MTI Issue 55 by Med-Tech Innovation Magazine

www.med-technews.com Issue 55 | Sep/Oct 2021

MED-TECH INNOVATION | NEWS MED-TECH

innovation

PLUS Med-Tech Innovation Expo 2021 preview A crucial material in fighting antimicrobial resistance Addressing contract manufacturing shortages

scaling up:

The challenges of making it big in microfluidics

ADVANCING HEALTHCARE

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CONTENTS regulars

COMMENT

Ian Bolland reflects on a return to a form of normality ahead of Med-Tech Innovation Expo

making medtech

A round-up of the latest industry news

12.

cover story

Oxford Product Design explains why making it big in microfluidics can be harder than making it small

17.

MED-TECH INNOVATION EXPO

Accumold throws the spotlight on micro moulding at this year’s show

24.

DIGITAL HEALTH

Sensyne Health analyses the role of algorithms and predictive models, and explains why new technologies are key for the future

34.

Real World Medtech

features 11.

IRELAND

MED-TECH

Sumitomo Demag analyses the injection moulding market and what’s driving new developments

INNOVATION | NEWS

15.

cleanrooms

Connect 2 Cleanrooms explains how to bring manufacturing in-house in a climate short on contract manufacturers

21.

ANTIMICROBIALS

Copper Clothing explains how copper materials can be used to help combat antimicrobial resistance

29.

REGULATION

TÜV SÜD explains the practicalities surrounding the UKCA mark

30.

HUMAN FACTORS ENGINEERING

BlackHägen shares theories and methodologies to optimise human factors engineering for usability

Ian Bolland finds out more about Dxcover and its rapid cancer diagnostic capabilities

THE TEAM editor | ian bolland ian.bolland@rapidnews.com portfolio sales manager | christine joinson +44 (0)1244 952 385 christine.joinson@rapidnews.com portfolio sales manager | victoria dunsmore +44 (0)1244 952 247 victoria.dunsmore@rapidnews.com

vp sales & sales talent | julie balmforth julie.balmforth@rapidnews.com head of studio & production | sam hamlyn designer | matt clarke publisher | duncan wood

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Med-Tech Innovation does not verify any claims or other information appearing in the advertisements contained in the publication and cannot take any responsibility for any losses or other damages incurred by readers in reliance on such content. All submissions are handled with care. Every precaution is taken to ensure accuracy, but the Publisher cannot accept responsibility for the accuracy of the information here. ©Rapid Medtech Communications Ltd. No part may be reproduced or transmitted in any form without the prior permission of the Publisher. ISSN 2046-5424

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from The editor We’re back!

[

f I were to reflect on one thing I have struggled with during my career in editing and writing, it would be my headlines not being succinct enough. For this one I haven’t got a problem with just the two words I’ve used to convey a simple message. You guessed it! This is a plug for the Med-Tech Innovation Expo. It has been a while, but I don’t think I will ever be as glad to see the NEC in Birmingham as I will be on the morning of the 28th of September when we host our first in-person event again for the first time in over two years. I’ll not use this column to be a preview of the show, you can read that later, but it’s fair to say that a lot has changed since we last gathered in the late spring of 2019. Our industry has been in the spotlight like never before in living memory as we have grappled with COVID-19, and perceptions of how technology can be used to take care of ourselves have fundamentally changed. The wider public is perhaps more confident at self-managing their health as many firms in the sector pivot towards a potential change in strategy of preventing illness rather than reacting to it. If anything

positive has emerged from the pain and suffering of the pandemic, it is that we are more conscious about our own health, and each other’s, and more tech literate when taking care of ourselves.

of Day One at TCT 3Sixty, discussing with my colleagues and guests about the impact 3D printing has had on medtech and pharma during a live episode of The MedTalk Podcast.

The Expo with which this publication shares its name will inevitably highlight the changes of different parts of the sector over the last two years, but it’s an opportunity to recognise the work that goes into the creation of these innovations. Whether it is those with the ideas, the material makers, the manufacturers, the designers, consultants – the list can go on.

I am confident that there is something for everyone at the NEC as we explore all facets of the medtech supply chain across our three stages, covering the different needs the industry provides for. I’m looking forward to learning about new developments away from COVID, whether they are new breakthroughs, new ways of working or, indeed, new devices. The world is a different place to when we last met, and I’m sure our two days together in Birmingham will reflect that.

It is also an opportunity, in some case, to recognise the work that some of the companies do elsewhere as TCT 3Sixty and Interplas will attest to, as a trio of Rapid News Group shows run in tandem. One example of the crossover is that you’ll be able to catch me on one of the stages in the afternoon

When not moderating on one of the stages that hosts our array of brilliant speakers, I look forward to meeting as many of you as possible on the 28th and 29th of September. It’s good to be back – now on with the show!

Our industry has been in the spotlight like never before in living memory as we have grappled with COVID-19 5

Making medtech

SALFORD PATIENTS FIRST TO USE LONG COVID APP

eople in Salford living with Long COVID are being supported with the help of a new mobile app and clinical website to track their recovery and improve their health. A team from the Northern Care Alliance NHS Group (NCA), has been working with Salford City Council’s Health Improvement Service to support people suffering from persistent symptoms after contracting COVID-19. Up until now the Salford team has been using the COVID-19 Yorkshire Rehabilitation Scale (C19-YRS) to aid diagnosis and assessment of Long COVID symptoms. This was initially being collated manually, with 24 patients being contacted each week since February. Now Salford patients will be able to download an app onto their mobile device and update their progress at varying stages of their recovery, allowing their clinician to make any changes to their care management plan. Programme manager Sarah Cannon said: “The app means information can now be sent electronically direct to the Long COVID Clinic Team, so they have information ahead of appointments. We can even decide on the length and type of appointments using the tool to match the needs of the patient.” The app, developed by Elaros, in partnership with The University of Leeds NHS Trust, allows patients to self-report symptoms and the impact their symptoms are having on their daily health and wellbeing. NHS England and NHS Improvement have recommended use of the digital platform within national guidance for post-COVID syndrome assessment clinics. The app uses scientific research and takes the patient through a series of questions to record their health status before contracting COVID.

£1.8m crowdfunding round to deliver ophthalmic and optical diabetes devices

ccuity, a UK-based medical technology start-up, has launched a crowdfunding round to accelerate the development of new optical screening and monitoring devices that aim to detect the early signs of chronic health conditions by scanning the human eye. Founded in 2019, Occuity has developed and patented contactless optical technology to obtain precise measurements from the eye. It is seeking investment of £1.8 million through the Seedrs platform to bring a range of new medical devices to market that use this technology for ophthalmic examinations, diabetes management, prediabetes screening and, in the

longer term, the early detection of Alzheimer’s disease. Efforts to bring these new devices to market are led by Occuity’s founder and CEO Dr Dan Daly, company co-founder and CTO Dr Robin Taylor, and Daniele De Iuliis, a 27-year veteran of Apple’s industrial design team, who joined Occuity as design director in 2020. Roll-out plan for Occuity’s new medical devices • Occuity’s first device is aimed at the optometry market and measures corneal thickness with micrometre level precision. This is due to begin clinical testing and is expected to be approved for use in the EU by early 2022.

SOFTWARE COMPANY HELPING IMPROVE PATIENT SAFETY AND CARE

ewcastle-based software company Surge has recently launched a dedicated new brand Surge MedTech, as it continues to grow in the digital healthcare space. In 2019, Surge partnered with the Great North Air Ambulance who were looking for a way to move away from paper records and keep a digital log of all the work they do including individual patient interactions. This led to the creation of ARCEMS, a system that enables paramedics to capture patient details wherever they are working via a mobile app. Capturing this information lets air ambulance services maintain a full audit log of their activities and then use this information to identify areas of improvement meaning patient care is continuously reviewed and enhanced. Following roll-outs at the Great North Air Ambulance, Lincs & Notts Air Ambulance and Hampshire and Isle of Wight Air Ambulance, the ARCEMS software then evolved to help out in the world of critical care patient transfers and the new ARCCTS software was born. In 2020, Retrieve South West, headed up by Scott

• T he company plans to launch a pre-diabetes screening device in 2024 to allow mass testing for the emerging signs of Type 2 diabetes at pharmacies and opticians. • In 2025, it intends to introduce a personal noninvasive optical glucose monitor that will enable people with diabetes to monitor their blood-sugar levels without drawing blood.

