MTI Issue 54 by Med-Tech Innovation Magazine

www.med-technews.com Issue 54 | Jul/Aug 2021

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PLUS How a changing diagnostic landscape is affecting packaging The compliance challenges facing IVDD firms

MED-TECH INNOVATION | NEWS MED-TECH

How better use of data can accelerate medtech’s evolution

innovation

New rules-

making the most of them HOW A SUPPORTIVE ECO SYSTEM WILL HELP BOLSTER INNOVATION UNDER NEW EU AI RULES

ADVANCING HEALTHCARE

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CONTENTS regulars 5.

COMMENT Ian Bolland discusses rumours surrounding public provision of lateral flow tests

MAKING MEDTECH A round-up of the latest industry news

12.

COVER STORY IDA Ireland discusses what new EU AI regulations could mean for medtech

22.

DIGITAL HEALTH

Withers & Rogers highlights steps that app diagnostic innovators can take to protect their ideas

25.

Meet the start up How MedicAir’s innovation aims to improve cognitive function

29.

real world medtech Ian Bolland speaks to NovaSignal about its ultrasound device that monitors cerebral blood flow

THE TEAM editor | ian bolland ian.bolland@rapidnews.com portfolio sales manager | christine joinson +44 (0)1244 952 385 christine.joinson@rapidnews.com

features 9.

INNOVATION | NEWS

A consortium receives €3.4 million backing for developing osteoporosis innovations

14.

ADHESIVES Intertronics explains the challenges behind using difficult to bond plastics in medical devices

16.

PACKAGING Paxxus gives us a flavour of the changing diagnostics industry, and how it’s affecting medical device packaging

19.

TESTING & INSPECTION Kistler outlines the critical nature of quality assurance

20.

regulation

Kallik explains the compliance challenges that IVDD firms have to face

26.

INDUSTRY 4.0 How better use of data can accelerate medtech’s evolution

vp sales & sales talent julie balmforth julie.balmforth@rapidnews.com head of studio & production | sam hamlyn designer | matt clarke junior designer | ellie gaskell

portfolio sales manager | victoria dunsmore +44 (0)1244 952 247 victoria.dunsmore@rapidnews.com

MED-TECH

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publisher | duncan wood

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from The editor Making sense of “freedom”

[

o, it was a delayed freedom, but a freedom nonetheless as new health secretary Sajid Javid has basically stripped away any restrictions immediately after his predecessor was caught breaching one he set in a liaison which I’m sure you have all seen by now. A big positive of this is I should see as many of you as possible at Med-Tech Innovation Expo in late September at the NEC. Hopefully this gamble from the government pays off, as they are now putting the onus on the public to “exercise caution” by taking “personal responsibility” which seems to be not-so-subtle code for shifting any blame if it goes wrong and is contrary to much of the sensible advice from a lot of scientists we have heard throughout this pandemic. For the record, those who see me on the show floor in September are likely to see me with a mask despite them no longer being mandatory as I feel it is the right thing to do in an attempt to put others at ease if nothing else. It’s not just about the individual, it’s about all of us. Further to this, I have been baffled on one level, though not surprised on another, about one of the government’s actions. Coinciding with the

lifting of restrictions is the proposal reported in some of the national press of winding down the free provision of lateral flow tests. This seems to be from playbook of Donald Trump who, during his presidency, took aim at testing as the reason for a surge in COVID-19 cases. Regular readers of my column, and listeners to The MedTalk Podcast, probably have a good idea of my stance on Boris Johnson and his Cabinet’s handling of the pandemic, but even I didn’t think they would go as far as to consider adopting that particular Trump policy. Burying heads in the sand won’t make the pandemic go away. Johnson said himself it is not over, which makes the downgrading of the importance of face masks and the consideration of winding down the provision of tests a misstep, to say the least. People will still get sick, including children who have yet to be vaccinated, hospitals will feel the strain – which makes me question any possible motivation for this. Not only that, but the reported abandonment of these tests seem to make even less sense when there are studies suggesting the rapid lateral flow tests are a more effective tool than previously thought.

One study, which included researchers from Queen Mary University of London and Oxford University, showed that in newly symptomatic patients, they can be just as accurate as PCR testing. This is worthy of applause to all those who have worked on developing these tests that have been crucial in stopping the spread of transmission, and lately allowing pilot tests to see if certain sections of the economy can re-open safely. Contemplating withdrawing measures, and indeed not backing certain parts of the industry that have produced tools to combat the pandemic when a rise in cases is anticipated seems weird at best, and at worst, reckless.

Regular readers probably have a good idea of my stance on Boris Johnson and his Cabinet’s handling of the pandemic, but even I didn’t think they would go as far to consider adopting that particular Trump policy 5

Making medtech

TWO NEW AI ASSESSMENTS OFFERED IN WELSH HOSPITAL

New bladder cancer test to launch in 2022

L S

t Joseph’s Hospital, in partnership with Heart & Lung Imaging (H&L), has become the first hospital in Wales to offer two artificial intelligence (AI)-enabled imaging assessments, which can identify a range of respiratory and cardiac conditions, potentially in their earliest stages. The Lung Health Check and CaRi-Heart Cardiac Health Check are both offered in partnership with H&L’s network of UK-wide consultant cardiothoracic radiologists. With the potential to eliminate unnecessary biopsies as well as to speed up diagnoses, the new Lung Health Check uses reporting supplemented by AI analysis to detect abnormalities which may be invisible on a conventional chest x-ray.

The more we are able to predict health outcomes, the earlier we are able to offer interventions which we know can have a positive impact such as changes in diet and exercise

It is based on AI detection and quantification of lung nodules, emphysema and interstitial lung disease to give a truly comprehensive assessment of a patient’s lung health. As well as giving those with a high risk of developing lung cancer the opportunity to identify signs of the disease at the earliest possible stage, it may also be used to look for the signs of other lung abnormalities and COVID-19 infection damage.

iquid biopsy provider Nonacus has partnered with the University of Birmingham to develop a non-invasive test for bladder cancer, which could be available by mid-2022. The test will use Nonacus’ liquid biopsy technology, and a panel of biomarkers validated by Dr Rik Bryan and Dr Douglas Ward from the University’s Bladder Cancer Research Centre. Dr Bryan said: “While blood visible in the urine should

always be investigated, over 80% of people who have a cystoscopy at a haematuria clinic are diagnosed with non-malignant conditions or have no abnormality. Unfortunately, the remaining 20% will need a further invasive procedure to confirm diagnosis. What is required is a highly sensitive and specific, noninvasive test that can rapidly determine those who need a biopsy and those who do not, and a urine test is the obvious place to start.”

CaRi-Heart – developed by Caristo Diagnostics and based on research funded by the British Heart Foundation (BHF) – brings together motion-free images of a patient’s heart arteries and AI-derived information to assess an individual’s heart health. The check combines the measurement of coronary artery inflammation with other clinical risk factors and can help calculate an individual’s risk of a fatal heart attack within the next eight years.

Vision receives ISO 13485 accreditation

Jane Carpanini, director of advanced diagnostics at St Joseph’s Hospital, said: “The more we are able to predict health outcomes, the earlier we are able to offer interventions which we know can have a positive impact – such as changes in diet and exercise. As end-to-end packages, both assessments offer patients the best possible care at each stage and have the potential to change thousands of lives in the process.”

Vision Engineering’s manufacturing facility includes design, machine shops, paint shop, cleanroom and assembly. It is replicated in the USA, with a manufacturing facility in Connecticut.

Vision Engineering has attained ISO 13485:2016 and EN ISO 13485:2016 accreditation from the British Standards Institution (BSI) and is now a BSI accredited contract manufacturer of mechanical, electronic, electrical, and optical medical assemblies and components.

