MTI Issue 52 by Med-Tech Innovation Magazine

www.med-technews.com Issue 52 | Mar/Apr 2021

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MED-TECH INNOVATION | NEWS MED-TECH

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How to adapt to a changing regulatory landscape Essential considerations for medical device design Improving traceability across production

Shifting the needle: How can new innovation aid cancer care? ADVANCING HEALTHCARE

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CONTENTS regulars 5.

COMMENT Ian Bolland explains why there’s an urgent need for a an inquiry into the handling of the COVID-19 pandemic

MAKING MEDTECH A round-up of the latest industry news

OPINION Wilmington Healthcare explores what the new NHS white paper could mean for medtech

12.

COVER STORY Roche UK highlights the continued innovations in cancer care and how it’s helping

22.

DIGITAL HEALTH

Sensyne Health considers whether the increase in remote patient monitoring is here to stay

28.

REAL WORLD MEDTECH Ian Bolland speaks to Mike Harris from Biocomposites about the use of calcium sulphate as a bone filler

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features 11.

INNOVATION | NEWS

Accumold explains the need for an experienced micro moulder in DfMM projects

16.

IRELAND How a lasting partnership led to mass production of PPE

18.

REGULATION How Medovate is dealing with the changing regulatory landscape with the new UKEU relationship

21.

TUBING

The University of Nottingham outlines the benefits of smart invasive devices

25.

MED-TECH INNOVATION EXPO

Our conference team provides a taste of what to expect in September

26.

Industry 4.0 The Sempre Group explains how the latest metrology software can streamline FAI reporting

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from The editor

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A public enquiry should be relished, not put off

year on from the first lockdown and messages to stay at home, the UK is now embarking on its emergence from a third lockdown, one that the government aims to be “irreversible.” As more than half of the adult population has received their first dose of a COVID-19 vaccine, at the time of writing, children are back at school and it is hoped that some form of normality will return by June. However, government must not be so naïve as to think this will be the only pandemic that will affect the UK so dreadfully as this one - costing in excess of 125,000 lives. Any time there has been a call for a public enquiry, those in the corridors have power have said that “now is not the time” while vowing to “learn the lessons.” If this is truly to be an irreversible path out of lockdown, then now is precisely the time hold an inquiry into the country’s response, particularly in the early phase of the pandemic and its preparedness. Its scope could cover the response from government itself, assessing schemes such as the ventilator challenge, PPE supplies, and whether courses of action that saw the health secretary break the law

were well intentioned if not the right call – and if he should be thanked as he suggested on one breakfast television show. Also covered here could be whether the life sciences industry and government are working closely enough together when it comes to pandemic preparedness, and if not, what changes need to be made, and whether procurement processes were properly followed in this matter of great urgency. This could also test some of the claims about the size of the UK’s diagnostics industry, including issues surrounding lab capacity for testing. One would hope the pitch for this part of the enquiry would be laid right now. This isn’t a case of finger pointing in order for someone’s head to roll for the huge loss of life experienced in the UK over the past 12 months; but to ensure that both government and industry are working in harmony for the common good, so that any supply chain issues can be addressed should we end up in a state of emergency again in the near future. The latter would also be generally beneficial for the industry and help the sector continue to succeed. Alongside this should be the NHS and its preparation for a

pandemic – not just in terms of staffing, PPE and capacity, but also in terms of the technology it uses. Increased use of digital technology has been one trend that has been accelerated by COVID-19 as we have seen an increase in remote monitoring and care in order to alleviate pressures and allay fears of infection that would come with in-person consultations. This also presents other challenges and issues when it comes to cybersecurity of smart medical devices and systems. Focussing on these areas in one of the first phases in any enquiry would not just aid preparedness of future health emergencies, but allow life sciences, digital health and the NHS to offer better services. This should be something that should be relished rather than shied away from.

If this is truly to be an irreversible path out of lockdown, then now is precisely the time hold an inquiry into the country’s response 5

Making medtech

AVACTA SIGNS DIAGNOSTIC LICENSING DEAL WITH BIOKIT

Perkin Elmer acquires Oxford Immunotec

P A

vacta, the developer of cancer therapies and diagnostics based on its Affimer and pre|CISION platforms, has entered into a license agreement with Biokit to incorporate Affimer reagents into a Biokit in-vitro diagnostic (IVD) product. Biokit is recognised as a Centre of Excellence with consolidated experience worldwide in research, development and manufacturing of assays and biomaterial solutions for IVD use. The license agreement follows an extensive evaluation by Biokit of certain Affimer reagents to detect a key analyte. Under the terms of the agreement Biokit has the right to develop, manufacture and commercialise through original equipment manufacturer (OEM) partners a diagnostic immunoassay for this analyte.

Avacta’s technology also enables us to innovate our assays with new reagents like Affimer reagents, an alternative to antibodies. We can now move onto the next stage of development 6

Avacta will receive royalties on future sales of any products brought to market following completion of product development and regulatory approvals. Financial details of the agreement were not disclosed. Dr Alastair Smith, chief executive of Avacta Group said: “I am delighted to have established this partnership with Biokit, a world-renowned IVD company, which further validates the Affimer reagent platform for diagnostics. Avacta’s diagnostics business model combines development of a wholly owned pipeline of products, including the SARSCoV-2 rapid antigen test, with licensing of Affimer reagents to diagnostic development partners such as Biokit. Dr Marta Palicio, innovation director of Biokit added: “Biokit is very pleased to have reached this agreement with Avacta. The agreement will increase the competitiveness of our customised assay offering for our partners. Avacta’s technology also enables us to innovate our assays with new reagents like Affimer reagents, an alternative to antibodies. We can now move onto the next stage of development, incorporation of this technology into new products. We hope this is the first of many assays containing Affimer reagents which will be developed by Avacta.”

erkinElmer has completed its acquisition of Oxford Immunotec after previously announcing its intention in January this year. Prahlad Singh, PerkinElmer president and chief executive officer, said: “Oxford Immunotec’s global role in fighting tuberculosis, particularly its trademark product, the T-SPOT.TB test, and the operations it has built are remarkable. We recognise the distinct clinical and logistical advantages of

the test and see a great opportunity to leverage our automation capabilities and commercial channel access to bring tuberculosis testing to more customers around the world.” Headquartered in Abingdon, UK, Oxford Immunotec is recognised as a specialist in proprietary test kits for latent tuberculosis. Its Interferon Gamma Release Assay (IGRA) identifies individuals who are infected with tuberculosis.

Period care firm among world’s most innovative UK-based period-care B-Corp, Callaly has been named to Fast Company’s annual list of the World’s Most Innovative Companies for 2021. The list honours the businesses that have turned the challenges of the last year into impact-making processes. Callaly was ranked at number 10 in the MIC list’s Design category. Thang Vo-Ta, co-founder and CEO of Callaly, said: “I couldn’t be more proud on behalf of the whole Callaly team for this recognition. From day one at Callaly our mission has been to make the lives of people with periods better and we have consistently lived up to this promise through our innovations and commitments to quality, sustainability and campaigning.

“This year has seen us reach some incredible milestones, from securing FDA clearance and exporting across Europe, to seeing our tampliner, the first design upgrade to the tampon in 80 years, named one of TIME’s Best Inventions of 2020. “To be recognised in Fast Company’s list alongside such incredible company is testament to the hard work and dedication from everyone here at Callaly and all those who helped us on our journey to-date.”