Grier, who is also National Critical Care Transfer Lead at NHS England, began using ARCCTS. The software proved essential during the height of the COVID-19 pandemic, where at its busiest there were 2,300 intensive-care patients moved between UK hospitals from September 2020 to March 2021, which represented a year-onyear increase of 191.5%. Speaking about the relationship with Surge, Grier said: “At times of significant pressure on our service during the recent pandemic wave, their support was an important part of our service’s ability to deliver critical care transfer to patients in the South West and beyond.” Following the continued growth and evolution of its software Surge has recently launched a new sub-brand: Surge MedTech.

Smartphone diagnostics tool part of respiratory disease trial

yfe, a cough monitoring smartphone app and digital diagnostics tool developed by an international team of scientists and public health professionals, is seeing its technology be incorporated into research in Spain in partnership with the University of Navarra, and involving over 800 participants. The study will introduce artificial intelligence technology and cough detection smartphone applications into epidemiological research for the first time. This methodology of digital cough monitoring for early detection of respiratory disease outbreaks at a community level has never been performed in research settings before. The trial is taking place in the city of Pamplona, Spain and the neighbouring municipalities of Cendea de Cizur and Zizur Mayor. Participants are monitoring their night time cough patterns using the Hyfe

Making medtech

• O ccuity hopes that its research and development will also support the delivery of a routine screening device capable of detecting early signs of Alzheimer’s disease by identifying biomarkers deposited in the eye. Dr Dan Daly said: “The eye provides a window into human health. Occuity’s vision is to use this window to identify chronic conditions faster and earlier with non-invasive, non-

smartphone app. Hyfe’s partnership with the University of Navarra, Zizur’s Health Center and Montreal University Hospital Center (CHUM) is centred around identifying if the digital study of cough monitoring can predict the incidence of respiratory diseases and potentially, the appearance of future outbreaks. Hyfe is an artificial intelligence platform that detects and tracks coughs as they happen in real-time via a smartphone or wearable device. The company’s software platform encompasses machine learning algorithms to accurately detect cough and cough frequency in a precise fashion, before using acoustic analysis to help detect and diagnose respiratory illnesses. All participants taking part in the research trial fully

contact handheld devices, and provide tools to manage those conditions better. “There is a huge opportunity to deliver a step-change over the next decade in optometry practice and the way chronic diseases like diabetes and Alzheimer’s are detected and managed. “We are inviting people who share our vision of transforming health screening to invest in our crowdfunding campaign to improve the lives of hundreds of millions of people worldwide.” Daniele De Iuliis added: “Thanks to Occuity’s ingenuity, it is becoming possible to detect and manage debilitating health conditions through a quick, non-contact eye scan. “We are developing gamechanging medical devices for use in non-clinical settings and by the patient. They will be kinder, more intuitive and more convenient than existing technologies, and they will be accessible to all.”

consented to have their medical data reviewed periodically throughout the course of the trial. From this regular analysis, the incidence of respiratory or cough-associated diseases can be established. Hyfe co-founder and CEO Joe Brew said: “COVID-19 has taught us that the old way of doing epidemic surveillance and monitoring is simply not good enough. For health systems to effectively stay ahead of rapidly changing realities, both at the patient level as well as the population level, we need to enlist novel methods, novel sensors, and novel approaches. The trial in Navarra is the first ever to implement the concept of “acoustic syndromic surveillance” in real-world settings. I’m confident we’ll look back on this as a pivotal moment in global health history.”

RESEARCHERS DEVELOPING ‘REVOLUTIONARY’ VR KIDNEY DIALYSIS PLATFORM

esearchers at Glasgow Caledonian University are working on a Virtual Reality tool that could revolutionise the way nurses, children on kidney dialysis and their families are trained. The 12-month project, in partnership with the NHS and funded by Kidney Research UK foundation, is exploring the development of a novel Virtual Reality kidney-dialysis training system that will enable patients, families and medical staff to experience and learn safely the process of dialysis. The GCU team is developing a Virtual Reality application that simulates a dialysis machine, its associated equipment, and the complete process, in a virtual patient. This will allow families to undertake training at their own pace in their home, and experience what dialysis may entail. Virtual Reality can provide feedback such as warning flashing lights, alarms, or via vibration. The application is intended to complement existing training, aiming to reduce the duration of inpatient education delivery and the frequency of outpatient educational visits. It can also simulate potential adverse scenarios to specifically prepare and train users for complications that may occur during the dialysis process but may not be routinely encountered during real-life training. Professor Vassilis Charissis, who is leading the project at GCU, said: “Dialysis is the

process by which a patient is kept alive when their kidneys stop functioning. The duration of such therapy can be years for some patients as they wait for a suitable transplant. For younger patients and their families, this is an extremely stressful time as they usually have very limited exposure to dialysis as a process, or to dialysis-experienced peers. This makes informed decisionmaking difficult and provokes anxieties in families about the choice of a dialysis method, and how they may cope with home-based therapies. “For patients facing renal replacement, this system could provide a fully interactive and immersive manual, guiding them through their options for treatment, supporting informed consent, training them through the early stages of the procedure if they opt to receive treatment at home, as well as acting as a reminder during the process and when troubleshooting of dialysis equipment is required.” The project will be developed and trialled in close collaboration with specialised NHS staff under the lead of Dr Ben Reynolds, consultant nephrologist, at the Royal Hospital for Sick Children in Glasgow. By streamlining such a system for the most vulnerable group of patients first, such as children, Professor Charissis says the researchers hope to expand the application for use to the whole population of renal patients.

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Sapphiros acquires Biocrucible to accelerate diagnostics platform to market

ills & Reeve has acted for the majority shareholders of Biocrucible, a Cambridge based molecular diagnostics company, on its sale to Sapphiros. Biocrucible is a molecular diagnostics company which applies isothermal amplification methods to disposable and point-of-care diagnostic technologies and seeks to enhance the behaviour and kinetics of engineered biological systems using its Molten Tags technology. The platform is currently being developed for the detection of SARSCoV-2, although the technology can also be used for the detection of other respiratory and non-respiratory pathogens. Sapphiros, an investment firm founded by KKR, and Namal Nawana, the former CEO of both Smith & Nephew and Alere, has been established to invest in growth-stage companies offering sophisticated nearpatient diagnostic technologies. The acquisition by Sapphiros will provide further investment and operational support to accelerate Biocrucible’s platform to market. Mills & Reeve acted for the majority

shareholders of Biocrucible, which has been a client of the firm since they were a start-up. Niall Armes, chief scientific officer at Biocrucible said: “This is an incredibly exciting moment for myself and the whole Biocrucible team who have built an amazing new molecular detection biochemistry”. “We will push hard to bring the next generation of molecular detection products right to where they are needed – in the home, in the doctor’s surgery, and in low-resource settings. “This is a very personal opportunity for me finally to realise my ambition to lead the diagnostics sector with advanced cutting-edge technology solutions. We intend to make molecular diagnostics as accessible as their lower performance lateral flow cousins.” Dr David Brooks, CEO of Biocrucible, added: “The acquisition of Biocrucible by Sapphiros is a powerful validation of our approach to develop market-leading consumer molecular diagnostics. We look forward to working together with Sapphiros to scale our technology and deliver tangible benefits to patients worldwide.”

Static Systems Group appoints new managing director

tatic Systems Group has appointed Rosie Cunningham Thomas as the company’s new managing director. Cunningham Thomas has more than 20 years of strategic and operational leadership in global corporates, SMEs, and start-ups. Over the past 12 years, she has specialised in leading and scaling early stage, innovation-driven health technology companies through critical growth stages to full commercialisation and clinically evidenced market acceptance. She has prior medical CEO experience at Episurf Medical AB, ToHealth Ltd., and FreeHand 2010 Ltd. Prior to her business leadership roles, Cunningham Thomas held several senior commercial positions at Bard BD and Smiths Industries’ medical division. Most recently,

she was the CEO at NuVision Biotherapies, a regenerative medicine company which develops biomaterials. Cunningham Thomas said: “I am delighted to be joining Static Systems Group (SSG) as it starts its next growth phase as part of Halma plc. The Turner family legacy is impressive, and together as SSG, we can honour this legacy whilst building for the future, creating sustainable and lasting

Creo to raise £35m for growth plans Creo Medical Group is raising about £35 million to support further growth of the company, including through potential strategic acquisitions. The fundraising includes a £30 million placing of shares to new and existing institutional investors and a £5 million open offer which will be available to all qualifying shareholders.

