MTI Issue 59 by Med-Tech Innovation Magazine

www.med-technews.com Issue 59 | May/June 2022

@medtechonline

MED-TECH INNOVATION | NEWS MED-TECH

PLUS innovation New Medilink Midlands CEO outlines his vision Regulatory issues surrounding AI Automating data collection to streamline compliance

Going beyond borderS - AN ITALIAN FEEL TO MED-TECH INNOVATION EXPO

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CONTENTS regulars

Comment

Ian Bolland explains why he’s excited about this year’s MedTech Innovation Expo

Making Medtech

A round-up of the latest industry news

12.

Cover Story

Ian Bolland speaks to Filippo Mansani from the Italian Trade Agency about the strong presence from the country at this year’s Med-Tech Innovation Expo

16.

Med-Tech Innovation Expo

In addition to his editor’s letter, Ian Bolland provides his preview to this year’s MedTech Innovation Expo

27.

Digital Health

Miiskin’s founder outlines the technological advances seen in dermatology

34.

Real World Medtech

Nuance Hearing explains its solution for the 'cocktail party problem'

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

10.

Medilink

MED-TECH

Med-Tech Innovation speaks to the new chief executive of Medilink Midlands Simon Himsworth about his vision for the company and his outlook on the industry

INNOVATION | NEWS

15.

Sustainability

Wideblue considers many of the practices under the microscope as companies strive for their sustainability goals

21.

Microfluidics

Xi Engineering outlines the importance of microfluidics in medical technology ahead of its MedTech Innovation Expo return

23.

Testing & Inspection

Velentium discuss test systems and why they should be developed in parallel with medical devices

29.

Regulation

Medidata examines the regulatory issues when it comes to the increasing use of AI 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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Show me the way (to MTI Expo)

t seems like barely a year since I was last writing an editor’s letter telling you why you should come to Med-Tech Innovation Expo. Admittedly that’s because our last show was in September as we made our first steps towards living normally again following a pandemic only for a fuel crisis to come along and challenge us too, but we are back nine months later with Med-Tech Innovation Expo 2022. For those who regularly read this magazine, you might be familiar with a lot of what I’m about to say given our yearround Expo features in this title, and there will be plenty of column inches dedicated to what you can look forward to on the show floor and stages – and for those who have picked up this magazine in Hall 10 at The NEC or prior to your visit to Birmingham (and sorry to those who can’t make it), then welcome to the magazine that runs alongside the show. Of course, we haven’t been the only show in town. Just in April I had the pleasure, along with my colleagues, to head across the Atlantic to connect with many of you and others, at MD&M West in Anaheim. It was my

first time at the event, which may surprise you but much of my time at the helm here has been taken up by COVID-19 and lambasting government policy. Believe me, I don’t like doing that all the time, and it was nice that once we were able to step off our flights that we could remove our masks to talk about new projects, new ideas, what’s changed and how things may or may not have been reshaped thanks to the events of the last two-anda-bit years. Though we’re still recovering the pandemic it felt like the buzz was back as we met new and old faces – some fresh eyed into the industry, and others re-energised at our newfound freedoms and ability to put the ideas into practice that may have been sat on for a little while longer than was perhaps desired. I’m hoping for more of the same when we all meet on 8-9th June. This includes two days of insightful thought leadership across our two stages and a return of Pitch@ Med-Tech Innovation Expo as our budding start-ups compete again. You can hear from those on the show floor plus enjoy

more insights about the latest technological development on the Introducing Health-Tech Stage. Then on the Med-Tech Innovation Conference Stage you can hear about how we can tackle the NHS backlog, new manufacturing practices as sustainability becomes the buzziest of buzz words and as we have all become familiar with diagnostics and got used to Brexit… what next in both areas? I’ll look forward to seeing as many of you as possible when I host a live episode of The MedTalk Podcast which focuses on the current regulatory environment but if it’s not listening to me chairing a discussion with three distinguished panellists that floats your boat then why not connect with those on the Medilink Pavilion? Or one of our international pavilions from Italy and Mauritius? There’s also exhibitors from Germany, the Netherlands, Switzerland, the United States, Hong Kong and more! I’ve not even got onto the return of the Awards, yet! So, which way to Med-Tech Innovation Expo? That way!

Making medtech

Adapttech raises £2.25m and launches new range B iomedical start-up Adapttech has raised £2.25 million from investors including Mercia Asset Management, ACF Investors, Wren Capital, and Wealth Club. The company has also launched the new Insight Range, a family of products that make it faster and easier to fit lower-limb prostheses and improve patient outcomes. The new funding will be used by Adapttech to further develop wearable technologies to help people with physical limitations improve their quality of life. The company’s flagship product, the INSIGHT system, has been upgraded into a full product range, with several new options for O&P professionals, including:

Aquarate’s Hydracup used in the NHS Hydration Project.

quarate’s Hydracup has been selected to be used in four NHS regions to help improve hydration and reduce urinary tract infections. This hydration pilot will be implemented amongst elderly patients across a range of care homes, domiciliary care, and acute care settings. By introducing digital innovations across such a broad range of care settings, the impact of the Hydracup can be measured comparatively, allowing the areas with the greatest potential to be scaled up subsequently. CCGs and ICSs are looking primarily to reduce UTIs and decrease dehydrated related hospital admissions, but monitoring fluid intake has many more advantages. Monitoring fluid intake allows care givers to proactively adjust care given to avoid dehydration, confusion, dizziness, trips, falls & fractures, kidney issues and can reduce the need for antibiotics.

• INSIGHT Sense: a portable, and standalone realtime analysis pressure measurement system; targeted at smaller O&P clinics to reduce hardware costs and help them provide house calls.

Frederico Carpinteiro, CEO, Adapttech, said: “With the new INSIGHT Range, we’re responding to requests for a scanner-less system, reduced hardware costs, and improved data collection. This new

• INSIGHT Digitizer: a standalone digitiser for prosthetic sockets that creates high-resolution 3D models; targeted at central fabrication and large O&P clinic groups.

funding comes at a time when we are developing exciting new technologies to benefit our O&P clinic customers and their patients. We look forward to continuing our trajectory in growing our revenues, product portfolio, and international business operations.”

• INSIGHT Pro: combines both the INSIGHT Digitizer and INSIGHT Sense; targeted at larger O&P clinic groups, central fabrication, and research facilities and universities.

