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t’s the buzzword that’s across every industry at the moment, and it’s going to be a factor both in business and policy areas alike going forward –as fires rage through Europe and North America (and have done in Australia), droughts take place in Africa and our climate gets increasingly volatile, it always makes for excellent public relations when a company trumpets their own sustainability practices as the situation across the world becomes all the more severe.
The words and phrases I associate with sustainability include; reusable, low pollution, recycle, efficient. But for the world to become sustainable there needs to be leadership.
There is certainly an appetite for a more sustainable medical technology sector. At MedTech Innovation Expo, I was delighted that we could host two insightful sessions on the subject – both with reference to net zero: Sustainability Strategies in Product Design and How to Achieve Net Zero Healthcare. But we know there is much more to talk about on the subject than we could’ve fit
into our two-day conference programme.
For me there has been a struggle to define sustainability, and this struggle leaves so much wriggle room that probably allows for green washing across the piste. Additionally, you can be charged by companies that little bit extra to offset your carbon footprint when you fly or on your oil and gas bill. But what does that do? Plant a tree? While planting more trees is welcome, it’s not the systemic behavioural change required.
For me, this practice gives licence for certain businesses to communicate they profess to care about the future of the planet while hiding any harm they contribute to it in plain sight.
Inevitably it’s going to be a factor at the next general election when that comes around – Labour have set out a clean energy policy, there are various net zero commitments currently in place from the incumbent government but there’s a
strain of thought from the right and far right for a rethink on such policies, and when a policy related to air quality is deemed to be a reason for success in the byelection, there's a temptation for it to be used as a lever to cling onto power. Until there is action from whoever is in office, it will only sound like lip service.
So, what does sustainability look like in the medical device sector? Clean manufacturing practices, minimal emissions from transportation, technology that allows for minimal waste, reusable or recyclable practices where possible and if not the case then low-emission sterilisation? These are all ideas that I have seen, and companies putting together ideas of how they can do their bit are welcome. Indeed there have been some excellent examples of sustainability practices in articles published in this magazine and on our website.
But there needs to be more, it feels like there’s a leadership void. It needs to come from somewhere. The question is –who is going to provide it?
Birmingham researchers are set to collaborate on a study that could result in a rapid non-invasive diagnostic test to identify stroke patients who need time-critical treatment before irreversible brain damage occurs.
Funded by the Stroke Association, the Golden HOur for STroke (GHoST) study will involve the West Midlands Ambulance Service University NHS Foundation Trust, Midlands Air Ambulance Charity, and University Hospitals Birmingham NHS Trust and industry partner Marker Diagnostics.
Ambulance personnel currently use symptom checklists to identify stroke, with a full assessment usually taking place at a Hyperacute Stroke Unit and followed by transfer to a specialist neuroscience unit for
treatment. In the UK, this transfer can add at least an hour to the treatment pathway.
The GHoST study, led by Professor Antonio Belli, professor of Trauma Neurosurgery at the University of Birmingham’s Institute of
Inflammation & Ageing, aims to identify biomarkers in blood, urine, or saliva, that will enable rapid diagnosis so patients can be routed directly to the most appropriate treatment centre.
Professor Belli’s research team has previously identified that
the concentration of specific molecules in saliva changes rapidly after a traumatic brain injury. A three-year study in elite rugby established that these biomarkers can be used in nextgeneration diagnostic tests that can rapidly and reliably detect concussion.
He explained: “Our previous studies detected ultra-early biomarkers and cellular responses that had never been reported in human studies before and resulted in a non-invasive diagnostic test that could change the way concussion is managed. In conjunction with our industry partner Marker Diagnostics, we’re now looking to repeat this success with stroke.”
The study will run for three years, with results expected in late 2026.
Cogniss, a no-code ecosystem for digital health, has launched its new global headquarters in Cambridge, UK, as the tech company's growing user base of health innovators acceleraters in the UK and Europe.
The establishment of the new headquarters follows Cogniss's recently announced partnership with ORCHA, and the appointment of experienced digital health leader Dr Lloyd Humphreys as managing director.
“There’s never been a more important time for the power of technology to help support our health workers and systems,” said Dr Humphreys.
“We know that the real innovation in healthcare is driven by the passionate workers on the frontline and we are excited to help drive a change in the way patients can access life-changing
treatment and support products - by empowering clinical practitioners and entrepreneurs to create their own digital health products.”
Cogniss CEO and founder, Leon Young, said the decision to move the company’s global headquarters ‘next door’ to some of the world’s most ground-breaking research hubs made perfect sense.
“At Cogniss, our whole purpose is to drive a paradigm shift in the way digital health can be delivered to patients, giving those with the subject matter expertise the ability to digitise and scale their work on their own - with quick development, low cost, best-inclass features and productised security and privacy. We're already delighted to be working with many incredible health practitioners in the UK and look forward to supporting many more.
Distec will be adding medical displays from LG Electronics UK to its medical technology portfolio. The medical displays from LG Electronics UK are a range of surgical and clinical monitors, designed to offer the best in class within a medical environment.
The healthcare technology sector is one of the fastest moving sections of the technology industry. Distec already partner with some leading specialists in healthcare technology and delivers a range of products including medical grade PCs and medical grade monitors.
LG Electronics UK has developed these monitors for the healthcare industry, with durable, dustproof and water
resistance technology.
Andy Byrne, sales and operations manager at Distec said: “The partnership between Distec and LG Electronics UK will enhance the quality of care for patients in the NHS. We hope to do this by providing healthcare professionals with the best technology in order to provide the best care to their patients.”
Philip Mitchell, channel manager at LG Electronics, added: “LG Electronics UK is committed to manufacturing the latest technology for the healthcare market. This new partnership with Distec will ensure that we are connecting with the professionals in the healthcare sector that need our solutions the most and facilitate our growth in the UK market.”
Funding streams from a new £33 million initiative to turbo charge innovation across the West Midlands and to bolster the region’s research and development capability were officially launched.
The West Midlands Innovation Accelerator is now inviting businesses to take advantage of the portfolio of support and funding available to develop ideas that can help reinforce the region’s position at the frontier of the UK innovation revolution.
The Innovation Accelerator comes through a share of a £100 million fund set up by the Department for Science, Innovation and Technology and delivered by Innovate UK in partnership with the West Midlands leadership. The funding will enable businesses to develop new products, processes and services that can spark commercial growth and investment. The scheme will have a particular focus on health and medical technology, clean technology, and a range of other sector specialisms.
The launch, hosted by Birmingham City University’s STEAMhouse innovation centre
in Birmingham city centre, saw the announcement of two Innovation Accelerator funding streams that are now up and running and actively looking for businesses to work with.
These included the first round of the Clean Futures Accelerator which is providing grants of up to £50,000, as well as expert support, to businesses with ideas that can make transport greener.