As well as allowing Creo to explore possible acquisitions, the funds will help accelerate the Chepstowheadquartered company’s commercial rollout of its products in the US, EMEA and APAC; develop its products and technology; invest in further clinical trials and R&D.

value.” Cunningham Thomas is a dual UK/US national having emigrated to the UK to marry her English husband. She is a pharmacist and earned a pharmacy degree from the University of the Sciences in Philadelphia and studied business management at the University of Pennsylvania. She will be based out of the SSG facility in Wolverhampton.

Creo chief executive Craig Gulliford said: “These additional funds will be used to accelerate the commercial roll-out of our suite of patented electrosurgical devices powered by our CROMA Kamaptive Energy Platform technology, but also provide us with the means to develop this portfolio to allow full integration with some of the leading robotic surgery technologies. “This also means that we are well funded to continue to explore further strategic acquisition opportunities, continue our research & development progress for new devices and allow us to the undertake the clinical trials necessary to target markets in China and Japan.”

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INJECTION MOULDING ON THE GROW

Darren Herron, UK national sales manager at Sumitomo Demag, analyses the injection moulding market and what is driving new developments for medical applications.

he global medical injection moulding market size was valued at $1.38 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 8.2% between 2020 and 2027. Much of this is being driven by advances in the home healthcare sector and an ageing population, which WHO predicts will double by 2050.

phase. With demand for its medical device injection moulding and toolbuilding services increasing, Avenue recently installed a new 100 sqm ISO Class 8 cleanroom area.

Plastic moulding continues to be used for many medical applications, including manufacturing implantable medical device components, test tubes, beakers, casings and housings for laboratory and medical equipment, drug delivery components and surgical equipment. With demand for medical devices at an all-time high across hospitals and laboratories thanks to COVID-19, this has had a positive impact on market growth.

Gerard Henn, Avenue’s general manager, said: “All medical programmes are lengthy as it can take two to three years to obtain approvals from the authorities, so there are many months of testing before a component or mould is ready to be scaled up to mass production.”

ALL-ELECTRIC INTELECT FOR HYGIENE SENSITIVE MARKETS Sumitomo (SHI) Demag recently supplied a 75 tonne IntElect all-electric injection moulding machine to Avenue, a Nolato Company, in Sligo, Ireland. The investment supports the growth in the company’s healthcare division, providing dedicated capacity to mould precision parts during the product development

The IntElect machine met Avenue’s brief for a small footprint machine for carrying out test runs during the development phase of projects.

The machine’s small footprint is down to the use of its own motors and drives. The model also has wide tie bar spacing and high clamp force for its size, allowing the use of larger moulds than would normally be accommodated by a 75-tonne machine. TRACEABILITY IS KEY Advanced batch tracking, contact-free inspection using cameras, and highly automated assembly are among the latest developments to meet the medical device market’s precision and quality control requirements. Traceability is not just about mandatory information and supply chain tracking. Real-time traceability is about being able to call up data and verify the exact settings used on the injection moulding machine when that individual plastic part was made, making connectivity to a Management Executive System (MES) vital. For example, when parts are being produced on multi-cavity tools, like pipettes, robots are programmed to remove and place the components into cavity-assigned racks. This means that if an issue with cavity 1 arises, the rack containing all corresponding cavity 1 parts can be isolated and the rack recalled, with all the production information stored in the MES. To enhance patient safety, there’s a drive towards using new and more innovative regulated materials with a better flow and high impact strength to mould components. The EU Medical Device

regulations came into force on 26th May 2021, following a one-year extension due to the pandemic. In Vitro Diagnostic medical device regulations (IVDR) become effective on 26th May 2022. In the UK, the market is currently regulated by the UK Medicines and Healthcare products Regulatory Agency (MHRA). This creates some complications in relation to the CE marking process on medical devices as the UKCA (UK Conformity Assessed) mark will replace the longstanding CE mark for goods, including medical devices, sold within England, Wales and Scotland. As there’s no hard border in Ireland, the CE mark still applies there. CONTINUED SUPPORT FOR THE IRISH MARKET With a large proportion of Sumitomo (SHI) Demag’s Irish customers in the medical market in Ireland, we last year opened a service and support office in Limerick, Ireland. This was to support its installed base of predominantly all-electric machines, providing on-the-ground preventative and reactive machine maintenance and troubleshooting support. Establishing an Irish office is also part of a post-Brexit insulation strategy that will moderate any potential concerns Irish moulders may have about dealing with a UK machinery supplier. A permanent in-country service and support base will facilitate timely spare parts sourcing and trading in euros without incurring hefty exchange fees. We firmly believe that Ireland’s talent base and this supportive infrastructure will continue to make Ireland very attractive to inward investment, especially in medical and biotechology R&D.

on the cover

Steve Green, head of design at Oxford Product Design, explains why making it big in the world of microfluidic devices is often more challenging than making it small.

icrofluidics is a key technology enabling the development of rapid in-vitro diagnostics (IVD). With applications including COVID-19 testing, cardiac arrest assessment and STD screening, decentralised rapid diagnostics are shaping up to be a major part of the future of healthcare and wellness monitoring. As the name suggests, microfluidics is about the movement and manipulation of very small volumes of liquids to automate test protocols or assays. Currently these assays are (most commonly) centrally processed in hospitals or labs by either large, expensive machines or human beings armed with a selection of pipettes and other gadgets. These current practices are costly, difficult to control and susceptible to human error, which is why the case is strong for microfluidic solutions. The manufacture of microfluidic devices is anything but straightforward. Having been involved in several in-vitro diagnostic product developments from a mechanical design perspective we appreciate the challenges that come from the scale of the features; they’re not called micro-fluidics for nothing. What we’re exploring here is not only the challenge of making very small things but making them on a big scale.

THE NOT-sosmall matter of scale 12

One way that many IVD providers have attempted to avoid microfluidic features is through development of novel sample processing consumables that can be manufactured using common mass-production processes. Although several have experienced commercial success it is arguable that the compromise is typically oversized consumables, overly complex analysers, and inefficiency in the use of both patient sample and reagents. Once the microfluidic puzzle is solved these ‘macrofluidic’ products are likely to become niche, if not a thing of the past.

microfluidics

Here are some engineering challenges typically faced with microfluidics: Manufacturing tolerances: +/0.1mm on a specified dimension for case-moulding of a handheld or bench top product is common and generally achievable. In microfluidics 0.1mm is often the size of the feature itself so we need to start talking about tolerances in microns. For the engineers reading - ISO fine doesn’t cut it here! Uncertainty: The ambiguity of evolving chemistry and/or detection technology typically requires many iterations of a device being developed and tested before settling on the design of the endproduct. Designing a platform to perform complex protocols with the requirement for parallelisation of several biomarkers into a single test can best be described as like trying to solve a maze with moving walls. Liquid interface: At such a small scale the influence of the interface between the fluid and the materials that make up the containing surfaces is significant. The surface energy of polymers is variable not only between different polymer types but by different surface finishes within the same polymer. Whether the face is rough or smooth can be the difference between hydrophobic or hydrophilic behaviour. Repeatability: Data is King in the world of in-vitro diagnostic development as the foundational science is based on the ability to accurately repeat fluid handling processes and precisely replicate quantitative results. Each design iteration has a significant lifecycle to support the production of a sufficient number of prototypes to allow for data to be gathered. Additionally, it requires a sizeable investment in quality control as inconsistency in production will produce inconsistent results. Methods for manufacture. The methods that can scale often involve specialist materials and

processes which are expensive, have long lead times and are uncommon. Academics have developed several techniques for making single or small batches of devices containing microfluidic channels, however these are labour intensive and cannot scale to production volume. This has led to a monopolistic or arguably nonexistent market for capable contract manufacturing organisations. Often these restrictions lead to the use of prototyping methods that do not reflect the end production process. TO SUMMARISE: (1) It requires a significant number of consumables to complete each iteration of assay testing. (2) It takes time to validate the production of each consumable design iteration such that the results can be trusted. (3) T he production of the consumables for testing tends not to be aligned with massproduction intent. The limitations of (3) feed into the effort required for (2); variability from (2) into the results for (1); requirements for (1) into the decision making for (3): a continuous circle of complexity and unavoidable compromise into which several start-ups have spiralled and struggled to surface. Let’s say you manage to navigate this and now have an assay, detection method and consumable design that has proven to be a winning combination. Just one final and significant hurdle to jump: transferring the design to production — how to ensure what you’ve proven to work at a small scale can be made at production quantities (+1million units per annum)? It’s a challenge but here are some of the areas we recommend focussing on to maximise development efficiency and your chances of technical success: Quality. Regulatory approval should fall out as the result of a well-considered and proactively

documented development strategy. Don’t fall into the trap of thinking that quality management is just a case of ticking the regulatory boxes. Foresight. Developing a manufacturing plan early and understanding the limitations of production material/process/ surface finish up front helps predict the variation (using the modelling method outlined below) and it is often possible to build in compensation to the prototype design where necessary (increasing the resistance of a channel as compensation for increased hydrophobicity in production, for example). Theorise. It is possible to model and iterate microfluidic designs theoretically before making anything. As with any model, ‘garbage in = garbage out’ so it pays to have past experience to inform your initial design such that you can have faith in the results. Some modular, bench-level testing must be expected for anything new or novel, but it is possible to save 2–3 development iterations by taking the time to construct and iterate a simulation of the proposed system before diving into the prototyping spiral described above. Communicate. It is important your team can communicate effectively across disciplines. Engineers, designers, biochemists, and labtechs need to find a common language such that can work together and stay informed by past efforts & intentions and stay aligned with the bigger picture. Microfluidic developments take on average 10 years to reach the market which means the people who start the project are likely to differ from those who finish. Without documentation of prior work and considered onboarding of new people it’s easy for a team to lose sight of the reasoning behind their current objectives. You can find out more by visiting Oxford Product Design at MedTech Innovation Expo – stand B70K.

