MTI Issue 53

Page 1 Issue 53 | May/June 2021




PLUS Why medtech should lead in smart manufacturing Preparing for UKCA compliance How to achieve sustainability goals



Challenges of powering small implants and devices ADVANCING HEALTHCARE

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CONTENTS regulars 5.

COMMENT Ian Bolland highlights the importance of collaboration moving forward


MAKING MEDTECH A round-up of the latest industry news


OPINION Wilmington Healthcare explores the implications of the new Medtech Directorate


COVER STORY Ian Bolland speaks to Denis Pasero about the challenges of battery powering newer and smaller medical devices



TÜV SÜD offers best practice advice to manufacturers of digital health apps


REAL WORLD MEDTECH Ian Bolland finds out more about MyGlobalHome’s vision for a digital health ecosystem in the home

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

features 15.


How companies are being helped towards ‘lights-out’ manufacturing


SUSTAINABILITY TR Fastenings explains how medical plastics is moving to a more sustainable model



COATINGS NuSil highlights the possibilities of in situ care silicones for medical devices




RQM+ outlines steps to be UKCA compliant


MED-TECH INNOVATION EXPO Oxford Product Design explores ways of maximising commercial success



CATHETERS & STENTS Mediplus explains how its innovation helps reduce patient trauma and stress

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

portfolio sales manager | richard york +44 (0)1244 952 367



publisher | duncan wood


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from The editor Stop, collaborate and listen



ll being well, by the time you read this we should be looking forward to shaking off the shackles of restrictions and getting something very close to normality. Obviously, the pandemic will have had a lasting change on many sectors of the economy, including life sciences. However, given the data that we’ve seen about the Delta variant, and cases rising again, I’m not embracing the optimism of “freedom” just yet, and it wouldn’t surprise me if there is a delay to further unlocking. I promised myself this time that I would try and stay away from politics, but after a certain infamous and incendiary select committee testimony at the House of Commons, it actually emphasises the point that I wanted to make. The picture painted by this individual is an example of what happens when you’ve got certain egos and those with a sense of trumped-up importance pulling in different directions. Identifying people’s strengths and working towards a common goal is the reason the vaccine roll-out is going as well as it is. In contrast, rats in a sack style squabbling can have some tragic knock-on effects. Since the pandemic began I’ve had the pleasure of conducting numerous interviews for our

website, magazine and The MedTalk Podcast and one word keeps cropping up: collaboration. The last 15 months or so has perhaps seen some unlikely bedfellows in attempts to upscale the manufacture of vital equipment the front-line needs to combat a deadly disease, new partnerships forged as different business from outside the sector have been looking to make their mark, new start-ups have brought ideas to the table and some competitors have teamed up for the common good. Possibly, one of the most extraordinary acts of this nature during the pandemic has been the U.S government granting a patent waiver when it comes to vaccines in order to increase global production. It remains to be seen whether it will be implemented, and what the consequences are for drug developers – though the lasting effects could be seismic. But this isn’t a call for people to surrender secrets that are the foundations of their business and what has enabled them to produce life-saving treatments. Transparency about what firms are trying to achieve and the ability to identify weaknesses or gaps in knowledge in order to accelerate a good idea to market should be a pretty

obvious move. But as well as accelerating certain trends in the space going forward, it has also accelerated an urgency in putting people and businesses in touch with one another for their own good. The collaboration has to come from government too. As Lord Bethell pointed out in his address to The Health Tech Alliance’s Parliament and HealthTech event, the digital infrastructure in place now compared to 20 years ago meant that we were better prepared to combat a pandemic – which given it has claimed in excess of 127,000 lives in the UK, one dreads to think where we would be. That requires collaboration, a theme running through the event. The pandemic has provided an opportunity for all of those involved in the sector to identify and refine the way they work and examine what’s missing. The desire to find ways to work together should be one key element we build on from this tragic period. Pooling the best minds, even if once thought of as competitors, can produce individual and collective good. From my standpoint, there can only be winners from this approach, not losers.


Making medtech

New platform launched for buyers and sellers of raw materials


oovinV has launched its new website which matches buyers to sellers of surplus inventory as it aims to resolve continuous and current supply chain

challenges – including in the medical sector. In the form of an online onesite shop, buyers are able to quickly find surplus material from across the globe, using

an advanced website search engine. Buyers can request quotes simultaneously and purchase listed raw materials at less than market value cost. Alongside this, MoovinV offer support on sourcing raw materials that are not listed on the site. MoovinV was founded by aerospace executives, who had first-hand experience with challenges such as line stoppage and acquiring raw materials quickly. Jacques Ouellet, CEO & founder, said: “We are incredibly excited to announce the launch of our new website, following months of commitment and hard work. After the impact of COVID-19, we hope the site can help a variety of industries with both their buying and selling process.”



martphone and Bluetooth technology, linked to a digital remote care system, has cut hospital admissions in the Stockport area by almost 40%, saved the NHS more than £2 million and empowered patients at home. A digital solution, developed by Norwegian medical software company Dignio and adopted by Stockport based Mastercall Healthcare, has allowed many COVID-19 patients to remain safely at home, instead of being admitted to hospital. The same system has also been used in care homes. Patients with smartphones and care home staff using tablets, simply download

an app and can be instantly connected to devices including: a thermometer, a pulse oximeter and a blood pressure monitor. Data is displayed on smart devices and transferred automatically to a web-based platform where clinicians follow up a large number of patients, in what’s often termed a ‘virtual ward’. Those being monitored also report their symptoms through a questionnaire, which together with the vital signs provides a good overview of their condition. They also can communicate with clinicians through instant messages or arrange video consultations if

they are required. Michaela Buck, chief executive of Mastercall Healthcare, said: “It’s all about the empowerment of patients, who like the fact that that aren’t totally reliant on health professionals. They can monitor their own condition, which in itself empowers them even more. So far, the figures are really encouraging. “We’ve demonstrated in the first six months of the pilot, based on a cohort of 249 patients, a 37% reduction in admissions to hospital and when you convert that into monetary terms, you’re looking at about £2.5 million saving to the system.”