ClearSky develops MCI diagnostic C

learSky Medical Diagnostics has developed an intelligent medical device that can objectively diagnose mild cognitive impairment (MCI), a condition often suggested as an early stage of dementia. It is estimated that 5-20% of people aged over 65 have MCI, characterised by minor problems with cognition, such as memory or thinking. ClearSky MD is a University of York spinout company that develops non-invasive medical devices for the diagnosis and monitoring of neurodegenerative conditions, including Parkinson’s and Alzheimer’s. Its prototype diagnostic device – MCI-Monitor – is worn by a patient while undertaking a standard clinical test known

as ‘the reach and grasp task’. The kinematic characteristics of reach-to-grasp actions and the visual attention while performing the task are captured by the MCI-Monitor and measured using AIpowered technology. Software based on unique biologically inspired computer algorithms provide an immediate result based on quantitative measurement of the patient’s visuospatial ability, memory, and executive function - three important cognitive functions. ClearSky’s initial studies have suggested that MCI-Monitor is able to differentiate between Parkinson’s with normal cognition, PD-MCI (Parkinson’s Disease MCI) and PDD (Parkinson’s Disease Dementia). Professor Stephen Smith, founder of ClearSky Medical

Diagnostics, said: “We are excited about the potential of MCI-Monitor to replace timeconsuming and subjective conventional clinical tests to assist healthcare providers in making a diagnosis early, easily, and accurately. “We’ve already applied our specialised ‘white-box’ machine learning algorithms across a number of devices to help diagnose and monitor neurodegenerative conditions, such as Parkinson's and Alzheimer’s, and would love support to accelerate the development and testing of MCI-Monitor.” The company is seeking partners to collaborate on launching MCI-Monitor to the general population and is looking to achieve its third CE-marked product.

Expo News

Rebekah Jordan picks out a few products and services that will be showcased by exhibitors at Med-Tech Innovation Expo, taking place on 8-9 June at The NEC, Birmingham.

Guardtech to display laboratory and cleanroom products and services The Guardtech Group will provide its controlled environment design & build solutions, as well as cleanroom-related products and services at Med-Tech Innovation Expo 2022. Guardtech will also include its furniture & equipment, along with its contracts in facility servicing, maintenance and decontamination, across the life sciences template.

The Group’s five divisions deliver high-performance custom cleanroom design and construction: • Guardtech Cleanrooms – modular controlled environments and laboratories with custom cleanroom design. • Isopod Rapid Cleanrooms – standardised models with ‘flat-pack’ delivery and optional self-assembly installation.

• Cleanroom Solutions – high-quality controlled environment design & build services, for larger turnkey construction projects. • Isoblok Pre-Fabricated Cleanrooms – pre-configured, plug-and-play pods. • CleanCube Mobile Cleanrooms – for quick turnaround projects, space utilisation and temporary applications.

You can find out more about Guardtech's products by visiting Stand G37.

Unipart to showcase digitalised supply chain solutions Unipart Logistics will demonstrate its digitalised solutions and consultancy services, that sustain performance across medical devices at Med-Tech Innovation Expo 2022. Unipart supply chain solutions utilise machine learning and predictive analytics to improve sale forecast accuracy and realtime visibility to deliver multi-channel fulfilment. Additionally, its warehouse solutions are ISO13485 accredited, backed up with digital technology and data science solutions, that combat the challenges facing the healthcare sector. Their capabilities across the life sciences sector continue with: • Digital supply chain solutions - span data science, IoT and sensors, picking solutions, robotic process automation, 3D scanning and printing and augmented and VR. • Inventory optimisation uses predictive technology, big data, and machine learning to maintain the optimum balance between stockholding and service. Able to forecast demand

and automate stock replenishment decisions to reduce inventory and improve availability for endusers. • Kitting and customisation scalable and compliant with industry and temperature control regulations. Full service kitting, co-packing, and fulfilment services to support enterprise and direct customer requirements. • Precision tooling and fixturing - mechanical engineering for precise tooling and fixturing solutions. Metlase offers quick-make laser-cut prototype, production grade fixturing and tooling for manufacturing solutions. You can find out more about Unipart's products by visiting Stand E40H.

iVis exhibit suite platform of corneal surgery medical devices iVis Technologies will present its low invasiveness treatments and customrefractive medical devices for therapeutic corneal surgery at Med-Tech Innovation Expo 2022. The iVis Suite will include its comprehensive, refractive products of medical devices across the life sciences sphere: • CIPTA - software that optimises patient’s quality of vision and minimises surgical invasiveness. Incorporates a variablewidth transition zone to maintain linear variation of the corneal curvature, minimising risks of regression. • iRes – high-resolution, custom-refractive and therapeutic laser, delivering micrometric spots for smooth corneal ablations in one-step, controlling the

plume effect and preventing thermal damages. • pMetrics – dynamic pupil assessment - accurately defines the optical zone of ablation, based on ideal pupil computation and accounting for anterior chamber depth; minimising treatment invasiveness. • Precisio – high resolution tomographer - HD morphological and refractive maps and ID data for eye registration. Linked to the iVerify application which grants an automated and objective debriefing process, allows clinical follow-up and analyses corneal surgical outcomes. You can find out more about iVis's products by visiting Stand E10. Register to visit at www. med-techexpo.com.

CLEAN

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MEDILINK

Footfalls and Heartbeats highlights smart fabric manufacturing process

ootfalls and Heartbeats has recently published a paper in the MDPI Engineering Proceedings, highlighting its technology as a viable alternative to the industry standard method of data capture for movement patterns and biomechanics. Footfalls & Heartbeats has developed a revolutionary and proprietary process for manufacturing smart fabric. Nanoscale interactions that take place within the fabric remove the need for wires or solid-state electronics; 'the textile is the sensor'. The paper, published by Footfalls, entitled: “Assessing the Validity of a Kinematic Knee Sleeve in a Resistance-Trained Population” is the first written by Nathan Toon, a recent graduate of Derby University who joined the company in September of last year. The study assessed the validity of a Kinematic Knee Sleeve (KiTT), designed, and manufactured by Footfalls, against Vicon, an industry leading, gold-standard motion-capture system.