Mark Curtis, managing director at Vision Engineering, said: “We are delighted to be awarded the ISO standard ISO 13485:2016 for our manufacturing facility. This ISO standards confirmation is a key statement of our ability to

address the requirements of our manufacturing customers across the world and provide certainty of the quality of mechanical, electronic, electrical, and optical medical assemblies and components. “It will help enormously in our worldwide business with medical device companies and also with Vision Engineering’s Manufacturing Services business line for wider sub contract manufacturing opportunities.”

MEDILINK

Liverpool firm signs first major distribution agreement

nteral Access Technologies (E.A.T.), a medical device company headquartered in Liverpool, has signed its first major distribution agreement with Medicina, a trust-wide distributor of medical devices for enteral feeding. Under the terms of the agreement, Medicina will market and sell DoubleCHEK to hospitals and end users in the UK and Ireland. The distribution agreement may be expanded to cover additional products and territories in the future. DoubleCHEK uses CO2 and pH indicators to prevent the misplacement of feeding tubes into the lungs, a ‘never event’ in the NHS. Using its valve and pump system, it collects small samples of aspirate to the indicator tests, ‘double checking’ correct placement and reducing the potential for harm. The distributor announcement follows a successful funding round in which the company secured £750,000 to manufacture the DoubleCHEK device in the UK. George Gallagher,

CEO, E.A.T., said: “Medicina is a great partner for E.A.T. They have the scale, infrastructure, reputation, and complementary product portfolio to power DoubleCHEK to a market share leading position. We are pleased that Medicina recognises the innovation and patient safety elements that DoubleCHEK offers to clinicians in the fight against Never Events.” NHS Supply Chain purchases one million nasogastric (NG) feeding tubes annually, which take skill and experience to insert correctly. Feeding tube misplacement results in significant patient harm and can be life threatening. Medicina managing director Tracey Macdonald said: “Enteral feeding is a critical need for many patients and offering DoubleCHEK will provide an additional layer of safety when nasogastric tubes are used to deliver enteral nutrition. We expect DoubleCHEK to do very well as there is a clear need for this product within the healthcare market.”

Anglia Ruskin to lead NHS entrepreneurship training

nglia Ruskin University (ARU) has been chosen as the official partner of NHS England and NHS Improvement to nurture healthcare innovators from across the country and help them gain the commercial skills, knowledge and experience they need. The NHS Clinical Entrepreneur Programme was founded in 2016 and has become the world’s largest entrepreneurial training programme in healthcare. In the first four years of the programme over 500 clinical entrepreneurs were recruited. Between them, 247 life science start-up companies have been created, over £270 million of funding has been raised through investment largely from the private sector, and more than

30 million patients and users have benefited from the innovations. ARU has drawn together a coalition of more than 60 cross-sector partners including NHS hospitals, multinational companies, and innovation and business support networks to deliver the programme. International partners and organisations in Northern Ireland, Wales and Scotland will also be establishing Clinical Entrepreneur Programme Chapters to encourage home grown life science start-ups. Professor Yvonne Barnett, deputy vice chancellor for research and innovation at ARU, said: “The global pandemic has demonstrated how important the UK life science industry is to our nation’s future. COVID-19 tests,

Bedfordshire team’s technology aims to transform battle against COVID

new sampling technology developed by a partnership between Life Science Group of Bedford, and the University of Bedfordshire, could transform the global battle against Coronavirus and other viruses by improving the speed and safety of sampling, whilst maintaining the quality of the viral sample. Public Health England (PHE) has validated the approach, confirming that the new testing buffer does inactivate the virus, making the samples non-infectious.

Life Science Group in Bedford and researchers from the University of Bedfordshire’s School of Life Sciences are working together to produce a range of second-generation ‘Stabilising Viral Inactivation Buffers’ for the transportation of samples for viral testing, with funding from an Innovate UK grant. The inactivation buffer is expected to work for COVID-19 samples, for other viruses such as Ebola and will have many different sample applications globally. The new Inactivir

vaccines and virtual medical appointments have been a key part of our battle with Coronavirus. “Now we look forward to delivering entrepreneurial education to the NHS nationally, building on our reputation as a regional anchor for health training and one of the largest providers of HE provision for healthcare professionals in the UK.” e X p o s e / Shutterstock.com

CAMBRIDGE, UK - JULY 23, 2015: Anglia Ruskin University in Cambridge, England. Anglia Ruskin University has its origins in the Cambridge School of Art, founded by William John Beamont in 1858.

range of ‘Stabilising Viral Inactivation Buffers’ is in the final stages of development. They will be used in sample tubes following the collection of saliva or swab material from the patient and will inactivate any viral pathogens during transportation to the laboratories. Jenny Murray, managing director, Life Science Group, said: “The positive results coming through from PHE have confirmed the importance of this approach in the global battle against Coronavirus and other viruses. “The benefits to the whole testing process are many and varied and include a safer and more effective way of handling a wide range of samples in the future.”

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Ireland

Irish consortium awarded €3.4m for osteoporosis innovations Funding from the Disruptive Technology Innovation Fund (DTIF) will allow a focus on breakthrough technologies in osteoporosis.

BC Biomed, Dublin City University and Dolmen Design & Innovation, a consortium of Irish-based industrial, academic and design engineer partners, have joined together to form an expert multidisciplinary team to address the growing global concern of osteoporosis. The consortium received €3.4 million funding by the Irish government’s Disruptive Technology Innovation Fund (DTIF), focussing on breakthrough technologies established under Project Ireland 2040. THE PROBLEM It is estimated that one in three women and one in five men over the age of 50 worldwide, will suffer bone fractures due to osteoporosis and 10 to 15% of those will require a reoperation. With more than 3,000,000 broken bones in Europe annually - of which 30% are osteoporotic - the predicted number of reoperations will cost approximately €450 million a year – a huge health and socio-economic burden. The gold standard for bone fracture fixation is the use of metallic implants including rods, plates, and screws. Despite their success in treating fractures in patients with normal bone density, the same cannot be said for osteoporotic patients. Implant failure that occurs with osteoporotic bone is generally attributed to the poor bone quality, not the implant. Simply put, there is not enough good bone for the implant

conditions. The combination of TCP and phosphoserine creates OsStic, a biomimetic-based adhesive with sufficient mechanical properties to fix osteoporotic bone fractures and allow rapid biological healing. THE TEAM PBC Biomed will lead the consortium comprised of Biodesign Europe and I-Form, the SFI Research Centre for Advanced Manufacturing, both located at Dublin City University, along with Dublin-based Dolmen Design & Innovation. Experts in their respective fields, this team will collaborate to bring OsStic to the clinics.

to affix to in osteoporotic patients, resulting in inadequate fracture healing. Osteoporosis has become a ‘silent’ epidemic, which calls for a breakthrough technology to address the growing concerns of unmanaged osteoporotic fractures and their potential effect on the global population. OSSTIC: THE PROPOSED SOLUTION Inspired by nature, PBC Biomed has come up with a bio-adhesive that can glue broken bones together and promote regeneration and healing – known as OsStic. Led by Dr. Gerard Insley, chief scientific officer of PBC Biomed, the idea for OsStic came from molluscs’ ability to adhere to wet rocks in intertidal shores. In order for an adhesive to function correctly in a wet in vivo environment, such as in bone, it must be able to stick to wet and fatty tissue. The molecule responsible for this adhesive property is phosphoserine, which is a component found in many proteins in the human body and is involved in the natural healing process of bone. When isolated and combined with tri-calcium phosphate (TCP), a natural building block of bone, the combination forms a paste with the ability to glue bone together in wet

Biodesign Europe and I-Form at DCU will provide technical expertise in driving the validation and testing of OsStic as a bone adhesive for surgical procedures. Prof. Nicholas Dunne of DCU will lead the academic side of the consortium, with the goal to accelerate the development of the first ever mechanically compliant bone adhesive with tissue regeneration abilities. Dolmen Design & Innovation, a product design and R&D partner, will provide their expertise in designing delivery methods for effective application of OsStic on patients’ broken bones. Martin Bruggeman, medical design director, will lead Dolmen in this development effort, by creating a solution to apply the bio-adhesive on to bone during surgery, minimising issues faced by surgeons during the procedure. PBC Biomed, with offices in Shannon and Memphis, Tennessee, is aiming to accelerate medical innovation in areas of orthopaedics, specifically bone healing and tissue regeneration. Paul Burke leads the PBC Biomed team, which aims to disrupt the current standard of care through the development of OsStic. The ultimate goal is to improve the wellbeing of patients with osteoporotic fractures, by reducing operating times, risk of infection, and need for hardware in complex fracture treatment.