Early Diagnostics Institute secures first stage funding


£210 million national flagship science and healthcare project, to be delivered from the North East of England, has secured initial funding to support development of its plans. The Early Diagnostics Institute (EDI) aims to create five blood tests, using state-of-the-art machine learning techniques, which will be trialled and rolled out across the NHS. Early diagnosis of disease often enables more effective patient treatment, and EDI’s vision is to provide powerful early diagnostic capabilities that will save time, money and lives, as well as helping to relieve the significant healthcare pressures of an ageing population. EDI plans to sell the tests worldwide under the NHS brand, and in turn it expects to bring millions of pounds worth of revenue funding back into the NHS. EDI will target diseases particularly associated with ageing – primarily cancer, diabetes and dementias. Working in partnership with the North East’s NHS Trusts and Universities, it is proposed that EDI will operate out of facilities in Newcastle and Darlington, with clinical work delivered throughout the region. The project has already secured significant regional, national and government backing as well as successfully securing initial funding to support proof of principle work. Further bids to regional and national bodies are underway.



Medilink announces UK Healthcare Pavilion partnership

Brain diagnostics firm awarded NIHR funding for disease progression analysis



edilink UK has partnered with the UK Healthcare Pavilion, a virtual platform designed to help overseas buyers discover and connect with UK organisations. The partnership will help British companies to increase exports and secure inward investment by showcasing the strengths of UK healthcare and life science. The digital platform features a searchable directory of UK companies, providing international buyers with a simple and intuitive way to identify and engage with UK

industry and healthcare organisations. Medilink UK will help promote the platform amongst its 1600+ membership base and help companies make the most of available opportunities. Speaking about the partnership Tom Elliott, international director at Medilink, said: “I am looking forward to working in partnership with the UK Healthcare Pavilion. UK academia, businesses and clinicians are world renowned, synonymous with innovation, and my hope is that this initiative catalyses a unified presentation of the life sciences and healthcare sector.”

xford Brain Diagnostics, a software company focussed on developing diagnostics based on changes in the brain at the cellular level, has been awarded funding by the National Institute for Health Research (NIHR) to assess CDM as a novel and promising tool to identify and predict disease progression amongst patients presenting with mild cognitive impairment due to Alzheimer’s disease. This multi-centre project, led by Oxford Brain Diagnostics, includes the University of Oxford Health Economics Research Centre, University Hospital Southampton NHS Foundation Trust, NIHR Community Healthcare MedTech and IVD Cooperative, Cardiff & the Vale University Health Board, University of Southampton, Cardiff University, University of South Wales

3P Innovation becomes two-time Queen’s Award winner


P Innovation has won the Queen’s Award in recognition for British excellence in international trade, following on from its award for innovation last year. The 2021 Queen’s Award recognises steady growth in international exports. Its international business strategy has led to the penetration of new

markets and a more diversified portfolio of clients, with 40% of new customers between 2017 and 2020 being international. Commenting on this success, 3P’s founder and managing director, Tom Bailey said: “In a year that has been challenging for everyone, the team at 3P innovation have worked

harder than ever to achieve remarkable international growth. This has provided us with further security and stability in an ever-changing market affected by COVID, and it’s great to see that UK innovation and international growth within the manufacturing sector are being recognised by the Queen’s Awards.”

and Bournemouth University – Institute of Medical Imaging and Visualisation. Dr Steven Chance, CEO, Oxford Brain Diagnostics said: “We are very excited to be working with our partners and the NIHR on this project. The award and funding only serve to highlight the critical need for continued investment in the UK for Dementia and to explore breakthrough technologies that can support improved diagnostics. Alzheimer’s remains a complex condition so examining MRI scan data from the NHS at the earliest stages of the disease provides an opportunity to estimate patient prognosis, assess the future economic impact patients will have in long term care and more importantly provide valuable time to families in adjusting lifestyles and getting access to

new drug treatments. We believe that this innovative approach will advance the stateof-the-art in measuring neurodegeneration and demonstrate the transformative role that neuroimaging can play in a clinical setting.” Over a three-year period, the project aims to deliver a number of key objectives. In order to support clinical effectiveness and clinical decision making, Oxford Brain Diagnostics will examine a total of 300 patient MRI scans. CDM will be used to distinguish patient cohorts and measure changes in brain structure across time points. This will enable the project team to assess how improved diagnosis will impact current patient pathways, patient outcomes and to deliver a national health economics analysis across primary, secondary and social care.


