MTI Issue 58 by Med-Tech Innovation Magazine

www.med-technews.com Issue 58 | Mar/Apr 2022

@medtechonline

MED-TECH INNOVATION | NEWS MED-TECH

PLUS innovation How SMEs can be supported through compliance Med-Tech Innovation Expo’s visit from Mauritius An insight into Surgery 4.0

Harnessing digitalisation - How Roche is delivering greater value in point of care diagnostics

MEDICAL DEVICE SUPPLY CHAIN INTELLIGENCE

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Co-located Shows

CONTENTS regulars

COMMENT

Ian Bolland offers his thoughts on the end of free lateral flow testing in the UK

MAKING MEDTECH

A round-up of the latest industry news

12.

COVER STORY

Roche outlines the value of digitally enabled solutions including how its cobas pulse device helps people with diabetes

20.

MED-TECH INNOVATION EXPO

Ian Bolland speaks to the Economic Development Board of Mauritius about its upcoming visit to Med-Tech Innovation Expo

27.

DIGITAL HEALTH

Bond Digital Health explores the advances of digital use in lateral flow tests

30.

REAL WORLD MEDTECH

Ian Bolland speaks to CMR Surgical about how the company became a leader in robotic surgery

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 portfolio sales manager | caroline jackson +44 (0)1244 952 358 caroline.jackson@rapidnews.com

features 11.

IRELAND

MED-TECH

nTopology explains how IMR and Renishaw developed an additively manufactured Anterior Cervical Interbody Device (ACID)

INNOVATION | NEWS

14.

DESIGN

Tone looks at the role of product design in advancing home healthcare adherence

23.

4.0

Two professors from the University of Leeds set out the key concepts for the future of surgery: “Surgery 4.0”

24.

CONTRACT MANUFACTURING Web Industries explains how CMOs can help medical device companies expand internationally despite supply chain challenges

25.

INNOVATIVE MATERIALS

Proxima explores the outlook for new and existing materials and manufacturing practices in medtech

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

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from The editor

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Living with… or forgetting about COVID?

he 1st of April marks the end of the free provision of lateral flow testing in the UK. Some would suggest that the date is quite apt, as it’s part of the government’s living with COVID plan, which removes one of the key tools that allows us to recognise whether we have a strain of a condition that has taken the lives of more than 162,000 people across the country, with deaths still averaging 140 per day at the time of writing this column. Tests are still readily available but if you want a test, that must be paid for out of your own pocket, not by the money that you have already paid to the taxman. Though you can argue that the cost of purchasing a test – with some companies offering them for £1.99 – isn’t that much, it’s still an unwelcome choice falling upon the population when other world and economic events are fueling a rise in the cost of living. Taking a step back, it would appear that those who can afford to test regularly may continue to do so – though this is not a guarantee, but an obvious knock-on effect of this policy is likely to be a widening health inequality in the UK dependent on income.

It’s hard to argue against it being a more ideological choice when it comes to reducing public spending after there has been such a necessary outlay to prevent even more suffering across the country. Then there’s the aspect of people getting COVID that don’t know about it. Chains of transmission are not broken and though the threat of death from the disease has now reduced due to most of the population having received three vaccinations, the daily death count shows that a diminishing threat is not one that’s eliminated. This reduces oversight on the disease which caused many operations to be cancelled, patients needing essential treatment, meaning there is a huge backlog that needs to be tackled. Though plans have been announced to try and tackle said backlog, allowing the disease to go through the population unmonitored appears counterproductive to those efforts. And what about new variants? There is a good chance that Omicron may not be the last of

the variants. Indeed there are now concerns about Deltacron. How do we know if we need to step up testing again to the same degree as previously if case numbers are slipping through the net? Recent months has seen a return to normality. With masks and testing to protect each other, these are not restrictions and never have been. To portray any public health measure that allows you to go about doing everyday things is barmy. The elephant in the room here is that this is entirely political after the prime minister presided over several seemingly lockdown breaching events that have belatedly required a police investigation, and a time when his own position has come under threat. With many lockdown sceptics in his party, should we really be surprised that getting rid of every aspect of ensuring that COVID is controlled and managed, is abolished and we pretend like nothing else ever happened? Maybe this will be one of many aspects investigated in the public inquiry which is due to begin soon.

Making medtech

MedCity makes ‘signiﬁcant’ economic impact with 12-fold ROI

n organisation that helps connect earlystage biotech, medtech and pharma companies with the life sciences sector in London, stimulated £12.4 million in gross valueadded contributions (GVA) during 2021 – more than 12 times the amount of public funding it received. In its annual impact report, MedCity, which is supported by the Mayor of London, also reported it had helped 24 companies raise more than £430 million in investments and created 120 jobs in the life sciences sector last year. Founded in 2014 to stimulate economic growth in the life sciences sector in London, MedCity’s success is underpinned by its efforts to drive inward investment and business expansion, supercharge innovation, and develop and support infrastructure.

CEO, Neelam Patel, said: “Despite a global pandemic and the impact of Brexit, we delivered a significant return on public investment in 2021, building on London’s reputation as a powerhouse for life sciences. “By attracting companies looking for partnerships and growth, enabling research collaborations and connecting life sciences companies with investors and R&D collaborators in universities and the NHS, we have succeeded in making a significant impact on the UK economy and securing the UK’s position as a global science superpower.”

Among its achievements in 2021, MedCity supported real estate projects across London including the £10 million GSK AI centre and the £1 billion MSD discovery centre at King’s Cross and the British Library’s ‘Living Knowledge Project’ at St Pancras. It also directly enabled 21 research collaborations, facilitated 50 new NHS contracts and 22 NHS pilots, supported 148 new industry clients via its existing programmes, and enabled the launch of UK Advanced Therapies, connecting five clusters from around the UK.

Eyecare entrepren raises £1 after rej dragons A

start-up founder has turned down two of TV’s entrepreneurial ‘dragons’ to furrow his own path – and has now landed private investment worth 1000% more for an even smaller stake. Eye health innovator and optometrist Dhruvin Patel, 29, created Ocushield while at university in 2015 to combat the effects of harmful blue light emitted from the tech devices we use every day. Ocushield produces and sells medically rated screen protectors to fit everyday devices, helping to cut blue light. Smartphones, tablets, and computer screens emit blue

Leeds breast imaging service ﬁrst in UK to use Densitas intelliMammo AI

he breast imaging service at Leeds Teaching Hospitals NHS Trust is the first in the UK to introduce a new artificial intelligence (AI) technology which evaluates the technical quality of mammograms. The Canadian software company Densitas has worked

with the team to customise the software to meet the needs of the department and the high image quality standards required by the NHS Breast Screening Programme. The technology will be implemented in both screening and symptomatic

breast services to provide mammographers with instant feedback and AI-generated positioning information when the image is taken. Dr Nisha Sharma, director of breast screening at Leeds Teaching Hospitals said: “Using AI will make a real difference to the quality of

our breast screening program and ultimately to the health outcomes of women in Leeds. Here at the Leeds Breast Screening unit we are delighted to collaborate with Densitas and build on this foundation for future developments that will improve breast care.”

Making medtech

neur

jecting

light, causing headaches, blurred vision, fatigue and dry eyes. Blue light can also negatively affect your sleep hormones. Ocushield’s technology – from screen protectors to bedside lamps, and even glasses – blocks up to 90% of blue light wavelengths. With more than 150,000 products sold far worldwide, Patel wants to take his business to the next level. Last year, he and business partner Asad Hamir, impressed

on BBC’s Dragons’ Den and secured £75,000 worth of investment for a combined 15% of the business from Peter Jones and Tej Lalvani. But during the six-month period after filming and before agreements could be signed, the business exploded with a further £750,000 in sales, which naturally shifted the valuation of the company. The Dragons couldn’t negotiate a new investment reflecting the increased value, so Patel turned down their offer.