MEDILINK

Manufacturer secures government order for 20m tests

he UK government has secured 20 million Britishmanufactured rapid COVID-19 tests from Derby-based test manufacturer SureScreen Diagnostics. These lateral flow antigen tests produce a result in under 30 minutes and have been validated by Public Health England (PHE). The SureScreen test will be used as part of the government’s rapid testing programme for those without symptoms, which has seen lateral flow tests deployed across the country to test NHS and care home staff, as well as in targeted settings including schools, universities and for those who have key worker status. The tests have been proven to detect the B117 ‘Kent’ variant of COVID-19. Results for the test at the laboratory validation stage show sensitivity against high viral loads was 97.1% and

specificity was 99.9%. Health and social care secretary Matt Hancock said: “Rapid lateral flow tests strengthen our national response to the virus significantly, helping us to identify the around one in three people who are asymptomatic and break chains of transmission in our workplaces and communities. It is excellent to be working with a UK firm to deliver millions more of these rapid tests.” David Campbell, director of SureScreen, added: “We believe our rapid antigen tests can really help in screening people both in the community and in clinical settings. Routine testing is crucial to help business, as well as hospitals and GPs.” SureScreen is a member of the UK Rapid Antigen Test Consortium, a coalition of scientists and manufacturers aiming to secure lateral flow tests and manufacturing capability for the UK.

Study finds demand for trauma trays

vamed, manufacturers of Rainbow Trays and Tamper Evident Rainbow Trays for anaesthetic drugs, has won an Innovate UK award to develop the Trauma Tray procedurepack/crash-box. Trauma Trays are secure and auditable complete procedure packs for use away from regular hospital environments such as rescue services, ambulances, field hospitals, care homes and in emergency departments. The secure tray packs will contain all equipment, supplies and, where appropriate, the drugs required to perform procedures in remote locations. A usability study led by TM-MIC/MD-TEC (Trauma Management MedTech Cooperative/ Medical Devices Testing and Evaluation Centre), sought specialist opinion from a select group of healthcare professionals working

New PPE face shields developed to help NHS go green ecman Advanced Healthcare Products is developing PPE with Optec – a new biomaterial reusable face shield system designed to help the NHS reach its carbon emission reduction targets. At the start of COVID-19, the urgent need for safe and comfortable PPE to protect frontline healthcare workers enabled British

manufacturing to demonstrate incredible agility. But it simultaneously raised concerns about the environmental impact of more disposable commodities. In a recent survey carried out by Tecman, 90% of the 156 healthcare workers surveyed communicated growing concerns about the environmental impact of PPE.

within the field of anaesthesia, regarding imagined use of the product outside of their typical working environment for RSI (Rapid Sequence Induction) procedures. The study suggested a good level of demand and acceptance for the Trauma Tray concept, yielding many key insights for consideration. Other healthcare professionals have provided significant and effective feedback into the Trauma Tray design, use, function and suitability, the value of which has been fundamental to creating a product that will address the needs of healthcare professionals in their working environments. Procedures identified that could benefit from a Trauma Tray include: Routine IV cannulation; arterial/central line insertion; tracheotomy; RSI or basic suturing kits. Funding from the

Innovate UK project has allowed Uvamed to develop Trauma Trays to a level where they have two tray types ready for evaluation by end users. An IV cannulation tray for use in a wide range of applications, and a more complex Central Venous Catheter tray to demonstrate the robustness of the design for both simple and complex procedures. Moving forward the company plans to design trays for more procedures including RSI and tracheostomy.

Tecman’s latest development tackles these concerns head on. Optec reusable face shield system from the Leamingtonbased company is underpinned by its four Pillars of Comfort, addressing the need for safe and comfortable protection that’s not only kinder to the environment but has a lower cost per wear. Since spring 2020, the Tecman team has been on a mission to make British-engineered protective visors the number one choice for NHS workers and has been working closely with the NHS ever since.

As part of this drive, the company invested over £500,000 in machinery that enabled them to boost production of their protective face shields to over 1 million units per week. In June 2020, its original face shield became one of the first to receive the category III complex design PPE level. In recognition of the product’s quality and comfort, the company’s face shield is specified by the NHS in its product framework and catalogue, and has already been used by hundreds of thousands of frontline healthcare workers.

Provider collaboratives:

The next big customer group for medtech? Oli Hudson, content director at Wilmington Healthcare, looks into one of the headline points of the new NHS White Paper, and explores what this might mean for the industry.

‘Integrating care: Next steps to building strong and effective integrated care systems across England’, the White Paper released by NHS England and NHS Improvement in February, had as a central conceit the increased importance of ‘place’ and the role played by providers. Place is considered in the White Paper to be a locale with a population of 250,000 to 500,000 and is roughly coterminous with a local authority boundary. ‘Places’ are expected to take on delegated budgets, with the ICS (integrated care system) only taking the lead where it is clear that work needs to be carried out over a larger footprint. Each place would typically have up to five hospital trusts, as well as ambulance, mental health, and community care services, which are now all expected to form integrated structures. These providers, working in groupings, collaboratively, seem to hold the future of the NHS in their hands, if this document is enacted as is; driving forward pathway change and service improvement and making the NHS ‘financially and clinically sustainable’. Every NHS provider will be expected to join at least one provider collaborative. It seems clear these collaboratives will take an ‘active and strong’ leadership

role in places. This will not be a totally smooth process, and some will struggle more than others to establish a new way of working after a near quarter century of competition with each other. However, written into this script is a need for provider collaboratives to challenge and hold each other to account. And ultimately the trauma of coping with the postCOVID backlog and having thinly spread workforce and resources may just force the process here. Collaboratives will need to enact mutual aid arrangements such as collective waiting list management and look at their combined and individual spend to see how they can enhance productivity and improve value for money. This could affect medtech in a variety of ways. Firstly, who is the decisionmaking unit that medtech is effectively selling to? In the old model, an account might be a large hospital with its own clinical directorate and its own procurement department. While there would be some aggregate purchasing and plenty of use of the NHS Supply Chain, with provider collaboratives new governance will be in place. Clinical decision making, including an influence on purchasing, will not sit at individual hospital level. What will this mean for a standard medtech account? Secondly, procurement decisions could well end up

in the hands of the so-called ‘lead provider’ a trust within a place that will sign the contract with the regional NHS. In fact, taking on this function is one of the marks of a provider collaborative having gone ‘live’. It will be important to establish who this lead provider is. For example, in the Nottinghamshire provider collaborative codenamed IMPACT, the lead provider is Nottinghamshire Healthcare NHS Foundation Trust. The place model will undoubtedly give rise to new pathways, too; both in a clinical sense, in terms of using the resources available within a place to change the model of care, as is being developed by the GIRFT initiative; and in the geographical location of services – in terms of some trusts specialising in particular clinical areas; and rationalisations within place, meaning some service reconfiguration, which could affect what some of your customers are actually carrying out. One of the main priorities of many provider collaboratives, for example, will be to keep patients out of hospital as far as possible. Lastly, the value proposition could change. Under the old financial system, individual trusts paid on activity and in competition with other providers were effectively incentivised to perform as many procedures as possible, thereby increasing trust revenue. With the

new contract-based system, the focus is much more on provider collaboratives achieving outcomes – built into the contract – population health – dependent on equitable provision across the whole system, not just by the individual organisation – and sustainability, meaning a stronger focus on long-term benefits to the place, and system. This last point – perhaps usefully for medtech – could result in less of a focus on short-term cost cutting if those longer-term outcomes are clearly evident from the use of a particular device, technique or product. This is clearly a space to watch – the next important release from NHSE/I will be its forthcoming publication on provider collaborative models. This is likely to include hospital groups, where trusts will band together in more formal organisations. Could they be medtech’s customers of the future?