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The new medical technologies directorate: what is it and what does it mean? Oli Hudson, content director at Wilmington Healthcare, explores the implications of the new government Medtech Directorate for industry and procurement.


hat will happen to medtech procurement in the wake of the pandemic? COVID has exposed vulnerabilities in government processes and distribution, as well as global supply chains. The most high-profile examples were ventilators and PPE, but other supplies have been in the frame, including consumables, complex capital equipment, a wide variety of diagnostics, and digital health products. Even as we begin to exit the pandemic, these supply problems will inevitably continue, as reported last month concerning the race to get on top of the acute and elective care backlog which is highly likely to bring an unprecedented surge of patients and commensurate demand for products. Additionally, Brexit has thrown up potential supply and distribution problems. Now HSJ brings news of an upcoming government response to this complex issue, with a DHSC leak revealing the setting up a new Medtech Directorate. In a sign that the pandemic has forced the government to take effective medtech procurement more seriously, some staff from the DHSC will form a core leadership grouping in the new body. We also know from the Queen’s Speech that the government intends to focus on the life science industries in the post pandemic ‘build

back better’ programme – mentioning this in the first paragraph of the speech. It’s therefore encouraging for medtech that the HSJ leak speaks of the pandemic ‘shining a light on the criticality of the medtech sector to the effective functioning of the healthcare system’ – better late than never – and of ‘the opportunity to build an even more thriving medtech sector in the UK.’ There was also an admission that procurement as a whole, especially national procurement, has been on a code-red footing during the past 18 months, and some sustainable, systematised and effective processes were now needed for medical devices. The new directorate will focus on six main areas: resilient supply chains; value for money; regulation of safe, high-quality products; sustainability; innovation to improve clinical outcomes; and promoting UK interests in global markets. A DHSC spokeswoman said: “This global pandemic has shown the benefits of bringing together a number of functions in this new directorate in order to improve our technological capabilities to support patients, suppliers and the NHS.” According to the memo seen by HSJ, there is already a fairly well-developed leadership structure, centring

around a so-called ‘Gang of Four’. No permanent director for medtech has been appointed yet, but Chris Stirling, a consultant from Stirling Advisory will become interim director. His recent expertise has been on the procurement of oxygen, ventilators, medical devices and clinical consumables during the pandemic, and was involved in designing the NHS Supply Chain commercial and operational model. Dr Sara Felix will lead on policy, strategy and regulation and lead the devices regulatory team will be a part of this function, having led the national supply disruption response designed to liaise with suppliers in the run-up to Brexit. The DHSC head of supply resilience and sustainability David Wathey “will continue to lead on customer relations and supply resilience and sustainability issues”. And national health strategy director Robert Moorhead “will continue to provide day-to-day leadership for the COVID programme and support the transition of continuing activities to the relevant permanent teams and the wind down of other programme activities”. This seems to be a move in the right direction, if it provides some badly needed strategic coherence in procurement for the new decade.

If this is also the start of supporting the industry at home, and prizing value, outcomes, resilience and sustainability, that’s also welcome. The race-tothe bottom atmosphere the industry has faced in the past could ease into something more promising if the directorate supports ideas of longer-term value and high-quality products; and allows new purchasing and regulatory practices that allow adoption at speed and scale. These moves are also to be seen in the context of integration and population health, with the NHS now prioritising patient safety, trusts aligning themselves to quality improvements in procurement and new techniques under the GIRFT initiative, and the likelihood, under the new integrated provider collaboratives, of joint and aggregate purchasing across systems and places. If all this holds true there are certainly opportunities for industry to move to a better place in terms of relations with the NHS; the unknowns are really whether the finances will hold up to allow this latitude, whether these systems will be geared to supporting UK SMEs as well as big medtech as the Queen’s speech seemed to promise, and whether the rebuilding and resetting of the post pandemic approach will last into the longer-term.


on the cover


lika believes that one of the main challenges of powering miniature implants in the sector is to make sure they’re properly powered while not compromising on design and power potential. Then there’s the issue of the end user, are they going to be prepared to recharge the batteries? Pasero explains: “You can’t expect any technology to have the same power when the battery is a few millimetres long, it needs a conversation with the patient. Is the patient going to be happy with charging the device by themselves? Perhaps every day? That’s not a given. People will be worried that they’ll miss a day. What’s going to happen to that implant? That’s a risk the designers are taking with good signs that this could be accepted at some point because what you have then is a much smaller device, a less risky operation, a device that you won’t even notice.”


MIGHTY After participating in a panel session discussing the exciting developments in neuromodulation therapies, Denis Pasero, product commercialisation manager from Ilika, sat down with Ian Bolland to discuss the design challenges for battery manufacturers when it comes to small, implantable devices. 12

Ilika is an expert in the manufacture of solid state batteries working with its customers to develop Stereax micro batteries for next-generation implantable devices. The company is presently fitting out a new facility which will enable it to produce these batteries at scale which will make them the first volume manufacturer of solid state micro batteries for medtech in the UK and possibly Europe. They’ve been working on adapting to smaller implants and batteries for a number of years. Pasero described some of the ideas that medical device developers have for implants as “almost science fiction” with some suggesting new devices and implants could be as small two millimetres wide, be placed in the heart, the lungs or inserted through a catheter. The use of solid state batteries compared to the more conventional lithium ion batteries can have its benefits. “There are miniaturised cylindrical batteries - take the AAA battery and the big medical battery giants are now designing miniature batteries that could fit onto your finger. The problem is they’re made