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cleanrooms

BRINGING IT IN-HOUSE: Addressing contract manufacturing shortages Joan Benson, regulatory governance & assurance manager at Connect 2 Cleanrooms, explains how to begin manufacturing in-house in a climate short on contract manufacturers.

onnect 2 Cleanrooms (C2C) is hearing from more and more organisations that have traditionally outsourced manufacturing but are now finding contract manufacturers have no capacity. Faced with the threat of not being able to outsource this vital service, organisations are investing in cleanroom facilities to bring manufacturing in-house. The drought in contract manufacturing capacity is partly fuelled by the recent trend for pharmaceutical and medtech industries reshoring manufacturing activity due to the global disruption because of the COVID-19 pandemic. Another contributing factor is that many facilities that have previously been available for contract manufacture have been required to repurpose into other areas, such as vaccine production. Companies who have no previous understanding of specifying or project managing a new cleanroom build may find this daunting. However, what’s ultimately more daunting, is the risk of not taking this step. There is a significant risk that the development of important routes to market, such as clinical trials, will be halted. Just as the medical device industry is governed by its own set of standards, cleanrooms must conform to ISO 146441:2015. The standard contains a range of classes with clearly defined particle concentration limits that determine the cleanliness of an environment. A cleanroom must be designed to achieve the appropriate class of air cleanliness and the nature of the process often dictates the classification required. EU GMP-compliant cleanrooms will also be classified according to the test methods in ISO 14644 but may have different limits and may require additional testing. Let’s look at some of the applications for ISO 14644-1 and EU GMP cleanrooms in the medical device fields and the crossover between the two standards.

Medical devices are regulated by the Medical Devices Regulations (MDR) 2002. All medical devices are given a classification depending on the level of risk associated with the device. The strictest control is for products with the highest risk. Class I - generally regarded as low risk Class IIa - generally regarded as medium risk Class IIb - generally regarded as medium risk Class III - generally regarded as high risk Most cleanrooms intended for the manufacture of medical devices must comply with ISO Class 5 to Class 8 standards, however all active implantable medical devices and their accessories fall under the highest risk category (Class III). A Class III Medical Device includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device. These devices should be manufactured in a GMP

cleanroom. Aside from the initial investment required, in-house manufacturing can bring big benefits to organisations—such as greater control over production runs and quality standards. ISO and MHRA-compliant manufacturing environments that are suitable for activities regulated under GMP can be installed into existing buildings, or even into modular cabins if space is at a premium. There is no doubt that bringing manufacturing in-house would require transformational change within an organisation, but this risk can be mitigated within projects by using 3D digital modelling to offer a unique preview of the cleanroom facility before it is built. This enables organisations to optimise the layout, simulate work and materials flow, and check maintenancerelated activities upfront. Over the years, C2C has developed proven envelope solutions and reliable HVAC concepts for many applications. All cleanrooms meet their required ISO classification, and some systems can also be qualified to EU GMP. In-house regulatory expertise allows C2C to input on the client’s user requirement specifications (URS) to make sure the planned facility will be compliant and the necessary regulatory standards achievable.

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Med-Tech Innovation Expo

SPOTLIGHT on: micro moulding

Accumold is showcasing micro moulding innovation at this year’s Med-Tech Innovation Expo.

he medical device industry is constantly looking for smaller products and components with ever more exacting and often micronlevel tolerances. The industry demands absolute precision, totally repeatable manufacturing processes, and zero failure rates for products that are frequently used in safety-critical applications. As such they must work alongside and partner with micro moulding experts that are working at the cutting-edge of advanced design and manufacture. For medical device OEMs, design for micro moulding (DfMM) is complicated, as the “norm” in terms of geometric complexity and material performance are different from moulding larger scale products. Working with micro moulding experts early in the product development cycle and at design reviews is important as they can offer vital insight into issues such as design for tolerance achievement, optimal gate locations, accounting for flash and mismatch, advice on prioritising and limiting critical dimensions, and material selection for optimal outcomes. At Med-Tech Innovation Expo, Accumold will be displaying a range of medical parts and components that it has manufactured over a long relationship with the medical device sector globally and through an innate understanding of DfMM. The company is truly vertically integrated, and as such it can operate as a one-stop partner in the development and manufacture of medical devices and components.

Under one roof, Accumold offers design and material assistance, micro tool fabrication, proprietary micro moulding services, cuttingedge metrology, assembly, and automation. This facilitates the streamlining of customer’s medical product development process, and the attainment of optimal outcomes in terms of timeliness, cost, and accuracy. Aaron Johnson, VP of marketing and customer strategy at Accumold, said: “We are proud to say that we have partnered with countless leading medical device manufacturers across the world, and with each we operate strategically to ensure that the product development process is as efficient as possible. Our over 30-year association with micro moulding and micro manufacturing really gives us the edge, and we are not only the most experienced micro moulder in the world, but also the largest. This affords our customers with the reassurance of working with a robust and secure company that can provide efficiencies that lead to affordable production, and one that has the capacity and infrastructure to ramp up to full mass volume manufacture. We are also ISO 13485 accredited, the stringent and internationally recognised quality management system for medical devices.” Micro moulding for medical device OEMs is an art form honed after years of expertise and troubleshooting, and it is vital that micro moulders have the business culture, personnel, and equipment in place to provide the service necessary to ensure a successful project outcome. Micro moulders for medical device OEMs will be dealing with low, medium, and high volume runs in a variety of different materials, all requiring different levels of validation. They must also have

the expertise in handling, storing, and processing often extremely expensive and sensitive materials that in many instances will be used in critical implantable applications. Johnson added: “The regulatory environment is one that is becoming more and more important for medical device OEMs and ensuring a partnership with a micro moulder that has an understanding of this environment is disproportionately important. Much of the focus today is on the 510(k) approval process, which seemingly changes week to week. In general, medical agencies the world over have toughened up in the area of product approval, and have started to request information from medical device OEMs never previously required. This has meant that the percentage of firstround 510(k) submissions requiring more information has gone up dramatically, often resulting in timeto-market delays and expense. Engaging a micro moulder with an innate understanding of the vagaries of the 510(k) process can save enormous amounts of time and effort.” Accumold wants to engage with any medical OEMs that will be at Med-Tech Innovation Expo and looks forward to meeting everyone at one of the first face-to-face events the company has exhibited at since the COVID-19 pandemic and will be located at stand D18.

med-tech innovation expo

Editor Ian Bolland picks out what he’s looking forward to as the Med-Tech Innovation Expo returns.

Two days, three conference stages and thousands of visitors, it really is good to be back. If you don’t know where to begin when it comes to MedTech Innovation Expo, then I am here to try and give you a couple of pointers on our conference stages away from simply searching the A-Z of our exhibitors and speakers.

THE INTRODUCING STAGE: As pointed out on our preview episode of The MedTalk Podcast, if you don’t really know where to start, then the Introducing Stage might well be for you; as it contains quick-fire presentations that last up to 20 minutes, with an agenda covering an incredibly broad spectrum of the industry. Our two-day programme covers topics including artificial intelligence in medtech, project planning, developing new products, assembling medical devices; meaning there is something for everyone covering different parts of the supply chain. One particular event I am looking forward to on Day 2 is Pitch@MedTech Innovation Expo. This event is sponsored by NIHR, SBRI, NHS England and NHS Improvement and will offer you the chance to see presentations from six promising start-ups in the industry before a panel of judges. As we have focussed on start-ups a lot in the past year or so, both in the magazine and on the website (as well as being a judge on the event itself), I’m really looking forward to seeing what ideas and products these bright minds present. Separate to this, but on a similar subject, on the show floor you can find more of this kind of thing in our start-up zone – something which I will be hoping to check out over the course of the two days.