Motion-capture systems are capable of recording joint angles such as the relative knee angle in the sagittal plane, the displacement of segments, and the angular motion of joints and segments. Relative Knee Angle is commonly measured when assessing squat depth to provide the user and coaches with information relating to range of motion or strength improvements that can be used to develop effective strength and conditioning strategies and rehabilitation plans. However, when recording motion through such systems, real-time data is not available, compromising the data’s value during a particular session. Additionally, these systems are not as accessible and are coupled with the need for specialist equipment and training. Wearable sensors that can be worn away from specialist settings and provide real-time and instantaneous data to users and coaches allows exercise or training methods to be adjusted

Cellomatics wins Queen’s Award for Enterprise C ontract research organisation (CRO) Cellomatics Biosciences has been recognised with the Queen’s Award for Enterprise for International Trade. Cellomatics is one of 225 organisations nationally to be recognised with a prestigious Queen’s Award for Enterprise. Employing 15 people, Cellomatics was founded in 2015 and specialises in the development of bespoke bioassays across numerous therapeutic areas including oncology, immuno-oncology, immunology, inflammation and respiratory. Last year, the company reported year-on-year organic growth of 30% since it was founded, in the wake of increased demand for its bespoke preclinical and early discovery phase laboratory services and expertise. The company’s exported business has increased over 15-fold, with export sales now representing

instantly, suiting the needs of the session to aid performance and rehabilitation in a way that is not possible with fixed and specialist motion-capture systems. Previous wearable sensors, such as smart watches focus on comfort for the user, rather than the quality of data. As a result, accuracy is often lost, leading to unreliable and invalid data. Footfalls and Heartbeats Kinematic Knee Sleeve (KiTT) aims to bridge the gap between comfort for the user and the collection of valid, accurate and actionable data. KiTT is a custom-knitted smart wearable knee sleeve, which is the first of its kind that knits the sensor directly into the fabric. Part of the KiTT is an electronics module, allowing data from the textile strain sensor to be transmitted to a portable device. Through comparing their KiTT technology against Vicon, it was found that The KiTT appears to serve as a practical alternative to Vicon without sacrificing the quality of the data.

approximately 50% of total revenue. Significant growth has come from clients based in Europe, Asia, and the USA. Cellomatics’ CEO and founder, Dr Shailendra Singh, said: “It is an absolute honour to be recognised with the prestigious Queen’s Award for Enterprise and for our excellence in international trade, particularly on the year of the Queen’s Platinum Jubilee. “Cellomatics has continuously moved from strength to strength since our inception over six years ago. We’re proud to have successfully completed over 200 projects in collaboration with approximately 70 clients in the last six years, with between 10 and 15 new clients secured each year, and around half of our clients placing repeat business. This has translated into strong revenue growth from an expanding international and diversified customer base.”

Nathan Toon, postgraduate researcher at Footfalls and Heartbeats and lead author of the paper, said: “I’m very excited to have my first manuscript published with the MDPI Engineering Proceedings. I hope that it will be the first of many, with the great supervisory team here at Footfalls and Heartbeats. Our findings show that Footfalls’ KiTT technology fulfills a real need in the field of sports science and rehabilitation and performs as a viable alternative to the industry leader.”

Rapid Fluidics strikes collaboration with Life on a Chip

apid Fluidics and Germany-based Life on a Chip have announced a collaboration agreement between the two consultancies. This brings together advanced skills in microfluidic design and rapid prototyping to serve clients developing microfluidic systems. With the combination of microfluidic expertise and next-day turnaround microfluidic prototyping, this collaboration allows customers developing point of-care diagnostics, organs-on-chip, or microfluidic detection devices to save time and money as they develop a working system. The partnership also allows both companies to leverage having a base in both Germany and the UK.

MEDILINK

A FRESH LOOK

Med-Tech Innovation News caught up with newly appointed Medilink Midlands chief executive Simon Himsworth to discuss his vision and the challenges likely to be faced by the company and life sciences as a whole in the immediate future.

ongratulations on the new role, but first if you could introduce yourself to our readers? Thank you. For the past 6.5 years I’ve been working with global biopharma organisations, helping them to solve industry-wide common challenges, and delivering industry-wide transformation programmes. Pre-pandemic it meant a lot of travelling globally, primarily in the U.S. and bringing knowledge and experience across the globe together to solve common industry-wide problems affecting all organisations and their respective supply chains. I’ve spent over 25 years leading the design and delivery business support and other organisational change programmes in both the public and private sectors. Before working in a global role, I’ve worked extensively in both the East and West Midlands and it’s great to be returning to my home region, and to continue working within

life sciences. I’ve been made very welcome within Medilink Midlands and I’m looking forward to leading the organisation into its next chapter. A new CEO inevitably comes with a new vision, what ideas can you share with us that you have for Medilink Midlands? Medilink Midlands has been a great champion to the life science sector and has shown remarkable resilience over the years, adapting to changes whilst maintaining the quality support for the sector. I want to see Medilink Midlands maintain that purpose and adapt to a new landscape post EU and pandemic. It’s very much about evolution not revolution, and I wish to continue our great work of supporting the industry and build on this with regional, national, and global partners across both the public and private sectors, by connecting and facilitating collaboration and industry support between academics, government,

businesses, and clinicians. What main challenges do you think the industry has to grapple with in the short-to-medium term? Coming new into the organisation, it’s great to be able to see things from afresh and from a wider perspective. One of my main missions in my first month as chief executive is to engage with key individuals and their organisations in the region to build up that wider picture and to listen to the needs of the region. Whilst there is the great opportunity for growth within the sector it needs to be supported by strengthening the technical workforce. The task of upskilling our existing workforce whilst continuing to nurture the next generation of STEM talent, will be a challenging one; which requires a collaborative approach from across the industry and government. The big challenge that isn’t going away is Brexit and the issues

Medilink

It’s very much about evolution not revolution, and I wish to continue our great work of supporting the industry and build on this with regional, national, and global partners across both the public and private sectors around supply chain and export and divergence between EU and UK regulatory systems. Companies are currently left to figure this out themselves with no clear answers and it’s going to be some time before things settle down. Client goodwill is at stake for many companies. Coupled with the rise in energy and raw material costs, we may see companies struggle. This presents an opportunity for us, ensuring we are at the forefront of delivering direct support to our industry. What challenges do you identify specific to Medilink Midlands that are high on your priority list to tackle? The key challenges for Medilink Midlands are continuing to champion and support our membership base and the wider regional life sciences industry amongst an uncertain funding landscape. We have the skills, the knowledge and expertise to deliver fantastic industry support and engaging thought leadership. We have seen how crucial this sector has been during the pandemic, and we need to ensure that as EU structural funding ends, life science companies in the Midlands are supported to continue their world leading research, development, and innovation. Therefore, high on my priority list is engagement with national and local government and industry thought leaders to ensure that the necessary support and correlating funding continues to flow into the sector. As an organisation, we now have formed one team that brings representation right across the Midlands. I’m working with my team to ensure that we are able to cross-pollenate our sector knowledge and experienced advisors so that all corners of our region benefit from the best insight and knowledge, and that we can deploy specialist skills and our resources to where it is needed in every part of the region. We will continue to be the regional delivery organisation to the life sciences sector, with specialist deployable advisory and events teams.