People even want to put something inside their heart; replace the idea of an external pacemaker with an internal pacemaker. That’s sci-fi but it exists out of conventional, usually lithium ion, chemistry so they have liquid inside. You need to ensure the liquid does not go inside the body, so it’s encased in a metallic can, like an AAA battery but smaller. The problem with that is the volume, as you reduce it down at some point you’ve got only can with no battery left inside. “They are limited to a level of miniaturisation unlike solid state which don’t contain liquids. They are just bare dies like an integrated component, like an IC chip without the packaging and it’s just a piece of ceramic, so you can make them very small – smaller than those cans. The challenge with miniaturisation is energy density. As the battery becomes smaller, you’d expect it to have less and less energy. At Ilika, as we miniaturise, we ensure we make the batteries very energy dense using patterning and energy dense chemistry.” Neuromodulation, Pasero explains, has been around for decades, but the miniaturisation of such devices

has allowed them to become increasingly closer to the brain, the spine and in general the organ to be treated. After his panel session with industry leaders from Teliatry and NXTStim, Pasero said that the experts know how to reduce pain levels within people, they just need the physical devices to allow them to execute it. He believes that this kind of miniaturisation began some years ago with the smart contact lens. “The very first one was created for diabetics, giving them real time sugar levels in the body by measuring glucose in the eye. This didn’t initially work very well and many thought smart contact lenses were never going to catch on. “However there’s now dozens of companies working with them and not just for health conditions. From sensors that measure sugar levels, to those that measure pressure in your eye. Glaucoma

is a condition that results from an optimised pressure inside the eye and with a little bit of electronics on the contact lens, it could read the pressure and even correct it. There’s also the smart contact lenses that get publicised more - the AR and VR ones, where the lens comes with a display. “The contact lens that can communicate with a device, like your phone. These are gaining a lot of investment. Some companies are getting hundreds of millions of dollars of investment for ideas like that. The market is huge, but what battery is going to be put on a contact lens? It’s got to be extremely small.” When explaining about the relatively easy accessibility of ultra-low power electronics, he spoke about the advancements that have been made in this area. “The idea of next generation implantable devices is to make them smaller and more efficient. For example, when you have a pacemaker or neuromodulation device, it’s quite large and it goes in your chest or in your back. When there is a large area you’ll have connectors inside the body, electrode not wires, going to the place where the operation needs to be. It could be your brain, right? Your heart? Or it could be on your spine, but the device itself can’t be next to it currently, because it’s too big. “So the idea is that you only make one device, if the device is small enough then it can be in your brain or at the back of it, it can be in your lungs, it can be on your spine. Then it becomes more efficient because it’s right next to the organ. People even want to put something inside their heart; replace the idea of an external pacemaker with an internal pacemaker. That’s sci-fi but it exists.”


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Why medtech should now lead the way in smart manufacturing Rachel Shelley, head of medical technologies, IDA Ireland, explains why medtech is well placed to lead in ‘lights-out’ manufacturing, and how companies in Ireland are being helped towards this.


ith the way we work in offices to factory floors having changed so rapidly in the wake of the global pandemic, digitisation is coming to the forefront as a solution to some of the challenges posed by a highly contagious virus. It offers safer, remote working for employees yet also faster, more efficient, agile and intelligent working for companies. So, it is clear to see why Industry 4.0 and ‘smart manufacturing’ is on the rise, and medtech has great opportunity to lead the way. Like many areas of digitisation, the speed of transformation pre-pandemic has, for many companies, become much faster since the COVID-19 pandemic began. According to a 2020 McKinsey report, as companies ‘reimagine operations for the next normal’ manufacturers are now reconfiguring their supply chains and their production lines to future-proof processes. Medtech companies are already making headway, harnessing its benefits of technologies such as robotics, automation, cloud computing, AI, machine learning and advanced enterprise software. Medtech has been an early mover towards automation because of its impact on driving productivity, particularly in a discrete manufacturing environment through better connecting systems and technologies. For a good example look no further that Stryker, with the largest medtech additive manufacturing centre in the world in Cork. The company announced it is investing more than €200 million at research and development across three of its Cork facilities. The funding is part of the company’s drive to develop next-generation products and services across its surgical, orthopaedics and neurotechnology and spine units. DePuy Synthes is also taking strides in Industry 4.0 with its facility at

Ringaskiddy, County Cork, which produces replacement hip and knee joints. This, and a sister Janssen plant in Cork have both been named by the World Economic Forum (WEF) as global lighthouses for embedding internet of things (IoT) into modern production. Lighthouses are selected from a survey of global manufacturing sites based on a successful track record of implementing Industry 4.0 technologies. DePuy Synthes Cork used IoT technology to create digital representations of physical assets leading to advanced machine insights, resulting in lower operating costs and a reduction in machine downtime. Janssen’s Cork site has digitally connected research and development, its internal and external manufacturing, and deployed advanced process control solutions to drive near real-time visibility of supply chain status. This has improved reliability by 50%, and accelerated technology transfers while reducing costs by 20%.

highly interconnected ecosystem and regulatory regime that supports a thriving Life Sciences industry.

Data, analytics and intelligence are fundamental to manufacture Greater intelligence and analytics from automated factories provide insight into machine health and productivity as well as operator issues, leading to more efficient working. Furthermore, when sensors and advanced analytics are combined with wearable devices it is possible to determine how those devices are being used in the real world. This offers enormous potential to improve the supply chain, enhance patient care and deliver on the increased demand for personalised care.