on the cover

NEW RULES -

MAKING THE MOST OF THEM HOW A SUPPORTIVE ECOSYSTEM WILL HELP BOLSTER INNOVATION UNDER NEW EU AI REGULATIONS

he use of artificial intelligence (AI) is fastgrowing across all industries, but healthcare has seen a boom with areas such as medical technology, devices, apps and informatics harnessing its benefits to improve patient care. For instance, AI can be used to interrogate and find patterns in large volumes of data and at the same time be used to help monitor patient care through remote devices and apps. Until recently there has been little in the way of regulation. However, two new EU Regulations, the EU Clinical Trials regulation, and the EU Medical Device regulation, have come into force. These regulations aim to tackle the possible risks to people – from lower-level need for transparency when talking to a chatbot to some high-risk systems that threaten the safety of people or society. HOW THE REGULATIONS AFFECT MEDICAL DEVICE AND APP COMPANIES The COVID-19 pandemic has accelerated the application of AI. For example, in the U.S. Northwestern University researchers developed an AI platform that detects COVID-19 by analysing X-ray images of the lungs. Called DeepCOVID-XR, the machine-learning algorithm outperformed a team of specialised thoracic radiologists — spotting COVID-19 in X-rays about 10 times faster. As healthcare concerns matters of life and death, it is understandable that standards should be higher. Innovation in healthcare is fastmoving and constantly pushes at the boundaries of the possible. This can bring significant benefits for people with chronic or undiagnosed illness, but it has to be applied correctly.

Dr Chantelle Kiernan, scientific advisor, Life Sciences IDA Ireland, explains the requirements needed for medtech companies to flourish under new EU AI regulations.

The changes will have a global reach. AI developers around the world will need to comply with the new regulations if they wish to access the EU market; with significant ramifications and fines if companies do not comply with the new obligations. The regulation aims to put human oversight and ultimate control over AI systems within four categorisations: • Minimal risk: free use of

ON THE COVER

For innovation to flourish and provide the next generation of healthtech that can help change lives, it is vital that the life sciences community works together to create a strong ethics culture applications such as AI enabled video games or spam filters • Low risk (AI systems with specific transparency obligations, for example providers making clear that users are talking with a chat bot) • High Risk – where AI technology is used in ways that could provide a risk to health and safety, e.g., critical infrastructure like transport, or in safety components of products such as AI application in robot-assisted surgery • Unacceptable risk – AI systems considered a clear threat to the safety and livelihood and rights of people will be banned. Medtech companies will need to show they have complied with a number of new obligations such as ensuring adequate risk assessments, validating the quality of the data used to train AI systems and ensuring the robustness and cybersecurity of AI systems as well as logging of activities to ensure traceability of results. The regulations also ensure that providers continue to monitor performance of the AI system and report any serious breaches, correcting or recalling any systems that do not conform.

good reputation for excellence. With an exceptional level of collaboration between industry, academia, state agencies and regulatory authorities, Ireland ranks among the top 10 most innovative countries in Europe and top 15 globally. Ireland also stands out as having the highest ratio of artificial intelligence (AI) talent in the European Union as a result of the strong historical partnership with international technology leaders. Mapping AI intensity has shown Ireland to be among five other countries (Finland, Cyprus, Luxembourg, Sweden, and the Netherlands) that are leading the EU in attracting or developing AI talent. Ireland stands out, with a ratio far above the others in this group. Such a high ratio could be linked to the many leading multinational technology companies that have a base in Ireland. Strong networks that include IDA Ireland, which support FDI investments, help drive this dynamic R&D sector. Ireland also has per capita the highest number of EurAI (European Association for Artificial Intelligence) fellows, supported by a large ecosystem of technology and scientific research centres

including one of the largest data analytics centres in Europe, Insight. The country’s first National Research Ethics Committees in the areas of “Clinical Trials of Investigational Medical Products” (NREC-CT) and also “Clinical Investigations of Medical Devices” (NREC-MD) have been established with responsibility for reviewing the ethics underpinning research proposals in these important areas of health research.

These new committees will review applications submitted through the National Office for Research Ethics Committee to streamline the process of the ethics review in areas under their remit. This will continue to ensure a strong infrastructure for health research which can only increase the capability of organisations within the country to continue with world class research leading to the creation of new medicines, further bolstering the national ecosystem. The new EU legislation is vital for AI to continue its contribution to healthcare and for the public to have trust in AI. However, companies involved have to grasp the nettle and it is crucial that they are given the support they need to successfully abide by the new regulations.

SUPPORT COMPANIES WILL NEED For innovation to flourish and provide the next generation of healthtech that can help change lives, it is vital that the life sciences community works together to create a strong ethics culture. A strong research infrastructure with top level support will be critical for companies who will need to abide by the new regulations. In Ireland, work is already underway within the global cluster of multi-national companies who have invested in the area to make use of the benefits of being part of the successful Irish eco-system. While not over-regulated, Ireland has a strong legal and regulatory landscape and Irish regulators across different sectors have a

Packaging

Learning about customer engagement Curtis Hogan, regional manager UK & Ireland at Oliver Healthcare Packaging, offers his perspective on entering the medical device packaging industry.

n any industry, putting the customer first is the key to success, but this is especially true when it comes to medical packaging. It’s a niche industry that requires significant knowledge and expertise to ensure you understand and are ready to meet the customers’ needs. TELL US A LITTLE ABOUT YOURSELF. HOW DID YOU GET YOUR START IN THE PACKAGING INDUSTRY? I was born and raised in the United Kingdom and have been with Oliver Healthcare Packaging for about two years now. My role at Oliver is to work with companies based in the UK and Ireland, in both the medical device and pharmaceutical industries. Coming out of school, I was looking for a stable industry that was also interesting to me. I started my career in nutrition. From there, I jumped to dental, then pharma. This experience led me to the sterilisation industry. All of these industries are related through their focus on health, medical and wellness. My last role in sterilisation, however, and the

work I do today at Oliver, are the most similar since they are both later in the medical supply chain. WHAT KEEPS YOU INTERESTED IN THE HEALTHCARE INDUSTRY? It gives me great satisfaction to work in a sector that truly helps people. A real need in society is served, from lifesaving products to pain management breakthroughs. Our industry is one with such potential for growth, fast change, and advancement for the future, which excites me. There is always something new coming to the forefront. HOW DO YOU FEEL YOUR PAST EXPERIENCES HAVE HELPED YOU PROVIDE VALUE TO YOUR CUSTOMERS? Everything is highly technical with implications for human health, life, and patient safety. You must be able to provide technical information as you meet commercial responsibilities. That can be hard but is also a nice challenge. My past experiences have helped build an understanding of the constraints

When it comes to patient safety and packaging, it’s important to be able to look at situations and suggest solutions from a different perspective

customers face when it comes to packaging their device. When it comes to patient safety and packaging, it’s important to be able to look at situations and suggest solutions from a different perspective. HOW MUCH DO YOU HAVE TO KNOW FROM A TECHNICAL STANDPOINT TO BE CREDIBLE WITH WHO YOU ARE SELLING TO? You need to have a good foundation of product knowledge, but we have a world-class technical team at Oliver, too. I can start a discussion, and then rely on our technical team to help with the specific science and troubleshooting. For example, at Oliver, my sterilisation background gives me a well-rounded perspective, and our technical team can expand on what I know as needed. Working with engineers, operations, or scientists requires the ability to address complex concerns. It is rewarding to be able to offer that. It’s also important to include other departments—it allows your customer to meet additional team members and benefit from the experience of the full team. The collaborative nature of Oliver’s culture is a point of differentiation customers appreciate. At the end of the day, it truly is a team effort. IN YOUR CURRENT ROLE WITH OLIVER HEALTHCARE PACKAGING, WHAT TYPE OF TRENDS ARE YOU SEEING AMONG CUSTOMERS? It’s hard to talk about trends without mentioning Brexit and COVID, but that has not gone by any means. The pandemic has caused an uptick in elective surgeries and that is where we’re seeing trends established. The sudden boom in elective surgeries is causing a lack of resources in hospitals, making it difficult to cater to the backlog that has occurred as a result of COVID. This shows the fluid nature and expansion of our industry. We must remain flexible and responsive.