Patel said: “After appearing on the show, our brand and revenue went up and up. We realised we were giving Peter and Tej too much of a good deal, but the dragons couldn’t negotiate outside of the den to make the deal more palatable. “While it was a shame we couldn’t have them involved, we’re sure Tej and Peter would have made the same savvy moves in our positions as budding business titans, so there’s definitely no hard feelings.”

Dxcover study on cancer diagnosis shows positive results C ancer diagnostics company, Dxcover Limited, has published its latest data from clinical studies on earlier detection of aggressive cancers. The study involving over 980 patients suffering from non-specific symptoms associated with brain tumours has shown that the Dxcover Brain Cancer Liquid Biopsy was able to detect 96% (45 out of 47) of patients with brain tumours and identified all patients with Glioblastoma Multiforme - the most aggressive type of brain cancer. Brain cancer is the most advanced application of the Glasgow-based company’s novel liquid biopsy platform for the early detection of cancer, but the company will also be publishing its capability across eight different cancers. The new publication in Neuro-Oncology Advances, showed that Dxcover’s test is sensitive in detecting patients with brain cancer, regardless

of tumour type. These results means that patients with non-specific symptoms, such as headaches, who have a positive test can be triaged to have fast-tracked brain scans, confirming their diagnosis earlier with potentially lifesaving results. In doing so there is also the potential to bring significant savings to healthcare services worldwide. The company is attracting significant endorsement from leading clinicians across the globe.

Dr Matthew Baker, chief technology officer at Dxcover, said: “Detection of brain tumours via liquid biopsy has always been challenging due to the bloodbrain barrier. This research shows the potential of our technology to revolutionise the clinical pathway by creating a triage system for patients displaying non-specific symptoms of brain cancer. By doing so, diagnosis will come at an earlier stage, leaving more clinical options for doctors to explore.”

DexCom’s glucose monitoring system receives CE mark

excom, a real-time continuous glucose monitoring specialist for people with diabetes, has secured CE mark for the Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with diabetes in Europe aged two years and older, including pregnant women. Dexcom G7 offers a way to help users gain greater control of their diabetes, so that they can manage it more confidently each day. It sends real-time glucose readings automatically to a compatible smart device or receiver, with no fingersticks required. Kevin Sayer, chairman, president and CEO of Dexcom, said: “Today marks an incredible milestone for our company and for people with diabetes in Europe. This all-new platform offers an incredibly powerful CGM that is simple to use, providing our users with insightful glucose data on one screen that helps them spend less time managing diabetes and more time doing the things they love. Dexcom G7 takes everything people love about G6 and makes it even better.”

MEDILINK

Optishield announces FDA registration for DHC Innovations

ollowing success in the UK, Optishield has announced the recent FDA registration for its creator DHC Innovations. With the regulatory aspects of selling to the US well underway, the company is looking forward to new markets overseas. Company CEO Donald Harrison said: “Medilink Midlands have been key to our progress in the UK offering proactive support and

guidance and have been instrumental again with our current access to key markets abroad. We are in negotiation with several US contacts and are very grateful for the opportunities gained through our Medilink membership.” Optishield has recently teamed up with Erin’s World frames and will be available to view on its stand at the 100% Optical exhibition at the ExCel Centre in London on the 23- 25th of April 2022.

GUARDTECH BRINGS HOME A DOUBLE

he Guardtech Group has won its second award in the space of two weeks after capturing the Business & Product Innovation accolade at the East of England Federation of Small Businesses Awards. Directors Ray and Mark Wheeler collected the award at a showcase at Newmarket Racecourse, just a fortnight after scooping the Business Innovation Award at the SME Cambridgeshire Awards at IWM Duxford. The father and son duo will now take their Guardtech Group team, and double awardwinning CleanCube Mobile Cleanrooms solution, to national awards in Glasgow (FSB, 19 May) and Wembley (SME, 2 December) in the hope of claiming yet more glory.

Guardtech Group director Ray Wheeler said: “We’re absolutely thrilled to have won our second award in quick succession. “Everyone at Guardtech strongly believes in CleanCube, as a great idea that has become a great product but receiving an independent award from such an esteemed body as the Federation

of Small Businesses is a real wow moment for us. “I’m so happy for the whole team – from the guys who designed these mobile labs to the teams who built them, we’re a dedicated, talented and diligent family business and the quality continues to shine through in the products and services we provide.”

IMED advises on how to engage with Notified Bodies

MED has offered some advice on how companies can improve their chances of being successful with their application with a Notified Body. The strain on Notified Bodies during the current climate is having a direct effect on manufacturers being able to sell medical devices, due to fewer notified bodies being designated to the applicable regulations. Concern is growing throughout the medical device industry, resulting in increasing pressure when co-ordinating an application with a Notified Body. ● Approach

a Notified Body well in advance! Lead times can be up to one year for even

a one-day stage 1 ISO 13485 audit, so it is important to have this conversation early and be presented with realistic timelines. Some Notified Bodies offer initial meetings with members of their sales and technical teams. ● Be

honest with where your company is at within the CE/ ISO 13485 timeline. If you are a startup company, just beginning to write your quality policy or design procedures, the Notified Body needs to be made aware. This is because a minimum of three months’ worth of evidence is recommended for review at the time of your stage 1 audit.

● When asked for

information during the initial quoting process, try to make sure all information is presented accurately and in full, from the start. Precious time can be wasted going between parties when information is incorrect or missing. To provide a quotation for an audit/ technical file review, the Notified Body will ask for details such as: number of sites, employee count for each site, what services are conducted at each site etc. Although this information may seem unnecessary for an initial review, it is required to calculate audit duration and subsequent cost.

● Due

to high demand, some Notified Bodies are only taking on new CE marking work for existing clients. This is discouraging and can put manufacturers who are not existing clients in a difficult position. One potential way to combat this potential obstacle is to approach a Notified Body first, for an ISO 13485 certificate (if your QMS is ready for an audit). This can get you into the Notified Body’s

internal ‘queue’ earlier than if you were to wait for your CE mark’s technical documentation to be compiled and ready. You can then continue to develop the necessary technical documents in the background, whilst awaiting your ISO 13485 certificate, which means that you will be considered an ‘existing client’ by the time your CE marking documentation is ready for you to apply with.

The new value proposition: what should now be highlighted about products? Oli Hudson, content director at Wilmington Healthcare, looks at why new angles on the value proposition are necessary.

In today’s NHS, procurement and purchasing decisions for medtech are made in a more nuanced and multi-layered way. The re-emergence of value-based procurement in NHS Supply Chain thinking, the pivot to system-led planning and population-based budgeting and pathways, workforce pressures, and the needs to engage with the backlog, patient safety, improved outcomes and sustainability have made considerations other than unit prevalent. Industry needs to understand this shift and build it into their thinking when engaging with the NHS. A new customer-centric value proposition is needed: with a strong, evidence-based argument that covers these wider considerations. Here is what it should include and how medtech should approach it. THE ‘MULTIDIMENSIONAL’ VALUE PROPOSITION Value still describes aspects of the product like the clinical efficacy, safety and patient benefits, the costed benefits it can bring,

and how it can help the purchaser with organisational challenges. What’s new is the need for the commercial pitch to speak to the requirements of the wider system, showing how it can support population health goals, deliver new and more sustainable ways of providing care, and help customers to manage strategic challenges. At Wilmington Healthcare we have been influenced when considering new aspects of the value proposition by Rob Berry, head of innovation and research at Kent Surrey Sussex AHSN, who has written about value at different levels of the health sector. In his view the new value proposition breaks down into five fundamental areas: clinical value, value to the patient, service cost value, organisational value, and system value. All these things should be borne in mind. But what could it mean in practical terms for medtech? COSTED PATHWAY ANALYSIS The most pressing needs of NHS customers now are to manage down cost and capacity pressures - it’s no longer enough for suppliers to point to the clinical value of the product in isolation. What’s required is a deep and granular understanding of the patient journey through a pathway, how much each element of their care costs and the benefits it brings, and how their proposition can deliver best value. One way of doing this is by developing a Costed Integrated Patient Scenario to help evaluate the different