THE HEALTHTECH STAGE: Here we focus on finished medical devices; from conception right through to their commercialisation as expert OEMs will look at research and development, clinical trial processes, regulatory hurdles, and materials used. With 14 presentations across two days, it’s hard to just pick one or two but I will give it a go! A couple that stand out for me include Clennell Collingwood from TTP plc discussing what is needed for a device to be successful in the future. Having previously seen the device in person, I’m also interested to hear about the development of Sky Medical’s Geko Device, as Matthew Watts will discuss bringing that to market. Having been developed to improve blood flow and help prevent DVTs, I’m interested to hear what goes into making this wristwatch-sized device, and the kinds of patients it can be used on now, and in the future.

med-tech innovation expo

THE MED-TECH INNOVATION CONFERENCE – IN ASSOCIATION WITH MEDILINK Here is where you will hear highlevel thought leadership from some of the most well-known names in the sector including KPMG, Cleveland Clinic and Innovate UK, as well as speakers from NHS England and NHSX among others. A couple of sessions catching the eye include Dr Neil Ebenezer from the Department for International Trade who will talk about the UK government’s support for medtech exporters on Day Two. As the economy recovers from COVID-19 in a post-Brexit environment, this a timely and necessary issue to cover as businesses look to maintain and grow their footprint in overseas markets. On Day One, I’m also very interested to hear from Dr Ashton Harper from Roche Diagnostics, who will talk about IVD Innovation. Diagnostics and home testing is something that more of the population has become accustomed to over the last 18 months or so, and it will be interesting to hear about the advances made in the sector, as well as how it can help tackle a variety of conditions.

WHAT ELSE IS GOING ON? It’s worth mentioning that this year Med-Tech Innovation Expo will be running alongside other Rapid News Group events: TCT 3Sixty – focussing on the understanding of the potential of additive manufacturing and 3D printing technology – and Interplas, the UK’s leading plastics industry event. If you’re planning a three-day stay in Birmingham, once Med-Tech Innovation has concluded, there is still some medtech to offer on the floor of our other two shows. BioCote will be showcasing the latest in antimicrobial innovations at Interplas and how they can be used in medical device materials, while Kistler – who featured in an earlier edition of this magazine – will highlight its manufacturing process monitoring systems. Kistler has seen a significant uptick in interest from medtech in its medical compliant versions of its systems since late 2020. At TCT 3Sixty, you will have numerous suppliers to the medical device industry. In an interview for this magazine, one company told me they went shopping at a previous show for a 3D printer so they can develop their anatomic models for surgical training in-house. That’s just one example of its imprint on medtech. On Day One of the shows, the close links will be highlighted further as you’ll be able to see myself and EPM Magazine editor Reece Armstrong host a live episode of The MedTalk Podcast with guests as we discuss the impact that additive manufacturing has had on medtech and pharma, which is sure to provide some interesting insights from the panel. Examples of those featuring on the TCT 3Sixty show floor include TRUMPF, who’ve recently supplied Smithstown Light Engineering – based in Shannon, Ireland – with a 3D printer to expands its manufacturing capabilities to support the medical device sector in the country. Regular readers of Med-Tech Innovation News will have come across 3D Systems, who have developed medical devices and anatomic models, as well as Ultimaker which made its network available to hospitals and healthcare networks as the world began to grapple with COVID-19.

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antimicrobials

FIGHTING AMR: HOW IT CAN COME Rory Donnelly, clinical research director of Copper Clothing, explains how copper can be a crucial material in the fight against antimicrobial resistance. THE THREAT OF AMR The World Health Organisation (WHO) has declared that antimicrobial resistance (AMR) is one of the top 10 global public health threats facing humanity. By 2050, drug-resistant infections will kill an extra 10 million people a year worldwide – more than currently die from cancer. A review of the annual 2020 WHO Antibacterial Pipeline Report, revealed that due to lack of antibiotic innovation, “the clinical pipeline and recently approved antibiotics are insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance.” As such, the WHO for the first time recognised the need to find novel solutions to tackle AMR and diversify non-traditional antibacterial medicines. However, antimicrobial solutions such as copper fail to be mentioned, highlighting a crucial gap in medical diversification and innovation globally. THE ANTIMICROBIAL BENEFITS OF COPPER Copper has been recognised as a medical tool for thousands of years due to its oligodynamic properties - which is the ability of certain metals to exert a lethal effect on pathogenic cells. After battle, ancient Egyptian and Babylonian soldiers used to shave their bronze weapons and add the filings to their wounds to prevent infection, and it has been used in Ayurveda medicine for centuries. More recently, copper has been used in areas with high-touch surfaces such as hospitals and theme parks around the world, to reduce the spread of infection. The US Environmental Protection Agency (EPA) has approved the registration of antimicrobial copper alloys with public health claims – including most recently to be used against SARS-CoV-2, the virus that causes COVID-19.

THE DEVELOPMENT OF COPPER MEDICAL DEVICES Various studies have demonstrated the antimicrobial properties of copper, and its use for medical devices is growing. At Copper Clothing we are pioneering research and development which is driving transformational change in the medical device industry. Building a cost-effective, antimicrobial wound dressing portfolio to enhance patient care, whilst reducing the wider economic burden on global healthcare systems. In a recent peer-reviewed study, our copperinfused wound dressings were found to improve surgical site infection by over 80%. Additionally, in the first study of its kind, copper-infused sanitary towels made by Copper Clothing have demonstrated a significant reduction (77%) in infection rates for childbirth by vaginal delivery (VD). This could have huge potential promise for reducing infection and in turn reduce the use of antibiotics in disease treatment. THE BARRIERS TO MEDICAL INNOVATION The pandemic has thrust conversations around the spread of disease into the spotlight, highlighting the efficiency of many superbugs to thrive on common surfaces – so why aren’t antimicrobial materials like copper being used more? As often is the case, a key factor is cost, with many hospitals switching from copper to stainless steel as a cheaper alternative. That said, stainless steel requires frequent cleaning and, it is clear from reports about rising hospital-acquired infections, this is not an adequate solution. Copper on the other hand has self-cleaning properties

which could help prevent this. This highlights the need for medical institutions to consider long-term costs over the short-term. Additionally, silver continues to be widely used in medical settings as an antibacterial, despite being more expensive and less effective as an antibacterial than copper. The NHS spends upwards of £20 million on silver wound dressings; yet silver does not work as an antibacterial without a high temperature or humidity present, whereas copper does. There is also growing evidence to suggest that silver is not immune to the generation of bacterial resistance which is a huge concern given how widely it is used today. Furthermore, there is a disconnect between the pace of industrial research and regulatory approval, which is slowing down the adoption of innovative medical devices into healthcare systems. While processes are needed to ensure high standards of quality and safety, it is crucial regulatory agencies do more to streamline the approval process and ensure the medical sector can keep up with evolving technologies. FUTURE OF PANDEMIC AND INFECTION PREVENTION The WHO has identified the need to diversify non-traditional approaches to tackle AMR. Yet naturally abundant resources like copper, which have the power to prevent the spread of infections, are not being fully utilised. If the COVID-19 pandemic has taught us anything, it is about the necessity to consider long-term costs over short-term ones. With a drug-resistance crisis looming, governments and public health agencies must not overlook crucial tools of prevention that lie at our fingertips.