Adhesives

Peter Swanson, managing director of Intertronics, shares his insight on using difficult to bond plastics in medical device applications.

Bonding difficult plastics in medical device manufacturing

any medical device manufacturers are turning to plastic substrates specifically formulated to resist harsh chemical and environmental end use conditions and provide functional advantages. However, such plastics may have characteristics that impact the ability of an adhesive to bond to the material. Plastic parts made from specialist materials are often joined using adhesives; there are advantages over mechanical means, including process speed and efficacy, lower stresses, and aesthetics. As new polymers enter the market, they create new opportunities for design engineers. MEDICAL DEVICE SUBSTRATES Polymer selection will depend on strength, ease of sterilisation, chemical resistance, and mechanical and dynamic properties. Commonly used materials are ABS, PMMA and PC. Nylons (PA), for example, are semi-crystalline polyamide materials used in devices for fluid management, surgical procedures and diagnostics, due to their good thermal, chemical and pressure resistance. Vascular catheter shafts, for example, are an application for nylons. Newer polymers are finding applications in the industry, including polyether block amide (PEBA) and cyclic olefin copolymers (COC/COP). PEBA delivers low friction properties, kink and pressure resistance, softness and flexibility, while being chemically resistant and lightweight. This flexible thermoplastic elastomer is replacing polyurethanes, polyesters and silicones in applications like medical grade tubing, catheters, connectors and medical films. COC/COP are a new class of amorphous polymers that are an alternative to glass

due to their clarity and compatibility with sterilisation. COC/COP film laminates are used in the assembly of in-vitro diagnostics (IVD), Lab-on-a-chip (LOC), and other point-of-care medical devices. Formulators have innovated to provide specialist adhesives that bond well to many newer substrates. While offering desirable properties for the application (e.g. low friction surfaces), many of these plastics have very low surface energies. If the surface energy of a material is below 50 mJ/m2, adhesives will not wet the surface, sitting as a round droplet instead of spreading out. Wetting is a prerequisite of adhesion for the plastic to be bonded effectively, so in this instance the manufacturer can contact an adhesives specialist who can recommend surface preparation techniques to trial. One surface treatment technology many have found success with is cold atmospheric plasma. The process involves turning a small number of gas molecules into plasma, partially ionized gas, to initiate a multitude of physical and chemical processes that treat the surface, increasing its surface energy, and removing contaminants without the use of additional chemicals. The piezobrush PZ3 handheld plasma surface treatment device is low cost, easy and intuitive to use, but there are options available to suit processes of different scales, volumes and speeds. ADHESIVES IN MEDICAL DEVICES Though there are many ISO 10993 tested bonding materials suitable for consideration in medical device assembly, specifying an adhesive and associated dispensing equipment always involves trade-offs. For example, twopart epoxies give high resistance to heat and the environment, but may require

several hours to cure, creating work in progress. Cyanoacrylate adhesives (CAs) cure quickly but have lower thermal and moisture resistance, and may experience blooming, a white discolouration on the surface of a part that impacts aesthetics. Silicone adhesives are very flexible, can withstand repeated sterilisation, and bond well to silicone substrates. UV curing adhesives are a popular choice, particularly for volume, automated processes, as these materials cure on demand when exposed to the right intensity and wavelength of light. UV curing materials can speed up the assembly process and reduce work in progress and can be formulated with fluorescing properties to allow easy bond line inspection and detection of adhesive coverage. Some manufacturers, such as Dymax, offer colour change UV curing adhesive technology to confirm cure. One new option on the market is Born2Bond Light Lock, a low-blooming CA that offers dual cure. Designed for applications that require fast fixturing, coating or surface cure, it can be cured by conventional CA curing mechanisms (usually exposure to surface moisture), which ensures fast interfacial cures, and using UV/visible light, to allow rapid bonding through transparent parts or quick curing of exposed fillets of areas. New medical device materials provide designers with opportunities for their new products but can exacerbate the bonding challenge. With careful consideration of the latest adhesive and cure chemistries, dispensing technology and surface preparation of the substrate, medical device manufacturers can develop repeatable, validatable processes.

Adhesives

Emmett McArdle and Xianbo Hu, R&D managers for Avery Dennison Medical, discuss a quartet of adhesive capabilities desired by medical device developers and healthcare providers — and why it’s such a challenge to deliver just the right mix.

Pressure-sensitive medical adhesives: In search of the holy grail

or many medical device professionals, the challenge to meet multifaceted healthcare market demands can feel like a modernday quest for the Holy Grail.

the adhesive’s grip should never cause skin trauma. Rubber-based adhesives deliver a strong grip but are not breathable and tend to be too aggressive for fragile skin.

This is certainly true when it comes to medical adhesives. One of the foundational building blocks for medical devices such as wound care dressings and wearables, these materials must deliver diverse performance capabilities. Here we look at four sought-after adhesive qualities.

It’s important to consider the entire adhesive spectrum relative to the desired end use. Adhesives can be engineered with varying levels of tack, and different carrier materials can be leveraged. For example, acrylic adhesives can be coated into breathable, soft carrier materials to improve comfort while delivering strong hold. Also, SSA can be engineered with high tack. Such SSA might be a good fit for some superabsorbent dressings, but atraumatic, or pain-free, release could be compromised by their higher degree of peel adhesion. However, high-tack SSA could be

REPOSITIONABILITY Repositionability is an important quality in some medical devices. For example, a healthcare provider may need to lift a dressing to examine a wound and then adjust and resecure it. Or a nurse may want to remove a self-adhering N95 respirator during a work break and then don it again to return to duty. Soft silicone adhesives (SSA) are the ideal choice for low-tack applications, such as advanced wound dressings. SSA retain their adhesive properties during repositioning. They do not remove skin cells during removal. If the opposite occurs and skin cells are pulled away, they can mask the adhesive, impacting its ability to reattach. Other repositionable options include soft acrylic adhesives. Device designers might turn to acrylics for applications requiring repositionability combined with stronger grip, longer wear time, single-use disposability or lower cost. STRONG GRIP AND ADHERENCE Strong grip and adherence are necessary for medical devices that must hold relatively heavy weight or stay secure for long periods under demanding conditions. For example, super-absorbent wound dressings contain large amounts of fluid between changes. Some wearables must remain securely attached through showering, exercise and other daily activities. Still,

suitable for wearables with mid-range wear times. GENTLE WEAR AND ATRAUMATIC REMOVAL Demand is growing for adhesives that deliver gentle wear and atraumatic removal. These qualities are critical in advance wound care for the elderly, infants and others with fragile, delicate skin. In addition to gentle adhesion, healthcare providers often want repositionability when treating serious or chronic skin trauma so they can remove a dressing temporarily to examine a wound, or to shift its position so that a clean portion of the dressing faces the wound, ready to absorb fluids and exudate. Gentle-wear dressings often must offer a hydrophobic barrier around the wound, keeping liquids away from both the wound and peri-wound area. This helps prevent maceration and wound enlargement. All the while, the dressing should remain comfortable for the patient, with minimal to no discomfort each time it is repositioned or removed. Here again, SSA are the preferred adhesive choice because they deliver the most important performance capabilities required for optimal healing and patient experience. EXTENDED WEAR TIME This is a challenging performance requirement facing today’s medical device developers. Some wearable devices now call for 30-day wear times whereas previous applications might have stopped at five, 10 or 14 days. With longer wear comes the need for adhesives to withstand many environmental stressors, from daily showering to exercise. Patients want and need to maintain active lifestyles, and their devices are expected to keep up. At the adhesive level, this means delivering the right mix of sustained grip, breathability and waterproof properties. Acrylic pressure-sensitive adhesives (PSA) can be engineered for strong hold, water-resistance and breathability. The latter quality is enhanced when the PSA are coated onto highly breathable carrier materials.

packaging

Paxxus explains how the pandemic has accelerated change for medical device packaging manufacturers, particularly in the diagnostics space.