The funding stream, led by Connected Places Catapult, in conjunction with the Black Country Innovative
Manufacturing Organisation and Coventry University, is designed to leverage the region’s rich transport manufacturing heritage, aligning with the West Midlands Plan for Growth to cement the area as home to the Green Industrial Revolution.
The other is the Biochar CleanTech Accelerator which has been set up by Aston University and local industry to develop technology that converts organic material into commercially valuable products. Sawdust, diseased trees and dried chicken litter are among the
many waste products that can be transformed into sustainable bioproducts.
The West Midlands Innovation Programme launched the AI and Future Tech Forum, in partnership with Tech WM, to help educate local businesses to adopt and benefit from emerging and disruptive technologies.
Andy Street, mayor of the West Midlands and chair of the WMCA, said: “Innovation is central to one of my key Mayoral missions to restore our status as the fastest growing region outside of London.
“The regional portfolio of projects at this event are a testament to that mission and look to fulfill our ambitions set out in the West Midlands Plan for Growth – a roadmap to unlocking hundreds of thousands of new jobs and to becoming the home of major global companies in this decade.
“I encourage all business interested in new solutions around health, medical and clean technologies to come and talk to the Innovator Accelerator teams and help make their ideas reality, thanks to this new funding.”
Organisations came together to join Medilink Midlands in celebrating the success delivered under the three ERDF funded programmes, INSTILS, SoLSTICE and ACTIS and to find out what is next for the region.
Interim chief executive, Melanie Davidson, advised that a total of £3.5 million in grants was achieved. This funding was able to leverage investment equating to £47 of private investment for every £1 of public funding. Alongside the funding distributed, Medilink Midlands’ Advisers delivered over 8,000 hours of innovation support to regional life sciences organisations.
The business support projects have delivered funding,
support, advice, and networking opportunities to companies during the eight years the projects have been in operation.
Davidson said: “The funding has been instrumental in the creation of over 208 high level jobs and we’ve been able to support 391 businesses on a one-to-one basis, with a total of 66 new enterprises created.”
Success stories from East Midlands businesses that have benefited from the funding include BlueSkeye AI, a company that has developed facial recognition AI to be able to detect depression; Neurotherapeutics, creators of a stimulation and monitoring device aimed at alleviating the symptoms of Tourette’s; Blum
Health, which offers bespoke specialist recruitment solutions throughout the healthcare system, and JT Rehab Limited, inventors of the S-Press, which allows patients the ability to continue with their physiotherapy at home.
Paul Cable, CEO of Neurotherapeutics (Neupulse), creators of a medical device aimed at helping sufferers of Tourettes manage their tics, comments on the company’s progress: “We carried out a clinical trial that started in March 2022 and completed in March 2023 and the results of that trial have been absolutely phenomenal. Short term, our goal is to get this device out there. There are so many people
who want this device. It will really make a big difference to their lives.”
Other East Midlands-based funding recipients included iethico, a business that has created a technological solution to the supply and distribution of medicine shortages; MumPod, which provides safe and convenient spaces to employers and service providers supporting pregnant and breastfeeding parents; Spirit Health, which works with the NHS to deliver a new way of delivering healthcare to those in the community, and VUIT, a company providing data analytics to healthcare providers to allow better understanding and more targeted practice of health in the community.
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Oli Hudson, content director at Wilmington Healthcare, looks at the NHS’s flagship medtech policy and what industry should read into it.
representing over £1 billion of funding (estimates based on NHS Accelerated Access Collaborative data and DHSC internal analysis, May 2022).
At Med-Tech Innovation
Expo I was keen to see and hear more about the NHS’s medtech strategy.
Released in February, it promised the most complete vision for the future of medtech in the UK for some years.
Trailed as a new way to harness the power of medical technologies to support and partner the NHS, post pandemic, it covers four priority areas that future government policy is intended to drive forward. They are: resilience and continuity of supply, creative innovation and dynamic markets, enabling infrastructure, and specific market focuses.
There’s a lot of promising material in the strategy. For years what’s come out of government has been piecemeal – a procurement strategy here, a promise of a new innovation hub there; the medtech funding mandate, which gave a selected few products ringfenced funding; and the Life Sciences Vision, a wide ranging position paper on the entire healthcare sector but not specific to medtech; and vague words of support in the NHS long-term plan refresh. To have this industry specific
policy feels like a sector first.
David Lawson, director of medical technology, Department of Health and Social Care, covered the main thrust of the strategy.
PRIORITY ONE: RESILIENCE AND CONTINUITY OF SUPPLY
This has clearly been built bottom-up from the experience of COVID. In that period, lines of communications between government and industry, and the NHS, improved no end because they had to; supply lines around the world are still compromised, and Brexit hasn’t made this facet any easier. So, constant open dialogue here is paramount and it’s good that the government has woken up to this. Sustainability is mentioned a lot, as medtech must assist the NHS its net-zero ambitions. These factors will play a big part in framework agreements and procurement matrices for years to come, as well as UK market access pathways.
PRIORITY TWO: CREATING INNOVATIVE AND DYNAMIC MARKETS
The government itself notes that in 2021, there were around 60 different programmes supporting innovative technologies,
But it also admits in the strategy that “despite the multiple pathways and significant funding, the innovation frameworks can be difficult to navigate, with the majority supporting only one of the many steps in the route to market - it is up to the innovator to research and link different programmes.”
A new implementation plan is promised with a more ‘joined-up’ approach – but we haven’t had the detail yet.
PRIORITY THREE: ENABLING
This is a really interesting one, as it takes into account not just the safety, quality, clinical effectiveness or cost of a product, but how it will be used, who will use it, who can access it, and even if it is needed. It exhorts suppliers to work with the NHS on understanding NHS demand, supporting clinical leadership in industry engagement, encouraging innovation in clinical areas of greatest need, and planning how innovations will be procured by the NHS to deliver patients the right products, at the right price and in the right place –more on this in a moment.
This examines the parts of medtech that the NHS needs to work with – especially diagnostics - to create solutions to the current diagnostics backlog. Plus also to Part IX prescription
items - commodity medtech – seeking to ensure genuine innovation in this are appropriately adopted. The strategy states that: “as well as a significant choice of product, clinicians and patients [should] have access to unbiased resources to help them compare and select the most appropriate product.” This sounds like the NHS is finally moving towards a single comparator platform, taking into account all possible products with the ability to evaluate and purchase different items for different clinical needs. Therefore it is clear that the three core components of the medtech vision are:
• Right product - which must be safe for all, clinically effective, innovative and sustainable
• Right Price - which must offer value for money, be outcomes-focused, take into whole pathway cost and be supported by quality data
• Right Place - which must include plans for access, availability, adoptions and resilience.
Wilmington Healthcare has been supporting medtech firms to meet these aims for some years – particularly in area two and priority three.
The medtech strategy offers a good bulldog-clip of policies to improve the lot of both patients and the industry as well as the NHS. The devil as ever will be in the detail and how the strategy is followed up; a grip by the centre will be paramount, as will ongoing dialogue with companies.