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antimicrobials

THE BENEFITS AND GROWTH

of antimicrobial medical devices David Hall, managing director of BioCote, explains more about the company’s antimicrobial technology and its growth potential.

ntimicrobial technology provides permanent protection against the growth of a wide range of microbes and, according to recent reports, demand for antimicrobial plastic products and coatings in the medical and healthcare sectors are increasing. BioCote’s antimicrobial additives are used in the production of a range of medical devices and equipment, from ventilators and breathing circuits to hospital beds and examination tables. In the medical and healthcare sectors, antimicrobial technology is primarily used to strengthen the stringent cleaning and handwashing regimes that are commonplace in hospitals, health centres, clinics and surgeries. Medical devices, products and equipment containing integrated antimicrobial additives are protected against the growth of a wide range of microbes, making them easier to keep clean and reducing the risk of crosscontamination. INTEGRATING ANTIMICROBIAL ADDITIVES Plastic antimicrobial medical items are created by integrating antimicrobial additives directly into the plastic material during manufacturing. Alternatively, additives can be manufactured into a coating to subsequently apply to existing medical devices or equipment. Antimicrobial technology might be used on an entire item, or just on key touchpoints – such as side guards, buttons and levers on a patient stretcher. Antimicrobial additives are made from antimicrobial materials (‘active ingredients’). We typically use silver ion

for healthcare applications – it is well proven and offers excellent efficacy. Additives are supplied to our partner customers as a concentrated powder, a liquid suspension or as masterbatch pellets, depending on the type of product being treated and its end use, and the production process. ANTIMICROBIAL BENEFITS Once additives are integrated, the treated product or coating becomes antimicrobial, and will be permanently and continuously protected against the growth of a wide range of bacteria, mould, fungi and some viruses – providing the product or coating itself is not compromised. As an example, the number of microbes on a plastic surface protected with our technology can be reduced by up to 86% in 15 minutes and by up to 99.99% in a 24-hour period. Our technology is effective against E. coli, MRSA, Salmonella, Campylobacter, Listeria and influenza A H1N1, and also reduces a strain of feline Coronavirus by 90% in two hours. Preventing the growth of microbes also reduces unpleasant odours, staining and material degradation – helping to extend product longevity. MARKET GROWTH Recent reports forecast market growth for antimicrobial plastic products and coatings – partly attributed to increasing demand from the medical and healthcare sectors. A MarketsandMarkets’ report estimates the antimicrobial plastics market will grow from $36.9 billion in 2020 to $59.8 billion by 2025, at a compound annual growth rate (CAGR) of 10.1%. Meanwhile, a report from Grand View Research says the market is expected to grow at a CAGR of 8.2% from 2020 to 2027. Healthcare is said to have led the market; almost 45% of current production is being utilised in medical equipment, and the healthcare end use segment accounted for more

than 31% share of global revenue in 2019, according to the MarketsandMarkets and Grand View Research reports, respectively. Furthermore, a ReportLinker report on global coatings for the medical devices industry projects the antimicrobial segment will grow at a 6.3% CAGR, to reach $5.3 billion by 2026 (the whole global market for coatings for medical devices, estimated at $10 billion in 2020, is projected to reach $14 billion by 2026, growing at a CAGR of 5.8%). In recent years, BioCote has seen the breadth of its healthcare sector partners – and the type of products being treated – increase. We work with manufacturers of breathing apparatus (such as ventilators and breathing circuits), aerosol therapy accessories and items like catheters, endoscopes and vaginal dilators. Other partners include producers of disposable gloves and staff pagers. We also partner with manufacturers of antimicrobial beds, examination tables and patient stretchers, and assistive and accessible bathroom solutions. Antimicrobial technology is also frequently integrated into other hightouch surfaces, such as door handles, switches and buttons, as well as floors, wall cladding and lighting. Working continuously to provide longlasting protection against the growth of microbes, antimicrobial technology complements cleaning and handhygiene procedures, helping to keep healthcare environments hygienically clean. Manufacturers of medical devices and equipment are therefore increasingly integrating antimicrobial additives into their products – and this growth is set to continue.

DIGITAL HEALTH

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TIME TO EMBRACE PREDICTIVE MODELS? Lucy Mackillop, Sensyne Health CMO, analyses the role of predictive models and algorithms in healthcare, and why new technologies are key for the feature.

ince the pandemic began the healthcare industry has transformed – and technology has been at the core. At the time of writing, over 47 million people in the UK have received at least one dose of a COVID-19 vaccine – a vaccine that was developed and tested in a matter of months. Research into tackling SARS-CoV-2 has been carried out at phenomenal speed, and technology adoption has accelerated to keep health services running while minimising the risk of infection. Embracing modern technologies and embedding new processes also presents an opportunity to look at further innovation – in the form of machine learning (ML). With ML techniques the vast quantities of data generated by technology adoption in healthcare can be analysed rapidly and the insights presented to the clinician to aid decision-making. The government has pledged an additional £250 million to boost the role of Artificial Intelligence (AI) – a clear indicator of the growing confidence in, and importance of these technologies. Its potential role in enabling medical professionals to work with greater efficiency, better understand individual patients and provide more personalised care is exciting. There are numerous examples of where technology is already having

a positive impact in the development of sophisticated algorithms that have significantly changed the way clinicians provide patient care during the pandemic. THE BENEFITS OF PREDICTIVE MODELS Predictive models and algorithms are generated

through analysis of large sets of real-world data, such as electronic patient records. One benefit of this is being able to predict the likelihood of certain health conditions developing in particular patient groups. This can potentially facilitate earlier intervention and help to identify treatments that are

likely to be most effective for a particular patient. There are many reasons why the healthcare sector has sometimes been slow to embrace these kinds of technology. For example, the fact that human interaction, not technology, is at the heart of clinician-patient relationships. However,

DIGITAL HEALTH

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Being able to manage long-term care remotely is a challenge, but specific short-term intensive support can be well addressed for patients suffering with chronic diseases, particularly when new treatments need starting

the use of technology has become widely accepted by clinicians as capabilities have developed and evidence of their clinical impact becomes apparent. One example of this in practice is SYNE-COV, a clinical AI algorithm launched by Sensyne Health, which provides real-time

decision-making support to NHS clinicians. Developed in collaboration with Chelsea & Westminster NHS Foundation Trust, SYNECOV provides a risk score for three potential outcomes when a COVID-19 patient enters hospital; intensive care admission; invasive mechanical ventilation and in-hospital mortality. The pandemic highlighted to clinicians that using modern technology can augment the decisionmaking process, enable clinicians to provide preventative care and relieve pressure on healthcare services – something that is going to be critical if we are to recover from the millions of GP appointments missed because of the pandemic. TECHNOLOGY TO SUPPORT MATERNAL HEALTH Maternal health is a great example of where technology has already been embraced by clinicians and patients and is helping to ensure the safety of expectant mothers and their babies. Regular check-ups and monitoring are a key part of the care of pregnant women. With the government advising a reduction of in-person appointments during the pandemic, virtual processes were put in place meaning pregnant women were supported through remote check-ups. As with much of our lives during lockdowns, video calls became the norm in healthcare. UK research found that over half (57%) of people believe the ability to see a healthcare professional remotely during the pandemic has been important and helpful. And for maternal health, these continued virtual connections have been critical in the ongoing support for women during their pregnancy. In addition to remote monitoring, predictive

modelling and algorithms have made it easier and safer for clinicians to identify when a pregnant woman may need a specific treatment or care pathway. They can better predict which women are likely to need medication to control diabetes during their pregnancy, or which women should adopt certain lifestyle measures and take earlier intervention to help them. WHAT’S NEXT FOR PREDICTIVE HEALTHCARE? Beyond maternal health, we will likely see this predictive healthcare model applied to other areas in the future. Chronic diseases like diabetes, obstructive pulmonary disease and heart failure will start to routinely benefit from predictive modelling and remote patient monitoring, not only making it quicker to identify illnesses, but also improving patient care. Being able to manage long-term care remotely is a challenge, but specific short-term intensive support can be well addressed for patients suffering with chronic diseases, particularly when new treatments need starting. For example, for patients with type 2 diabetes who are transitioning to using insulin therapy or heart failure patients post discharge from hospital, short term monitoring can provide intensive support and care. COVID-19 has caused technology to become an invaluable asset for the healthcare sector more than ever. As understanding around these technologies and acceptance of them increases, there are more opportunities for it to make a difference and revolutionise the way healthcare is delivered and received. Healthcare may have been slower to embrace new technology than other sectors, but AI and ML are now helping to drive a digital healthcare revolution.

med-tech innovation expo / DIGITAL HEALTH

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EMPATHY AND AI

FIG 1: Ellie | Source: Teresa Dey/USC Institute for Creative Technologies

Thomas Provan, strategist and Kaylene Kau, senior UX designer and strategist, Recipe Design, discuss how some of the latest developments in AI can benefit healthcare.

s the exponentially increasing power of computer systems allows for countless innovations in diagnosis and treatments, Artificial Intelligence (AI) will continue to revolutionise healthcare. There is, however, a barrier that AI will have to overcome to be truly effective, and oddly, it is a very human barrier - trust. AI, a faceless automaton comprised of lines of code and presented to us on screens, has the potential to communicate with people empathetically, in a way that builds trust and understanding. But first, people need to trust AI enough to begin using and interacting with it.