MOVING WITH THE TIMES HOW MUCH DO YOU FEEL THE DIAGNOSTICS LANDSCAPE HAS CHANGED DURING THE PANDEMIC? The pandemic has contributed to an incredible shift in diagnostic testing. Many diagnostic companies are in the midst of bringing brand new methods and platforms to market which equates to new challenges for the entire supply chain. The scale and volume of demand for new and creative formats have increased significantly as testing continues to boom in both clinical settings and at-home environments. From discovering allergies to identifying genetic risks at home, the ability for consumers to manage their own health has resulted in a widespread recognition and acceptance of numerous new diagnostic platforms and tests.

For this reason, the diagnostic landscape has experienced an exponential increase in new players all hoping to better support patients in all settings. WHAT EFFECT HAS THIS HAD ON THOSE WORKING IN MEDICAL DEVICE PACKAGING, LIKE YOURSELVES? The explosion of new players and methods in the diagnostic space required packaging suppliers, like us, to pivot rapidly in terms of our manufacturing focusses. During the first few months of the pandemic, we very quickly recognised the need to prioritise our offerings of materials for diagnostic testing kits. We collaborated with our partners to quickly recommend primary packaging materials and

identify appropriate materials that can be used in conjunction with components inside of their diagnostic devices. By offering both pre-engineered solutions and developing new structures to address specific requirements, we have been able to support several major companies as they have introduced novel tests to the market. WITH PEOPLE NOW BECOMING MORE FAMILIAR WITH HOME TESTING, WHAT KIND OF EFFECT DO YOU THINK THIS WILL HAVE ON THOSE WORKING WITHIN DIAGNOSTICS PACKAGING GOING FORWARD? Human factors have already had an enormous impact on the development of devices and their respective packaging and we expect this focus to only gain strength going forward. Many athome tests are being administered in a less controlled environment, compared to clinical settings, by consumers who may not be trained. Consumer storage,

Packaging

Human factors have already had an enormous impact on the development of devices and their respective packaging and we expect this focus to only gain strength going forward opening, and sample collection techniques are important considerations for device manufacturers and packaging suppliers as all these factors could have an undesirable impact on the outcome of an at-home test. As a supplier of healthcare packaging, one of our top priorities is reducing risk to the patient. We have developed certain materials that are more durable and able to withstand a harsh distribution cycle as the products make their way to the consumer. Materials may also need enhanced barrier properties to promote an extended shelf-life and to resist moisture or light in uncontrolled environments such as a medicine cabinet located in a humid bathroom. Finally, unlike clinical settings, the consumer is in full control of their selection of an at-home diagnostic test. User-friendliness and shelf appeal are new significant considerations for diagnostic device manufacturers while collaborating with their packaging supplier. The product must appear reliable and safe to the consumer, and the packaging must provide simple and intuitive access to the device. HOW DO YOU ADAPT WHEN THIS PART OF THE MARKETPLACE IS GOING THROUGH A PERIOD OF QUICK CHANGE? It is incredibly important to have the appropriate material building

blocks in place that can be quickly combined to meet the evolving needs and requirements of the industry. For the diagnostic market in particular, we are proud to offer a portfolio of engineered materials that can be tailored for use as primary packaging or as internal components. In addition to a product offering that directly supports diagnostic companies, our technical team loves to support fast-moving projects. We frequently collaborate with our clients to develop solutions to meet new and challenging requirements like containing hard-to-hold chemical reagents. WHAT CONSIDERATIONS DO YOU HAVE TO MAKE WHEN IT COMES TO PACKAGING NEW INNOVATIONS IN DIAGNOSTICS? There are several additional factors to consider when packaging new diagnostic products. Our team needs to identify any possible interactions between the diagnostic component itself and the proposed packaging so that the device displays accurate results. Additionally, device protection is vital as the product makes its way to its final destination. Barrier properties are designed for each product to provide light and environmental protection as well as to reliably contain aggressive chemicals throughout the product’s journey. Other considerations that we think about with our clients is how the new device will be accessed and how the reagents are released. For example, does the material need to peel or pierce at a specific force to release the reagent? Does the device packaging require a precise lineartear for ease of user access? Will the package survive the expected distribution channels including handling by the consumer? These and more are all considerations for designing packaging for new innovations in diagnostics. GIVEN THERE IS AN INCREASED FOCUS ON SUSTAINABILITY, COUPLED WITH THE CHANGE

IN DIAGNOSTICS, HOW CHALLENGING IS IT FOR MEDICAL DEVICE PACKAGING FIRMS TO KEEP UP WITH THE RATE OF CHANGE? While we have been able to keep up with the rate of change, the rapid shift in priorities comes with a new set of challenges in terms of sustainability. We have seen this as an opportunity to promote and expand sustainable product offerings. For example, we can help a client use less material in their packaging, or switch to a mono-material solution to support their sustainability initiatives. In addition to utilising sustainable components, we know how crucial it is to work closely with MRFs (materials recovery facilities) and advanced recyclers to innovate and expand the sustainable packaging options available to the market. FOLLOWING ON FROM THAT, WHAT MATERIAL SOLUTIONS DO YOU HAVE TO ADDRESS THESE ISSUES? We recognise that sustainable thinking must expand to beyond just primary device packaging. While downgauged foil pouches, flow wrap material, and singlepolymer barrier overwrap are popular amongst diagnostic companies looking to promote sustainability with the primary packaging, we must also consider the critical components within the actual diagnostic device. We often recommend AccuPierce, our pierceable aluminium foil lidding, for internal applications (like critical assay reagents) requiring chemical resistance.

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Testing and Inspection

Critical to The importance of quality assurance in medtech Paul Roberts, sales manager, advanced manufacturing for Kistler Instruments, outlines the critical nature of quality assurance for medical device manufacturers.

lthough quality assurance (QA) has progressed from “end of line” manual inspection, often on a random sample basis, to automatic in-process monitoring of critical stages in the manufacturing operation using custom designed computer systems. Where critical components are being produced in quantity, typically for aerospace, defence and vehicle manufacturing applications, QA procedures are precisely defined and legally binding resulting in the availability of commercial, cost effective monitoring systems from several specialist producers. Medical device manufacturers must demonstrate that their products meet the highest safety and quality standards and provide proof of the reliability and precision of quality assurance monitoring not only throughout their own manufacturing process but also that of their suppliers. In medtech, where in-process monitoring is critical, manufacturers have had to adapt and use systems from other sectors which may or may not meet the strict FDA and MDR regulatory requirements. Companies that manufacture and market medical devices are fully liable in the event that their products fail to function accurately and consistently. Producers of medical devices as well as plant and machinery manufacturers operating in the medtech and pharmaceutical sectors are confronted with huge challenges, especially when it comes to integrating process monitoring systems into automated production and packing processes. In response to the need for a process monitoring system for the medtech sector, Kistler Group has developed

the new maXYmos TL ML in-process monitoring solution specifically for the medtech manufacturing sector with FDA and MDR-compliant functionalities. A development of the well proven maXYmos TL system widely used in many manufacturing sectors, the new system visualises process profiles and offers an extensive range of interfaces for connecting sensors. The system is integrated directly into the production line to monitor and evaluate the quality of every step in the manufacturing process on the basis of an X-Y curve. With the help of evaluation objects (EOs), users can adapt the curve evaluation to the specific monitoring task. For instance, the tolerances defined in the process validation can be used for this purpose. Based on this specification, the system automatically identifies each product as good or bad at each stage in the process which not only ensures that every product is 100% in specification but also increases productivity and reduces costs by rejecting any that fail before any further, wasted stages in the process. The functions integrated in maXYmos TL ML conform to the regulatory requirements and the system hardware also meets the specific requirements for measurement equipment that apply in medtech, including: • Designed to accommodate small measuring ranges (force-displacement monitoring, torque sensor technology) • Integrated user management compliant with FDA regulatory requirements • Audit trail of all changes to testing processes, with time and user indexing for end-to-end traceability of each individual product