Read the full piece on www.med-technews.com.
Let’s talk about the current innovations in stroke care. What’s really exciting you?
There are so many innovations coming in stroke care that it is hard to think of only a couple and perhaps the really exciting thing is how all of the small innovations will compound with one another. I feel that the ability to diagnose a stroke in an ambulance will make a big difference to stroke care. The earlier we can give clot busting drugs and get the patient to a centre capable of mechanical thrombectomy the better. The best way to do this is to diagnose patients in the ambulance and redirect the ambulance to the appropriate hospital rather than the nearest hospital. I am working with a company that is developing ‘helmet tech’ to make this possible. Similarly, I think we need to prevent strokes better. Intracranial atherosclerosis – narrowing of the arteries of the brain – is a massive global problem that is the leading cause of strokes. In many cases if this were treated early it would not result in a stroke and so it is imperative to develop the right technology to manage this condition. Finally, I think novel drug candidates will help not only protect the brain may also result in better prevention of strokes and so all of these things may intersect to make the risk of a debilitating stroke decrease significantly in the coming years.
At Med-Tech Innovation Expo, you spoke about stents that could remove clots. How big a step forward was this in stroke care?
The development of the appropriate technologies and techniques was perhaps one of the biggest steps. Prior to the use of stent-retrievers other devices existed and although these did the job they were of a sub-optimal design. The use of stentretrievers was a game-changer and really heralded the transformation in stroke care that we have seen since they were first used. Although the original devices were never intended to remove clots from the brain I am privileged to have worked with, and have as a friend and mentor, probably the first person in the world to remove a clot using a stent-retriever - Prof Hans Henkes. Since the first pioneers started this technique there have been lots of device and technique innovations that now mean we can successfully remove the clot in over 90% of people and with a very favourable risk profile. In fact, the main risk from the procedure is failing to remove the clot but further work is being conducted all the time and we are confident that our success rates will continue to improve.
You also mentioned the role of AI in stroke care. Can you give us a little insight as to how it’s helped technology evolve in this area?
This technology has been a gamechanger and I believe it will continue to offer new advantages to stroke clinicians and interventional neuroradiologists.
Following his keynote fireside chat with Johnson & Johnson MedTech UK & Ireland at Med-Tech Innovation Expo 2023, Dr Paul Bhogal from Barts Health NHS Trust, shares more insight about the future of innovation in stroke care.
When dealing with a stroke every minute is important and so speed is of the essence. Getting the patient to a centre capable of performing mechanical thrombectomy as fast as possible therefore becomes essential so that we can save as much brain as possible and increase the likelihood of a good outcome. In this regard
Brainomix has been incredible – the fact that I can access the images performed at a hospital 100 miles away within seconds means complex treatment decisions can be made rapidly and the patients can get transferred to us rapidly. Being able to access those images on our phones, iPads, or laptops means that we can make these decisions anytime and anywhere. We have already shown this is speeding up the treatment pathway and this will have a beneficial outcome for patients in the long run.
You also mentioned pulmonary thrombectomy – the same as with stroke but in the lungs –how much do you think innovators and treatment pathways can learn from other areas of the sector? Within modern medicine there are innumerable silos and whilst clinicians are great at sharing knowledge on individual patients, we perhaps are not so good at sharing expertise on processes, pathways, and patient flow. Meeting and sharing ideas with one another can help to change this. This is not restricted to clinicians – allied healthcare specialists, innovators working in the field of telemedicine, AI, remote diagnostics etc. must also play a pivotal role in modern medicine – we all see different facets of the same problem.
As with all people we can often be blind or simply unaware of new solutions to age old problems. We should try to forget phrases such as ‘this is how it has always been done’ rather, we should ask questions such as ‘what would this look like if it were easy?’ These sorts of thoughts open our minds to new possibilities and new ways of working and collaborating sometimes with unimaginable results. This was part of the reason I founded the BRAIN Conference – so that people from a wide background could come and share their ideas and expertise with clinicians so that together we can push the boundaries of medicine safely and effectively.
Tell us why medtech innovators should come along to BRAIN?
BRAIN is the pre-eminent conference for interventional neuroradiology, neurosurgery, and stroke in the UK and we have a global reputation as being one of the most innovative and forward-thinking conferences dealing with neurological
problems. We have a faculty and speakers from across the globe and a worldwide audience that last year exceeded 5,000 people. The opportunities to meet leading clinicians and other innovators from around the world are unsurpassed.
One of the most important differences for BRAIN is how the talks are structured. At BRAIN we focus on putting talks on a theme together so that it is easier for the attendees to see the connections and start to understand topics and ask probing and challenging questions. If you don’t understand a topic, how can you even hope to find novel solutions or even ask pertinent questions? This has already led to novel technologies and approached being developed and we are only at the start of the journey.
How was your Med-Tech Innovation Expo experience?
It was fantastic and I had several very interesting conversations following my talk. The audience was engaging and enthusiastic and open to challenging the status quo and looking for novel solutions to the various problems that exist within healthcare within the UK but also further afield. Meeting people from a huge variety of backgrounds is exciting and intellectually stimulating and I love seeing how different pieces of a puzzle can fit together. Sometimes this can be introducing two people and acting as the bridge and in other cases it can be developing my own ideas in partnership with engineers or translational scientists.
Prior to the use of stent-retrievers other devices existed and although these did the job they were of a sub-optimal design. The use of stent-retrievers was a game-changer and really heralded the transformation in stroke care that we have seen since they were first used
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Oliver Bisazza, CEO, MedTech Europe, explains what was discussed at the recent MedTech Forum taking place in Dublin.
First, the 2023 edition of the MedTech Forum took place in Dublin, why?
We were absolutely delighted to host this year’s edition of the MedTech Forum in Dublin, given Ireland’s status as a global medtech powerhouse. Ireland’s manufacturing output generates more than €13 billion worth of medtech exports. There are some 450 medtech companies in Ireland, and they employ more than 48,000 people.
Ireland has proven it possible to create the right conditions for the innovative medtech industry to thrive.
Were there any common challenges at the MedTech Forum that were discussed?
Yes, it was definitely a red thread during the whole MedTech Forum. We discussed not only Europe’s fundamental strengths in delivering health and medical solutions, but also the actions needed to make the European regulatory environment for medical technologies more predictable, less prone to delays, more conducive to innovation, and overall, more sustainable in the long-term.
Many sessions concluded that to remain a global leader in medical technologies, the EU must deliver a more patient-centered and
innovation-friendly regulatory framework that addresses the system-level challenges of today while preparing for the opportunities of tomorrow.
How has the medtech landscape changed lately, in the eyes of MedTech Europe?