We will continue to look at the specific needs for each of our clients and activities, ensuring that they are locally relevant and address priorities; one size may indeed not fit all. The delivery of our support will be able to be more flexible, our connectivity and insight will have further reach, and our membership value will be increased. The last couple of years have seen many changes, notably with COVID and Brexit, what changes have you seen that the lay person perhaps won’t have done with life sciences? COVID has brought the life science industry to the forefront. It has highlighted the importance of this sector and the impact that many Midlands based companies have had on the pandemic response; utilising the expertise, knowledge and skills of region support the NHS. Speaking with the many stakeholders across the Midlands as part of my introduction as chief executive, it is clear that both the skills agenda and the digitisation of services and technologies has accelerated in order to respond to the pandemic and has highlighted its importance for the future; but has really only scratched the surface of what is possible. Therefore, it is essential to build upon this to ensure we remain at the forefront globally.

that we are likely to see a reduction in the amount that is currently available. How we fill that funding void will in turn affect how Medilink Midlands is able to provide the business and innovation support that has proven so vital to the region’s life sciences industry. So, my key priority, is to understand that funding landscape and to secure the continuation of that support for the sector. Is there anything else you’d like to add? In summary, the focus of Medilink Midlands will be to evolve our support, events, and membership offerings, which will bring greater value to the region by being able to deploy multiple specialisms across the whole region to where they are needed. I am looking forward to growing our membership offering and for it to become a 'must have' for a medtech business with a base in the Midlands. This will enable us to continue to support our medtech and life sciences partner organisations, their innovations, commercial activities and general 'licences to operate' within a highly regulated and complex sector. It will enable us to our expand our voice of the industry back to central government, particularly The Office for Life Sciences, regional government, the NHS, academia and other valued stakeholders and partners. Contact Medilink: info@medilinkmidlands.com www.medilinkmidlands.com

Though the UK left the EU in 2020, there has been this almost transition period where the last of the EU funding grants can be spent in the UK, how big a challenge is securing funding to replace that, both for you as a company and for your members? As ERDF ends, replacement sectoral focused business support that accelerates and supports innovation, particularly into the NHS, is still unclear. What is emerging is

on the cover

Going beyond borders - AN ITALIAN FEEL TO MED-TECH INNOVATION EXPO

his year’s Med-Tech Innovation Expo will have a slightly different feel to the last year. Not simply because of us all having greater experience of live events prior to the last outing, but with a strong Italian presence providing even more of an international feel to this year’s exhibition. When explaining one of the main reasons for the decision to exhibit with such a large presence at Med-Tech Innovation Expo, Filippo Mansani from the Italian Trade Agency pointed to the established relationship between the UK and Italy when it comes to trading and co-operation in life sciences. “If you look at the net exchange between Italy and the UK, one of the most prevalent things that you see imported and exported between us is pharma, medical and machineries. “Medtech is one of the primary sectors for the Italian ecosystem and in our exports, especially to the UK. We have a really mature ecosystem in Italy in medtech.” As part of this ecosystem, Mansani highlights the work that goes on in research and development from universities, and the many spinouts that emerge from these institutions. Mansani also identified that the willingness to visit this year’s show from so many companies shows an eagerness to expand beyond national borders. “We have several clusters around the main corporates dealing with the pharma and medical sectors. “They look at the UK as one of the main markets to start exploring potential collaborations with local partners.” The 18 companies accompanying the Italian Trade Agency come from across the sector attempting to address different needs and may also have different aims as to what they want to achieve from their Expo experience.

Ian Bolland caught up with Filippo Mansani, head of innovation and high-technology capital goods at the Italian Trade Agency to find out more about its visit to MedTech Innovation Expo, along with 18 companies making up the Italian Pavilion at this year’s show.

“It’s going to be different for every company. Some of them are more well-established so I guess their target is more towards potential clients or partners, and those at the early stage might be looking more towards investor partners.” Four start-up companies, for example, delve into different areas. One focuses on the development of miniaturised devices to help urinary incontinence (UI), another company iVis is looking for a strategic partner to help expand its 4D Suite platform used for corneal refractive and therapeutic surgery, as

ON THE COVER

Medtech is one of the primary sectors for the Italian ecosystem and in our exports, especially to the UK. We have a really mature ecosystem in Italy in medtech well as companies that can do ad-hoc production. The start-ups within the Pavilion demonstrate the broad range of what Italian medtech has to offer. All the companies have brought at least one product to market in different fields. Specialisms include packaging, sterilisation, connecting manufacturers and distributors, infection control and many more. The COVID-19 pandemic saw an urgency for certain types of medical devices and technology and Italy was no different with Mansani saying it helped accelerate the transformation of ideas into products – especially when it comes to digital health. Referring to the sector in Italy, Mansani again alluded to the ecosystem and ideas emerging from the universities, but also the state support and initiatives that are available. “We share research centres and the market is growing. We have really important applications for several cross-sector activities and functions within the medical, pharmaceutical and life sciences space. “We have new funds that the government has launched during the pandemic which is also boosting venture capital. There is even more attention on the investment and corporate side and a willingness to implement new trends and new technology.” The Italian Trade Agency has also been supporting the companies with brokerage events so they can make new connections and establish new deals and partnerships. Coming to Med-Tech Innovation Expo is an opportunity for the companies to do some good quality networking, something Mansani points out when asked what would make a successful