To meet the need for manufacturing companies to embrace and accelerate their adoption of digital technologies, a new national Advanced Manufacturing Centre (AMC) will open in Limerick in early 2022. Funded by the Irish Government, the AMC will help both multinational and indigenous manufacturers to access, try, adopt, deploy and scale smart manufacturing technologies. It will also focus on upskilling for future production skills. Given so many firms are considering the benefits of digitisation and how best to get started, the AMC will focus on helping companies understand where they might implement emerging technologies to transition current manufacturing into smart manufacturing.

Ireland provides innovative support to boost Industry 4.0 production When it comes to adopting Industry 4.0, Ireland is giving medtech companies a head start. High profile companies like Stryker and DePuy Synthes have been attracted to Ireland by the talent pool,

Medtech companies have much to gain from digitisation and is well positioned to lead the way in smart manufacture. However, it is access to the right infrastructure, skills and a supportive ecosystem that will drive the industry transformation.


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Applying nano-coatings to protect from viral infections Simon Mercer, director at Signo-Nanocare, looks at how antimicrobial technology applied through nano-coatings can be used to reduce the transfer of Hospital Aquired Infections.


hile the pandemic is far from being over, we are all welcoming the chance that vaccines have given us to be able to meet, socialise and return to some form of normality. For many, this will mean the hope that routine surgeries put off over the last 12 months will happen and attending a doctor’s surgery or hospital and picking up an infection is not quite as life threatening as it has been perceived by many in the last year. The pandemic has sharpened the focus on the transmission of infections via the hand-surface-hand transfer route in the public’s mind, one which has always been taken seriously in healthcare. While the COVID cleaning regimes continue, they are also impacting on other transient microbes such as MRSA, Staphylococcus and Streptococcus infections that can be as deadly as SARS-CoV-2. The annual data collated by the Nuffield Trust on the number of HAI, such as Clostridioides difficile and MRSA, show that they have remained at a stubbornly constant level since 2013/14, with only minor changes in the number of hospital and community onset cases. Of equal concern, the annual data on the Escherichia coli have shown a consistent low level of infection with hospital cases, however cases of community on-set have risen dramatically since 2015/16, contributing to a sharp overall increase. There is much debate as to the achievable level that HAI can be held to and ‘zero tolerance’ may be seen as a lofty aspiration; after all, the eradication of an infectious disease has only been achieved with Smallpox. However, the constant challenge remains in healthcare settings to reduce the number of HAI and with many (MRSA and C. Difficile) there is a need to break through the consistent plateau of cases, and to affect the next level of reduction. While the existing infection prevention measures have brought about the reductions seen today, further decreases can be achieved by using new technologies in surface protection.

The performance requirements of the “optimum” type of antimicrobial surface technology are outlined in a recent briefing paper ‘Smart surfaces to tackle infection and antimicrobial resistance’ by Imperial College London (ICL) Institute of Molecular Science and Engineering (IMSE). The paper highlights ten ideal properties for an antimicrobial surface treatment as: • Safety - the surface must remain safe for regular contact with patients, staff and visitors. • Healthcare economics – the surface must represent good value healthcare. • Simple application technology – the surface must remain antimicrobial for months/years. • Rapid antimicrobial activityantimicrobial activity occurs rapidly. • Prevention of biofilm formation – must have the ability to prevent biofilm creation or disrupt existing ones. • Compatibility with current cleaning and disinfection products – any extensively used chemicals should not interfere with the antimicrobial action. • Retention of activity with low-level soiling – the presence of organic matter or dirt should not interfere with the surface activity. • Does not promote clinicallysignificant resistance or reduce susceptibility – there is theoretic risk of the development of resistance or susceptibility to the surface. • Sporicidal activity – C. Difficile spores present a particular challenge to antimicrobial surfaces so the solution should be effective against this particular pathogen.

killing and rendering it untransmissible through surface contact. The physical nature of the kill ensures that the coating is non-mutagenic and does not aid antibiotic resistance. Antimicrobial nano-coatings have enabled a breakthrough in the permanence of anti-microbial effect that allows healthcare settings to break the plateau floor of hospital acquired infection rates with a constant background kill of pathogens. Signo-Nanocare launched Liquid Guard in 2019, a long-term antimicrobial nanocoating that has been proven effective after one application against MRSA, Clostridioides difficile, Escherichia coli, Staphylococcus, Streptococcus as well as SAR CoV-2 for 12 months and longer on virtually any surface.

While the existing infections prevention measures have brought about the reductions seen today, further decreases can be achieved by using new technologies

A multi-disciplined team drawing on skills from the materials, engineering and science backgrounds working with nano-coating technology has developed an antimicrobial nano-coating that kills bacteria, viruses and yeast pathogens on surface contact along with meeting all ten of the ‘ideal properties’ put forward by the ICL IMSE briefing paper. The antimicrobial nano-coating, when applied yearly to a surface, creates an invisible layer of nano-spikes that ‘puncture’ the cells’ outer wall, physically



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Green goals: Optimising end-to-end sustainability for single-use devices George I’ons, head of product strategy and insights, Owen Mumford Pharmaceutical Services, explains how medical device manufacturers can make single-use devices more environmentally friendly.