Fundamentally! Beyond the medical technology industry’s sector-specific developments, the mega trends of digitalisation and sustainability have contributed to a revolution in the way innovation in medical technologies is happening. They also drive the need for a more forward-looking regulatory mentality to allow innovation to thrive.
Legislative activity of the EU in this area has been, rightly, immense – and much more needs to be done to ensure that all the rulesin-development which will impact medical technologies will actually work together to deliver products to patients. The EU’s Digital Strategy, driving regulation on artificial intelligence, cybersecurity, and data, including the European Health Data Space and the European Green Deal will legislate tectonic changes, including in the area of product design, are coming with a substantial set of new or updated requirements for medical technologies.
Against this background, substantial legislations are also being
revised, such as the ones on Product Liability and Corporate Sustainability Due Diligence. It is paramount to include principles that ensure patients across the EU can benefit from a high level of protection and businesses are provided with legal certainty.
All these new rules will significantly impact the way and speed in which technologies can be brought to and accessed by patients and healthcare professionals.
Anything else you’d like to add?
Sure, let’s look at the near future for a second. This EU legislative cycle is slowly approaching an end (NDRL: in 2024). So now is a good time to reflect on what has been achieved and what is still to be done.
We need to solve existing challenges in a comprehensive, sustainable manner, setting the tone for a future environment that will allow patients to continue benefiting from first-line, quality medical technologies and more equitable access to healthcare, and health systems to build the long-term resilience they need.
All healthcare stakeholders will have a role to play in shaping a healthier Europe and the medical technology industry in Europe stands ready to contribute and collaborate to make this a reality!
ew innovations in recent memory have done more to transform healthcare than the use of connected technologies. However, they also introduce several potentially significant cybersecurity risks.
Like other data sets, healthrelated data includes confidential information that could be misused when accessed by those with malicious intent. Names and addresses of patients, medical conditions and diseases, prescribed drugs, and therapies, as well as details about insurance coverage, are just some examples of sensitive data collected by connected medical devices that could be vulnerable to cybersecurity threats and breaches.
Unfortunately, instances of cyberattacks against connected medical devices are becoming all too common. With the anticipated growth in the deployment and use of connected medical devices, the number of cyberattacks is only likely to increase.
Amidst this growing threat landscape, regulators in major jurisdictions are increasingly aware of the need to provide the industry with clearer and more direct regulations and guidance on developing connected medical devices that can help secure them from the most likely cyber threats.
Evidence of the growing concern among regulators is perhaps best exemplified by the evolution of the European Union’s (EU) regulations that are applicable to medical device cybersecurity considerations:
● 1993 – The Medical Device Directive (93/42/EEC) includes a single sentence that indirectly refers to cybersecurity-related concerns.
● 2017 – The Medical Device Regulation (MDR) includes six paragraphs in Annex I that directly address cybersecurity considerations.
● 2019 – The Medical Device Coordination Group (MDCG) issues its “Guidance on Cybersecurity for Medical Devices”. This provides detailed descriptions of basic cybersecurity concepts, secure design and manufacturing practices, documentation, and instructions for use, as well as post-market surveillance and vigilance.
● 2021 – Implementation of the European Medical Devices Regulation. New devices must now meet the requirements of the MDR before they can be placed on the European market.
In the U.S., the Food & Drug Administration (FDA) has published several pieces of guidance applicable to cybersecurity issues in medical devices. Issued in 2014, the FDA’s guidance, “Content of Premarket Submissions for Management of Cybersecurity of Medical Devices”, outlines considerations that manufacturers should include as part of their device design and development phases, and which should be documented in their submissions under both its premarket notification (510(K)) and premarket approval (PMA) programmes. The FDA’s most recent guidance related to cybersecurity, “Postmarket Management of Cybersecurity in Medical Devices”, was issued in late 2016 and provides a framework for medical device cybersecurity risk management, as well as details on remediating and reporting cybersecurity vulnerabilities.
These and other regulations and guidance reflect the growing cyber threat, as well as the evolution of thinking about how manufacturers
can minimise them. However, there continues to be considerable divergence within the industry on the best ways to effectively address cybersecurity issues specific to medical devices.
While there are several industryaccepted standards available that are applicable to cybersecurity issues in general, medical device manufacturers have lacked a lifecycle standard that directly addresses the issue of cybersecurity as it impacts connected medical devices. The absence of a dedicated standard has held back efforts to deploy common strategies to protect advanced connected medical technologies from current and future cybersecurity concerns.
To fill this critical void, the International Electrotechnical Commission (IEC) has developed a new standard focused exclusively on cybersecurity issues impacting software used in connected health technologies. This includes medical devices, and consumer-oriented health products and applications.
Released in December 2021 after more than three years of discussions and deliberations, IEC 81001-5-1 is an important supplement to IEC 62304, “Medical device software – Software lifecycle processes,” which establishes a common framework for the life cycle processes related to medical device software.
Specifically, IEC 81001-5-1 addresses security issues related to all types of “health software,” which is defined in the standard
as: “Software intended to be used specifically for managing, maintaining, or improving the health of individual persons, or the delivery of care, or which has been developed for the purposes of being incorporated into a medical device.”
As this definition clearly confirms, the broader scope of “health software” includes not just manufacturers of medical devices but also software developers, whose products and applications are used in a variety of health-related systems and devices, as well as software as a medical device (SaMD) and softwareonly products intended for health-related uses.
IEC 81001-5-1 also covers the entire product lifecycle of health software, from product development through postmarket use and monitoring. For this reason, the standard also recognises the critical role of healthcare delivery organisations in maintaining effective cybersecurity practices, emphasising the importance of bilateral communications between device manufacturers and software developers, as well as those responsible for the actual use of connected devices.
Like other process-related standards, IEC 81001-5-1 details the activities to be undertaken by the manufacturer or software developer as part of the overall product development lifecycle to help ensure protection against cyberthreats. Specific activities are described in clause four through to nine of the standards, as follows:
● Clause 4 - General requirements
● Clause 5 - Software development process
● Clause 6 – Software maintenance process
● Clause 7 – Security risk management process
● Clause 8 – Software configuration process
● Clause 9 – Software problem resolution process
IEC 81001-5-1 also includes several informative Annexes that can help manufacturers and developers meet the requirements of the standard. Annex B provides guidance on the implementation of lifecycle activities to help ensure the security of health software. Annex C provides a detailed discussion of the threat modelling, a systematic approach for analysing the security of a device or an application to facilitate the identification and prioritisation of potential security threats. It also offers details on several approaches that can be used to develop an accurate threat model.
The growing cyber threat landscape for connected medical devices requires that device manufacturers and software developers take a proactive approach in designing their products to minimise the risk of potential cybersecurity vulnerabilities. IEC 81001-5-1 provides a detailed roadmap that manufacturers and developers can adopt, thereby helping to ensure the safety and security of their products through the entire lifecycle.