show for the trade body and its accompanying businesses. “These companies are looking to network and to explore new trends and how the market, especially in the UK, is moving on. Mainly it’s all about networking and exploring new trends.” Mansani also alluded to every region in the country having the capability to foreign direct investment strategies to attract new talents and new incentives to do business in the sector. Explaining the possible incentives, Mansani said: “For example, these can be start-up visas or definite investors in your company that are incorporated in one of the regions in Italy.” He explained that similar schemes were on offer in the UK such as International Collective and Enterprise Investment Schemes. When alluding to the outlook and challenges faced by companies in the sector, Mansani focused on the outlook for Italian start-ups and their challenges when it comes to securing investment and highlighted one particular obstacle. “In Italy funding is available until Series A fundraising and then companies need to explore funding avenues, opportunities, and partnerships elsewhere after that.” As well as having the opportunity to meet with several companies from Italy, visitors will also have the opportunity to hear from the Italian Trade Agency about new trends from the country and how to access the market on Stand E10. Med-Tech Innovation Expo takes place on 8-9th June. You can register at www. med-techexpo.com.

Featuring on the Italian Pavilion are: • Hakomed Italia • MWC • LED Spa • Relief Srl • Senosan • Fifth Ingenium • Viktor Elettromedicali & Physio • IRCA Spa (Zoppas Industries) • Endotics • Ecs Srl • Ric3D Srl • DM Packaging Group • AMD Engineering Srl • 1Flex Technology • Food4Future Srl • Ivis Technologies • Biochemical System

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Sustainability

Why sustainability is vital in the future production of medical devices

Barry Warden, managing director, Wideblue, runs through several of the sustainability considerations required for a medical device company.

ustainability is an issue that as medical device developers and manufacturers we need to embrace, but it is not straightforward. We need to realise that future profitability will be linked to sustainability. From the beginning of the design process, manufacturers already take many factors into account, and now must consider sustainability. When considering medical device sustainability, often people think about the end of the lifecycle and whether the device is recyclable. Also, what are the costs involved, and downstream environmental impacts associated with disposal? Medical device waste is a global problem as devices become more complex and incorporate more electronic components and mixed materials. Sustainability also means reducing carbon emissions, energy and water use, and material waste across its entire lifespan. Sustainable medical devices are better for the environment and attractive to consumers and can provide cost savings, investor attractiveness, and improved brand and competitive advantage. As medical device designers we have been working to respond to the increasing demand for environmental sustainability from the market while ensuring that safety and usability to healthcare workers and patients is at the top of our priority list. MATERIALS According to the UK Government, plastic waste in the oceans may treble within the next decade. Everyday single-use plastics can take

over 400 years to biodegrade. Medical device manufacturers need to investigate using more sustainable and different materials in their equipment, such as reusable plastic biobased material. With net zero targets in place and environmental sustainability now an important priority for medical plastics and device manufacturers and their supply chain, the industry is now moving in a new direction, that of a sustainable and ecofriendly plastic product, or reducing the number of and swapping materials in the make-up of devices Taking sustainability issues into account in the design stage does make for a challenging process, but the rewards will come both in terms of the environmental impact of your products and ultimately in profit. DEVICE DESIGN As designers and manufacturers, can we reduce the dimensions or weight of the product to minimise materials used? Can we shrink electronic components to reduce their disposal impact? Is there an opportunity to reduce the battery size, switch to a more sustainable battery technology, or alternative energy storage methods?

the technology built into a smartphone to bring eyecare to low-income communities. Using existing technology, rather than developing this from scratch, reduces cost and the product’s impact on the environment through reduction in raw and processed materials. MANUFACTURING PROCESS The production process should also aim to be ecofriendly. Always consider what manufacturing options are open to you, and whether you could reduce energy and water use. Reviewing the manufacturing processes plays an important role in reducing the environmental impact of production. New manufacturing technology can also help reduce waste, whilst improving productivity and shortening time to market. Having a sound understanding of where energy is used within the design and production of your device is key to reducing the long-term environmental impact of your product. PACKAGING Packaging has huge environmental implications and is an area where most companies are now really trying to

cut back. We are always asking ourselves how packaging waste can be minimised, and if recyclable or compostable packaging materials can be used? We are also moving from paper-based documentation to on-device wherever possible. DISTRIBUTION Distribution is important when you are trying to lower your carbon footprint but represents big challenges, especially with exports. Things to consider include manufacturing and warehousing locations that can minimise long-distance transportation and using electric vehicles. DISPOSAL Efforts to reduce the volume of disposable components are constrained by the need to maintain safety standards. The risks associated with hazardous medical waste and biological contamination, as well as the high cost of product sterilisation and reprocessing, have prevented many businesses from moving away from disposable products. However, more must be done to transition from single-use devices to more reusable devices, and materials need to be used which can be recycled or degrade naturally.

Generally, most medical devices are now getting smaller and smarter, which helps with sustainability issues. One reason medical devices are shrinking is because they are being designed for mobile applications which requires the integration of wireless technology, making them more portable. Our Peek Retina ophthalmic device harnesses

Med-Tech Innovation Expo

Back with a bang Nine months following its return after the spate of COVID-19 lockdowns, Med-Tech Innovation Expo returns on 8-9 June, and Ian Bolland picks out a couple of things to look out for at the 2022 running of the event.

s part of Manufacturing Week at The NEC, Med-Tech Innovation Expo is a great environment to come across new technological developments, trends, product demonstrations, and that opportunity to make those all-important new connections and leads. With over 100 exhibitors, three pavilions, two conference stages, and a start-up zone, it means there will be plenty of activity on the show floor across the two days. The companies vary from those specialising in injection moulding, packaging, consultancy, materials innovation, distribution, and logistics allowing for everyone across the sector to make the business connections you require.

Here’s a few things I am looking forward to: PRODUCT DEMONSTRATIONS As the show connects the entirety of the design to manufacture supply chain, the show floor will cover of a full range of materials developers, manufacturers, device developers, but also products that are required to operate in the manufacturing environment. Packaging specialist Shawpak (Stand C25) will be bringing along its 4-side seal packaging machine. Manufactured at its facility in Derby, the company says its 4SS-6030 machine incorporates the latest technologies and functionality to ensure high efficiencies and low maintenance. This is also the first Expo the company has decided to showcase the machine on a show floor.