components in a patient’s care and show how the pathway can be optimised. DEMONSTRATING VALUE IN POPULATION HEALTH Another consideration is around population health, with all organisations in the NHS expected to improve health and care experience and outcomes. Organisations will need to demonstrate that resources are fully optimised to meet the long-term needs of patients. To assist this, medtech could show the preventative value of propositions that can prevent a patient’s condition from escalating to the point where they will need more costly treatment and care; or the social value of propositions that can reduce a patient’s dependencies by relieving their symptoms – allowing them to do more things than before. The service value of propositions that successfully reduce demand on certain health services, and/or allow patients to be treated in a more appropriate (community) setting, is paramount. It is important to remember the experiential value of propositions that improve the quality of a patient’s experience by reducing inconvenience or providing a less invasive way of treating them, and the efficiency value of reducing the frequency with which a patient may require follow-up care. With capacity pressures challenging all parts of the NHS, an effective value proposition could include resourcing benefits of freeing up clinical time or remodelling the staffing mix required to administer a treatment.

ADDRESSING STRATEGIC PRIORITIES Propositions should also support the strategic priorities for the NHS, as described in the latest NHS operational planning guidance. Managing the backlog will be a priority for all systems, meaning that customers will be receptive to any solutions that can build in additional capacity to reduce case lists, particularly where the proposition may help them manage down pressures on clinical teams. Another noteworthy area is the increasing focus on access and health inequalities. For example, the NHS planning guidance is explicit about the potential consequences of delays or interruptions in cancer care due to the pandemic, highlighting the patients not currently receiving treatment who would otherwise have likely presented over this timeframe. Medtech can use population and prevalence data to help the NHS find ‘missing patients’ and prioritise those in the greatest need. CONCLUSION Intrinsic product value is still important – but these other attributes will increasingly affect the commercial appeal. The stakeholder landscape is changing, and NHS customers need more sophisticated and rounded analysis of value. Medtech will need to bear in mind all these requirements and come up with evidence to show the impact a product or technical intervention can make through a whole pathway.

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IRELAND

A better way to develop 3D printed orthopaedic implants?

Christopher Cho, staff application engineer at nTopology, explains how an alloy used by the engineers of Irish Manufacturing Research (IMR) and Renishaw affected the manufacture of the Anterior Cervical Interbody Device (ACID).

dditively manufactured orthopaedic implants have rapidly become one of the most exciting developments within the medical device industry. With advancements in manufacturing outpacing regulatory guidance, the U.S. has been a hotbed for the sweeping innovation that additive has enabled within orthopaedic devices. Despite a reputation for leading in robust and expensive validation processes, the FDA has scrambled quite a bit to determine how best to regulate this emerging technology. However, as the process for clearing additive orthopaedic devices became more widely understood, the largest obstacle to advancing 3D printed technology became apparent in the limitations of design software. For as long as many of us can remember, CAD tools have served as the unchallenged monoliths of digital design, with parametric solid modelling and surfacing proving to be the modern successor to drafting by hand. But as demand for additive-enabled complexity increased, traditional CAD tools have proven to be ineffective at designing 3D printable devices. With orthopaedic implants, nextgeneration devices have demanded wildly elaborate geometries not fit for the CAD paradigm of old. Whether the need be contoured organic shapes or dense trabecular structures, traditional parametric CAD falls short in both performance and practicality. Enter nTopology, a design software solution that allows engineers to create high-performing parts and reusable design workflows that can be deployed across entire part families and product lines. Its core implicit modelling technology reduces the design cycle and engineering efforts necessary to develop an orthopaedic device by alleviating the process of lattice structure generation.

IMR’s engineers needed to control many design parameters and perform thousands of iterations to identify the most suitable design for the structural elements of the implant and its lattice. During later stages of development, file compatibility against downstream build preparation software also became a critical consideration.

CASE STUDY: IMR DEVELOPS SPINAL IMPLANTS USING NTOPOLOGY To develop spinal implants that feature osseointegrative lattice structures, Irish Manufacturing Research (IMR) leveraged nTopology’s lattice generation capabilities.

The solution To overcome these challenges, the engineering team used nTopology to optimise the design of the device via a segmented approach. The final implant design was composed of a solid structural region and a porous lattice design region.

From there, IMR was able to validate the performance of these two regions both independently and in combination. During their development process, adjusting pore size and beam thickness was an exercise of relative ease, allowing a structure that best promoted osseointegration to be discovered rather quickly.

The goal was to create an additively manufactured Anterior Cervical Interbody Device (ACID) that could help restore intervertebral height in patients suffering from conditions ranging from degenerative intervertebral disc disease, spondylolisthesis, to spinal stenosis. Using nTopology, IMR’s design engineers created controlled design processes and optimisation workflows that generated cage designs ready for additive manufacturing. The resulting implant design used a porous lattice that promoted osseointegration and vascularisation. The challenge The engineering teams approached this project with three main design requirements: ● Develop a spinal implant that is additively manufacturable ● Create a lattice structure with a characterisable pore size allowing for bone and blood vessel growth ● Maintain mechanical properties that matched those of bone.

The Result Using nTopology, IMR achieved rapid and performance-driven development of a spinal implant that improves patient outcomes in conditions where intervertebral height saw compromise. The engineering team reduced the expected project completion time from years to months and leveraged automation to consolidate the design cycle from hours to minutes. TRACEABLE DESIGN PROCESSES Having a traceable design process means a proper “paper trail” lives alongside every product you develop. This trail is integral to tracking all product-defining parameters, critical design decisions, and generated design outputs. Traceability ensures that your business is fully prepared to undertake all corrective and preventive actions to resolve arising concerns. Bluntly, whether you are working on sized products or even patient-specific devices, a traceable process indicates that you know what you are doing. When designing a medical device in nTopology’s functional design environment, the final output is defined by the steps taken to get there. If a single input parameter changes, the resultant output must differ. This may appear obvious, but it is not an implication often considered when wielding traditional CAD tools. By implementing a “reporting workflow”, a design engineer can capture all relevant information in an automated fashion. Therefore, any adjustments made to the workflow generate a new design and automatically generate an accompanying report that updates alongside the 3D model. These capabilities can help minimise risk in the design phase and facilitate a seamless design experience.

on the cover

Harnessing digitalisation - delivering greater value in point of care diagnostics

he COVID-19 pandemic has broadened the public’s understanding of point of care diagnostics and reinforced their critical importance to healthcare. However, beyond the horizon of the pandemic lies a future with great potential for point of care diagnostics – one in which digitallyenabled solutions deliver even more value to healthcare systems. Those of us working in the point of care space are excited to deliver on this potential. MOVING ‘BEYOND THE TEST’ RESULT For a generation, point of care diagnostics have been important tools for healthcare professionals to obtain a diagnostic number from which a clinical decision could be made, say a patient’s blood glucose level or a C-reactive protein result. But as we have come to appreciate, while incredibly important, an accurate number can only accomplish so much on its own. As we look at healthcare in 2022 and beyond, raw diagnostic numbers will not be enough if we want to deliver greater value to stretched healthcare systems or enable more innovative models of care. Numbers leave healthcare providers with the burden of quickly determining ‘what to do with the patient next.’ Imagine being a nurse or doctor in a hospital, seeing countless patients with all manner of health conditions. Each day, you capture endless numbers to make the best decisions about each patient’s individual care plan while under tremendous pressure. It is a lot to ask. But what if instead you had practical insights and care recommendations in the palm of your hand? What if you could tell in an instant, ‘This is definitely not a heart attack or stroke. This patient should be dosed with this much insulin?’ These insights are more than just words on the screen. They can literally separate life from death.