The key benefit to manufacturers is that they can bring their product developments and innovations to market much more quickly

• Optional blocking of ports for secure integration into the customer’s data structure • Direct printer connection so that test records can be documented as hard copies. OPTIMISED PRODUCTION PROCESSES GIVE MANUFACTURERS A COMPETITIVE EDGE The new maXYmos TL ML process monitoring system aims to give producers of medical devices, as well as machinery and plant manufacturers operating in the medtech and pharmaceutical sectors, an easier solution to the validation of their production processes. With 100% inspection of each step in the manufacturing process, the need for mandatory process validation in production can be completely eliminated. Qualification of the production equipment is the first requirement for proof of the system’s safety. For this purpose, Kistler supplies ready-to-use checklists for Installation Qualification (IQ) and Operational Qualification (OQ). An in-plant calibration can then be performed to validate the measurement system at any time in-house or by the Kistler calibration service available throughout the world. This also makes requalification of assembly plants much simpler, because the entire measuring chain is calibrated. The key benefit to manufacturers is that they can bring their product developments and innovations to market much more quickly giving them the competitive edge that is such a critical factor in this industry.

Regulation

SHARP FOCUS: IVDD manufacturers must place compliance top of the agenda Bob Tilling, VP global sales at Kallik, discusses the compliance challenges facing in vitro diagnostic device manufacturers.

he EU’s In Vitro Diagnostic Regulation is set to be implemented in May 2022, with further UDI implementation deadlines set for critical in vitro devices (IVDDs) used to detect life-threatening diseases (Class D) in 2023, 2025 (Class B and C) and 2027 (Class A). IVDR is set to reshape product classifications, quality management and how existing products already sold within the EU are managed in a bid to improve device safety, effectiveness and traceability, with over 80% of devices previously not requiring certification under IVDD (In Vitro Diagnostic Directive) now requiring IVDR certification. Manufacturers must ensure timely compliance with every aspect of IVDR to avoid financial impact, operational disruption and permanent damage to brand reputation in the event of consumer harm caused by device quality or traceability issues. ACT EARLY Manufacturers that have already completed an MDR compliance project for May 2021 may be tempted to sit and delay IVDR efforts. But the scale of these compliance tasks and the wideranging impact regulation has on operations and the supply chain is often underestimated, and only uncovered during the initial assessment stages of a compliance project.

There are many nuances to labelling under IVDR, including major differences between medical and in vitro device artwork, and layout design changes to accommodate increased traceability information such as Unique Device Identifiers. The sheer volume of work means manufacturers that embrace IVDR compliance as an early business priority and plan accordingly will stand a greater chance of succeeding without incurring major expense or affecting day-today operations. A key takeaway from successful Kallik projects helping manufacturers comply with MDR was the value of adopting a best practice approach to successfully hit deadlines. Companies that have chosen to ‘go it alone’ and push ahead with compliance efforts using manual processes and legacy in-house systems have often struggled as the scale and complexity of the task becomes apparent. There are four core aspects for success when establishing an IVDR compliance project: 1) Don’t be caught out by project scale and complexity Businesses should look to identify the scale of their compliance task as early as possible, determining exactly how many devices and associated labels and artworks

The sheer volume of work means manufacturers that embrace IVDR compliance as an early business priority and plan accordingly will stand a greater chance of succeeding 20

exist across their global operations and supply chain. Kallik’s work on MDR compliance projects for medical device manufacturers identified affected assets numbering in the low thousands to over 150,000 – so the volume of work must not be underestimated. Siloed data in legacy departmental systems, disconnected regional offices and even new product lines introduced by mergers and acquisitions can all significantly expand the scope and timeframe of the project once identified. Product translations and global supply chain nuances are another common surprise when assessing the project complexity. Internationally focussed businesses will need to amend each label and packaging asset in various languages, significantly increasing the scale of work. 2) Remove the bottlenecks Identifying every silo containing affected assets within a manufacturer’s global business footprint is the first step to compliance, but businesses should also look to consolidate these assets into a single central source before actioning changes. Business leaders struggling with disconnected legacy systems should consider adopting an

Regulation

end-to-end label and artwork management solution to avoid these pitfalls. These solutions typically provide a centralised asset library to consolidate artwork, logos, phrases and other critical product data. This ‘single source of truth’ significantly eases the monitoring, editing and management burdens, helping businesses focus solely on dedicated compliance work through label editing. 3) Consolidation is key when amending assets Once manufacturers have consolidated existing assets and standardised associated data, attention can turn to identifying and actioning specific changes that must be made to each label and artwork to achieve compliance. These can range from label sizing and placement, to warning symbol positioning and UDI inclusion – with the ever-present threat of further changes to accommodate translations and country-specific regulatory requirements.

This is another situation where a centralised label and artwork management solution can add value to the process. 4) Automation and cloud-based technology can ease the burden One key takeaway from initial MDR compliance projects is the sheer inefficiency of many ‘traditional’ methods and manual work to update assets. As the scale of these compliance tasks increase and new regulations are announced, the processes become unacceptably slow, expensive and inaccurate – with the ever-present risk of introducing human error. Introducing a cloud-based, centralised solution that leverages automation will eliminate much of the uncertainty caused by manual processes. The result is an efficient operation, following bestpractice procedures, providing a certain outcome. Such solutions harness rules-based automation to eliminate the need to manually search for, update and republish assets to ensure compliance,

and deliver significant cost and capacity savings that scale over time. IVDR TODAY, UKCA TOMORROW? While IVDR marks a major change to the way IVDD manufacturers operate, it is not the end of the road for industry regulation. Further changes such as UKCA markings for medical devices sold into the UK market are also in the pipeline, and further national and regional regulations are highly likely to follow, trigged by developments such as Brexit. This represents a perfect opportunity for manufacturers to establish a strong, futureproof digital foundation to deal with future industry challenges and enhance wider business processes.

DIGITAL HEALTH

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PANDEMIC PAVES WAY FOR INNOVATIVE HYBRID HEALTHCARE Maya Ward, associate director, Gresham House Ventures, writes about how the pandemic means that a hybrid healthcare model is readily achievable.

hile the heroic abilities of the NHS have been on display throughout the COVID-19 pandemic, the last year has also exposed the longstanding limitations and frailties of our underfunded healthcare system. With an estimated 100,000 unfilled posts and staff turnover expected to increase due to emotional exhaustion, the health service’s workforce stands to be further stretched by an ageing population. By 2030, one in five people in the UK will be aged 65 or over – individually costing the NHS 2.5 times more than the average 30-year-old. However, a wave of private investment is flowing into the sector. We are seeing a new type of hybrid healthcare system emerge, where the sizeable supply-demand disparity is being partly alleviated by innovative enterprises accelerating the structural shifts brought forward by the pandemic. Major crises are often the catalyst for innovation. Just as the Great Fire of London taught city planners to build smarter, more resistant urban environments, COVID-19 could help shape a more efficient healthcare system. CATALYSED BY COVID While healthcare has previously been a laggard in technological take up, the pandemic has accelerated both the adoption and proliferation of digital health solutions. The opportunity for modernisation has received

the buy-in of healthcare professionals and patients, who witnessed the practical application of digitalisation first-hand during the pandemic. Notably, the pandemic has accelerated remote patient monitoring via digital medical devices. Wearable healthcare technology is becoming more advanced – smaller, cheaper and more accurate. This better enables devices to be paired with digital applications that deliver real-time health insights and longitudinal data sets, which are particularly beneficial when supporting people suffering from chronic conditions. For example, during COVID-19, oximeters have been used to keep patients out of hospitals. If a patient’s readings start to decline, a healthcare professional is notified and can intervene. Remote technology is also increasingly being applied in hospitals and care homes, where wireless monitoring devices in the room, rather than physically on patients, can be used to detect falls or a change in vitals, alerting healthcare professionals of incidents or patient deterioration. This supports the wider trend of patient empowerment. Patients can make active lifestyle changes to improve their health based on self-analysis aided by digital devices and software, which in turn saves time and money for the healthcare system over the long term.