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MED-TECH INNOVATION | NEWS

DESIGN

Ensuring success in precision plastic part fabrication Aaron Johnson, VP marketing & customer strategy, Accumold, explains the importance of an experienced micro moulder in a design for micro moulding (DfMM) project.

t the very conception of a micro moulding project, the focus at the design stage needs to be on the scale of the proposed part itself and on its internal geometries. All too often a conceptional design will be impossible to produce, and because of this DfMM has to be a primary consideration, as the unique challenges can hugely influence the success or failure of a project. The ultimate key to success is to work with an expert micro moulding partner early in the product development process, so that all the DfMM considerations can be aired and addressed as soon as possible. Typically, the less baked an idea is when the micro moulder is engaged the better, as the earlier the design of a micro product can be influenced and adjusted to optimise manufacturing outcomes, the better in terms of cost and timeliness of production. Essentially, DfMM ensures that not only will the end product be fit-for-purpose but that it is also optimised for the production processes that will be used to manufacture it, in this case micro moulding and automated assembly. An expert micro moulder will be able to advise on issues such as material choice, draft angles and undercuts, part lines, ejector pin locations, gate locations, the likely flow of material in the mould, wall thicknesses, etc. Critical to success in micro moulding is micro tooling. Tooling in any manufacturing scenario is always the most costly and time consuming part

of the product development process, but when looking at micro moulding, the tolerances and complexity that is often required in micro moulds make it especially critical.

necessary, an expert team of engineers, an understanding of the correct manufacturing methodologies, and the tooling and processing expertise to ensure optimised outcomes.

Micro tooling is an art in itself, and an expert micro moulder will be able to design, build, and maintain moulds in house, and also have the expertise and experience to optimise tool fabrication. One size does not fit all when looking at micro tooling, and micro moulders will work alongside customers to drill down into the specifics of a particular application, understand the effects of a certain material, cycle time expectations, part criteria, and expected volumes before beginning to cut steel.

When dealing with miniaturised plastic parts and components, the assembly part of the product development process must be considered early in the design cycle, again demanding a collaborative and pragmatic relationship between customer and micro moulder. When dealing with micro scale parts and components, the cost of manual assembly is prohibitive, and often requires levels of precision when dealing with sub-micron tolerances that are impossible to achieve. Automated assembly is therefore a must in most scenarios, requiring that a micro moulder is able to understand the methodology of micro assembly, and achieve the extreme positional accuracy required.

In house tool fabrication — in fact vertical integration in general ensuring that design, moulding, metrology and validation, and automated micro assembly are all undertaken in the same facility with departments working collaboratively — is vital in a micro moulding scenario where tolerances are so tight. The probability for successful outcomes increases exponentially when the responsibility for project and production, timeline, and execution are controlled within a single entity. Every stage of the product development process in a micro moulding product development project is driven by an obsession with the attainment of micron and sub-micron tolerances, and when it comes to micro moulding per se it is key that a micro moulder has the business acumen and experience

Success in micro moulding is predicated on the forging of a truly collaborative and transparent relationship between micro moulder and client. DfMM and decisions made at the early design stage will have effects when it comes to micro tool fabrication, micro moulding, and micro assembly. Because of this — and the need to have an unswerving focus on the achievement of extremely tight tolerances and to validate design intent — all departments involved in the product development process must work together from the inception of a product design and have a keen eye on DfMM issues to ensure the outcome is successful.

on the cover

SHIFTING THE NEEDLE: HOW CAN NEW INNOVATION AID CANCER CARE?

Chris Hudson, director of access and innovation, Roche UK, considers how innovations post COVID-19 can aid the treatment of cancer.

e find ourselves at a pivotal time for health technology. While on the one hand, we are facing the biggest public health threat for a century; on the other, we are developing solutions to tackle this threat faster and more efficiently than ever before. Collaboration has been vital throughout and industry has played a huge role in supporting the NHS and those on the frontline of the UK’s response to the pandemic. In addition to the enormous impact of COVID-19 itself, another concerning aspect of the pandemic will be the fallout on the NHS. Foremost is the impact on cancer care. There have been significant delays to cancer screening, and waits for further diagnostic tests and treatment. It is estimated that around three million fewer people were screened between March and September 2020 in the UK, and nearly 44,000 fewer patients started treatment for cancer between April and January 2020/21, compared to the same time periods in the previous year. There is also a concern that people with possible cancer symptoms are less likely to go to their GP since the pandemic started. This has placed the NHS Long Term Plan of diagnosing 75% of people with cancers at an early stage into jeopardy and highlights the greater need for innovation in healthcare. The challenge is clear and health technology is more important than ever as we look to overcome these challenges in cancer care – both to speed up diagnosis and target treatment to improve quality of life and outcomes for patients. THE CANCER TECH ACCELERATOR PROGRAMME This vital need for innovation is a theme highlighted in Cancer Research UK’s Early Detection and Diagnosis of Cancer Roadmap, which highlights accelerators and innovation ecosystems as mechanisms by which data-driven and diagnostic opportunities have the most chance of successful adoption into health systems. One way in which Roche UK is rising to this innovation challenge is by fostering collaboration and driving forward new innovation in the sector. As such, Roche UK is incredibly proud to have recently participated in the launch of a new Cancer Tech Accelerator programme with Cancer Research UK and Capital Enterprise to help budding entrepreneurs.

ON THE COVER

Leaders in the healthcare space have always had to find innovative ways to do more with less, without compromising patient care The Cancer Tech Accelerator will equip researchers with the entrepreneurial, business and technical skills required to develop their tech-led innovations. Focussing on the stage before company formation, it is specifically targeted at academic researchers developing earlystage technologies relying on data, artificial intelligence (AI) or medtech to advance the early detection, diagnosis, monitoring or treatment of cancer. As part of Cancer Research UK’s Entrepreneurial Programmes Initiative, the Cancer Tech Accelerator will enable researchers to develop and test the commercial potential of their innovations. They will have access to advice from experts from Roche UK, Capital Enterprise and Cancer Research UK, alongside mentors from across the healthtech ecosystem. THE VALUE OF MEDTECH INNOVATION The need for innovation and new technologies has never been more vital. The NHS faced challenges even before the pandemic: from an ageing population, long-term conditions and significant funding issues. Leaders in the healthcare space have always had to find innovative ways to do more with less, without compromising patient care. These challenges have been significantly compounded by the pandemic and the need to support the cancer community to regain ground lost during COVID is more vital with every week that passes. The dawn of new technology such

as AI, machine learning, digital solutions or new tools among more traditional medtech – presents an opportunity to help alleviate some of the pressure, both on waiting lists and on healthcare professionals, while also offering potential for ground-breaking progress in what healthcare can do. Roche Diagnostics has invested heavily in digital pathology in the UK. We’ve seen some great progress with the Northern Pathology Imaging Co-operative in Leeds – an ongoing project that began with a £10.1 million investment from UK Research and Innovation. The partnership, led by the University of Leeds and Leeds Teaching Hospitals, includes nine NHS hospitals, seven universities, Roche Diagnostics and a further nine healthtech companies. It is supported by £7 million from industry and is now in its second round of funding. The consortium is set to become a world leading centre for applying AI research to cancer diagnosis. In pathology, AI offers particular value as it can be trained to recognise the patterns of disease – for example, searching for small areas of cancer in a large sample. It can help make cancer diagnosis more efficient and accurate, so that diagnosis can be given even more confidently. Pathologists examine biopsies, using a microscope, to decide if a sample shows cancer, and what type of cancer it is. Digital pathology takes this a step further – it makes it possible to scan and create digital images of microscope slides, so they can be examined