While there are several industry-accepted standards available to cybersecurity issues in general, medical device manufacturers have lacked a lifecycle standard that directly addresses the issue of cybersecurity as it impacts connected medical devices
Managing director of Intertronics, Peter Swanson explains the company’s history and how it pivoted from a soldering tip distributor into an adhesives supplier to the medical device sector after Med-Tech Innovation recently visited the company’s Technology Centre.
Intertronics specialises in adhesives — including materials and technology — for the medical device assembly sector. This includes bonding, coating, sealing, encapsulating, potting, masking, and gasketing products, together with the most appropriate equipment and accessories for surface preparation, mixing, application, dispensing, and curing them. The company focuses on helping customers achieve productivity, quality, profitability, and return on their investment (ROI). However, the business started out as a small supplier of soldering tips.
I was born across the Atlantic in New Jersey — my parents were both American. My father worked for a solder business called Alpha Metals, at that time a small familyowned company.
They started exporting to the UK, and in the early 1960s my father began travelling here, visiting, and supporting UK customers. Soon, he started bringing his young family with him. Over my childhood, we moved across the Atlantic seven times as a family, until we moved more permanently to London in 1970. I was grateful for a good education and was accepted to Jesus College at Cambridge University to read mathematics before switching to law. On graduating, after considering a further degree in business, I decided I was done with studying and explored the possibility of starting my own business.
At that point, the only industry I knew anything about (and then, not really very much) was electronics, as I had worked in my father’s office over some holidays. In those days, printed circuit board assembly factories often had lots of operators who were hand soldering. They were making TVs, VCRs and pagers, for example. I found a supplier of soldering iron tips that was slightly cheaper, and slightly longer lasting, than the market incumbents, and set off trying to sell them.
Intertronics grew slowly at first, but from 1982 to 2000, we started to grow consistently. We were servicing the printed circuit board assembly market with soldering, repair, and other consumable products. The UK and Ireland had many companies making high volume electronics, including large contract manufacturers like Solectron, SCI and Flextronics — and mobile telephone makers like Nokia, Motorola and Ericsson. But in the early 2000’s, there was a quite sudden market shift, as all these companies moved to locations like Eastern Europe, Mexico, and China.
With our main customers disappearing, we realised that a new strategy was needed. So, we decided to focus intently on a nascent part of our business, adhesives. We would be able to leverage our existing skills, and market ourselves in the same consultative way, but to a wider range of technologybased customers
— including the medical device assembly sector, now one of our biggest.
HOW DOES THE BUSINESS SUPPORT THE MEDICAL DEVICE MARKET TODAY?
We are one of the UK’s most respected suppliers of materials and equipment to the technology and high-performance assembly industries. We have a team of 25, serving around 3,000 customers from our base in Kidlington, Oxfordshire.
We supply a range of products from our carefully selected supplier partners, who have shared values, excellent service and technical support, and synergies with each other. Alongside this, we have a growing range of our own adhere branded products.
Every adhesive application is unique, complex, and challenging. Choosing and evaluating an adhesive involves considering every aspect of the application, from design
Choosing and evaluating an adhesive involves considering every aspect of the application, from design to production to processing, in line with the business’ priorities, like performance, productivity or process improvement. Because of this, medical device manufacturers look to specialists like us to support them with product selection and integration
to production to processing, in line with the business’ priorities, like performance, productivity or process improvement. Because of this, medical device manufacturers look to specialists like us to support them with product selection and integration. This relationship works best as a long-term partnership that covers both current and future processes, rather than one based on the transactional supply of materials. We understand the culture and drivers of the medical device market, and we speak the language.
WHAT MAJOR CHANGES HAVE YOU SEEN IN THE SECTOR IN THAT TIME?
Medical device manufacturers often use polymers and substrates we don’t see much in other industries. From PEBA or nylon 12 in catheter making, to COC or COP used in the assembly of in-vitro diagnostics (IVD), we need to have adhesives that bond to the specialist substrates of the sector.
Over the last few decades, the use of UV curable adhesives has grown significantly. Their introduction gave medical device manufacturers the ability to cure a material in seconds, on demand, facilitating a significant productivity boost.
In addition, light curable adhesive processes are easy to measure, control, and validate — enabling much needed process repeatability and robustness to a highly regulated sector.
Over the years, there have been advances in UV curing materials. For example, novel adhesives for wearable devices formulated without known skin irritants, materials able to withstand sterilisation cycles, and dual curable cyanoacrylate adhesives. Alongside this, there has been a shift from mercury arc broad spectrum lamps to narrow spectrum LED UV lamps. To enable this, many adhesives have been formulated especially for LED UV curing.
The industry is moving fast and there are an increasing number of adhesives available that have passed ISO 10993 tests. Training is available that covers the variables to consider when specifying materials and application equipment, and that helps build an understanding of the advantages and limitations of different adhesive technologies.
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Alan Thomas, marketing at ZwickRoell, provides some insight into the firm’s mechanical testing of wire stents.
When arteries in the heart become blocked due to coronary artery disease, one way to effectively treat the condition is to implant a stent to keep the coronary arteries open, allowing them to supply blood to the heart more efficiently. Stents are one of the most widely implanted medical devices, and the process of installing the stent into the body is only minimally invasive. Therefore, ensuring the safety and efficacy of every stent is critical and consequently demands rigorous mechanical testing.
A variety of stents are manufactured by braiding or knitting thin metal wires. This is commonly done on a metal caliper called a mandrel. Several materials can be used for the wires and common ones are medical grade stainless steel, nickel-titanium alloys, cobalt-chromium alloys, and magnesium alloys.
Stents are subjected to heavy loads when inserted and left in blood vessels and these loads must be simulated before the stents can be safely used. Along with obtaining accurate material characteristic values, determining the radial compression strength is the most important test for stents. Stents must exert a radial force that is sufficient to ensure the device remains in the narrowed artery and prevents constriction of the blood vessels.
Mechanical testing systems incorporating a 37°C temperature chamber, are employed to simulate tests at body temperature. Radial compression test fixtures are specifically designed to test stents and are available to accommodate various diameters and lengths. The fixture simulates the pressure placed by the
artery on the stent. The stent is inserted, compressed radially to a minimum target diameter, and then released. Testing software supports the sequence by measuring the values, compensates for possible self-deformations, and accounts for the very slight frictional and inertial forces that arise during measurement.
Along with tests for the entire system, components such as single wires and stent struts are also mechanically tested. This includes the tensile strength and strain at break, as well as the minimum yield strength. It defines the force at which a material under a single-axis tensile load demonstrates no permanent deformation.
Precise strain measurement on thin wire in a uniaxial tensile test is best achieved by means of an extensometer. The probability of error is much smaller since measurements are taken directly at the specimen and therefore outside the force flow.
Selecting the most suitable extensometer is essential. The difference is whether the extensometer contacts the specimen during measurement.