Technology is pushing the boundaries of what we trust when it comes to our health information, particularly with mental health and symptom reporting. In 2015, a group of researchers at the Institute of Creative Technologies in the University of Southern California created “Ellie”, a pseudo-therapist AI. Ellie uses facial recognition software, eye tracking, speech analysis, and a plethora of other technologies that allow for a deeper understanding of the patient. Interfaced using a reactively animated onscreen persona, Ellie asks the participants questions and changes her body language depending on the answers

AI, when thoughtfully designed for trust and compassion, can help unlock opportunities for smart healthcare. It can allow users to improve the ways they monitor and track their health, whilst supplementing professional diagnosis and treatment plans

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given. She smiles when the participant smiles, she leans in when the participant leans away, all to reactively initiate trust. Yet, for all her human qualities, the artificiality of the experience removes the direct fear of judgement from the user. During trials diagnosing US military veterans with PTSD, it was found that participants were more likely to share symptoms of their mental health with Ellie than on trauma assessment forms. Whilst never used in isolation, this kind of smart and empathetic healthcare can be invaluable, as an artificially empathetic diagnosis tool that patients can trust and provide with their sensitive information.

alleviate patient reservedness through anonymity, whereby patients may feel more comfortable disclosing personal medical information to a ‘non-human’. However, replicating the established codes of human, emotional warmth is decidedly more difficult. We can hypothesise that healthcare practitioners (HCPs) and AI healthcare systems will each have roles to play in the future of healthcare, playing to their respective strengths. For instance, it may be that AI healthcare systems are more effective in the early, triage stages of diagnosis and treatment, before patients have more need to interact with a human medical professional.

Human beings aren’t the best at conveying information about our health. Medical professionals, despite years of training on “bedside manners,” can find how patients communicate their conditions and symptoms difficult to decipher, as fear of judgement can prevent patients from being honest about their health. People can be wildly inaccurate about their lifestyle, but technology can circumnavigate this problem through monitoring biometric and health data, whilst offering a ‘private’ way of recording our symptoms.

When designing smart healthcare systems, considered design choices can provide an experience that feels non-judgmental, whilst conveying the cues of trustworthiness and medical expertise. Patients will require a combination of these factors to willingly offer their personal information and feel comfortable taking advice. These design strategies can be diverse and varied. Anything from the Ellie-like interactions of smart healthcare interfaces asking reactive questions, to suggestions based on information gathered on the user.

This hidden opportunity for smart healthcare can be made or broken in how we interface with it. To be trusted, AI must first be deemed trustworthy. This can be achieved through thoughtful design, user education and consideration for how patients derive meaning from their healthcare experiences. Smart healthcare systems must identify and respect the many expectations, fears and requirements each user has, in order to effectively respond with holistic solutions. The trustworthiness of AI will hinge on many different factors. One example of a key tension at play is navigating the balance between a patient’s fear of human judgement and their desire for human comfort. AI can

Smart connectivity provides the user with suggestions based on their behaviour or environmental conditions, for example, warning the user of potential allergens and asthma triggers through aggregated data analysis. Providing this pattern recognition, combined with useful, ‘everyday’ asthma reminders, builds empathy by making the user feel understood, whilst providing a sense of control and the ability to positively impact their health. Additionally, one of the most important ways of communicating trustworthy advice is by showing the AI’s “thought process.” Much of the distrust of technology comes through misunderstanding or fear of misuse of data. However, if the system is meaningfully designed to show collected data in an easy, understandable way, patients might be far more willing to interact and trust the smart healthcare system they are using. An example of this is symptom-tracking app ADA, which doesn’t hide its calculations. Rather than providing information

from the mystery of its algorithms, communications are provided with reasoning as to why those suggestions are being made. Even when inputting information, ADA explains why the information is necessary and what it might be used for. This transparency helps to facilitate more meaningful healthcare interactions and develop trust with users by removing the fear of veiled judgement. AI, when thoughtfully designed for trust and compassion, can help unlock opportunities for smart healthcare. It can allow users to improve the ways they monitor and track their health, whilst supplementing professional diagnosis and treatment plans. AI healthcare systems have the potential to become the bridge between healthcare at home and in hospital, generating rich, reliable data sets and removing the need for inperson assessments. Key to ensuring these systems are successful, both with users and commercially, is to conceptualise, design and develop with trust, care and compassion for patients in mind.

[FIG 3: ADA app | Source: ADA]

The system behind Recipe Design’s conceptual smart metered-dose inhaler (MDI) device - ADD•FLO - uses information about the user to provide meaningful suggestions for preventing asthma exacerbations.

[FIG 2: ADD•FLO app | Source: Recipe Design]

Recipe Design will be speaking more about the intersection of trust, judgement, empathy and AI in smart healthcare at the Med-Tech Innovation Expo’s HealthTech Stage on 29th September at 1pm. Recipe will also be sharing ADD•FLO, a connected asthma care system designed to deliver empowered, empathetic patient experiences.

Custom Medical Solutions - Human-machine interface applications - Components for medical environments - EMC compliance - Easy to use and clean sales.uk@schurter.com +44 1296 319 000 www.schurter.com

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regulation

UKCA MARK: The practicalities

Itoro Udofia, director, Medical Health Service at TÜV SÜD, a global product testing and certification organisation, explains what you need to know about the UKCA mark.

KCA marking (UK Conformity Assessed marking) is the UK product marking requirement that is now required for any product being placed on the market in Great Britain (GB) - England, Scotland, Wales, substituting the European Union’s (EU) requirements for CE marking. As from 1 July 2023, it will be mandatory for every medical device, to display the UKCA marking. For medical devices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how medical devices are now being regulated. As of 1 January 2021, medical devices being placed on the market in the UK must follow new legislation - the Medical Devices Regulations 2002 (SI 2002 No 618, as amended). While all medical devices, in vitro diagnostic devices (IVD), and custommade devices must be registered with the MHRA as from 1 January 2021, depending on the classification of a product there is a grace period according to the device type and its classification. While it is possible to register devices ahead of the dates below, there is no legal obligation to do so: From 1 May 2021: • Active implantable medical devices • Class III medical devices • Class IIb implantable medical devices • IVD List A products

Where third-party conformity assessment is required, a UK Approved Body is needed. However, Class I device and general IVD manufacturers can self-certify against the UKCA mark. It is important to note that the exception to the rule is Class I medical devices that are sterile or have a measuring function, as they require approval from a UK Approved Body. If the manufacturer is located outside the UK, they must appoint a UK Responsible Person (UKRP), who must be based in the UK. The UKRP then acts on behalf of the outside-UK manufacturer to ensure that their obligations are carried out, and it is permitted for an importer or distributor to act as a UKRP. In all instances, where the UKCA mark has been affixed, the name and address of the UKRP must be included on product labelling. Under the NI Protocol, the CE mark is still required in NI. So, even after 30 June 2023 CE marked medical devices can continue to be placed on the market. Under these rules, qualifying goods are those in free circulation in NI - not those under a customs procedure or in an authorised temporary storage facility before being moved between NI and GB. If a UK body carries out a mandatory third-party conformity assessment, then a UKNI marking must be applied – but must be accompanied by EU conformity marking (e.g. CE

marking). Goods with both the CE and UKNI marking cannot be placed on the rest of the EU market. If a mandatory third-party conformity assessment was carried out by an EU-recognised notified body, goods with the CE marking can be placed on NI and EU markets. As a deviation from the GB requirements, the Medical Device Regulations, 2017/745(EU MDR) and the In Vitro Diagnostic Medical Device Regulations, 2017/746(EU IVDR) apply in NI from 26 May 2021 and 26 May 2022, respectively. This means that GB manufacturers will require an EU Authorised Representative, located either in NI or the EU, to place products in the NI market. The changes being made to accommodate UKCA marking requirements necessitate a new approach and it is imperative to register products with the MHRA as soon as possible. To register with the MHRA you must show evidence that your medical device has undergone conformity assessment by a UK Approved Body, which must be based in the UK. Following approval from a UK Approved Body, the manufacturer will be able to affix the UKCA mark (in Great Britain), or UK(NI) mark (in Northern Ireland). Alternatively, if your products are CE marked, then you may also use your CE certificate as evidence to register with MHRA until 30 June 2023.

From 1 September 2021: • Class IIb non-implantable medical devices • Class IIa medical devices • IVD List B products • self-test IVDs From 1 January 2022 (Note: in Northern Ireland, these products must be registered by 1 January 2021): • Class I medical devices • general IVDs Any medical devices that were previously registered with the MHRA before 1 January 2021, do not require re-registration.