on screen, and shared between hospitals more easily and with speed. This, along with the benefits and promise of AI, has the potential to revolutionise cancer diagnosis and how treatment decisions are made, while also reducing costs to the NHS, and increasing access to more personalised healthcare. We also work in genome sequencing through platforms which help to digitise tissue slides to both aid clinical decisionmaking and provide reassurance in diagnostic accuracy. This technology also has AI backing from a computer that has learnt how to detect mutations. In addition to supporting clinical decision-making, there are also enormous benefits for workflow. For example, during the pandemic many people are working from home, a situation which looks set to remain even after we emerge and return to a version of normality. LOOKING AHEAD The NHS is facing an uphill battle to return to a more normal pace of work post-COVID. Innovations in medtech are not designed to replace healthcare professionals. Rather, they can enable them to work more efficiently in the face of growing demand and a shortfall in capacity, and thereby help to deliver better outcomes for patients. Ultimately, the sooner a patient is diagnosed, the sooner they can be treated effectively and the better the prognosis. The answer is to keep innovating. Recovering from COVID-19 will take time but speeding up the diagnosis and treatment of patients with cancer through medtech innovations should play a huge role in addressing the considerable backlog in cancer care. COVID-19 has taught us so much, not least that necessity is not only the mother of invention, it is in fact the driver of collaboration, enterprise and new and innovative ways of working. The ethos of partnership and collaboration which is central to the Cancer Tech Accelerator has more than proved the benefit it can bring over the last 12 months, and by identifying and supporting the next generation of innovation it will continue to do so long into the future.

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DESIGN

Seven considerations in medical device design Dan Purvis, CEO and co-founder of Velentium, highlights seven factors for medical device manufacturers to consider when designing their product.

esigning a medical device is not a simple undertaking. With advances in automation and AI happening alongside the buzz over “disrupting” industries, it’s not uncommon to see start-ups with big dreams of creating new tech that delivers superior therapies, improves patient outcomes, and changes the course of medical innovation. These are great dreams – they deserve to be pursued. But as all companies who enter this arena discover, there’s a lot more going on in medical than in typical consumer projects. One major concern in medical device design is minimising time-to-market. This is a critical metric not just from an ROI and cost-recoup standpoint – sometimes, “one more month” can mean the difference between sink and swim – but because delay means a lengthier wait before your device is available to patients. Time-to-market represents efficiency of cost and schedule. Failure to hold it down usually stems from not paying enough attention to seven key design considerations. Keeping these at the forefront of your design efforts may feel like an overabundance of caution but pays dividends later in the lifecycle and reduces overall time-to-market.

One major concern in medical device design is minimising time-to-market

1. KEEP IT SIMPLE. If you want an MVP, as in Most Valuable Player, design an MVP – as in Minimum Viable Product. Maintain an uncompromising, laser-like focus on your device’s target indication. Deny “feature creep.” Ruthlessly cut “nice-to-haves.” Remember, you can add new features to the next generation. 2. DESIGN WITH APPROVAL IN MIND. When it comes time to approaching regulatory bodies like the FDA, you’ll need a DHF – Design History File. As its name suggests, this is a complete record of the entire design and development history of your device. Retrofitting this document package after the fact won’t pass an audit. Don’t neglect regulatory research during R&D. From the outset, you need to know who the approving authorities are for each of your target market regions and what they expect. 3. DESIGN WITH THE USER IN MIND. Whether your intended users are trained professionals or patients, human factors are a big deal. You’ll have to design and get approval for formative and summative studies that demonstrate the usability of your device. Interface design and user experience should be accounted for early. If you tolerate clunky and arcane at the proof-ofconcept stage, you’re setting yourself up for a hard pivot to simple and intuitive. It could mean scrapping your concept work and starting back at square one. 4. DESIGN WITH SECURITY IN MIND. Regulators expect manufacturers to prove that their devices are secured. This means conducting vulnerability evaluations and deploying mitigations

during design, employing best practices during development and production, and being capable of monitoring emerging cybersecurity threats and securely delivering remote updates to devices “in the field.” 5. DESIGN WITH MANUFACTURING IN MIND. How “fiddly” are your manufacturing procedures? Unnecessary manual processes and custom inventory drives up lead times, takt times, and production costs. And what about testing? Testability is an important part of design and development. With the right planning, the same test system designed to characterise your device can be efficiently scaled for validation testing, verification testing, and ultimately, manufacturing testing on the production floor. 6. SPRINT TO GATE. The regulatory environment appears to demand a “classic waterfall” or “engineering vee.” Rigid adherence to this paradigm is slow, but it’s more than possible to adopt agile principles within the formal approach. During project planning, map design and development milestones as “gates” and schedule sprints for each one. This sets the pace, keeps energy high, and allows you to see resource loading challenges before they turn into problems. 7. DESIGN WITH SPEED IN MIND. Once you’ve mapped your project plan and resource plan as a series of sprints, you can minimise your team and maximise your effort for each “gate.” Divvying up the project enables efficient working groups, involving no more people than is needed to reach each milestone on time.

Ireland

Eugene Canavan, medical design director, Design Partners, and Derek Kelly, managing director, MeHow, spoke to Med-Tech Innovation News about how years of collaboration resulted in them developing essential PPE during the COVID-19 pandemic.

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DESIGN PARTNERS A key design principle was comfort and fit – how long did it take to find the right design? As time to delivery was a factor Design Partners carried out short sprints of primary research, prototyping and user testing to iteratively define and test solutions. Our medical product development process was used to define the product requirements and usability challenges early in the process. These insights were then carried into sprints of design conceptualisation and prototyping for usability testing. Engineering and design for manufacture aspects were addressed in parallel by our in-house engineering team in consultation with MeHow Medical on the materials and manufacturing challenges. The key challenge of comfort and fit was understood and defined early in the product development life cycle. It was addressed by using a PVC material designed to provide a combination of structural stiffness

around the lens area and softness against the user’s skin. This was achieved in the same component part by changing the structural design of the PVC. The lens area also provides structural robustness when assembled into the PVC element, while still allowing the PVC to be soft and conformable. This helped address another challenge which was the propensity for products such as this to fog up and impair user visibility. Why did Design Partners choose MeHow? Design Partners has a long partnership with MeHow Medical Ireland, so they would be a first point of contact for expert advice. Design Partners’ initial user research and conceptualisation pointed to a design solution of both hard and soft materials to answer the fit and comfort requirements. We knew from our experience of working with MeHow that they had a lot of expertise in medical grade materials that could answer this requirement, and could rely on its international

A key requirement for this project was finding local solutions to provide PPE to ease supply chain challenges. As Design Partners and MeHow are both located in Bray, it was perfect 16

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capability and expertise to fill other manufacturing knowledge gaps. Also, a key requirement for this project was finding local solutions to provide PPE to ease supply chain challenges. As Design Partners and MeHow are both located in Bray, it was perfect. Were already approved components and materials a major consideration? One key requirement was the solution, including manufacture, was to be provided in Ireland. This requirement was set by the Department of Health and HSE in Ireland to ease PPE supply chain challenges. The fundamental project challenge was to meet regulatory design and manufacture standards in a new product. Both Design Partners and MeHow Medical are ISO 13485 certified; Design Partners for usability, design and engineering and MeHow for manufacture. MeHow can produce components in certified cleanrooms using recognised medical grade materials and resins. Therefore, the only real challenge was to CE mark our BioVue Goggle product. We answered this new challenge together with BSI. MEHOW How challenging was going from stent manufacturing to goggle manufacturing? The challenge was not as great as you would initially think, because:

Ireland

• Our partnership and history of working with Design Partners has allowed us the confidence of designing and manufacturing safety goggles that are best in class. Design Partners engaged with the HSE and front-line workers in order to understand their requirements from a fit and function point of view. The main feedback received was to design googles that were comfortable to wear for long periods of time. We chose the most suitable resin which allowed us to deliver a product that meets the full specifications required for PPE and is comfortable to wear with clear vison and anti-fog protection. • In MeHow, we had all the manufacturing ingredients to make the goggles including injection moulding, class 100K cleanrooms and lens coating expertise from our telecom days. This lens coating expertise assisted in recognising the requirements needed for the anti-fog and scratch resistance required for the lens. This allowed us to commit to the design and functionality of the goggle, while simultaneously giving the HSE a commercial solution to their requirement.