Clip-on extensometers are cost-effective but can falsify
measurements because of the direct contact they make, or they can damage the specimen. This is the danger with specimens made of thin wire. The weight of the clip-on extensometer alone could lead to bending of the specimen. Furthermore, there is a risk that the knife edges slip and damage the wire. A safe, accurate way to measure strain is to use a non-contact extensometer. Non-contact extensometers incorporating lasers, are designed for tensile, compression, and flexure tests on various materials. They create a speckle pattern on the surface of the specimen, which is recorded by a full image digital camera. This creates a virtual gauge mark on the specimen, whose movement under load is tracked with a special correlation algorithm. The evaluation of two sequential images shows the strain of the specimen with a resolution of less than 0.15 μm. This non-contact strain measurement is also used on stents to obtain accurate material characteristics for the finite element method (FEM) simulation, from the beginning of deformation until strain at break.
Using non-contacting extensometry, the operator
needs a few seconds to set the various gauge lengths. It is easy to mount and dismantle, and is combined with largely automated test sequences. This increases the integrity of the tests because subjective influences are minimised, which is particularly efficient and useful in routine testing or for tests with integrated production chains. Measuring specimen strain inside a temperature chamber can be done using a non-contacting instrument. Another consideration is the ability to test the fatigue strength of a stent under a periodically changing force. To investigate the durability of stents a fixture is available that allows up to 30 stents to be accommodated simultaneously. This, with an electric torsion drive, is used with a low force capacity servo-hydraulic testing machine and allows both separate and superimposed loading of the stents with compression and torsion. The gripped area can also be equipped with a fluid chamber to facilitate testing under physiological conditions.
With stents or any other implantable device, the cost of failure can be extremely high.
What does true innovation look like in medtech? As an industry, we need to evaluate the needs of a market with fresh eyes and from different perspectives. We need to challenge ourselves and ask, “How can we do even better?”
My answer is: “Start with the patient in mind!”
At Avation Medical, before we even started working on designs for our treatment option for overactive bladder, we spent months understanding patient perspectives – how their symptoms and (perhaps most importantly) available treatment options affected their lives. This led us to envision a product that has set a new bar for OAB therapies: The Vivally System.
Vivally is the first FDA-cleared, closed-loop, non-invasive wearable neuromodulation system, with a mobile application, to treat patients with urinary incontinence and urinary urge, common symptoms of overactive bladder.
Overactive bladder (OAB) may sound trivial, but it is a chronic, progressive condition with a constellation of symptoms that include urinary urge, urinary frequency, urinary incontinence (UI), and disrupted sleep due to night-time voiding. People with symptoms think about their condition 24 hours a day because it impacts every aspect of their lives. They adopt behaviours to compensate for their condition -- constantly scanning for bathrooms while out in public, choosing to wear dark pants, carrying a change of clothing, and frequently
excusing themselves from work meetings. As their symptoms progress, they may avoid social situations altogether. People with OAB have increased rates of anxiety and depression. Many have decreased work productivity, and some experience job loss.
OAB is incredibly common, impacting 1 in 6 adults. If you are picturing your father’s elderly Aunt Edna, you might be wrong. OAB and Urinary Incontinence (UI) affects men and women, and adults as young as 18.
Despite the availability of many different treatment options for OAB, most patients drop out of the care pathway or choose not to be treated for their symptoms. Why? Because current options all have drawbacks that cause patients to simply say, “No, thank you.”
The numbers tell us all we need to know. Of the 42 million people currently living with OAB and UI in the U.S., less than 20% have been treated with drug therapy. Less than 3% (i.e., fewer than 1 million people) have been treated with invasive therapy.
When developing Vivally, patients told us they would rather wear a diaper or simply try to endure life with their symptoms rather than be treated.
It’s not hard to see why consumers say no to these treatment options. Medications have undesirable side effects, including increased risk of dementia, and patients worry about interactions with other medications. Invasive options like Botox require multiple
injections into the bladder wall through a cystoscope in a procedure that needs to be repeated every six months and is associated with urinary retention (which can require self-catheterisation for weeks or months). Percutaneous tibial nerve stim requires a puncture from a needle-electrode into the ankle and weekly travel to a physician’s office to receive therapy. Sacral nerve and tibial nerve implants require major surgery, a permanent foreign body, with the potential for reoperation and scarring.
As medical device innovators and disruptors, we are taught to focus on safety and efficacy. But those standards are not enough. Successful therapy, including for OAB, must also be patient-friendly and eliminate the drawbacks of currently available options.
For Avation Medical, that meant a non-invasive, drug-free, surgery-free, and implant-free solution. It also meant a therapy that is comfortable, easy, convenient, personalised for each patient’s unique needs, and partnered with a mobile app that provides an e-diary to drive awareness and therapy compliance.
The Vivally System achieves these goals and is the first FDA-cleared, closed-loop wearable therapy system with a mobile app. Vivally works by delivering an electrical signal to the tibial nerve through a wearable device on the ankle. The electrical signal travels through the peripheral nerves to those that control the muscle
People with symptoms think about their condition 24 hours a day because it impacts every aspect of their lives. They adopt behaviours to compensate for their condition
surrounding the bladder. Vivally allows patients to perform physicianprescribed therapy in their own homes when it is convenient for them, and treatments are done in as little as 30 minutes, once per week.
Closed-loop technology provides several benefits.
Vivally calibrates therapy to the patient’s own EMG signal (an indicator of nerve activation), allowing the physician to establish a personalised therapeutic output range for each
patient, and sensors built into the garment continuously provide objective confirmation that the target nerve is being activated during therapy. Proprietary algorithms automatically adjust output in response to patient movement, allowing wearers to move about freely during therapy and be confident that the nerve remains sufficiently stimulated. Ensuring consistent nerve activation means that only minimal stimulation is needed to achieve a
positive therapeutic effect, which improves user comfort. Two multicentre clinical studies performed with Vivally delivered efficacy rates that rivalled implantable neuromodulation, and showed high patient satisfaction, good adherence to a therapy schedule, and improved quality of life.
Finally, the non-invasive profile of the Vivally wearable also means that neuromodulation therapy is now
accessible to patients earlier in the care pathway.
To innovate is to imagine a better future for patients, and then build it. Even though young start-up companies like Avation Medical face many hurdles -financing, regulatory, reimbursement, technical, supply chain, and more – when the patient is top of mind, the focus remains on the outcome, and the goal can be realised.
After winning this year’s PITCH start-up competition at Med-Tech Innovation Expo 2023, Sally Collins from the University of Oxford told us more about the innovation taking the first prize.
First, congratulations on winning PITCH, how did it feel when you were announced as the winner?
I was completely shocked. There were so many fantastic innovations being presented that it must have been an extremely difficult decision, but we were really honoured that the panel picked our software as their winner.
