. Data integrity is a new requirement. False. Data integrity is a requirement of the quality management system standard ISO 13485. Section 4.2.5 describes the need to have records that remain legible, identifiable and retrievable. Likewise, similar emphasis

is placed on documents in Section 4.2.4. Data integrity issues are found primarily in certain jurisdictions. False. Intentional and accidental breaches to data integrity are discovered internationally. Incidents in high-income countries are reported by every regulator, for all types of products assessed, and in every country inspected. WHAT DO I NEED TO DO TO MAINTAIN DATA INTEGRITY? According to the WHO guidance, “Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.” As with many quality practices, it is important that senior management is engaged and ensures that an effective data management system is in place. Data integrity principles apply throughout the whole product lifecycle, impacting both paper and electronic records. It is normal to think that strong scientific principles will ensure data integrity, but these also are insufficient. The onus falls again on senior management to create a culture of quality that embraces the ALCOA principles. Data integrity is a very important part of doing business, and the most important step is getting ready now. Be aware, do what is required and remain vigilant!


Innovative materials

Making innovation



novus Medical has come a long way since the development of its first laparoscopic box trainer and the formation of the company in 2012. The company is expanding rapidly, with the majority of its manufacturing – including 3D printing – now being carried out in its factory based in St Helens. While the team build its surgical simulation devices which are specifically designed to support trainee surgeons in mastering their surgical techniques, it also develops its own electronics and consumable products with a level of functionality and realism it feels is unmatched by its competitors worldwide. The design team continues to develop innovative ways of enhancing the portfolio of products. This year alone has seen £1 million investment going towards design of a new laparoscopic AR system which is to be launched early 2020. Dr Elliot Street, who worked as a junior doctor in the early years of the business is the CEO and co-founder, explains that after the initial formation of the company and those first few challenging years the company is now at the stage where it is expanding in key business areas, and investing in equipment and processes that will see Inovus Medical go from strength to strength. He said: “What we wanted to do first was answer an unmet need in the world of surgical training and specifically laparoscopic training, so we set up a


company with three strong core values that major on accessibility, affordability and functionality. “Initially the key focus was to develop extremely affordable box trainers that trainee surgeons could benefit from using, at a price they could afford. When we started it was just a webcam in a plastic box. I was a medical student and Jordan (Van Flute), co-founder and CTO, had just graduated. We saw a gap in terms of what was being delivered in training and there was a real lack of access to good quality, affordable laparoscopic trainers. “The first product we made, we bent a piece of plastic with a heat gun around the side of a fridge and drilled some holes in it. We produced a couple of promotional shots, coded our own website, uploaded it online and sold our first laparoscopic box trainer. We used the money to purchase a more efficient device for shaping the plastic, from that point every time we sold a box trainer, we upgraded our machinery.” Along with the box trainers that one may be more accustomed to, the company also manufactures in house, a range of consumables which have been designed and developed using materials that act in the same way as real tissue. This allows realistic models to be placed inside the box trainers and operated on. Thanks to the recent investment the company is bringing these medical models to life through the use of Augmented Reality. Dr Street explained that a major driver of the idea was to provide the trainees the ability to perform a virtual procedure in the most realistic way – repeatedly stating his desire for products to be affordable, accessible and functional. The simulators that are being developed include those that can be taken home, as well as those that can be used in an institutional setting. “Our haptics are real haptics. You don’t

need sensors because we’re putting in models that feel and act with a level of realism unexperienced to date. The thing that’s giving you all that haptic feedback is a real, tangible model and then we build a digital environment around that to increase the level of realism and immersion. “You can’t beat the haptics of using the instruments you’re going to use in real life and picking up materials that replicate real tissue and even give the same tension you would expect of real tissue. Some materials we have are proprietary to us and we have invested a great deal of time developing them to fulfil our customer’s requirements, these newly developed materials allow the use of energy devices in a simulated environment as they react in much the same way as real tissue when subject to these devices.” “We’re taking the empathetic insight of what our customers are going through and the difficulty they have with delivering or taking part in surgical simulation training and we’re saying: ‘leave that with us, we’ll find the answer.’ “Thanks to the Inovus products training surgeons are now able to practice in a safe, controlled environment away from the patients but on a material, that is behaving like a real tissue behaves.” It’s not just surgeons who can be the beneficiaries, as medical device companies can also show their products in the best light with a more realistic tissue while displaying them to potential customers. “We’re offering them a product that shows their instruments in the best light so when they want to go and demo to a customer, they’re able to use non-animal by-products so they don’t contaminate their demo kit.” During the last three months the company’s product range have been showcased and received with great interest and excitement at some of the

Innovative materials

Thanks to the Inovus products training surgeons are now able to practice in a safe, controlled environment away from the patients most acclaimed global congress’ held across the globe. With an increase in interest from customers both clinical and business led and the added advantage of some substantial funding from investors and innovation awards Inovus has now grown to a team of 18 strong with expertise in, manufacturing, engineering, electronics, design, software, import & export (across the globe) and marketing. As demand for Inovus Medical products has increased significantly during the start of 2019 with two of the existing products relying heavily on 3D printing and with a further three new products under development that will require printed parts. The company has invested in a production level SLS 3D printer, supplied by 3D Systems, allowing them to manufacture their plastic parts with a finish level equivalent to that of injection moulding. Speaking about its relationship with Inovus, Simon van de Crommert, sales manager of 3D Systems in the UK, Ireland and Benelux, said: “I first met Inovus at an exhibition in the UK. Inovus visited out stand as they were struggling with the high tooling cost and long lead times associated with their new products. Inovus is a small, innovative medical company in need of a new cost-effective, low-volume production method for their new products to help reduce the product development cycle and accelerate time to market.” Inovus’ plans for the months ahead will see the launch of a range of products that will have technological advanced features as the company moves towards the introduction of augmented reality simulation devices – aimed to further enhance the surgical trainees experience.


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


The IQoro device activates the neuronal pathways to and from the brain allowing it to rebuild, improve and regain its control over muscles involved in swallowing. It was part of a project recently recognised by CW Innovation as a finalist in its Dragonsâ&#x20AC;&#x2122; Den style programme, receiving funding as a result.


TriMedika has developed an infrared thermometer that aims to reduce infection and help patient comfort by having zero contact with the patient. It gives a temperature reading within one second and can instantly form part of an electronic patient record.


University of Aberdeen spin-out Mime Technologies has recently received funding to develop a product that can monitor the vital signs of airline passengers in-flight, and allow cabin crew to communicate with clinicians on the ground when a medical event occurs.


GiveVision has developed a clinically validated low vision aid called SightPlus that aims to help visually impaired people to see up close and at a distance. Pushing a button can allow a simple zoom function for clearer vision, aiding independence.




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Profile for MTI Magazine

MTI Issue 45  

MTI Issue 45