The only real, and brand-new, challenge was to learn how to CE mark the BioVue Goggles. What was your initial reaction after receiving the call from Design Partners? It was to say that we make highly technical components for stent delivery systems and we have no experience in making ‘goggles’. However, once Design Partners explained the work the COVID-19 Alliance group was doing and its objective of making safety goggles for the HSE to protect our frontline workers, we embraced the challenge. DESIGN PARTNERS AND MEHOW What lasting effect will COVID-19 have on Irish medtech manufacturing? EC: Ireland has a known and highly respected medtech sector that is resourced by a highly skilled work force with specialised expertise. It has successfully supported large medtech corporations for decades and will continue to do so. However, there is an opportunity to leverage this capability in supporting home grown medtech start-ups where an agile approach to innovation creation, although smaller in scale, is still of high value. New medical

technology start-ups combined with the ability to realise it into a manufactured end product is a compelling combination. Expert manufacturing in Europe, especially automated and at high value is cost effective and trustworthy. Also, as extended supply chains are problematic, and manufacturing in far away locations can no longer be justified based on cost alone due to other concerns such as sustainability, means essentials critical to the population health are sourced locally. DK: I believe the lasting effect will be positive as this pandemic has challenged Irish manufacturing as never before. Many companies have made their own brand products as a result of shortages in supply of product on the island of Ireland particularly in PPE. Irish medtech manufacturing has generally existed to support the larger corporations in Ireland. Over the last 20 years we have built up a strong expertise which is respected worldwide. This has allowed our sector to build up a highly skilled workforce in conjunction with best-in-class manufacturing facilities including cleanrooms, manufacturing equipment, metrology, automation, etc. Therefore, when the pandemic hit, Irish medtech manufacturing had all the skills in hand to deliver for Ireland. It can use this new confidence to manufacture and distribute its own brand products to markets further afield.

Regulation

Ian Bolland caught up with Alan Finnerty, technology director at Medovate, to establish how the company is adapting to a changing regulatory landscape following Brexit.

Turn and face the strange: Adapting to regulatory changes

istributing medical devices in multiple countries means companies like Medovate have many factors to consider. The UK’s new trading relationship with the European Union (EU) is one too, as firms operating in the UK will have to carry the UKCA mark – with a grace period available until July 2023. Currently, three notified bodies in the UK carry the new regulation: BSI, SGS and UL International. In Medovate’s case, its SAFIRA device is certified under the Medical Device Directive (MDD), and with the EU transitioning to the Medical Device Regulation (MDR) in May this year, the grace period in this case allows the company to continue with an MDD/CE mark until the middle of 2024. Explaining the challenges the company faces, and how it aims to address them, Finnerty explains: “Because of UKCA mark we will need to get that when the CE grace period finishes in 2023. We’re then going to submit for both UKCA and CE MDR at the same time. In terms of the documentation, UK MDR 2002 is the European MDD adopted into UK law. As it stands the technical requirements are no different but as soon as Europe transitions to MDR there’s going to be quite a gap between the UK regulation and European regulation. For us, the transition ought to be pretty smooth because both the UK and our SAFIRA CE documentation are already at MDD level.” The gap that Finnerty refers to is one that he describes as “the biggest unknown” for medtech manufacturers. The Medicines and Medical Devices Bill gives the Medicines and Healthcare products Regulatory Agency (MHRA) the powers necessary to change the 2002 law. Finnerty believes more harmonisation and transparency between notified bodies would be positive and may make the UK an attractive investment proposition in the medical device sector.

“I think in the UK if we were able to get greater clarity and greater harmonisation across the notified bodies that would assess the technical documentation that we would submit; and giving good, firm timelines, I think that would be really helpful to give manufacturers good confidence in timelines and costs, etc., to bring new medtech to market. “One of the risks I see is that, if you’re a manufacturer based outside of the UK and you’re looking at your market launch plan, you’re obviously going to go for US FDA or CE for Europe because you’d have access to large markets, and the UK and others would follow on thereafter. I think what we need to do is make the UK approvals process as least burdensome as possible, so the UK isn’t further down that queue in access to new medtech.” Medovate also distributes its SAFIRA product in Australia, New Zealand and Israel. Finnerty suggested the approvals process in these countries is aided by already having accreditation from the FDA and CE mark. When discussing any divergence that may occur with the UKCA mark, he suggested a similar approach would be one of the least burdensome options to take.

“In our case we went with submitting our CE mark technical information to get approval – so we chose that route. “At the moment if a product only has UKCA mark, that route wouldn’t be available to a UK manufacturer – they would have to get the CE mark or US FDA approval to get approval in those three territories to sell their product.” For those operating in Northern Ireland, there is the added complexity of the UKNI mark. “For an overseas manufacturer, once they have a European notified body approval with CE mark they can sell into Northern Ireland. A UK manufacturer will need UK NI mark to sell into Northern Ireland or CE mark. It is more complex, and I think for us as a UK manufacturer, because we would go with BSI, they could award us both CE and UKCA or UKNI marks from single submission, so that would be least burdensome for us. “Any medical device company that is not using a UK notified body who can do that will have to work with their existing non-UK notified body and its UK notified body to get access to the Great Britain market.”

REGULATION

Interpreting ISO Standards to streamline testing and submissions Kimberly Ehman, from WuXi AppTec & Bob Przygoda, from Adventure Biocompatibility Consulting, explain how ISO 10993 Standards impact on biocompatibility evaluations for global submissions.

SO 10993 standards provide guidance and requirements for the biological evaluation of medical devices, but their application and interpretation can vary between regulatory bodies and reviewers. Currently, regulatory agencies within the European Union accept ISO standards without exception. Notified Bodies (NBs) review submissions for CE mark for regulatory agencies. However, the specifics of each NB’s submission requirements differ slightly. The EU Medical Device Regulation (MDR) has an arguably more complex interpretation of ISO 10993. Substances that are carcinogenic, mutagenic or toxic to reproduction, or have endocrinedisrupting properties at a concentration above 0.1% by weight, a justification for the continued use of the material and assessment of the potential risk is required. This applies to any invasive device, even if exposure is for less than 24 hours. MDR requires that any device sold in the EU shall meet current standards. Any evaluations following older ISO standards require a gap analysis and, if needed, supporting justifications. While performing new testing procedures is not technically required to satisfy the requirements of all new standards, complying to EU MDR may prompt additional evaluations to fill gaps in data or meet testing parameters. While NBs have broad acceptance of the ISO 10993 standards, the intricacies of their acceptance still require attention to small variances. These NBs use ISO 10993 as a baseline, where others have a more selective means of acceptance. As of February 2020, the Japanese MHLW wholly recommends using ISO 10993 standards and further expands upon them – holding biocompatibility tests to a high standard. Officials require separate extraction strategies for sensitisation and genetic toxicity testing; an attempt to deliver sufficient extractable chemicals to represent the whole device or to deliver more extractable chemicals that could be

administered by standard extraction procedures. The U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) do not recognise all current ISO 10993 standards. When submitting under either jurisdiction, manufacturers should dedicate time to understanding the acceptance criteria of each part to the standard. With submissions in the U.S., many parts of ISO 10993 are only partially accepted, meaning manufacturers should review the agency’s latest guidance documents and database of recognised consensus standards. Devices containing novel materials will likely be subjected to greater scrutiny than those containing well-established materials, and additional testing may be necessary. The NMPA does not universally accept current versions of ISO standards and may prefer conformance to previous versions. It is essential to reference the Chinese standards and the equivalent versions of the ISO standards with every submission. Still, subject to an individual reviewer’s discretion, risk-based evaluations are accepted based on the reviewer’s perspective. Additionally, the regulatory body evaluates medical devices with CE mark or 510(k) clearance using alternative procedures. Thus, device submissions already holding EU and U.S. clearance can streamline the review process by taking alternative regulatory pathways when submitting a device to the NMPA.