Ian Parfrement, head of point of care customer area at Roche Diagnostics, outlines the value digitally enabled solutions can bring to healthcare systems, including its cobas pulse system.

DIGITALISING POINT OF CARE DIAGNOSTICS When we think about the future of point of care diagnostics here at Roche, this is what we envision: solutions that are designed with the needs of patients and healthcare professionals first in mind, combined with the high quality and performance they have come to trust. We envision solutions that reduce the very real pain points experienced by healthcare professionals in their working lives and that open up whole new innovative models of care. We believe one of the keys to this is harnessing the power of digitalisation. Right now, new digital health solutions are shifting the diagnostics paradigm. New digitally connected instruments are coming to market that can link to electronic medical records and other devices, providing a comprehensive understanding of a patient’s medical history and helping providers spend less time speculating on what might be wrong with a patient. As a result, they can make more confident care decisions

ON THE COVER

cobas® pulse system

We envision solutions that reduce the very real pain points experienced by healthcare professionals in their working lives and that open up whole new innovative models of care and reduce unnecessary and costly testing. Such innovations are especially useful in resourceconstrained settings where laboratory infrastructure is limited and in emergencies where every second counts.

capabilities similar to that of a smartphone.

Taken together, these enhanced capabilities can lead to faster and more accurate clinical decisions, more effective patient management and better use of valuable healthcare resources.

When first developing this solution years back, our vision was to transition from the handheld blood glucose meter that had become the status quo to an enhanced point of care platform for digital health solutions. We therefore combined a highly accurate blood glucose meter with the latest module of Roche’s cobas infinity edge suite of diagnostic software solutions, called smart.

THE COBAS PULSE SYSTEM: A CATALYST FOR THE FUTURE OF CARE Here you might ask how Roche Diagnostics plans to offer greater value to healthcare by playing in this new digital space? It starts with our latest point of care solution that we introduced in select European countries in January this year. The cobas pulse system is an industryfirst, digitally enabled point of care solution that combines the form factor of a high-performance blood glucose meter with the simple usability and expanded digital

By marrying innovations in hardware and software, the cobas pulse system will serve as a digital platform that enables developers of digital health applications to access healthcare professionals as customers for the first time creating a new business-to-business partnership model for the future of digital health. The benefits of such a model? It means that the cobas pulse system comes equipped with a range of Roche-selected thirdparty digital health applications that perform a range of clinically

valuable functions for improved care delivery – from clinical decision support to the measurement of vital signs and biomarkers. Better yet, the platform confers near limitless opportunities to expand the functionality of the cobas pulse system down the line. As the first customers begin to pilot the cobas pulse system, we are excited to document tangible examples of how it improves care for patients and the working lives of busy healthcare professionals. However, at the outset, we already know this well: leveraging digitalisation and translating single data points into more meaningful insights must happen if we want to deliver more value to healthcare. In some respects, we are just at the start of this exciting journey, but it is one we are thrilled to lead. Learn more about the cobas pulse system: https://diagnostics. roche.com/global/en/products/ instruments/cobas-pulse-system. html

cobas® pulse system

Design

PRESSURE POINT: WHY THINKING BEYOND FUNCTIONALITY CAN HELP INCREASE HOME MEDTECH UPTAKE

Oscar Daws, co-founder and managing director at Tone Product Design, looks at the role of product design in advancing home healthcare take-up and adherence and what it means for medtech.

ccording to The NHS Long Term Plan: “When ill, people will be increasingly cared for in their own home, with the option for their physiology to be effortlessly monitored by wearable devices. People will be helped to stay well, to recognise important symptoms early, and to manage their own health, guided by digital tools.” We all know the NHS has experienced relentless pressure over the past two years. November 2021, for example, saw the busiest month on record for A&E, with more than two million patients requiring attention at emergency departments and treatment centres. That was up half a million on the same time the previous year. Add to that the backlog of patients on waiting lists and the needs of an ageing population and it’s clear that the NHS must look to new ways to manage its resources. The good news is that advances in home healthcare technology have opened up a host of opportunities, and in many cases can provide better care. (A report by the AJMC noted that treatment at home has been shown to be faster and more effective.)

Whether it’s monitoring sleep or medicine compliance, helping with post-operative physiotherapy or dementia, or assisting an ageing population to remain healthy and independent for longer, there are key benefits to encouraging people to manage their health at home and avoid the trip to hospital. Home is usually a safe, relaxing space that removes the fear of a hospital setting, which for many will have been exacerbated by the pandemic. People can enjoy the comforts and amenities that they’re used to, while avoiding the upset of unfamiliar surroundings. Leveraging the power of the home can also benefit clinical trials. An important point raised at GIANT Health 2021 was one of simple logistics. It can be both expensive and time consuming to travel to a hospital or clinic, and many prefer a hybrid approach. Allowing people to do more from home makes it easier for them to access the care they need. But we must remember, if we’re to capitalise on medtech advances and encourage adoption and adherence among patients in the home, devices must be designed

with the utmost respect for people’s home environments and emotional needs, as well as their physical ones. Nobody wants their sanctuary to look like a hospital, or to be embarrassed when visitors pop by. In a medical facility you can get away with designing for function alone. At home, that’s not good enough. There’s evidence that some medical companies are beginning to prioritise this. Luas Diagnostics, for example, understood the need for discretion when designing its patient-centric drug-management system. The device is small enough to fit into a case and be concealed in a drawer. The team knew that it was unlikely anyone would want to have the device displayed on a surface, where friends and family might ask questions. ENSURING A ‘HUMAN’ RESPONSE Many of us, whether we suffer from a particular condition or not, are now used to monitoring our health passively via wearable devices such as smartwatches (heart rate, blood pressure, sleep patterns, etc). But as the surge in medtech continues, so will the demands placed on

Design

end-users. And with no healthcare professional (HCP) to hand in many cases, patients will increasingly be asked to deal with diagnosis and illness management themselves. We mustn’t ignore the psychological and physical challenges that all this poses for end-users. A device might be complicated to use, for instance, and people may fear using it incorrectly. Or they could simply be embarrassed to have it on show in their homes. Patients need to be motivated and engaged and understand the value of what they are being asked to do. This is especially true of rehabilitation and chronic therapies, which can require long-term management. Well-considered design can go a long way to improve adherence, alleviate emotional issues and boost the overall user experience. Taking a more patient-centric approach to the design of every touchpoint enables smoother remote patient monitoring and care. Clear instructions can reduce the anxiety that may arise when there’s no HCP present. Consumerstyle packaging can guide patients through complex set-ups and onboarding. The pack for Proteus,

The home has amazing potential as a place to improve health and deliver therapies, but it’s not enough to simply transplant hospital-style equipment into houses an ingestible sensor that allows HCPs to monitor drug compliance remotely, was designed to make it easier for patients to set up at home, taking the fear out of ‘getting it wrong.’ This was achieved with a thoroughly considered ‘step by step’ unboxing experience and simple, compelling content to reduce confusion. HOME IS WHERE THE HEART IS Most patients are not medical experts, and designs must be rigorously tested at early concept stage to uncover usability or contextual issues before they become baked into the engineering of the product. But while product usability and efficacy will always be paramount, of course, as we shift focus from hospital care to homecare, so product designers

and medical device developers will need to give much more thought to how their products affect people’s mental wellbeing. The home has amazing potential as a place to improve health and deliver therapies, but it’s not enough to simply transplant hospital-style equipment into houses. If we’re to maximise that potential, we need to accept that how people feel in their own homes affects the quality of their lives. Our homes are where we take refuge from the rest of the world, where we raise our families and socialise with our friends. Very few of the objects that we buy for them are purchased with only functionality in mind. The same consideration should be given to homecare medical technology.