n England, the NHS is responsible for 4% of total carbon footprint, with a higher percentage of plastic waste compared to other industries. Unlike other industries, healthcare waste may be infectious, resulting in about 5% of NHS plastic waste being recovered. The pandemic has helped shine a light on this issue, due to the increased demand for Personal Protective Equipment (PPE). Since February 2020, the government has distributed over 11 billion items of PPE to health and social care services in England, compared to just over 2.4 billion in 2019 – representing an increase in waste, and highlighting the need to take action. In tandem, there is wider public awareness of environmental issues, leading to greater pressure on healthcare procurement teams to use their purchasing power to address this – around 60% of the health service’s carbon footprint can be attributed to the procurement of goods and services. Proactive businesses are therefore likely to benefit commercially from establishing sustainability goals and objectives. The challenge for

manufacturers of disposable medical devices is to reduce the overall impact in a financially viable way. The need to control infection and to comply with safety regulations makes it difficult to avoid using certain singleuse medical devices. The UK does not encourage reprocessing and reuse of single-use products while the EU’s Medical Device Regulation introduces strict reprocessing guidelines. Sterilisation also has limitations. It may be costly and require high levels of energy, cancelling out the sustainability benefits of reuse. Some sterilants may also have toxic properties. In the US, 50% of all sterile medical devices are sterilised with ethylene oxide as it is the only effective method for many devices but releases harmful emissions, causing the FDA to call for the development of new methods or technologies. Rather than reusing a whole device, some of its materials may be reused. The most widely used plastic for medical devices is Polyvinyl chloride (PVC) which can be recycled several times without losing its critical properties. In one UK take-back scheme, disposable and non-infectious PVC medical devices from over 30 participating hospitals, including oxygen masks, oxygen tubing and IV bags, are turned into products for the horticultural industry. In this way, useful plastics are kept in circulation rather than being incinerated with other healthcare waste. New technologies could further aid this process for plastics that are more difficult to recycle. Sustainability shouldn’t only be a consideration at the end of a product’s life cycle. Device designers can assess various methods of reducing plastic use from the outset, such as reducing the number of components


or choosing alternative materials. One company is now making pregnancy tests with plant fibres, meaning they can be flushed and then biodegrade within ten weeks. There may be scope to reduce environmental footprint across multiple stages of the device manufacturing process, from minimising primary and secondary packaging, to choosing recyclable labelling. The manufacturing site should undergo a sustainability review. Improving energy efficiency and opting for clean energy sources could reduce overall costs, and savings can help fund sustainability initiatives. Investments in process optimisation and new technologies may also support environmental efforts. For instance, additive manufacturing can reduce scrap waste by as much as 90% compared to conventional manufacturing, and speed up production of device prototypes, so products can be refined and tested more efficiently. As manufacturers explore possibilities of adding digital capabilities to devices, innovative approaches will be needed to maintain sustainability. Connected medical devices can reduce some of the burden on healthcare but adding electronic elements to a disposable device presents a new obstacle to sustainability. One response is hybrid design, coupling electronic components with disposable device components. Many successful sustainability initiatives are already in place but need to be implemented on a much wider scale. The UK has been a leader in healthcare sustainability initiatives, setting up the Sustainable Development Unit in 2007. As we face new challenges, we must keep up the momentum to make a bigger impact. A pre-pandemic estimate suggested that one million tonnes per year of non-infectious medical plastics are available for recycling in the US, with equivalent amounts in Europe and Asia. Working together, the industry can start to make a dent in that figure.


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Greener medical plastics: Sustainability and the environment

Kevin Rogers, director of plastics and rubber commodity at TR Fastenings, explains how medical plastics is moving towards a more sustainable model.


ver the last century plastics have impacted all industry sectors by providing solutions to the world’s evolving needs. In recent years, material improvements have seen a surge in demand for plastic in rapidly advancing industries such as healthcare. Today’s most ground-breaking medical applications are dependent on plastics; from MRI and X-ray machines to prosthetic limbs, artificial joints, heart valves and the smallest of tubing, modern healthcare would not be possible without the use of plastic materials.

chemicals like petroleum. Operating temperatures can vary by hundreds of degrees Celsius and its molecular structure can be engineered to present different characteristics—to be flexible or hard, transparent or opaque. They are recyclable, durable, strong, lightweight, water resistant and relatively easy and inexpensive to manufacture. Most modern plastics are made from fossil fuels like natural gas or petroleum; but as new technology emerges, plastics are also being produced from renewable materials like corn or cotton, recycled oils, secondary plastics, and even CO2.

With net zero targets in place and environmental sustainability now a priority for manufacturers and their supply chain, the industry is now moving in an entirely new direction. Here, we explore how plastic meets the sustainability agenda.

Plastics fall into two primary groups: Thermosets strengthen when heated, but cannot be melted or re-moulded once set, e.g. melamine, vinyl, silicone and acrylic.