understanding of each specific device and tailor evaluations accordingly. Guidance outlined in ISO 10993-1 and EU MDR increased the importance of materials characterisation, physical and/or chemical information, and risk assessments. Regulators expect detailed chemical information supporting biocompatibility test plans and additional testing like extractables and leachables (E/L) studies to identify all chemicals of potential toxicologic concern.

Whichever governing body a manufacturer plans to submit to, they should review their submissions closely. The acceptance of 10993 varies from regulator to regulator and standards continue to evolve.

Recent updates to ISO 10993-18 include advanced chemical characterisation requirements and the exposure dose estimation. First, manufacturers must submit multiple replicates during chemical characterisation testing. Then during study development, toxicological data and exposure assumptions must inform chemistry study design and execution. The extraction protocol is defined by the duration and type of contact, with prolonged and long-term contact being subject to the most rigorous extraction procedures. Part 18 has revamped how manufacturers understand their device’s chemical constituents, setting a baseline for other sections of ISO 10993.

With each new version of the ISO 10993 series of standards, manufacturers can begin to see where regulators hope to push biological evaluations in the future. Short-term perspectives might focus on the additional test methods and evaluation procedures, but in the longterm, experts are aiming to gain a better

With regulatory expectations for increasingly complex chemical characterisation study designs, the toxicological risk assessments (TRAs) based on these data follow suit. Experts are required to navigate the large datasets and prepare for the changes coming in the new version of ISO 10993-17.

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Tubing

GETTING SMARTER How smart invasive devices support data driven medicine Professor Steve Morgan from the University of Nottingham writes about the benefits of smart invasive devices after it secured over £800,000 in funding for a smart breathing tube last year.

nvasive devices such as urinary catheters and central venous lines are commonly used in healthcare. They serve a useful purpose but are essentially ‘dumb’ devices used to transfer fluids or gases to or from the body. The global catheters market was valued at $45.26 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.4% from 2021 to 2028, according to Grand View Research. A high prevalence of chronic disorders leading to hospitalisation has driven the growth of this market. There is considerable interest in incorporating new sensing technology within these catheters to facilitate ‘smart’ catheters that can monitor key physical and physiological parameters, contributing to the Internet of Medical Things. The large datasets obtained from such devices can be used to train deep or machine learning algorithms to recognise changes in a patient’s condition. For example, Silicon Valley based company Potrero Medical has developed a smart foley catheter that measures urine output, intra-abdominal pressure and core body temperature. Algorithms are then used to help to predict acute kidney injury earlier. Different sensing approaches can be used. Commercially available miniature microelectromechanical systems (MEMS) technology, which integrates sensors or actuators, can be embedded within a catheter. Swedish start-up CathPrint AB is developing a process for printing flexible electronics

directly onto catheters. Our interest is in the integration of optical fibre sensors into invasive devices. Optical fibre sensors are a highly versatile platform technology that can make a range of physical and biochemical measurements. This sensing capability, coupled with their small diameter, flexibility and immunity to electromagnetic radiation means that they can add greater functionality to existing medical devices. In collaboration with Nottingham University Hospitals NHS Trust and P3 Medical, we are developing a smart endotracheal tube known as iTraXS (intra-tracheal multiplexed sensing) which utilises optical fibre pressure and perfusion sensors to monitor the cuff-trachea interface. Incorrect cuff inflation pressure causes significant problems for intubated patients. Around 3% of intensive care patients intubated for over 48 hours suffer tracheal stenosis due to high contact pressure impairing mucosal perfusion, and 1,900 patients per year require tracheal resection in the UK alone. 50% of surgical patients in the UK complain of sore throat related to high pressure. If cuff pressure is too low, this also causes harm through increased pulmonary micro-aspiration of fluid materials, a major contributing factor in ventilator associated pneumonia (VAP). VAP occurs in 10-20% of ventilated intensive care patients and on average increases length of stay by six days, and

Optical fibre sensors are a highly versatile platform technology that can make a range of physical and biochemical measurements

mortality by up to 50%. Each episode costs approximately £12,000 in the UK and $25-40,000 in the U.S. While adequate contact pressure is required to reduce microaspiration and to enable positive pressure ventilation of the lungs, high pressures cause ischemic injury. These competing requirements create a narrow target for the optimal contact pressure. It is essential to develop a sound value proposition to support adoption of the technology. Conventional ‘dumb’ devices are low-cost disposables, for example, an endotracheal tube typically cost £3-5 and purchasers may be reluctant to invest in a smart tube priced at £100-£200. These sums are a tiny fraction of the cost of surgery, or stay in the intensive care unit, but a business case still needs to be developed based on clinical evidence of the reduction in VAP or prevention of tracheal injury. Nonetheless, the future is highly promising for smart invasive devices. The range of sensing technology; connectivity within the Internet of Medical Things; and the prevalence of artificial intelligence will lead to better treatment and diagnosis, improved patient outcomes and more efficient healthcare.

DIGITAL HEALTH

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HOW SMARTPHONE TECHNOLOGY CAN AID COVID-19 TESTING Mobile health start-up iXensor explains how its company disrupted the conventional COVID-19 testing paradigm in Europe.

n October 2020, the European Commission issued a Recommendation on COVID-19 testing strategies, in which the use of rapid antigen tests was encouraged continuously as a way of strengthening testing capacity. The extent and intensity of these efforts vary from country to country and are constantly changing as the infection rates change and new technologies come into play. The conventional COVID-19 testing deploys the PCR test, and the access to PCR tests is primarily limited to healthcare facilities and private medical labs. Its prolonged turnaround times, which take one to three days for reporting test results, can hinder the swift detection of infected cases. MHEALTH TECHNOLOGY TO ENABLE NEW COVID-19 TESTING PARADIGM: iXensor, a mobile health start-up, that was fostered in Silicon Valley and incorporated in Taiwan, developed a fully digitalised rapid antigen testing and digital platform for COVID-19 management. PixoTest provides computer analysed COVID-19 test results, lowering the risks caused by misinterpretation of human eyes. The palm sized PixoTest