Tell us about your innovation
Our technology is based on the OxNNet Toolkit which uses a stateof-the-art fully convolutional neural network (OxNNet) to automatically identify and segment solid organs within 3D ultrasound images. It then employs our patented measure of single vessel 3D Fractional Moving Blood Volume (3D-svFMBV) to provide the only validated quantitative measurement of tissue perfusion available for ultrasound imaging. The research leading to its development has been conducted at Oxford University over the last 12 years funded by several institutions including the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NIH), Oxford University itself and the NIHR. The OxNNet Toolkit presents significant potential for application in clinical diagnostics. It is particularly relevant in obstetrics, where ultrasound is the imaging modality of choice given its safety and availability.
What unmet need does
In the UK, eight babies a day are stillborn, leaving families devastated and costing the NHS over £12 million a year.
The greatest risk factor for stillbirth is foetal growth restriction (FGR), usually secondary to poor placental implantation. If they survive, a baby with FGR will usually require a prolonged stay on neonatal ITU costing around £1,445 a day. With over 42,000 babies a year born growth restricted, this places a considerable financial burden on the NHS, estimated at over £61 million a year.
The current methods to assign risk of FGR early in pregnancy are based on maternal history and clinician judgement alone. These perform badly and many women deemed ‘low-risk’ are unaware their baby is failing to thrive until they present with a compromised baby or even a stillbirth. If stratified as ‘high-risk’, women receive serial growth scans with the aim of delivery before in utero demise occurs. However, the current riskassessment performs so poorly that many ‘high-risk’ women deliver well-grown, healthy babies after a pregnancy riddled with anxiety about their baby’s health.
We felt that a reliable, costeffective first-trimester screening method for FGR was desperately needed. This would not only improve pregnancy outcomes but decrease unnecessary stress for the women undergoing increased surveillance for no clinical benefit. The NHS Long Term Plan aims to reduce stillbirths by 50%, so developing a robust risk assignment tool which enables targeted monitoring and timely delivery should provide a major step towards achieving this.
Many studies have shown that estimation of first-trimester placental volume can predict the growth of the foetus later in pregnancy, with FGR babies usually having abnormally small placentas at the time of the dating scan (c.11-13 weeks). However, the only commercially available software tools to segment organs such as the placenta from ultrasound images are often inaccurate, labour-intensive, and prone to human error. These tools are only semi-automated requiring an operator to guide the segmentation so they cannot process large volumes of data in real-time, which is a crucial requirement for a population-based screening tool as would be required for prediction of FGR. Further imaging studies have indicated that poor vascularisation of the early placenta is linked to development of pre-eclampsia later in pregnancy. This aligns with the hypothesis that the underlying cause is inadequate conversion of the maternal spiral arteries failing to perfuse the developing placenta sufficiently. If the perfusion of the first-trimester placenta could also be quantitatively assessed prediction of pre-eclampsia should also be possible.
The OxNNet Toolkit can process a simple, static 3D-ultrasound image in real time and automatically identify and map-out the placenta and the placental bed (the interface between the placenta and the uterus). It then calculates the placental volume and uses our patented technique for 3D-svFMBV to measure the perfusion of the placental bed. These metrics are
then combined with other risk factors to generate an individual risk-prediction estimate for foetal growth restriction and pre-eclampsia developing later in pregnancy.
If we can identify women at highrisk of FGR early in pregnancy, we can not only instigate increased monitoring of that pregnancy, but also test potential new therapies currently being developed which may increase the growth of the placenta and prevent FGR from occurring in the first place. These therapies may be as simple as high concentration beetroot juice which has shown promise in animal models. As being born with FGR increases the risk of obesity, diabetes & cardiovascular disease in adulthood, any such treatment would have significant long-term health benefits for the baby later in life as well as hopefully preventing stillbirth.
What plans do you have for it now?
Currently, the FirstPLUS and OxPLUS studies (funded by the NIHR and Sir Jules Thorn
Translational Biomedical Research Award) are collecting firsttrimester 3D-ultrasound images from 7,500 unselected women in two different NHS Trusts to test the utility of the OxNNet Toolkit in the real-world and facilitate a full healthcare economic analysis relevant to the NHS. These studies will form the basis for regulatory approval of the software in this clinical setting. Oxalis Medical is a proposed Oxford University spinout company being developed with Oxford University Innovation (OUI) to take the OxNNet Toolkit to market as part of a risk-stratification algorithm for the prediction of adverse pregnancy outcomes.
Give us an insight into its potential – it focuses on babies now, but how broad a scope could it have?
Our tool's adaptive nature has proved highly effective when applied to small and diverse datasets (sparse data), outperforming networks trained from scratch. With transfer learning, it has the potential to automatically segment any solid organ or tumour from a static 3D-ultrasound image
and estimate the perfusion of the target. This has numerous potential clinical applications including in a wide variety of tumours. Fundamentally, if the target can be captured within a static 3D-ultrasound and identified with the human eye we can probably segment it and estimate perfusion.
Is there anything else you feel that you need to help this innovation realise its full potential?
Money and more research. We are currently seeking initial investment for Oxalis Medical and are applying for funding from a variety of sources to expand the technology to other organs and clinical situations.
Tell us about the PITCH experience (if you have any further comments to make)?
The experience of pitching to both funders and an audience of highly innovative people who have all travelled a similar path with their ideas was daunting to say the least but ultimately, an extremely rewarding experience. Thank you for the opportunity.
Frederik Dejans, global product & IoT director, Schoeller Allibert, examines why more companies need to embrace smart packaging.
Embedded internet of things (IoT) technology is facilitating revolutions in the healthcare sector. As digitalisation enables leaps and bounds in the collection and handling of patient data, benefiting everything from medical devices that monitor vitals to electronic health records, the market for IoT in medicine is expected to reach $13.3 billion over the next two years.
But as data collection becomes more common, the question emerges – is IoT being used as effectively as possible throughout the medical supply chain?
In today’s connected global economy, medical and pharmaceutical businesses are faced with challenges never seen before. The growing demand on supply requires increasingly complex logistics operations; meanwhile, suppliers must maintain the trust of end users, patients, regulators and stakeholders, prioritising safety, and transparency to achieve this.
In response to these challenges, bold investments must be made in digitalisation technology to create a stronger, more robust supply chain.
The importance of security in medical supply chains by nature requires many controls and touchpoints. Quality control measures and adherence to regulatory requirements, while vital for risk management, can cause delays or disruptions in the supply chain.
In high volume markets like medical and pharma, the cost of such delays can be substantial. As a result, investment in technologies that can provide enhanced oversight and transparency, harnessing data about shipment locations, is critical to success. Although the cost of implementing such technologies may appear high, the risks of negligence can be much greater.
To overcome these hurdles, many businesses are now exploring the benefits of digitalising their packaging by integrating IoT platforms. These smart solutions equipped to packaging provide hitherto unseen visibility over the supply chain and unlock sources of data previously thought unreachable. These technologies provide additional layers of operational security, and in many ways represent a revolution for the sector.