THE FACTS • In 2019, global plastics production reached 370 million tonnes, with 57.9 million tonnes produced in Europe; generating more than €350 billion in the European plastics industry. • 60% of plastic products and parts have a use phase of between 1 to 50 years plus and this lapse of time determines when they will potentially become waste. • 5% of worldwide oil supply is used to manufacture plastic, producing around 5% of the polluting hydrocarbons. THE SCIENCE Plastics are polymers, long chains of molecules made from repeating links called monomers, often produced from

Thermoplastics, as used by TR Fastenings, can be reheated, remoulded and reused repeatedly, such as polyethylene (PE), polypropylene (PP) and polyvinyl-chloride (PVC). These are generally in place for many years, and can be recycled. VERSATILITY AND RECYCLABILITY The variety and complexity of modern injection moulding means multiple ‘metal’ parts can be replaced by a single plastic component; reducing costs and retaining necessary strength and integrity, increasing efficiency and lowering emissions. During the moulding process, some thermoplastic material is left over and can usually be recovered from factory components like sprues, gates, flash and runners. While the plastic has been used

once, it can be used again by blending it with virgin resin - known as “regrind”. Not all plastic products are the same and not all have the same service life. Some are a product in itself and some are part of an end-user product. According to a report by the Ellen Macarthur Foundation, plastic usage has increased twenty-fold in the past 50 years and is expected to double again in the next 20 years. COVID-19 RESPONSE COVID-19 triggered an upturn in demand for TR’s fasteners and components for medical devices needed on the front-line, typically used in ventilators, ultrasound machines, imaging equipment and defibrillators amongst others. Plastic components such as cable management, PCB fasteners and various other clips have also been in demand and can often be reused or recycled. A SUSTAINABLE FUTURE The strength of TR’s partnerships enables us to keep up to date with advancing technologies and to react quickly to changing requirements, with sustainability a key factor. The rise in demand for plastic fasteners has seen TR’s range expand. The medical plastics industry is complex with growing opportunities to advance sustainability from design inception through to product end-of-life. The transition to a low-carbon circular economy is on its way, with plastics continuing to shape our lives.




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Endless possibilities? What in situ cure silicones can offer medical devices Benny David, PhD., director of business development, NuSil, talks to Med-Tech Innovation News about the new possibilities that in situ care silicones can offer medical devices. WHAT APPLICATIONS USE MEDICALGRADE SILICONES? Medical-grade silicones have a long and proven track record of use in healthcare applications. This biomaterial is used in everything from soft silicone adhesives used in wound care products to components in medical devices implanted in the human body. Today, silicone can be found in applications such as cardiovascular pacemakers, cochlear implants, drug delivery devices, joint replacements and intraocular lenses. Silicone is appealing in medical devices due to the material’s polymer stability. They are also chemically inert, biocompatible, and easy to clean and sterilise with highly customisable formulations. WHAT POSSIBILITIES DO IN SITU CURE SILICONES OFFER FOR IMPLANTABLE MEDICAL DEVICES? In situ curing silicones bring personalised medicine to implantable devices. Normally, these devices are formed, cured and sterilised outside the body before the implantation procedure. NuSil’s patented dispensing system provides an alternative to surgical implantation by allowing uncured, pre-sterilised silicone to be delivered directly into the body, precisely where the device is needed. The silicone forms into the shape of the implant site — rather than a one-size-fits-all approach with standard implant shapes. Once delivered, the silicone cures in situ at body temperature.

The result is a “real-time” implant that creates opportunities for novel customised therapies that require less invasive implantation procedures. It offers application potential for cardiovascular, neurological, urological and ophthalmic aesthetic implants. WHAT CHALLENGES DID YOU FACE IN DEVELOPING THIS TECHNOLOGY? The challenge was to find a way to package both the uncured silicone and sterilisation chemistry in a safe, all-inone delivery system. The solution is a pre-filled, dual cartridge dispensing technology. Each cartridge contains a gas-permeable plunger seal that allows an ethylene oxide (EtO) sterilant gas to permeate the seal and sterilise uncured silicone inside the barrel. The silicone is then delivered directly to the point where the implant is needed. HOW ARE IN SITU CURE SILICONES DEVELOPED? An extremely versatile material, silicone’s chemical make-up can be fine-tuned to match specific material properties, including durometer, elasticity and fatigue resistance. We collaborate closely with customers to ensure the in situ-cured silicone meets their requirements and functions as intended. For example, hardness can be precisely defined in a silicone device intended to provide orthopaedic support; likewise, an in situ-cured silicone implant used to cushion a joint can be formulated for a specific level of softness.

IS THIS TECHNOLOGY SPECIFICALLY FOR LONG-TERM IMPLANTS? Yes. Like all of our medical-grade silicones, the silicone is formulated, manufactured and purified to meet the strictest regulatory requirements. We maintain more than 700 Master Files (MAFs) with the U.S. Food and Drug Administration and can provide the relevant regulatory support needed to help smooth the path to commercialisation. WHAT BENEFITS DO YOU FEEL NUSIL OFFERS THAT OTHERWISE WOULDN’T BE AVAILABLE? We bring innovation and manufacturing expertise to every project. NuSil can supply off-the-shelf medical-grade silicones as well as custom formulations that meet precise process and device performance requirements. Our team understands how to move a silicone component or device from design to fullscale manufacturing. WHAT FURTHER ADVANCES DO YOU ENVISAGE? We expect to continue to see in situ cure technology enabling novel therapies that hadn’t been possible without this innovation in applications that could include orthopaedics, cardiovascular, aesthetic or neurological therapies. For example, recent advances in the field of sustained release drug delivery are incorporating long term implants that leverage in situ cure technology.