Human Factors Engineering

THE INFLUENCE OF

aesthetics ON USABILITY ENGINEERING

Sean Hägen, founder & director of research and synthesis, BlackHägen, shares his theories and methodologies to optimise human factors engineering for usability.

ow a medical product’s impression enables usability has scientific premises in human factors/ usability engineering (UE) and industrial design. Each discipline shares theories that, when harmonised, can become a method to optimise usability, which is ease of use and use safety. The importance and challenges in the relationship between medical device design, UE and the aesthetic development process significantly impacts usability and delight. There are two theories that complement each other to create an applicable methodology: affordance and product semantics. UE Research has documented the nature of a user’s choices and user interface behaviour, as it is influenced by aesthetics, specifically initial visceral impressions and intuitiveness of use. Consider, the apparent usability of a device may be just as important to the actual usability. The initial impression of a device and the user’s expectation for how it will function and meet their needs is often critical to safety and efficacy in the healthcare context of use.

These initial impressions can be characterised and planned for, via the theory of affordances. That is, a user’s perception of potential interaction with an object based on its properties, are referred to as its affordances. In this capacity it is a subset of product semantics. When designers are developing a user interface, the decisions and anticipation of successful interactions are related to aesthetics and are most crucial in the design process. The industrial design theory of product semantics informs the design process and enables a self-evident user interface through the qualities of the device’s aesthetic, form, texture, colour, and metaphor. The aesthetic composition, or semantic, of a design does not literally explain what it does, rather, it influences how the user interprets it. When the two theories are integrated, product semantics can be a framework methodology to proactively enable the desired affordances in the design of a device. The application of a perceived attributes methodology, where attributes of function and aesthetics define user perception of value, can align the cross-functional team in the development and the interpretation of requirements.

This method can connect the two theories of product semantics and affordances into a cohesive approach to enable a meaningful and appropriate aesthetic by providing a common vernacular across development disciplines. A common challenge that usability engineering specialists have characterising user needs and user interface (UI) requirements is trying to understand and characterise intuitive use, or worse yet, “ease of use.” Having a common definition of function, aesthetic and ultimately, value can help characterise such ambiguous requirements with a documented baseline. Use-safety impacts the design from the perspective of regulatory objectives, engineering being the lead stakeholder. Ease of use impacts design from the perspective of marketing business objectives. However, the engineering stakeholders for regulatory objectives are not necessarily the same as those focussed on technology or usability. Use-safety is the responsibility of UE, which may be initiated as part of system engineering or implemented as part of quality engineering. Often the implementation of these varied agendas is translated into user interfaces by industrial design. The UI design is responsible for influencing the user to behave and use the device as

intended by both the device manufacturer and the user. The connection of these disciplines and objectives is typically documented in requirements. This is where the deployment of a product semantics methodology, enabling intended affordances through a collaboration tool such as perceived attributes, can align all the designers’ interpretations of the requirements. Consider the UE process and the validation of the UI design. Formative studies typically identify tasks that have usability issues and many of those are characterised as not intuitive, requiring the design to be more user friendly. Those evaluations are purposely designed so that the user does not know how the device is intended to operate in order to expose usability issues and, by default, demonstrate intuitiveness. When UE report on usability issues, there is language used to describe the deficiencies. These can inform the development of the perceived attributes that, in turn, inform the product semantics. Consider product semantics as a design language for optimising usability, aesthetic, shape, form, colour, and metaphor, which speaks to the end user and is open to their interpretation. Where the syntax is the affordance and the vocabulary is its perceived attributes informed from the UE process.

Human Factors Engineering

How the pandemic shone a LIGHT on Human Factors Greg Thay, managing director of Thay Medical, deliberates just how important human factors has become with the development of medical technology during the COVID-19 pandemic.

paid the price for this. They will not be forgotten. And they helped to improve healthcare, making it safer.

The improvements have been forced upon us all, and amazingly we all have adopted them, accepted the changes, and implemented them without bias or negativity. We all know how severe COVID-19 can be, and it is the uncertainty of its effect that makes it more unpredictable, yet we have found solutions in vaccines, prevention, and recovery of the virus and in how we live day to day.

We learnt to develop medical devices quickly – ventilators, personal protective equipment, and telemedicine. Software became vital for day-to-day living, as did a good internet connection. In healthcare, appointments and consultations with physicians went online, medical devices were improved to incorporate telemedicine and the Internet of Things. We became more connected even though we were isolated. Within hospitals, Human Factors became vital to understand workflows, connectivity, and interactions between healthcare workers. Where clinical practices had been established over time, many were again assessed to protect the patient and the clinician from the potential for transmission of COVID-19. The focus on PPE made paramount – the 3D printing of face shields now a distant memory, but one we should not forget. Not just because we found a solution for the inadequate supply of these products, but for the positive effect of people working together to find a solution to protect those on the front-line of the pandemic.

wo years ago, we lived in a world not yet familiar with the word ‘COVID-19.’ It is amazing to think that one term could affect the planet in such a dramatic way. Obviously, in a negative way – knowing the true number of COVID-19 related deaths is likely to be above what any government may publicly portray. But in a positive way this pandemic has improved our lives in many ways – especially in healthcare.

One science that was brought to the attention of the world was Human Factors Engineering. From the onset, a user or patient focussed approach to preventing people from getting COVID-19 was adopted – the restrictions, the lockdowns, the focus on personal protective equipment (PPE) and the changes in lifestyle we all had to make all helped in some way. The population of healthcare workers had no choice but to protect themselves and their colleagues to look after the volumes of patients who required assistance and hospitalisation. These frontline workers, along with others outside of healthcare, put other lives ahead of their own and some

Another area that was improved using Human Factors Engineering was risk management. Where workflows and procedures were revised to include protective measures, they were tested before implementation, evaluated for the outcome and improved where deficient. This is a Human Factors Engineering process.

These workflows were assessed for the potential for harm, the probabilities for virus transmission and mitigations implemented – an example being the flow of movement. We now accept in many buildings, single routes through corridors and in open areas, with signs and instructions on where to walk, in which direction and how far apart we should be. In some cases, this has made workflows more efficient, but has definitely made them safer. Risk Management is even more important now. Additionally, we all have learnt more about physical ergonomics – a vital part of Human Factors Engineering. Working from home for many office workers has meant looking at our own working set-up, our own equipment and furniture and making decisions on what is best to prevent repetitive strain injuries, back troubles, and musculoskeletal disorders. We learnt quickly how important desk-chair height ratios were, how important distance reading was, how lighting could affect eye strain and how balancing work and health were to maintain our lifestyles which we wanted. The Human Factors, Health and Safety, and Ergonomics organisations such as the Chartered Institute of Ergonomics and Human Factors (CIEHF) took a responsible approach and invited its experts to publish best practices such as how to develop ventilators, how to create safe workplaces and how to manage patients with COVID-19 in healthcare settings. All to guide the public and healthcare on the optimal route through this pandemic.

MED-TECH

INNOVATION EXPO 2021 MED-TECH | UK 28-29 September 2021 | NEC | BIRMINGHAM INNOVATION | EXPO

MED-TECH INNOVATION CONFERENCE

IN ASSOCIATION WITH

MATT WHITTY >> Deputy Director of Innovation, NHS England

TONY DAVIS >> Director of Innovation and Economic Growth, West Midlands Academic Health Science Network

DR KAREN SPINK >> Innovation Lead for Precision Medicine, Innovate UK

LOUISA SIMONS >> Chief Operating Officer, Innovate UK

LISA HOLLINS >> Director of Innovation Delivery, NHSX

TRAVIS LAIRD >> Chief Business Operations Officer, Cleveland Clinic, London

DR NEIL EBENEZER >> Medical Technology Specialist, Department for International Trade (DIT)

JANE VAN AKEN >> Director of Product Development, Spirit Health Group

MATHIEU LETOMBE, CEO, Withings >> DR DEEPTI PRASAD, Multichannel Strategy Director, Boston Scientific >> MARCUS STOW, Wing Commander Stow, OBE, MStJ, PMRAFNS, Innovation Advisor, JhubMed >> GREG BAILY, Technical Director, Huntleigh Healthcare >> EDWARD FITZGERALD, Clinical & International Lead, KPMG Islands Group >> STEPHEN HART, Chief Operating Officer, Virti >> GRAHAM EWART, CEO, Direct Healthcare Group >> ASHTON HARPER, Head of Medical Affairs for the UK & Ireland Roche Diagnostics >>

HEALTHTECH STAGE