The aptly named Shoe Cover Magic (C20) will be bringing its own little bit of wizardry with its shoe cover machines – where you can simply place your foot in right area for the machine to add and remove covers. At a time when infection control has never been talked about more, this kind of offering is useful for the cleanroom environments and adds that extra layer (literally) of infection security. Speaking of infection control, one company where this will be a core focus is BioInteractions (B5). At the recent MD&M West show in California, the company launched TridAnt, a new coating technology for medical devices which it says presents a shift in infection protection against a broad range of pathogens. You can hear more about this product and more about infection control with medical

devices from BioInteractions’ commercial director Arjun Luthra who will be delivering a seminar on Day 2 on the Introducing Health-Tech Stage. Speaking to Med-Tech Innovation and Medical Plastics News at MD&M West, Luthra says the company’s latest technology kills a minimum of 99.999% of germs and compared the company's drive to develop antimicrobial technology to that of Formula 1 racing. He said: “The faster you are or the more elite while you're fighting for the smaller little minuscule or seconds. It’s the same thing. We're fighting for the one in a million or one in a hundred million. We're fighting the one in a hundred billion. It's really changing the likelihood that a pathogen will likely be there in that environment.”

Med-Tech Innovation Expo

CONFERENCE STAGES Luthra’s talk is just one of several insights that you can expect across our two conference stages, as he addresses infection prevention measures and associated healthcare infections. The Med-Tech Innovation Conference Stage in association with Medilink UK brings together a programme covering the pressing issues affecting the industry today – ranging from new potential in manufacturing, how the pandemic has affected approaches to innovations, building a technology ecosystem in social care, helping to combat the backlog in the NHS and, of course, the topic of how to maximise potential in international markets.

That’s not all, as I’m particularly looking forward to hearing from the Day Two Keynote speaker, Karen Taylor from Deloitte, who has led research into the changing face of diagnostics and will present some findings as part of her seminar surrounding innovation in this part of the sector.

With over 100 exhibitors, three pavilions, two conference stages, and a start-up zone, it means there will be plenty of activity on the show floor across the two days On the Introducing Health-Tech Stage, sponsored by Hessen Trade & Investment, there will be a mix of those who are exhibiting on the show floor as well as compelling talks about developing innovations during the recent pandemic and bringing products to the NHS. An esteemed panel of guests will discuss the pressing regulations in the medical device sector and how they are going about navigating that environment. The afternoon of Day Two will see the return of PITCH@Med-Tech Innovation for the second successive year, brought to you by NIHR, SBRI and Innovate UK – where several budding start-ups will compete against one another in quick-fire sessions as they showcase their innovations and why they feel they have the potential to have a lasting effect on the health service, and develop further as a company. You’ll be able to read an interview with the winner in the next issue of Med-Tech Innovation News. PAVILIONS AND ZONES The international feel to the show this year will be a big

highlight, as you’ve no doubt picked up on in my Editor’s Letter. A mainstay of the Expo is the Medilink Pavilion and that returns once again, populated with exhibitors from their membership while the aforementioned PITCH contenders will feature on the start-up zone – giving visitors the opportunity to find out more about their exciting ventures away from the spotlight. This year also sees the international feel of the show expanded as the Italian Trade Agency is accompanied by 18 companies from the sector to make up the Italian Pavilion – while the Economic Development Board of Mauritius returns to the show after its most recent visit in 2019, bringing along three medical device companies. The international feel doesn’t just stop with the Pavilions as companies from The Netherlands, Switzerland, Germany, the United States and Hong Kong are among those who have a presence on this year’s show floor.

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How, What and Who: Does the medtech sales model need a rethink? Oli Hudson, content director at Wilmington Healthcare, looks at challenges in the current medtech sales model – and a possible route through them.

Many clients are coming to Wilmington Healthcare with the same set of issues – restricted access, time poor staff, an inability to carry out demonstrations and evaluations in the same way as pre-pandemic times. The reasons for this are hardly opaque; the NHS is suffering from four deepseated challenges; dealing with the care backlog; a workforce crisis; changing the structure and delivery of healthcare via integrated care models; and responding to a new efficiency drive which gives an overall annual savings target 2.2% this year – up from 1.1% in the previous one - to save £4.75 billion. This means clinicians are taken up with the caseload before them with little time to evaluate or gain evidence for innovation; procurement departments are trying to find in-year savings; and the process of contracting varies from system to system. Theoretically, new procurement models as mandated by NHS England should allow for aggregate purchasing, greater spending power and longer term investment, a recent article by my colleagues at HSJ has shown that these are in the forming stage. At system and local level, there is a mixed

picture on leadership in terms of procurement. While much more collaboration is happening, individual trusts still act independently upon their own protocols and there is still no ‘one way’ of seeing the purchasing and procurement process. Also, a new paradigm of working digitally, and a general digital first trend in terms of preferred engagement routes for stakeholders, and medtech is left with some big questions on what to do next. HOW AND WHAT: OMNICHANNEL AND TAILORED CONTENT Some medtech companies are adopting a different approach – one that is both hybrid face-to-face/digital and tailored. Rather than relying on just call volume and field work, content and comms are taking a more central place. Omnichannel marketing – involving companies accelerating their digital approach and adding selfservice portals, webinars, microsites, and social-media content— is supporting remote interactions with both HCPs and nonclinical stakeholders. Omnichannel is becoming the preferred engagement technique. And, most companies are equipping their reps with virtualcommunication tools and digital content and training them in remote selling. But at its heart it demands tight customer segmentation and compelling content to suit - and in this, medtech

is still developing its approach. It will be important to vary content and comms to suit audiences at strategic/ system or place level, and by customer type, for example clinical, commissioner, or procurement. A series of articles by my colleague Simon Grime – written with pharma in mind but just as applicable to medtech - covers this in more depth. He says: “The goal needs to be a genuine and continually enriched 360-degree view of each individual customer, covering their stage of engagement, their preferences, their previous behaviours, and touchpoints online and their engagement with different content types. It requires comprehensive and fully integrated data which paints a picture of the customer as an individual and responds to them as such.” This research should include analysis of local demographic data – especially health inequalities, the local population health picture, and how new techniques and products can address them. On content, compelling patient stories are also becoming more popular and Wilmington Healthcare has been involved in the production of these, in one case helping to move a minimally invasive heart valve replacement technique into the mainstream by using illustrative narrative. WHO: STAKEHOLDER MANAGEMENT So, if omnichannel and hybrid F2F/digital working represents the how – and