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Innovation in Miniature

Case Study:

Design

HOW ACCURATE LOW FLOW PUMPS HELP AUTOMATE DIABETES CONTROL DEVICE

The Profil Institut für Stoffwechselforschung GmbH [institute for metabolic research] is using Watson-Marlow OEM pump technology in a medical device designed to automatically measure and control blood sugar levels in patients suffering from diabetes.

ach of Profil’s ClampArt glucose clamp devices use three Watson-Marlow 400ST/RX pumps. A total of 28 ClampArt devices have already been completed and have been used routinely in clinical practice for more than eight years, resulting in several hundred thousand operating hours without a single pump failure. Profil is a contract research institute (CRO) that specialises in performing clinical trials on new diabetes medication. One of its core areas is the study of glucose clamps – complex procedures that determine the properties of newly developed insulin preparations. After administering the blood sugar-lowering medication to a patient, a small amount of blood is continually taken over a period of up to 48 hours to analyse the blood sugar level minute-by-minute. Until recently, such tests had to be conducted manually, making them labour intensive and subject to problems such as inaccuracies and human error. ClampArt is Profil’s automated glucose clamp solution. After entering a target blood sugar level, known as the clamp level, ClampArt can control and maintain this level by administering glucose automatically. Bedsides measuring glucose concentrations, the method of pumping such small amounts of fluid, both precisely and at very low flow rates, was one of the main engineering challenges to overcome. SELECTION DILEMMA “The selection of a suitable pump was a big factor in the development of ClampArt,” says Dr Tim Heise, lead scientist and co-founder of Profil. “Initially we experimented with several

different pumps that proved unsuitable. The main problem was that glucose clamps operate with very low flow rates of only 7.5 ml/h and consequently with tube diameters of only 0.4 mm.” None of the pumps tested originally by Profil could provide the precision needed at such low flow rates. Furthermore, the tubes could not withstand the constant, high contact pressure. That is, until the institute made an enquiry with Watson-Marlow. Watson-Marlow recommended using its 400 series OEM pumps, which have been designed for flow rates of just 0.2 µl/min up to 2 l/min. When combined with a wide selection of pumpheads and control units, pump solutions can be configured to suit specific customer requirements. TRIO OF PUMPS In ClampArt, a total of three Watson-Marlow 400ST/RX pumps are deployed. The first supplies the body with a sodium chloride and heparin mixture to prevent the blood from clotting, while the second ‘sensor’ pump continually takes a small amount of blood from the patient. This is pumped into a mixing chamber, where it is mixed by the third pump with a haemolysis buffer and transported to the measuring unit so that glucose concentration can be measured. The solution involved minor customisation as the small tube diameter of 0.4 mm meant the gap between the pumphead rollers and the track was too big. As a result, Watson-Marlow increased the roller sizes in the pumphead, making the gap the ideal size for the tubes used. This solved the problem of high contact pressure and offered longer tube life.

SUCCESSFUL OUTCOME “Watson-Marlow gave us expert advice during the development process,” confirms Dr Heise. “We are very satisfied with our specially designed pump model because it supplies the low flow rates we require with the highest degree of precision.” As glucose clamps can last up to 48 hours, the pumps must work reliably. Test patients usually remain at Profil overnight, so the pumps need to operate as quietly as possible. The pumps can also be programmed and controlled individually by means of a separate control line, while in terms of safety they operate at only 12-60V and stop automatically whenever the cover is lifted. This made it easier to obtain CE certification for ClampArt. “After several years of research and development we have created, with ClampArt, an analysis instrument that has been used successfully in our clinics since 2012. As far as we know, there are no rival products with comparable performance in either Europe or the USA,” concludes Dr Heise.

REGULATION

Supporting SMEs through regulation and compliance

Phil Brown, director of regulatory & compliance, Association of British HealthTech Industries (ABHI), explains the launch of a new scheme designed to help SMEs through the regulatory and compliance processes.

n February, I was delighted to see the commencement of a new £7 million Health Technology Regulatory and Innovation Programme, a joint initiative by ABHI and CPI, funded by Innovate UK, that will support healthtech SMEs to navigate new regulatory processes. Companies have until 12:00 on 31st May 2022 to apply for grants, and the programme will operate a rolling call, allowing for weekly review and distribution of funding. Up to £30,000 is available for each SME to spend with UK, European or global regulatory affairs providers in activities such as global submission support and preparation, technical road mapping, and guidance on regulatory standards. Support for businesses is, of course, always welcome, but the health technology industry is unique in that it is primarily made up of small and medium sized companies, meaning that funding like this is hugely beneficial to those that may not necessarily have the internal resource to manage complex regulatory requirements. At ABHI, we have around 320 members, and we are able to offer those companies with regular insights and practical guidance on regulatory change to support their own strategies. But we are very much aware that there are thousands of UK SMEs not within our membership who do not have this level of support. The beauty of this programme,

therefore, is that it is open to all, and comes at a time of important change for the sector. In Europe, the transition to the MDR and IVDR is very much underway, and in the UK, the MHRA is developing new sovereign regulations under what are very tight timelines for the post-Brexit market. This has created something of a perfect storm in terms of capacity within the regulatory system to support innovators with change. When we consider the new requirements for diagnostic companies, for example, whereby many will now need to go through the Conformity Assessment Body process for the first time, that question of capacity is even more acute. There is huge competition to secure technical expertise, so to be able to give SMEs a foothold in this environment, through financial help and understanding, is vital. After all, many of these innovations will one day go on to enhance, and even save, the lives of patients.

This programme, therefore, is built to support companies, both in terms of what milestones they need to reach to be compliant, and the detailed requirements along the way, for example, the data needed to develop a technical file, or clinical studies, and to ensure regulatory programmes include aspects such as post-marketing activities. To be able to view regulation strategically, and part of a holistic business strategy, rather than a mere check box exercise, is another important ambition of the programme. As it will not only satisfy the immediate technical needs of a business but will futureproof innovations further down the line and will support a wider trend within the industry towards outcomesbased regulation. From a practical point of view, the programme will provide SMEs, both ABHI members and non-members, with the

ability to work with credible consultants and experts, to progress their regulatory strategy. The funding can be applied to several areas, ranging from global registrations, mock audits, and quality work, through to clinical and technical guidance and advice on reimbursement models. ABHI will be providing a suite of training aids for SMEs to utilise in the form of instructional videos, and we will also be developing a report which details the current ‘health status’ of the regulatory landscape, both in terms of Europe and the UK. This work will also provide a useful exercise for our wider engagements with regulatory stakeholders, and to ensure the needs of SMEs are always considered. The funding is offered to SMEs developing or supplying products in the medical device and diagnostics area, including in-vitro diagnostics. To apply to this programme, and for more information, companies should visit CPI’s website.

Med-Tech Innovation Expo

SMART TECHNOLOGY: Mark Yeeles, VP industrial automation, Schneider Electric UK and Ireland, explains how undergoing smart transformation can be beneficial to medical device manufacturers.

s we enter the new age of automation and smart factories, digitisation will be essential for the future of the medical device industry. Although not without challenges, the overwhelming benefits of automation, digitisation and the turbo-charging effect of smart technology enable factories to produce more while lowering costs.

In the last two years, the medical device industry has come under pressure to meet the increasing demands of their customers and partners while ensuring the affordability and accessibility of equipment for all. The sector has quickly realised that adopting innovative technologies to address unprecedented situations and bring transformational changes to the way product life is managed is critical.