Analyser transmits digitalised test results to PixoHealth Pass App users in as short as five minutes for people with high viral loads. The PixoHealth Pass App serves as a free digital health pass for app users to access the controlled places which demand a negative PixoTest COVID-19 antigen test result. The app retrieves test results via an encrypted QR code format simultaneously as soon as the PixoTest Analyser finishes the analysis of the rapid test. The testing-toreporting processes are entirely integrated without the need for manual record and interpretation of test results, demonstrating rapid, cheatproof, and connected testing experience to organisations and test recipients. DIGITAL PLATFORM TO ESTABLISH NEW NORM: To meet the public health and social interests of getting back to post-pandemic normal, iXensor offers the additional PixoHealth Pass Admin App and Web Portal,

complementary with PixoTest, as an enterprise solution for COVID-19 screening and access control. It supports organisations such as schools, manufacturers, multinational logistics companies, event organisers, and health authorities to easily maintain safety and sustain operations. PixoHealth Pass Admin App verifies the authenticity of PixoTest displayed by PixoHealth Pass App users with one scan on a smartphone. One QR code scan takes a few seconds to complete, and the scan can bring benefits to an entire organisation. As it further empowers organisations using PixoHealth Pass Admin Web Portal to keep digital records of people’s COVID-19 test results and trace COVID-19 related symptoms. The digital tool allows for prevention to becoming an outbreak cluster, swift contact tracing, and the implementation of

prompt and targeted isolation and quarantine actions. INTEGRATED DATA MANAGEMENT MECHANISM MEETS GDPR: GDPR imposes challenges on how healthtech companies bring forth innovative products. iXensor has taken the principle of GDPR compliance into account in the early stage of solution design. The PixoTest and PixoHealth Pass products work together with a fine balance of offering convenience while complying with privacy policy to users. Up until now, iXensor has rolled out multiple clinical studies in Europe, Asia, Africa and Latin America. As of 25th March, the IXensor’s PixoTest is undergoing the submission process for CE marking and WHO EUA.

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Med-Tech Innovation Expo

Take to the stage

Med-Tech Innovation’s conference team guides us through what to expect across three stages for September’s show at the NEC in Birmingham.

s the world weathers the storm caused by Coronavirus, and as we start to emerge from lockdown, preparations for MedTech Innovation Expo continue at full speed. The show will host three conference platforms to allow the attendees to learn about the latest breakthroughs, emerging trends, and forces shaping the medtech sector. The organisers will also give visitors an opportunity to meet and network with thought leaders who will review cutting-edge applications and offer real-life insights from medical design and plastics, digital health, and pharmaceutical manufacturing industries. To help delegates navigate this summit, our conference team looks at the content available at this year’s must-attend gathering. Med-Tech Innovation Conference in Association with Medilink UK CPD-Certified The Med-Tech Innovation Conference is the UK’s annual summit for medical device OEMs, created in a collaborative effort with Medilink UK. This platform will display the sector’s biggest names, policymakers, and influencers, who will offer senior-level experience and perspectives on regulatory and

market access challenges and Brexit disruptions. The speakers will provide the audience with practical takeaways as they debate how to accelerate impactful and cost-effective products, deliver value-based healthcare, and further drive ingenuity within the sector. Industry professionals will be able to follow key executives like Travis Laird from Cleveland Clinic, who will outline how it has advanced innovation through empathy. Lisa Hollins from NHSX will bring her experience of quality improvement and efficiency to appraise the digital innovation in the NHS, and Dr Neil Ebenezer from the Department for International Trade will establish how the UK Government can support medtech exporters. There will also be keynotes from NHS England, Boston Scientific, Innovate UK, KPMG, and more. HEALTHTECH STAGE SPONSORED BY HASSEN TRADE & INVEST CPD-CERTIFIED This platform has been created to showcase medical devices that are revolutionising the industry by enabling novel and personalised treatment methods, and a more accurate diagnosis. High-level organisations have been invited to discuss the innovation and commercialisation processes behind their finished products and to give advice and commentary on issues surrounding R&D, clinical trials, and material compliance. The sessions on this stage will not only encompass wearable equipment but will also focus on digital and drug delivery technologies. Visitors can expect a programme that features experts from blue-chip businesses, including Edith Bianchi from Medical Device_S2T Solutions, who will be delivering insights into

the development of a drug delivery patch device. Martina Donohue from Shimmer will also demonstrate a wearable sensing platform designed to meet the needs of clinical trials, and Dr Michael Crichton from HeriotWatt University will highlight how mechanical material considerations help manage wound healing. The line-up also contains firms including TTP plc, Sky Medical Technology, Inovus Medical, and Nemera. MED-TECH INTRODUCING STAGE Med-Tech Introducing Stage will host rapid-fire format presentations, delivered by the most prominent Expo exhibitors, on the best technology available on the show floor as well as new and exciting products and services. Attendees will get the chance to engage face-toface with the vendors who will evaluate components that are critical for developing life-saving medical devices, including the latest specialist equipment and materials. Start-ups will be in the spotlight during the PITCH@ Med-Tech Innovation Expo 2021 session, sponsored by NIHR, SBRI, NHS England, and NHS Improvement, where acceleratorstyle demonstrations will take place. Speakers on this platform will include Peter Swanson from Intertronics, who will review light curing adhesives for bonding medical devices, and current developments that impact their quality. Dave Easton from Zener Engineering Services will look at how organisations can address some common GMP project issues, and Phil Marsden from Unitive Design will discuss the latest technical trends and challenges to imaging. Delegates will also see CPI, IPP, AHSN, Steris AST, Qosina, as well as other forward-thinking organisations.

Industry 4.0

Ditching the paper: The benefits of automating First Article Inspection report Jason McGlynn, commercial manager for Ireland at industrial metrology specialist The Sempre Group, explores how the latest software can streamline the FAI reporting process.

uman errors and complex offline data capturing can have dangerous consequences in the medical device industry. Take an insulin pen as an example — if any dimensions are slightly incorrect it could lead to false deployment, overdosing or underdosing — putting the user at risk. First Article Inspection (FAI) ensures that all measurements are verified before production begins. However, if it’s documented on an isolated file, can manufacturers be sure that every part is compliant to the original design? During the early stages of product development, medical device developers must find the best way to convert a concept and 2D drawing into a 3D, functioning product. An FAI report is a design verification and historic file that provides a reported measurement for each manufactured part. The report consists of a ballooned drawing that points to the individual dimensions and requirements of the part. Developers can use this data to ensure that the final product meets specifications, and manufacturers can use the report to ensure that measurement data of final products correlates with the original dimensions in the design. Completing the report requires engineers to collect and validate all dimensions of the product. This can include distances between edges, positions of holes, diameters or shapes of holes, weight, density or surface finish. The report will also identify the critical to quality (CTQ) dimensions that will be regularly measured during production to monitor quality.

Inspecting these parameters confirms that everything meets expectations before the production run starts. The FAI report gives the developer a pass/ fail criteria for the part that they can link back to the balloon drawing and then use for critical to quality dimensions in future quality checks. NO MORE SPREADSHEETS Manually ballooning a design, gathering data and inputting results into a report is a time-consuming process prone to human error. Consider this example, an engineer takes notes of measurements from metrology equipment and inputs the dimensions into an Excel file. While these spreadsheets can be a valuable tool, if users do not input the information correctly, it can have costly consequences later in production. When working with spreadsheets, there is no guarantee that data will be accurately moved from measurement equipment to the report file. Using an isolated document also creates gaps in traceability, which can have a negative impact on production. For example, manufacturers often carry out an FAI report when a part design changes or there has been a lapse in production of that product. If they cannot easily connect the original drawing, product and each report, the process will never be fully traceable and there is no guarantee that any future products are identical to the original drawing. AUTOMATIC REPORTING Automating the FAI reporting process enables developers to improve traceability and avoid wasting time

and money on manual ballooning and isolated documents. High QA Inspection Manager, for example, allows developers to automatically identify geometric dimensioning and tolerancing (GD&T) from models, identify critical dimensions and input all the data from the ballooned drawing. The software then automatically extracts all of this data to populate reports, such as the FAI report, to comply with industry standards including ISO 17025 and 21 CFR. Automated quality management system (QMS) tools offer manufacturers an allin-one solution for quality management, collecting and storing data at every point, from drawing to final product. They eradicate the need for time consuming paperwork and filing, so engineers can easily communicate important quality information across the supply chain. Medical device manufacturing teams can also benefit from automated reports later in production, for example when producing reports to reflect a change in a design, process or material. Manufacturers can automatically compare the original ballooned drawing with the new report, offering full visibility to the entire team. While medical device developers can successfully complete a FAI report on an Excel document, it will not offer both the precision and accuracy required in the medical industry to keep patients safe. Automating a FAI report automatically links data from drawings, models and production to ensure that all products are developed and inspected correctly, improving traceability.