compelling exchange of value and relevant content the what – where does that leave the who? Here, research into the marketplace is equally necessary. New NHS policy stresses the centrality of clinicians in the decision-making process – in changes to pathways, setting, technique and procurement. The GIRFT programme is proving influential as a clinician-led, bottom-up approach to reducing variation and improving standards of care – as well as accelerating innovation adoption. Simply, it is clinicians that are most important to convince and empower. Research is also needed into how clinicians are grouping themselves – into clinical networks for example, or into hub-and-spoke models – and are taking amendments to pathways forward. Another group of stakeholders charged with assisting industry are the AHSNs, who should be able to assist clinicians develop business cases and overcome obstacles to adoption. The 15 AHSNs should be on the radar for innovation, particularly for NICE approved products that have already earned their place in therapy via clinical and cost-effectiveness and to enhance the evidence base. Each system and place will throw up clinical champions for therapy areas and surgical techniques. Somewhere in the overlapping networks of clinical influence and accountability, there will be those capable of enacting change with access to transformative power. It is these such individuals that medtech must engage.

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Microfluidics

S IC ID U L F O R IC M E R A Y H W IMPORTANT IN MEDICAL TECHNOLOGIES?

icrofluidics has been a rapidly growing field within a range of engineering disciplines over the past few decades, with applications running from thermal control of microelectronic devices to chemical process engineering, and even simple fluid-based computational logic! But nowhere has the precision control of tiny quantities of fluid found more uses than in the medical sciences. Thousands of centimetre- or even millimetre-scale devices have been developed for use in highvalue drug production, emulsion generation, cytometry, drug detection, drug dosing, cellular analysis, cancer detection, or a whole range of other specialised diagnostic applications. Microfluidic devices are characterised by the handling of very small quantities of fluid, either as continuous flow in a channel, storage in microwells, or as droplets on a chip; typical volumes range of femto- to picolitres (10-15 – 10-12 L)! Because the manufacturing processes for many microfluidic systems were originally developed in the semiconductor industry, they also lend themselves well to the direct integration of micromachined sensors and actuators: Labs-on-a-Chip! In diagnostics as well as pharmaceutical production, one clear advantage of a microfluidic approach is a reduction in the consumption of expensive reagents and catalysts (i.e. platinum, palladium, rhodium). Similarly, a reduction in the generation of waste products is desirable because handling may be non-trivial, either requiring complex and energy intensive processes for breakdown into nontoxic substances or specialised long-term storage. If microfluidics can reasonably be employed, costs may be reduced not only on the input and waste effluents, but also on other peripheral process factors

such as capital costs due to reactor modularity, energy efficiency, or better process control.

such as at the surface of catalyst particles in production or singlecell sorting in diagnostics.

Microfluidic platforms significantly increase the fluid surface-tovolume ratio, which provides a range of process-control advantages. One of these is rapid mixing; where two reagent streams come into contact, for example at a T-junction, complete and homogeneous mixing occurs on a far faster scale than in macro-scale mixing. In many applications this is critical because incompletely mixed reagents may allow undesired sidereactions to occur. Additionally, this rapid mixing plus the small channel size allows for a high degree of thermal control. Highly exothermic or even explosive reactions may be carried out safely because only a small absolute amount of heat is generated, and it is quickly removed. Consistent temperatures in the fluids leads to more consistent yields, whether in production or in diagnostics.

The physics of these multiphase microfluidic processes can be extremely complex! Generating the desired droplet or bubble size requires a lot of fine-tuning of channel shapes and sizes, as well as pressures and flow rates. Biological cells or catalyst particles may clump or stick to walls, forming blockages, so it’s important to understand channel and particle surface properties, and whether flow patterns will reduce adhesion and blocking risks.

While microfluidic platforms offer a range of safety, cost, and processcontrol advantages, there are challenges which remain topics of ongoing research and engineering development. One of these areas is in quantifying the effects of manufacturing tolerances. Because the channels are so small, deviations from a designed cross-section profile may have an outsized effect of factors such as pressure drop or mixing behaviour. Another area which often presents challenges is in multiphase flows. In microdroplet generators, two immiscible fluids meet at a junction, with highly repeatable droplet size distributions resulting; these are often used in emulsions for drug encapsulation and dosing. Similarly, microbubbles may be used for gas-liquid reactions that require extremely fast mixing. Solids entrained in a flow similarly allow for enhanced process control,

Because of the complexity of these processes, physical device manufacture and test can become expensive and time-consuming. Computational modelling, while not a replacement for physical testing, can greatly reduce development time and costs. Correlation of modelling results with existing experimental data can give confidence in the fundamentals of a baseline model and can then help accelerate new design iterations. Xi Engineering Consultants has extensive experience in Finite Element Simulation with COMSOL Multiphysics for a broad range of engineering applications, including microfluidics. Xi has been working on several medical related projects with the most recent one being LUMICKS (Amsterdam, Netherlands) on the design and characterisation of Lab-on-a-Chip devices incorporating acoustic cell-manipulation capabilities in microchannels for single-cell cancer detection diagnostics. Indeed, this is another medtech success story as we met at the 2021 show and began developing collaboration ideas since! Xi Engineering will be at stand B37 at Med-Tech Innovation Expo 2022. For more information visit www.med-techexpo.com.

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Testing & Inspection

EXPLORING THE VIRTUOUS CYCLE: TEST SYSTEM DESIGN

& DESIGN FOR TESTABILITY

Jason Swoboda, senior program manager at Velentium, explains why device test systems should be developed in parallel with the device itself, and in partnership with its designers.

s developers, we’re comfortable with the idea that design informs testing. However, design teams are often less familiar with the ways in which test system development can and should inform design. This concept is the basis for a key consideration in development called “design for testability.” This means considering what should be tested and why, as well as when and how those tests will take place, as early as possible in the development

1 FIRST, design the test system in partnership. Our team was tasked with creating a test system to put one element of a device through its paces. The product included a PCB with an onboard chip that drove a motor. Our system was meant to prove the motor would be able to do what the product needed it to do. To accomplish this, we designed a fixture that used digital communication to drive the motor using the same techniques as the control program inside of the end product. This meant we didn’t need to wait on the team creating the PCB firmware to perform motor tests. It also meant that we couldn’t be 100% certain that our test software would drive the motor in exactly the same way the device firmware would. We could have instead used an actual controller board from the product as part of the test fixture and exercised the functions of the motor using productionreleased software. It was a missed opportunity, and a lesson that if the test plan calls for testing an element of a product system, look for opportunities to incorporate related elements directly into the test fixture. That way, you can test the subsystem as a unit in addition to testing its individual components.

lifecycle. Test engineering will be able to do its best work by developing test plans and systems in parallel with the device itself, and the device design will be improved when principles of testability and findings are incorporated into the design. Here are a couple of principles, illustrated with real examples.