Technologies including big data, robotics, machine learning, artificial intelligence, augmented reality, and 3D control have significant roles in boosting the efficiency and productivity of factories. Ultimately, they enable

MED-TECH manufacturers to respond with new products, packaging formats and materials to meet the changing demands of clients. To keep up with innovation, it is expected that the medical device industry will see more smart manufacturing solutions that focus on fundamental value propositions, such as improving manufacturing agility, optimising end-toend manufacturing costs, digitalising validation practices, compliance management and production operations. So, how will the sector utilise smart manufacturing technology? It’s time for the industry to take the following steps on its innovation journey. MEETING THE CHALLENGES IN THE MEDICAL DEVICE MARKET Innovation in manufacturing technology has never been more critical and in greater demand in the medical device market. During the pandemic there has been a need to increase manufacturing operational agility, maintain product quality and improve time to market, while keeping costs low and limiting downtime for improvements. The key to success is bringing the “smart” concept to plant assets & equipment, energy management, and continuous and batch processes, as well as to the plant operators and the asset & equipment suppliers and distributors. This is where smart manufacturing solutions come into play. SMARTER IS BETTER The National Institute of Standards and Technology (NIST) defines the smart landscape as “fully integrated, collaborative manufacturing systems that respond in real-time to meet changing demands and conditions in the factory, supply network

and in customer needs.” Smart factories that embrace planning, supply chain logistics and all aspects of product development and innovation, have almost limitless potential. Medical device manufacturers, just like other manufacturers, need to bring the benefits of digital transformation to all people, assets and processes involved in the manufacturing ecosystem. One thing is sure: entering the new age of smart factories requires the right balance between automation and robotics, never forgetting the pivotal role that humans have to make production processes successful. Once this has been realised, efficiency and resilience will become the norm, and manufacturers can thrive in an increasingly competitive market. Those failing to adopt smart manufacturing technologies and practices are likely to fall behind in short order and potentially disappear. INVESTING IN INNOVATION To address industry trends, market drivers and challenges, we expect the medical device industry will see more smart manufacturing solutions that focus on key value propositions, such as improving manufacturing agility, optimising end-to-end drug manufacturing costs, and digitalising validation practices, compliance management and production operations. By digitalising quality and production processes the industry will benefit from end-to-end traceability to ensure product integrity. This is particularly evident when it comes to medical device production who can use smart manufacturing solutions to meet the constantly changing industry pressures and demands. These technologies enable

INNOVATION | expo

manufacturers to enhance processes, quality, line performance, competitiveness, and compliance.

Another benefit of smart manufacturing that is driving today’s digital transformation is the ability to deliver workflow software solutions to enforce production rules and manufacturing procedures, enhance knowledge management, and drive collaboration across the workforce. WHAT DOES THE FUTURE HOLD? Medical device companies are seeking solutions to improve product quality and reduce costs. Smart manufacturing will enable information-driven operations which offers virtually infinite potential to improve business performance.

These smart manufacturing solutions will help the medical device industry digitalise their operations, which will help companies to reduce time-tovalue, improve efficiency and asset utilisation, and ensure product integrity, regulatory compliance and safety requirements are met.

Med-Tech Innovation Expo

More than sun and sea: WHY MAURITIUS IS A PLACE TO DO MEDTECH BUSINESS

Ian Bolland spoke to Mrs. Nirmala Jeetah from the Economic Development Board about its visit to Med-Tech Innovation Expo 2022, and the incentives for medical device manufacturers to do business in Mauritius.

hough to the lay person Mauritius is probably well known for its sun, sea and being a popular holiday destination, the country’s Economic Development Board is keen to highlight at this year’s Med-Tech Innovation Expo its attractiveness for investment in the medical device and life sciences sector.

and wants to do more contract manufacturing activities.

The Economic Development Board previously exhibited in a world when COVID-19 wasn’t around at our 2019 event, but is now back for more, and they’re not alone as they have medical device companies accompanying them to the 2022 edition.

“I would say for Mauritius it’s the ecosystem, the lifestyle, and the cost of doing business, and accessibility with the infrastructure, connectivity and for the labour. Because you need people to work and it’s easy to recruit people.

Co-exhibiting with them in June 2022 is catheters and stents manufacturer Natec Medical; personal protective equipment (PPE), medical tubing and moulds provider Xtruline; and orthopaedic and dental implants and bone substitutes manufacturer Noraker Capricorne.

“The government wants to promote manufacturing and right now we have the premium investment scheme that is focusing on pharmaceuticals and medical devices. With the Premium Investment Scheme you can get exemptions duties, taxes that are levied but also in terms of utilities. This is a new scheme to encourage those in the healthcare sector.”

Noraker Capircorne is a great example of a company with French roots that established a presence in Mauritius. Their research is undertaken in France, but its manufacturing base is in Mauritius as the company can capitalise on several tax credit and rebate schemes. Natec is also setting up a life sciences centre in the country

Mrs. Nirmala Jeetah, who oversees the bio-industry and project development directorate at the Economic Development Board of Mauritius, explains more about the incentives there are for life science companies to do business in the country.

The sector accounts for 5.6% of the country’s Gross Domestic Product (GDP) and Mrs. Jeetah highlights this is a relatively new industry for the Mauritian economy with companies abroad starting to express their interest in investing. The Economic Development Board wants to

work with more companies to bring more life sciences manufacturing to Mauritius. “There is a life sciences and pharmaceutical hub that has been earmarked for Mauritius where we have invited companies to set up. There’s already one company that has shown interest in manufacturing its products in Mauritius and we have another South African company that has shown interest in setting up in the pharmaceutical sector.” In any business this requires building connections and networking, a major reason why the Economic Development Board is exhibiting in 2022 in its first outing at the show since COVID-19. “It is an opportunity for us to create more awareness about high-tech manufacturing in Mauritius, especially for the healthcare sector. “That is the main reason for us to exhibit; to create more visibility for Mauritius, but also for other companies that are accompanying us to better get new orders and contacts. “To be global we need to attend these types of events, and this type of event specifically is a very specialised event in this sector. That’s the reason why we

Med-Tech Innovation Expo

It is an opportunity for us to create more awareness about high-tech manufacturing in Mauritius, especially for the healthcare sector have targeted this event, that’s key for us.” Connecting themsleves and the trio of accompanying companies with others, as well as creating awareness for Mauritius’ life science sector, is a key factor behind exhibiting at this year’s Expo. “For us it is important that these companies network and do some matchmaking with other companies and to create awareness for them with other companies that we represent in medtech. “That is all of the supply chain, all of the different service providers and we will have all of these visitors coming so: new contacts, new orders, this is the forum for these companies to increase awareness about these products, get new orders, get contacts and that’s the main reason why we are participating but also Mauritius being not just the sun, sand, sea and holidaymaking but also that we do business. “Also, we have the whole ecosystem for clinical trials because the last time we participated we met a few investors as well that have shown interest, and we met companies in medical devices manufacturing and some from Ireland. I think they were quite surprised to see Mauritius. “People don’t know about Mauritius being the medical devices manufacturing site or destination. They know

Mauritius for holidays so we want to create more awareness, get more insights from the different seminars and workshops we do have and that could help us be up to date with the different technologies. The different seminars and the different tools and techniques that are happening overseas allow us to keep abreast of developments in this area at an international level, also.” Creating awareness not just for the industry body, but also the companies that are accompanying the Economic Development Board to the NEC as they try to meet with others ahead of the event and capitalise on their presence. “Last time we met with Medilink and we want to sort out more collaborations that can create more awareness with those companies, and more synergies, sharing of information and things like that. These are the main things, especially working with the industry associations so at least the companies which are well established, very much advanced in terms of technology, manufacturing processes and all that so you keep learning from them.” The Economic Development Board of Mauritius will be on Stand D10 at Med-Tech Innovation Expo, which takes place on 8th-9th June at The NEC, Birmingham, UK. For more information on visiting and exhibiting, visit www.medtechexpo.com.