Meet the start-up

MEET THE STARTUP: MAKING C-SECTIONS SAFER Med-Tech Innovation News spoke to Barry McCann, CEO of NUA Surgical - innovators in women’s health. Its flagship product is SteriCision, a self-retaining retractor specifically designed for C-Sections. TELL US ABOUT HOW NUA SURGICAL STARTED. WHERE DID THE IDEA COME FROM? Our story began in 2017 when I was on the BioInnovate Ireland Fellowship and carrying out research in the area of women’s health. During the clinical immersion stage of the programme it became clear to me there was a major unmet need when it came to caesarean sections. C-Section is the most frequent surgery in the world, accounting for 29 million births each year. However, new mums are still at a higher risk of haemorrhage, infection and even death when undergoing a C-Section as opposed to a vaginal birth. Regardless of the size of the patient, all C-Section incisions require retraction in order to safely gain access to the uterus, deliver the baby, identify bleeds and safely repair tissue. Currently, this is achieved through hand-held metal retractors, disposable O-Ring retractors (which have been adapted from abdominal surgery), or simply additional staff members using hands in the incision. A lack of innovation has left obstetricians with tools that are not designed for the current patient demographic, particularly when operating on obese patients. This has a direct impact on the safety of the patient and newborn child. WHAT WENT INTO THE DEVELOPMENT OF STERICISION? HOW DID YOU BRING THE DEVICE TO LIFE? Upon discovering this unmet clinical need, I got together with experienced polymer engineers to look into developing a solution. NUA Surgical co-founders Marie-Therese Maher and Padraig Maher have years of experience in polymer engineering and project

management. We secured an Enterprise Ireland grant of around €500,000 to research a solution. Based in NUI Galway, we developed SteriCISION, a surgical device that aims to deliver safer C-Section outcomes through improved access and visualisation, bringing real benefits for clinicians, hospitals and patients. HOW DOES YOUR DEVICE MEET WHAT YOU DESCRIBED WAS PREVIOUSLY AN UNMET NEED? It is designed as a sterile, single use disposable surgical retractor device, providing multiple ergonomic and clinical benefits to the clinician, particularly when operating on high BMI patients. Crucially, it reduces hand use within the incision thus reducing the potential for bacteria entering the wound. It also enables clinicians to safely repair tissue and identify bleeds because it retracts the tissue out of the surgeon’s view. Additionally, the device aims to save valuable time in the surgery – increasing theatre throughput and enhancing patient recovery. The functionality and design of SteriCISION provides unparalleled support for obstetricians performing one of the most common major surgeries in the world. WHAT CHALLENGES DID YOU FACE ALONG THE WAY? Establishing a start-up company is certainly a long-term game. It takes persistence, patience and a tight team. Every step along the way is a learning curve, and the important thing is to learn quickly. Every meeting, presentation or pitch enables you to be more knowledgeable about your product and your market, and the tough encounters along the way have really helped us improve and bring focus to our business strategy. For example, we first entered the InterTradeIreland Seedcorn competition in 2019 and lost out at the

regional final stage. We took on board the feedback and advice and entered again last year, and were thrilled to be named 2020 all-Ireland overall winner – a real stepping stone to bringing this device to market and really making a difference in women’s health. As well as a cash prize, the InterTradeIreland Seedcorn competition provides you with investment expert feedback on your business plan, and shortlisted companies get the opportunity to pitch to investors and business leaders. The award win demonstrates that we are investor ready, and key to that success was learning from the challenges we faced along the way. WHICH MARKETS ARE YOU CURRENTLY OPERATING IN? We plan to bring our inaugural device to the US market by 2022. The US is the most expensive country in the world to give birth, yet it ranks amongst the worst of developed countries for maternal morbidity and mortality. As our entry market, there is established reimbursement, a clear regulatory pathway and significant pull from clinicians, patients and hospitals for improvements in this procedure. Initially, SteriCISION will be sold directly to key hospitals and growth will be achieved through strategic partnerships with specific distributors.

How calcium sulphate can fill bone voids

an Bolland caught up with Mike Harris, CEO of Biocomposites, to discuss the use of its calcium sulphate product as a bone void filler. Biocomposites is based in Keele, in close proximity to Stoke-on-Trent which was at the heart of the potteries industry in the UK. The intrinsic knowledge about calcium sulphate that has been developed from its past is transferring into medtech today. The company has five products including stimulan, an antibiotic carrier approved for use in bone and soft tissue, and genex – a synthetic bone graft that supports natural healing. While 2020 was transformational for many businesses, in the case of Biocomposites it was perhaps a more conventional transformation as stimulan received approval for use in the European markets with three antibiotics

- gentamicin, vancomycin, tobramycin – and the company won an orthopaedic solutions tender within the NHS. Despite COVID-19, there was no need for Biocomposites to stop. Harris said: “I think we’ve seen a whole number of challenges, but we’ve always been able to make products. We’ve not stopped during the whole COVID crisis and we’ve always been able to supply as much product as we need to hospitals.” Calcium sulphate is generally used in bad fractures, with Harris elaborating that an insertion of the material allows the body to recognise where bone should be and goes about addressing it. “It starts building bone across that calcium sulphate, but at the same time the calcium sulphate for a period – depends how much fluid is around in the area, say 12 weeks – will dissolve and leave trabeculae in a bone, which starts to form there. “If you have a big gap between two pieces of bone it will never heal, and that’s what they call non-unions, where there’s a gap that it doesn’t know it’s got to bridge. “As soon as you put calcium sulphate in the body, it recognises there should be a bridge there and the body starts to put trabecula bone in place.” The company is therefore able to have a footprint in the NHS with trauma patients, particularly those with infection. “We’re especially useful in infected trauma. You can imagine a really bad accident when a bone breaks, but it also breaks the skin. You’re automatically infected at that stage.

“As soon as you have an open fracture, that’s classed as infected. You’ve got to give some serious antibiotics at that stage. “If you imagine how you get an open fracture, you’re probably going to be doing something quite extreme, outdoors. You’re not just falling over. You’re coming off a motorbike or skidding. “You can use it use it in open fractures which are classed as infected. Probably the biggest area it is used in is when surgeons are treating infection – that may be in bone, it may be in soft tissue.” Inevitably the treatment of infection is accompanied with certain antibiotics. With antimicrobial resistance being such a prominent issue in life sciences, Harris explains how Biocomposites products – in this case stiumlan – can help tackle it. “When we normally talk about antimicrobial resistance, we talk about it in a setting where there is a maximum systemic dose of the product. One of the advantages of this product is because you get higher local doses, you’re less likely to get antimicrobial resistance and when you do, you’re more able to treat it. There are higher doses of antibiotics. These things aren’t black and white, it’s about a dose you can get to that microbe.”

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MTI Issue 52

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