The growing trends for integrated IoT technology in medical packaging provides real-time alerts if products enter unsafe conditions during transit. In today’s globalised market, technology such as this has never been more important. Digitally connecting assets and having complete supply chain oversight provides a clear, comprehensive record of your products’ entire journey.
Schoeller Allibert packaging is designed specifically to meet the needs of the medical device sector. Secure, tamper evident, and traceable, these products protect medical devices as they pass safely through the supply
chain, and utilise data in a way that makes it work for businesses.
Recognising that every supply chain can make smart use of data to inform decision making, many of our returnable transit packaging solutions can be supplied with integrated smart technology such as RFID tags. These provide a more ‘passive’ way for packaging to ‘communicate’, and in our experience, most customers choose either IoT or RFID.
These solutions work in concert with our bespoke SmartLink platform, which creates a network of intelligent assets by connecting them using a LPWAN network. SmartLink is an end-to-end digital supply chain enabler, helping packaging to be managed and controlled from a single point. SmartLink provides visibility over shipment locations, temperature, and humidity data to ensure product protection, and can be integrated with ERP data to help ensure expiration dates and shelf lives are respected.
Asset tracking technology can have the additional benefit of helping you achieve robust provenance. Providing a comprehensive record of a product’s manufacturing journey, from the materials used in its production to regulatory approvals, is easier than ever with the data supplied by connected packaging. This evidencesupported provenance provides confidence to regulators, healthcare providers, and patients; something that is particularly important for operating internationally.
Supply chain oversight and proving provenance are not the only factors at play in modern packaging design. It's increasingly important that packaging benefits sustainability, by making your logistics operations more efficient.
Up until now we have seen the medical and pharmaceutical sectors primarily concerned with ensuring security and safety. However, as expectations for businesses to operate more sustainably mount, we are seeing more businesses consider how they can boost their green credentials through their choice of packaging.
Alongside its potential for connectivity, switching to plastic returnable transit packaging (RTP) grants access to durable, long-life solutions that are easy to clean to ensure hygiene requirements are met. Reusable hundreds of times before it needs recycling, plastic RTP provides a more sustainable solution to the discardable paper, wood, and board packaging designs that are in widespread use.
Keeping packaging in use for years at a time enables businesses to move towards a closed-loop system that is circular by design. With longer lifespans than singleuse alternatives, returnable RTP avoids unnecessary use of raw materials and minimises the energy and material consumption of recycling, with research finding a reusable plastic crate produces 88% less emissions than a single-use cardboard box.
Smart use of digitalisation technologies like SmartLink can compound these sustainability benefits. Connecting assets can optimise material and product journeys and help to minimise container loss or damage. Not only does this reduce waste, but it enables operators to plot the most
efficient journeys for products, removing the need for unnecessary journeys. Seeing the supply chain as a connected whole rather than siloed processes enables the benefits of an intelligent supply chain to make themselves clear.
The medical device sector can realise true gains in efficiency and sustainability. With new technologies emerging that provide better, more consistent data, the industry can achieve significant market acceleration while minimising its impact on the planet. A combination of digitisation and automation technologies, operating alongside equipment that can make the most of it, will provide the much soughtafter prize of secure, transparent, more sustainable operations.
The growing trends for integrated IoT technology in medical packaging provides real-time alerts if products enter unsafe conditions during transit. In today’s globalised market, technology such as this has never been more important
Medical Technology Innovation Facility, or MTIF, provides a facility for two equally important stakeholders: the academics and students who have the opportunity to work on their research projects and develop new ideas, and commercial enterprises small, medium or large to hire so they can have a specialist facility to help develop and commercialise their products.
Featuring a bioactive surfaces laboratory, an imaging suite, ISO Class 6 white and yellow cleanroom space along with the resource to manufacture and demonstrate technological capabilities, it caters for both needs on the site.
Companies can manufacture their products at the facility, with 3D printing and other manufacturing machinery at their disposal, along with a dedicated imaging suite which contains equipment for testing and inspection from recognised brands including Zeiss, Leica and Olympus among the systems at their disposal. The imaging suite covers bioscience, engineering, sport science and physics among its subject areas.
Up to seven companies currently use the facility on a regular basis, including Design Matter who featured
at this year’s Med-Tech Innovation Expo, but MTIF say there is room to accommodate more.
In its proof-of-concept space alone there is room to accommodate up to three companies – depending on the size of the companies who’d enquire to use the space.
One of the innovations that has emerged from the facility was a t-shirt fitted with flexible, resin-printed sensors on fabric which can monitor vital signs, and other activity – something that could be used for sports organisations to gather fitness, compliance or rehabilitation data and any other health needs. The sensors are printed onto a standard t-shirt using a screen press –with the technology developed on thin film circuit boards that are adapted for screen printing with testing available on site. Testing can even go as far as to how many washes the t-shirt can endure – with the industry standard 34 the target.
While sport might be the obvious example, with sensors being able to cover everything to measure fatigue or to measure the impact a blow to the head by a participant wearing a helmet – there is a route to market for this kind of technology being used for monitoring patients – such as heart monitoring – in a more discreet manner.
The textiles centre at the facility also included a medical sleeve which can be used for monitoring vital signs and encouraging rehabilitation through electronic stimulus – the device is being developed with more home care in mind.
These projects are overseen by Dr Yang Wei, associate professor of the School of Science & Technology at the university, and the lead of the Smart Wearable Research Group. Last year, engineers announced a project developing the smart textile arm sleeve to use electrical stimulation to reduce swelling and discomfort for patients
with lymphoedema – made from a breathable fabric with integrated printed circuits and electrodes.
That’s just one example of the types of innovations taking place at the facility.
MTIF has also recently welcomed enquiries relating to their GMP C Cleanroom space and testing capabilities. This, along with the bioactive surfaces laboratory which is equipped with industrial scale genomic sequencers, also provides a space for those operating in the pharmaceutical and diagnostic space to complete their own projects, or with MTIF as a contractual research partner. The facility also has a BioXP DNA and mRNA printer – one of only four in the whole world! This fully auotomated machine can develop and print synthetic DNA and mRNA for research purposes.
Though the facility is based in Nottingham, there is already the scope for expansion, as MTIF is ensuring it connects with relevant organisations on both a national and international scale – connecting with hubs across the UK and going as far afield as China.
On the more local scale, there is a second site two miles from the Clifton Campus as the Development Centre at Boots Enterprise Zone provides rentable validated, managed, and maintained laboratory and cleanroom space.
Ian Bolland was given a tour of the Medical Technology Innovation Facility at the Clifton Campus at Nottingham Trent University, finding out more about the opportunities there are for businesses to develop their products.
23–25 October 2023 | Lisbon, Portugal
Register now at www.topra.org/symposium23MTI
An amazing few days of talks, networking and exhibiting. I left feeling smarter and extremely excited about what’s to come next.
— Simon Brough, Head of Business Development, PharmiWeb