Meet the start-up

MEET THE START P: BRINGING INNOVATIONS CLOSER TO HOME

Juliet Bauer, SVP and UK managing director of Livi, explains how the company has gained traction in the UK with its digital health solutions. First, give us a sense of where it all began with Livi? Our mission is to build better, more accessible healthcare for patients, and to equip GP practices and other healthcare providers with digital tools that enable them to deliver services more efficiently. Livi launched in the UK in 2018, with just one contract and a team of 15 staff. Since then, we’ve grown at an astounding rate - we now cover eight million patients under NHS contract. Livi is part of Kry, which was founded in Sweden in 2014. Enabling patients to see a GP via video consultation when they most need it was the first step on the journey, and last year Livi was rated ‘Outstanding’ by the Care Quality Commission. This was a watershed moment for us, and it means our digital healthcare service can stand side by side with the best in the industry. Give us an overview of the technology behind Livi? Livi offers a suite of digital solutions that improve patient access and provide critical capacity for clinicians and health systems. Our MJog by Livi batch messaging technology is used by more than 4,500 GP practices in the UK and allows GP practices to communicate important information quickly to patients. This obviously made a huge difference during the pandemic. In 2020 our technology was used to send over 200 million messages for COVID-19 vaccinations, appointments for flu jabs, and other vital communications. The pandemic has changed how people use technology in relation to their health, have you made advances with your own developments?

The pandemic accelerated the adoption of virtual consultations. Using Livi meant that despite lockdowns, patients were able to access a GP without having to visit surgeries and expose themselves and clinical staff to unnecessary risk, and surgeries were able to continue to support their patients. The pandemic and lockdown restrictions also saw a sharp increase in the number of people suffering from mental health problems such as depression and anxiety, compounded by a lack of access to mental health professionals. We recently launched a Talking Therapies service, allowing patients to see a psychologist remotely, and receive treatment for several mental health conditions. Later this year we’ll add Internet Cognitive Behavioural Therapy to our talking therapies service, following a successful trial in Sweden. The service will support psychologists to see twice as many patients suffering from mental health issues including depression, anxiety, and stress. It seems that Livi takes the simple things, via technology, to the patient’s doorstep, is there more to it? It’s no secret that some people see digital GP services as a temporary solution to a temporary problem, and now it’s time to get back to the doctor’s waiting room. But this view fails to account for the transformative effect services like ours can have on improving healthcare. My vision is harnessing the power of scale, technology, and data to create transformative solutions to improve population level health outcomes.

Our technology will soon be able to match patients living with long-term conditions, for example, to the clinician with the most appropriate skillset. In Sweden analysis of our patients’ data has shown that our algorithmic patient matching tools reduce avoidable hospitalisations by 20%. With this technology rolled out at scale, there is so much more we could do. Right now, we have innovations closer to home. In January this year Mjog by Livi was integrated with the NHS App. Currently in its pilot phase, this integration means patients can receive messages from their GP directly in the NHS App. This will make patient communication safer, thwarting the scammers who targeted people with fake messages during the pandemic, and will open the door to powerful population-level health interventions. We also launched Mjog’s remote monitoring service, allowing GPs to send patient surveys to monitor conditions such as asthma, anxiety, and depression. With data coded securely to patient records, those who need help can be identified faster, and quickly access the support they need. It is easy to see how this technology could power population level campaigns for smoking cessation or weight loss, with patients accessing high-quality support directly in the NHS App. This is scale, technology, and data in action. What plans do you have for the company going forward? This year we will be continuing to scale our services to help more patients and give them better access to healthcare. We will also be working hard to scale our mental health services and try to address the impact the pandemic has had on people’s mental wellbeing.

4.0

SURGERY 4.0:

WHAT REALLY CONSTITUTES THE FUTURE OF SURGICAL RESEARCH? Professors David Jayne, professor of surgery and Alejandro Frangi, Royal Academy of Engineering chair in emerging technologies at the University of Leeds set out the key concepts contributing to the future of surgery, or ‘Surgery 4.0’.

urgery 4.0 is the future of the surgical speciality. It’s a continuum, no longer beginning and ending at the tip of the scalpel but encompassing the entire patient journey from diagnosis to recovery and beyond. The surgical procedure itself is just one aspect of an entire digital pathway. Almost everyone is familiar with the concept of robotic surgery, whether that’s from personal experience or an interest in sci-fi, but robotics is also only one aspect of Surgery 4.0, which incorporates other concepts such as novel diagnostics, personalised interventions, computer modelling and virtual reality. Surgery 4.0 has the potential to bring improvements to patient safety and outcomes, enhance clinician training and offer new ways of evaluating novel technologies.

we could monitor patients’ implants through on-implant sensors, Element could use similar technology to detect when the safety of those medical implants might be compromised.

In industry, we have already seen the benefits of the digital transformation (Industry 4.0), which has revolutionised the way the medical products are manufactured and supplied. These same processes are now slowly being integrated into healthcare. One example is Element who have expertise, for instance, in large-scale testing networks of distributed turbines. Using intelligent sensors and artificial intelligence, they can detect when these turbines reach the end-of-life stage, anticipate potential failures, and put mitigation policies in place. These sensors can precisely measure at what point the turbines need to be replaced for safety reasons - preventing wasteful disposal of those still working well. But this has implications for surgery too. As improvements in surgery have resulted in patients living longer, happy lives after implants, it has become increasingly important to know that these implants remain safe and functional. Assuming

The fourth dimension is computational. Improvements in access to patient data alongside advances in computer modelling will allow researchers soon to predict the best interventions for each individual.

Surgery 4.0 is seeing the clinical community and regulators looking for ways to move away from the traditional bench, in vitro, in vivo, and Randomised Control Trials (RCTs) as the only sources of scientific evidence on the safety and efficacy of medical products. Surgery 4.0 will use in silico, i.e. virtual or computational, trials to inform innovation and certification of surgical procedures and devices. Conventional trials can be resource-intensive, slow, and ultimately only probe these technologies in constrained scenarios or limited populations.

When the same techniques are applied to complete virtual populations, in silico trials can be used prior to gold standard RCTs on human trials to detect early failures or offer an ethical way to evaluate new treatments in rare diseases or paediatric populations. In silico trials also have the potential to represent the target population more accurately, as traditional studies tend to underrepresent certain groups due to inclusion or exclusion biases or limited access to patients. Imagine a case where a cerebral aneurysm patient can not only be fitted with a life-saving stent, but stent bespoke to their specifications and needs. This is close to being

a reality thanks to in silico analysis of blood flow models to customise the perfect stent for any patient. A bespoke stent would be easier to fit as well as resulting in improved outcomes for the patient. Additionally, cuttingedge virtual reality operating theatres could allow the surgeon to hone their skills and practice the procedure on a simulation of the patient. Or surgeons-intraining could perform virtual surgeries to complete their training programmes. Experts across the UK are working on a variety of ground-breaking advances in the surgical field and contributing to the shift to surgery 4.0. The Centre for HealthTech Innovation is a joint research initiative between the University of Leeds and Leeds Teaching Hospitals NHS Trust to accelerate the development of exciting technologies to address some of society’s biggest healthcare problems. The National Institute for Health Research (NIHR) is also making strides in the area of predictive medicine, with the NIHR Sheffield Biomedical Research Centre having an In silico (Predictive) Medicine theme. Surgery 4.0 will revolutionise the whole patient journey. The UK will continue to build capacity and capability in this area to work with forward-thinking surgical research companies and academics. The NIHR is a great place to start if you want to build a multi-disciplinary team that will work collaboratively to ensure you generate the evidence you need to support the adoption of your medical device, digital technology, or diagnostic in the NHS.

Contract Manufacturing

SUPPLY CHAIN

AGILITY AND STABILITY:

Three ways CMOs ease international expansion Ralph Tricomi, director, market development, Web Industries, shares three ways a contract manufacturing organisation (CMO) can help medical device businesses expand internationally despite supply chain challenges.

rom Brexit to Omicron, medical device OEMs are always adapting to uncertainty. Who would have thought the first quarter of 2022 would bring blockages at the Canadian border, continued ports congestion, truck driver shortages and escalating container costs? For U.K.- and Ireland-based OEMs, these are just a few challenges associated with entering the North American market. But the potential spoils make it worth the effort to consider expansion. The U.S. medical device market alone is the world’s largest, with 40% of global market share, according to SelectUSA, and it’s projected to grow to $208 billion by 2023. The opportunity to expand across the Atlantic is sizeable. Some OEMs choose to engage CMOs to expedite and ease the entry process. A Grand View Research study found that “the U.S. medical device outsourcing market size was valued at $21.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 10.3% from 2021 to 2028.” Contract manufacturing made up 55.5% of overall outsourcing in 2020. This data suggests many device OEMs are prioritising outsourced manufacturing. Here are three answers why: 1. COLLABORATIVE INNOVATION Medical device OEMs benefit when they can focus on core competencies and outsource other processes to contract manufacturing partners. It’s increasingly common for brand owners to devote attention to design, development and marketing while delegating other processes to third parties, trends, and product innovation.