Tech-enabled diagnostics and imaging tools should also help ensure greater standardisation. There is a significant shortage of radiologists in the UK, but tech platforms that utilise artificial intelligence to carry out initial screenings of an MRI or CT – which are then verified by a radiologist – better leverage healthcare professionals’ time and often provide more consistent outcomes. As a result, we should see the lines between primary and secondary care blur, with technology facilitating more joined up care provision in local ecosystems, involving pharmacies and community care providers, and many digital providers straddling the primary / secondary lines. In this way, digitalisation should actively support the move towards integrated care systems. FIRMS AT THE FOREFRONT These emerging hybrid healthcare solutions offer a significant investment opportunity. The digital healthcare software and services companies we invest in leverage technology to better support clinical outcomes, as well as enable greater access to healthcare professionals. This is about ensuring patients access the right support in the right

format at the right time. For example, eConsult, digital triage services provider to GP surgeries now has a c.50% market share and covers more than 3,300 GP practices as a result of growth acceleration. Developed by clinicians, the service enables the remote closure of c.70% of cases – hugely advantageous in optimising resource and capital allocation. While a hybrid healthcare system can improve outcomes for patients and better leverage time-poor healthcare professionals, a long-term approach is vital. This is where the active engagement and deep networks of a healthcare focussed venture capital trust can provide support and long-term capital. For example, our networks allow us to ensure private healthcare providers possess diverse skillsets. Following our recommendation, eConsult recently appointed a nonexecutive director deep experience in driving growth through effective proposition development. With a proven ability to bring small innovative firms to scale, venture capital trusts can help pave the way for a better healthcare future.

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Meet the start-up

MEET THE STARTUP:

THE AIR THAT I BREATHE Med-Tech Innovation News caught up with Dr Connor Bryant, founder of MedicAir, a producer of medical grade air purifiers to help improve cognitive function.

FIRST OF ALL, TELL US ABOUT MEDICAIR, HOW DID YOU START OUT AND END UP IN THE MEDTECH SPACE? MedicAir is a UK-based company manufacturing medical grade air purification technology, on a mission to provide clean and safe air to all indoor spaces. We started off in 2019 as dentists, developing MedicAir specifically for the dental profession, inspired by South Korea’s approach to dental hygiene. When the pandemic hit, we ramped up production and our product, available across the UK, most of Europe, the US and Australia, is already significantly disrupting the impact of airborne viruses such as influenza and, of course, COVID-19. TELL US ABOUT THE PRODUCT ITSELF AND WHAT TECHNOLOGY IS BEHIND IT? The product is a medical grade air purification technology that removes 99.9% of MS2 virus (COVID surrogate) diseases within an area of 27.5m^3 in 30 minutes. An on-screen display shows air quality levels, relative humidity and room temperature. The product plugs into a socket and operates with minimal noise, whilst using the same power as a fan, so users do not have to worry about electricity costs or disruption. The filters only require changing approximately once a year which can be done simply, meaning no engineer is required - a common necessity with other air filtration systems. WHAT IS IT MADE OF AND HOW DOES IT REMOVE CONTAMINANTS? MedicAir’s unique system eliminates invisible contaminants through a five-stage filtration process.

The tech includes an anti-bacterial coated HEPA-13 filter with a 6.7m2 surface area and filters out 99.95% of all particles down to 0.3 microns, whilst the activated carbon layer removes harmful VOCs and odours. The 24W UVC bulb targets viruses and other microscopic contaminants. The unit disperses clean air that is filtered for viruses, bacteria and particulates. HOW WOULD YOU DEFINE YOUR ROLE IN THE MEDTECH/HEALTHCARE SPACE? We are a company founded in science, by scientists, and we are passionate about research and development being at the forefront of our thinking. We see our role as innovators in the medtech space with an ability to quickly pivot according to market requirements.

WHAT RESULTS HAVE YOU SEEN BECAUSE OF THE PRODUCT? MedicAir’s technology is based on peer reviews; MedicAir commissioned testing by leading industry player, Airmid Health Group, the environmental test chamber assessment demonstrated that. When challenged with MS2, the air purifier was capable of reducing the average airborne concentration of the virus from 7.52 to 4.41 Log10 PFU/m3 after 60 minutes of operation. Calculating the percentage reduction based on the PFU/ m3 results, there was a 99.9% reduction of airborne MS2 within 30 minutes of MedicAir operating. ANYTHING ELSE YOU’D LIKE TO ADD? We have experienced a YOY growth exceeding 1000% from January to May of this year, following increased public concern for air quality particularly within medical facilities, schools, offices, and restaurants is behind the company’s rapid growth. MedicAir devices can be found in NHS and private hospitals in all major cities across the UK, as well as care homes, dental practices, warehouses, and offices. However, the MedicAir system is not just about solving the COVID problem, it is equally successful in combating the effects of hay fever, asthma and allergic reactions to dust and pet dander. Our products are designed to fit seamlessly into any environment, enabling the user to safely continue with everyday activities in the safe and certain knowledge of premium quality air. We are passionate about clean air and believe it is a fundamental human right. Clearly, it took a pandemic for many of us to realise just how important clean, hygienic air is and we now need to shift our focus from reactionary to preventative.

Industry 4.0

Using data better Accelerating medtech’s industry 4.0 evolution Andrew Borland, University of Liverpool Virtual Engineering Centre 4.0 lead, currently leading an SME manufacturers programme in Cheshire and Warrington, explains the opportunities available through industry 4.0.

ver the past 18 months, we have witnessed mass global collaboration within life science and healthcare. As in so many other sectors, the pandemic has also catalysed structural change on an incredible scale. The adoption of processes and technologies has accelerated out of necessity. Effective vaccines which can take decades to develop were unveiled in less than a year. A plethora of in vitro diagnostics (IVDs) were designed, ratified, and manufactured at record speed too. Running alongside this, digital health tools to enable contact tracing were launched at scale globally. Human ingenuity and resilience have been rightfully celebrated in delivering this innovation, but the supporting role emergent technologies have played should also be acknowledged. Far from just turbocharging the response to COVID-19, industrial digital technologies (IDT) have been pivotal to enabling healthcare delivery, research, and product development more generally.

on impossible just a decade ago. Data has been described as the new oil in the machine, but it is also a raw material. When extracted, refined, and put to work properly, its potential for medtech is huge. From personalised medicine and treatment planning to drug development and the design, prototyping and validation of medical devices and intervention. Medtech is a highly regulated sector where quality, safety and efficacy are non-negotiable requirements. Understanding the importance of data science and data engineering is implicit for diagnostics developers and digital health businesses. But manufacturers of more tangible medtech products also know they are data-driven; receiving it downstream from supply chains and producing it within their factories. Common challenges for many of these businesses, particularly SMEs, are knowing what data is useful, and how it can be paired with artificial intelligence, human insight and digital engineering tools.

Clinical trials shifted to remote-first models in many cases. Patients received care via telemedicine and remote monitoring with a seamlessness many would have thought impossible prepandemic. Medical device manufacturers accelerated the adoption of smart factory and production line technology to go from concept to market faster. Underpinning almost every facet of the global healthcare mobilisation to meet the challenges of the last 18 months is data.