2 SECOND, just because it's measurable doesn't mean it's significant. Know your “why.” Test engineers get laser-focused on how precisely we can measure. Test systems have the potential to perform measurements far beyond what is truly necessary. Or there can be a sensitivity mismatch between the test fixture hardware and the DUT. On a high-pressure test system, we were asked to use a particular model transducer that senses up to 40,000 PSI and translates that to a digital signal with 0.25% resolution, meaning the transducer output readings are accurate to within 100 PSI. Yet the test protocol we received indicated that the client wanted us to perform a test where the DUT was subjected to 17,000 PSI and held there for a certain length of time, during which the pressure was not to fluctuate by more than 10 PSI. So, the test spec called for a transducer that is “only” accurate to within 100 PSI, but the test protocol demanded an accuracy of 10 PSI. This is a situation where test engineering needs to go back to the design team and ask some questions. What is truly required of this product? What must the test demonstrate? As Velentium’s CTO, Randy Armstrong, frequently advises: “Know your why.”

3 THIRD, design test systems for intelligent data capture and reuse from the beginning. Where automated test projects are involved, start logging all test data early and build functionality into the control system. This allows you to repeat tests using data “played back” from a prior test or set of tests, instead of always having to use a “live” DUT. Gathering the full testing data set allows test engineers to refine the control system for the test fixture itself. As soon as you know what the test inputs and outputs are, start logging. The design and test engineering teams can decide later on what’s valuable to continue collecting for feedback on the system. This approach provides the software and hardware development teams the capacity to test against specific scenarios that hadn't been considered before. When tests fail, it allows you to look back, DVR-style, at its cause. The hardest automated test problems to troubleshoot are often those that can’t be replicated for lack of data. By taking this approach from the outset, it builds an opportunity for continuous improvement of the test system, a great troubleshooting tool for test engineering and more granular insight into the DUT performance. By working in tandem from early on, design and test engineering teams develop more efficiently, reducing cost- and schedulerelated risks and leading to better final products.

MED-TECH INNOVATION

7-8 JUNE 2023

NEC | BIRMINGHAM | UK

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Medical Device Supply Chain Intelligence

Testing & Inspection

Remaining data compliant in the world of medtech Mike John, technical director of industrial metrology specialist The Sempre Group, explains how manufacturers in medtech can automate data collection to streamline compliance reporting and gain insights.

n the world of medical technology and healthcare, quality management is key. Manufacturers must comply with increasingly stringent regulations, such as ISO 13485: 2016 and ISO 17025 and be able to provide a fully traceable report that proves quality throughout the product’s lifecycle. Whether the device is a wearable blood pressure monitor or a drug delivery system like a metered dose inhaler (MDIs), ensuring reliability and safety is critical. The world of medical devices is just as stringent. Manufacturers must be 21 CFR Part 11 compliant, which means ensuring that all electronically generated information is fully traceable and free of gaps where human error can occur in data collection and introduce untraceable faults. This means keeping a trail of where data is amended, stored, transferred, or accessed.

THE FUTURE IS AUTOMATED Manual data collection is time consuming and lacks complete traceability, increasing the risk of human error because there is no guarantee that operators input data from one source to another accurately. By reviewing incorrect data, operators risk adjusting machinery unnecessarily, stopping production or allowing lower quality parts to pass inspection. Consequently, production levels are damaged, and parts become non-compliant, harming the manufacturer’s reputation. The production and quality process can never be fully traceable unless there is a digital thread connecting drawing to product to report. For example, a medtech developer could take notes of measurements

in a first article inspection (FAI) report and input the dimensions into an isolated Excel file that isn’t linked to the original ballooned drawing or future quality checks, making it difficult to guarantee that all parts meet specifications. Instead, the operator uses fully traceable automated data collection systems, such as High QA, to streamline FAI reporting. Another example is the Prolink SPC Data Collection Software, which, as well as being 21 CFR Part 11 compliant, allows manufacturers to extract real-time data from any device to enable full analysis and reporting. By using High QA, developers can scan entire drawings, or multiple pages, and extract the geometric dimensioning and tolerancing (GD&T) data and critical dimensions, with all the tolerances automatically allocated. Using this data, they can generate FAI, Production Part Approval Process (PPAP) and other reports, and store future measurement data in the same centralised system. A REFORMED INDUSTRY By using automated, real-time data collection software, those in the medtech industry can extract realtime data from any device to enable full analysis and reporting. Without relying on isolated documents, manufacturers can communicate important quality information to stakeholders and reduce the time needed for compliance reporting.

Analysing the reports provides medtech developers with full visibility over production quality processes, so they can demonstrate and identify areas for improvement. For example, if they notice that parts on a wearable device are not compliant, the report will say when the fault occurred and help them resolve the issue. Over time this will decrease the number of defective products, reduce material waste, and improve productivity so that healthcare facilities and other customers receive fully compliant parts and devices sooner. Medtech and medical device manufacturers can also use software and data to make proactive changes during production. For example, if a part does not meet specification, software like Reaction Plan Manager will instruct the operator on how to adjust the machine to correct the issue without needing a specialised engineer to assess the process. By adjusting tooling as soon as an issue is spotted, engineers can ensure that fewer parts are manufactured out of tolerance, reducing scrap. As the amount of data usage continues to grow exponentially, we need to understand how to make the best use of it. The same can be said for the highly regulated medtech industry — by analysing reports acting on the results, manufacturers can make the informed decisions that will improve efficiency, reduce costs, and ensure compliance. The Sempre Group will be exhibiting at Med-Tech Innovation Expo on Stand D13 on 8th-9th June at the NEC, Birmingham. For more information visit www.med-techexpo.com

DIGITAL HEALTH