When they use CMOs, medical device makers can direct their resources to product design, development, patient care, healthcare provider expectations and demand trends while assigning manufacturing details to a CMO partner. OEM-CMO collaboration is made seamless these days by enhanced business-to-business digital communication. Companies can establish secure virtual connectivity for sharing and collaborating on designs, project plans and production forecasts. In-person visits and on-site inspections are still important but boots on the ground are not necessary to keep information flowing and projects moving forward. 2. SUPPLY SECURITY AND PREDICTABILITY Since the pandemic’s onset, one of the greatest issues facing OEMs has been supply chain uncertainty. Partnering with a nearshore or onshore CMO close to the target market eases materials inventory management, supply chain predictability and securitisation. Stretched global supply chains are vulnerable to delays, capacity constraints, ports congestion and supply shortages. In 2021, approximately 8,000 to 12,000 containers of medical supplies were delayed an average of 37 days by U.S. transportation congestion at ports, on railroads and with trucking, according to research by the Health Industry Distributors Association. By outsourcing to a North America-based CMO, OEMs simplify raw materials and components sourcing. They rely on their contract manufacturing partner’s

supply chain knowledge and relationships. The CMO connects the dots to match vetted suppliers with the bill of materials and can manage raw materials inventory. In addition, OEMs who outsource to an established CMO partner will have a skilled workforce, already in position.

take a device from late-stage product development to mass-scale commercialisation, including these stages: 1. Feasibility evaluation 2. Project definition and planning 3. Technical transfer, process verification and validation 4. Commercial production

3. SPEED AND SCALE Speed to market matters. The ability to manufacture and distribute — at mass scale — within the target launch window plays a significant role in whether a device is a commercial success. Unfortunately, there have been COVID-19 diagnostic tests and other solutions that never made it to market because of supply chain challenges or regulatory issues. While these risks can impede any organisation, they are intensified for international OEMs trying to expand in the U.S. market. Hurdles might have been avoided or overcome if they had the right partners to help them build their North American business. A full-service CMO collaborates with an OEM to

For U.K.- and Ireland-based OEMs looking to expand internationally, a CMO partnership offers a rapid means of accessing new geographic markets without extensive capital expenditure and time to stand up new factories or convert facilities into medical-grade operations. With strong medical device industry growth, it’s an ideal time to consider international expansion, particularly in the United States. There are headwinds, including global supply chain shortages and delays. With the right CMO relationship close to market, device OEMs will have a trusted partner to help surmount the difficulties, seize on new opportunities, and share their innovations with more customers.

CMO CAPABILITIES CHECKLIST Facilities certification and standards compliance: ISO 13485, Current Good Manufacturing Practices (CGMP), ISO 9001, ISO 14001, and in U.S., designation as U.S. Food and Drug Administration (FDA) Registered Medical Device Establishment. ✓ Systems integration and security: Connectivity via ERP, CAD/CAM, EDI and other technologies, with rigorous security standards and protocols. ✓ Automation: High-speed, continuous manufacturing and packaging lines. ✓ Tech transfer: A proven process for transferring an OEM’s solution from small batches to mass production.

✓ Experienced team with industry expertise. ✓ Positive references. ✓ Ample cleanroom manufacturing capacity. ✓ Openness to site visits and inspections. ✓ Compatible corporate culture. ✓ Strong supply chain relationships. ✓ Financial stability.

Innovative Materials

MAKING STRIDES:

A BRIGHT FUTURE FOR INNOVATIVE MATERIALS AND MEDTECH Kevin Coker, co-founder and CEO of Proxima Clinical Research, explores the outlook for new and existing materials and manufacturing practices in medtech.

ew cures call for new science as well as the application of new and improved manufacturing materials and processes. With the rapid advancements in regenerative medicine, the industry predicted we’d be able to print human organs 10 years ago, but the technology has not advanced enough. Still, it has doubled in advancement every year, much like the progression of computers that once took the space of an entire building, to today, where we have smart phones that fit into our pockets and cameras so small, they fit on the head of a pin. Today’s medical technology has finally caught up to the dream of printing live tissue and the only missing part to live organs is the vascularisation and innervation. Even amidst the COVID-19 pandemic, the advent of 3D printing in regenerative medicine— using innovative materials such as bioabsorbables—shows us how and where medical invention is gathering momentum. This illustrates that even under immense stress, humans are capable of tremendous advancements, and 3D printing is a key area to watch.

MATERIALS SCIENCE The evolution in materials science is one of the driving factors for exponential growth in medtech. Some of the most exciting scientific developments making their way into commercial applications can be seen in the areas of bioprinting and additive manufacturing. These processes are becoming a reality in everything from bioabsorbable materials appearing as key components of medical devices to full-scale organdevelopment in regenerative medicine. 3D printing technology

was developed 40 years ago and began as a process of additive manufacturing by overlaying polymers one layer at a time through an extrusion process. Today, printer types and functions are as vast as the applications themselves along with substrate material choices, including biological and bio-absorbable materials with the potential to change healthcare forever. BIOABSORBABLE INKS AND MATERIALS A main component of 3D bioprinting is the bioink, which is vital in the design of functional organs and tissue structures. Bioinks can have a variety of properties to suit the specific application but usually fall into two main categories: cell-scaffold based approach and scaffoldfree cell-based approach. In cellscaffold, the bioink consists of biomaterial and live cells, which are printed to develop 3D tissue structures. In this form function, the scaffold usually biodegrades the living cells that were printed behind in a structured format. The scaffold-free cell-based approach entails additive layers which build up the bulk of the tissue. These Bioinks are “printed” through various methods such as inkjet bioprinting, selective laser sintering (SLS), and stereolithography (SLA). There are many choices of bioinks, such as agarose-based inks, collagen-based substrates, hyaluronic-based inks, and synthetic materials. Bioinks used in the 3D bioprinting processes need to exhibit biocompatibility, biodegradability, and non-toxicity to cells. Ideally, they also provide a source of nutrients for the remaining structure. Different methods allow for a variety of

controlled porosity, permeability, and mechanical properties. ADDITIVE MANUFACTURING With those challenges in mind, and as the technology advances, additive manufacturing, which is the cumulation of the bioinks through the printing process, has solidified its place within current and new medical device prototypes. For example, hearing aids are being 3D printed on a large scale today, and the hope of scientists is to one day alleviate hearing impairments altogether with regenerated living tissue rather than devices or surgery used today. ORGAN LEVEL PRINTING As companies continue to advance the technology, 3D bioprinting will play an increasingly larger role in full-scale organ-level regenerative medicine to solve very challenging biological problems such as vascularisation and innervation of printed biological tissue, giving promise to the future of functioning organs such as kidneys, livers and lungs. One example of this promise is the recent acquisition of Volumetric Biotechnologies by 3D Systems, as they advance their platform for human organ printing. 3D Systems and Volumetric plan to develop a sizeable biofabrication facility in Houston’s East End Maker Hub, further positioning the city as a hub in life sciences innovation. THE FUTURE Medtech innovation is booming, and innovation is maturing in directions never seen nor explored. New technologies and innovative materials are changing medical care as we know it. This innovation is positioning 2022 as an incredibly promising year for a variety of innovative materials and their applications.

Cross Manufacturing Precision Sealing Solutions

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