WHAT DO I NEED TO KNOW? WHEN DO I NEED TO KNOW IT? HOW ACCURATELY DO I NEED TO KNOW THIS? Those are three of three key questions almost any medtech businesses looking to formulate a data strategy should start with. For manufacturers, in particular, data is often captured in silos across individual areas of production. Without the in-house skills to take a helicopter view of which of those data points is the most valuable, the sheer volume of data from each can be daunting.

Supported by industry 4.0 technology, our collective ability to capture, analyse and interpret huge datasets has enabled a response that would have been nigh

A lack of in-house expertise, or top-level systems architecture, is often further compounded by the interoperability of individual products.

Very few manufacturers have systems that are sophisticated enough to update autonomously in real-time across the entire operation, based on analysing individual data inputs. The result can be to default to analogue processes (pen and paper) to keep track of overall production and to make within-day changes. Not only is this inefficient, it also breaks the digital ledger. Therein lies the major risk, especially for smaller and mid-sized businesses in medtech supply chains. Many run the risk of being ruled out of tenders by larger corporates, or health payers, if they are not able to demonstrate a solid level of data literacy and a transparent digital record of production. For medtech to continue to evolve, it must learn from other sectors which have found the right recipe for collaboration between industry and regulators. Aerospace is a prime example. It too is highly regulated, with safety and quality foremost considerations. Its businesses and regulators share real-time data readily and the R&D process is streamlined as a result. Patients (or service users), industry, regulators, clinicians, and payers, must find a common approach to data that satisfies everyone. Businesses will naturally want IP protected; patients must be reassured that data will be anonymised; while regulators will demand unfettered access. There will be some trial and error in finding this balance. But medtech innovation will be ultimately accelerated by better capture, analysis, interpretation and, crucially, sharing of data.

Med-Tech Innovation Expo

Getting the most out of Med-Tech Innovation Expo

A new addition ahead of this year’s Med-Tech Innovation Expo is the visitor portal, allowing you to plan your visit to the NEC, develop contacts and leads, and ultimately help you get the most out of this year’s show. The portal gives you a full list of exhibitors and speakers and allows you to allocate time to set up meetings and attend seminar sessions accordingly. The conference programme, speaker line-up and exhibitor directory will be visible exclusively within the event platform to those who register for the event. Each visitor will have a diary within the platform where they can manage recommendations, meeting requests, conference sessions, and more, allowing for a streamlined experience at the show. It gives you the ability to view the full list of attendees, whom you can send instant chats and meeting requests. The portal also allows you to develop an online profile for potential buyers to explore, all of which is trackable and enables

you to see who has expressed interest in your company. Companies are able to upload information about products and services, which will be recommended to buyers based on what they told us when they registered. Setting up a profile and access Logging in via med-techexpo. com, click on the sidebar and scroll down to Exhibitor Portal where you will be redirected to sign in with the email address and password you used in your initial setup. If you aren’t set up as a user on your company’s account or want to allow access for a colleague, please email: mtiops@rapidnews.com. You will be redirected to a welcome page. By clicking on task list, you can build your company profile by following the on-screen instructions. Your company profile will be visible to show visitors. On a tick box page within the task list, you will be asked to select the kind of companies that you are interested in doing

This is a very exciting piece of new technology as it will provide you with a way to connect with attendees like never before business with, and which best describes your products and services. Filling this out will allow us to provide visitor recommendation to those in attendance. You are also provided with the opportunity to add a welcome video or bespoke profile picture, along with links to your social media platforms. Exhibitors can also add resources and online staff to have access to the portal, and those who will be manning your stand at the show. This allows visitors to select members of staff that they would like to book a meeting with. Order lead capture and the ability to browse leads will also be available to exhibitors. Arranging meetings Visitors can request meetings with you using the meet up option. The standard time put on the meet up for a meeting is 30 minutes, but this can be edited. Exhibitors can also invite visitors to their stand too, using the marketing assets tab. This is a very exciting piece of new technology as it will provide you with a way to connect with attendees like never before. We look forward to seeing you at the NEC in September. Med-Tech Innovation Expo will take place at the National Exhibition Centre (NEC), Birmingham, UK, from 28 – 29 September 2021. Visit https:// med-techexpo.com/ for more information about the event.

New Product Launches Dynamic Features Technology Pavilions 3 Conference Stages 1-2-1 Meetings Programme Start-Up Zone

28-29

MED-TECH INNOVATION EXPO

SEPTEMBER 2021 Be inspired by thought-leaders and discover new solutions, materials, machines and applications from over 300 exhibitors. Join the fastest growing event in medtech. We’ll see you there!

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Ian Bolland spoke to Diane Bryant, chairman and CEO of NovaSignal about the company’s ultrasound device that monitors cerebral blood flow.

A Nova way to flow N

ovaSignal’s device combines artificial intelligence (AI), robotics and ultrasound to improve brain health. The company’s technology allows clinicians to look at blood flow patterns in the brain in real time, allowing them to be alerted to any changes or risks to the patient.

a standard survey; where you raise your arms, smile and speak. It’s crazy. We’re in the 21st century. With our device you put it on someone’s head; 350 milliseconds to find the arteries, less than two minutes to present velocity and presence of emboli, and then you’re off into formal treatment.”

Bryant explains that the technology uses transcranial doppler ultrasound which has been around for over 40 years, but adding AI and robotics to it has allowed it to keep track of the blood flow in the main arteries, detecting the presence of plaque or emboli.

The device is available through distributors in the UK and Irish markets, with the product granted the CE mark. NovaSignal will also apply for the UKCA mark for when it comes into force in 2023.

Explaining further, she said: “From those parameters, velocity and blood flow in the brain, and the identification of particles, you can then diagnose any ischemic or haemorrhagic stroke. “The beauty of this is the robotic system and for the automated collection of cerebral blood flow data, and the algorithms have obviously been developed. The search algorithms can lock on the arteries in 350 milliseconds, that is something no human, no matter how highly trained you are, can find the temporal window in the brain where the spell instance is the narrowest and lock on your major artery.” With the company based in the United States, the company seems to be aiming to increase access for hospitals to have access to better diagnostics and treatments for conditions like stroke. Bryant outlines that NovaSignal’s technology aims to bring about more modern and, as a result, better diagnostics and treatment of brain related conditions. “Today when you walk into 77% of all hospitals and clinics in the U.S they have no way to diagnose a stroke other than

In terms of its use, it can most likely be found in an operating theatre and has been used on patients during open heart surgery and liver transplants among other operations. It can also be used in intensive care units, and for lengthy periods, with comfort a necessary factor during the design process. “If you have a stroke, there’s a 30% probability you’ll have a second stroke so the doctors at that point have to get to the root cause. So, you can go into the ICU for 14 days to be continuously monitored. Without our device there’s no way to monitor continuously so our device is used in the ICU. “The patient can lay in it, it’s comfortable like everything else in hospital with a degree of comfort and be monitored for eight hours.” The third use is for hole in the heart, which affects a quarter of the world’s population, with some completely unaware of the condition, which NovaSignal can detect with bubble injections.

right to left shift and present itself in the blood flow in the brain. So, we can then monitor and count the bubbles so not only can we say there’s a hole in the heart, we can say how large the hole is. We’re the only device that can noninvasively, without radiation, sedation, say you have a hole in the heart and it’s of the size that it should be closed.” This is down to a trend of continuous monitoring, the data collected by the device that’s stored in the cloud informing treatments going forward. Bryant summarised: “All of that data is being aggregated into the cloud. It’s obviously with a virtual private cloud. But that data then is sorted forever so when you have a stroke your physician can pull all of our historical data and say “here.” It’s progression over time rather than just that current snapshot in the moment.”

“They inject the bubbles which, if there’s a hole in the heart, they can cross the

The beauty of this is the robotic system and for the automated collection of cerebral blood flow data, and the algorithms have obviously been developed 29

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