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Five steps to prepare for UKCA compliance Ed Ball, senior associate, RQM+ summarises the requirements of the UK Conformity Assessment certification (UKCA mark) and highlights top priority areas for attention.


s of the 1st of January 2021, the UK has entered the transition period towards its new regulatory regime. As well as achieving compliance for the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device businesses with products on the UK market need to plan for how they will obtain a UK Conformity Assessment certification (UKCA mark). Manufacturers have until the 30th of June 2023 to obtain UKCA marking for their devices. Over the coming months, manufacturers will have to keep a close eye on the emerging UK regime as it takes shape. This article aims to help manufacturers make sense of the current UK regulatory landscape by providing five steps businesses can immediately start integrating into their planning. STEP 1: IDENTIFY DATA GAPS FROM MDR/IVDR EFFORTS The UK Medical Devices Regulations (UK MDR) 2002 – which will continue to apply in England, Scotland and Wales until June 2023 – are based on the EU directives for medical devices and in vitro diagnostic medical devices, but it is likely that future UK legislation will come to closely resemble the MDR and IVDR. This means that efforts and resources invested into complying with MDR and IVDR could be repurposed for

UKCA marking. Manufacturers should therefore begin by assessing the gaps in data and documentation and plan strategically around these in order to eliminate any unnecessary duplication of activity. STEP 2: REVIEW COMPLIANCE EFFORT FOR EACH PRODUCT IN PORTFOLIO Given the added financial cost of meeting this new compliance requirement, businesses should review their portfolio and the regulatory status of each product and assess the compliance effort required for each device. Manufacturers are advised to build a compliance ‘risk matrix’ of products based on device classification, CE mark status, UK regional sales and level of preparedness. From there, manufacturers must consider whether it makes commercial sense to continue to supply all product classes to the UK. STEP 3: SOURCE YOUR STRATEGIC PARTNERS Businesses outside the UK must source a UK-based Responsible Person (UKRP). In order to register with the Medicines and Healthcare products Regulatory Agency (MHRA), all UKRPs must have a registered place of business in the UK and be identified on the device’s labelling or IFU alongside the UKCA mark. Once a UKRP is appointed, clear communication channels must be established for managing and sharing documentation. The conformity assessment of certain device classifications for the UKCA mark relies upon UK Approved Bodies rather than EU Notified Bodies. At present, only three UK organisations are acting as Approved Bodies so there is a risk

of them becoming quickly overloaded with demand for their services. Manufacturers who require the services of a UK Approved Body are advised to liaise with their EU Notified Body to determine their intentions for the UK market and/or engage with one of the Approved Bodies currently listed. STEP 4: GET A HEAD START AND ANTICIPATE DELAYS While June 2023 may seem a long way away, businesses should consider the time required for their documentation to be updated and reviewed. With the UK no longer part of the EU, it is likely that EU-based manufacturers and UK importers will see an increase in administrative tasks relating to importing and exporting medical devices, in turn increasing costs. Practical issues within the supply chain may emerge after June 2023 once the CE mark is longer recognised, so it’s vital that all parties are clear on the implications of any new procedures and controls. Keeping close contact with the relevant regulatory authorities will help businesses stay au fait with the developing situation. STEP 5: STAY ABREAST OF NEW DEVELOPMENTS AND GUIDANCE We can expect to see further guidance from the MHRA during the transition period, as businesses start submitting their UKCA documentation and common pitfalls begin to emerge. It is likely that clarifications from the MHRA will be required to help businesses make sense of how requirements should be met. Businesses may be able to avoid any pitfalls in their own submissions by monitoring for updated advice from the MHRA and the UK Approved Bodies.



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HOW HEALTHY ARE DIGITAL APPS? Richard Poate, senior manager at TÜV SÜD, a global product testing and certification organisation, discusses how health apps can be regulated, and offers best practice advice to manufacturers.


s well as medical device apps becoming a growth area in healthcare management in hospital and community settings, the role of apps used as part of fitness regimes and for social care situations is also expanding.

Scotland and Wales) until 30 June 2023, after which UKCA requirements will apply in full. This is intended to ensure they are regulated as being acceptably safe to use and perform in the way the manufacturer or developer intends them to.

IEC 82304-1:2016 - Health software – Part 1: General requirements for product safety – applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware. To be used by manufacturers, it covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

As the healthcare app industry grows, so too will the potential risks. When patient safety is involved, the risks become much more personal - ranging from a slight inconvenience to having to call the emergency services. For example, if an app for medication dosage gets it wrong by putting the decimal point in the wrong place the effect can be fatal.

However, now more than four years old, this standard does not completely cover the significant rise of health and wellbeing apps. Currently under development, future technical specification ISO/TS 82304-2 - Health software – Part 2: Health and wellness apps – Quality and reliability - is intended be used alongside Part 1 to provide confidence in health software products such as apps. In the EU, standalone software and apps that meet the definition of a medical device are still required to be CE marked in line with the EU Medical Device Regulation. Following Brexit CE marking will be recognised in GB (England,


The regulatory landscape can be very confusing for digital health providers as ‘old’ regulations and standards are being ‘adapted’ to meet the very different scenarios that these solutions throw up. Healthcare regulators globally are wrestling with how to provide a suitable regulatory regime for these innovative products and services. Consequently, software developers and users are struggling to understand whether apps qualify as medical devices. As the healthcare app market develops and manufacturers tussle to get products to the market, there is real industry concern about how these apps will be controlled. There is a fine line between a medical/ wellness app and a medical device. Consequently, manufacturers and

developers are not classing some apps as medical devices when they should be. This is often because software developers are not necessarily aware of the regulations or rules that relate to bringing healthcare or wellness apps to market, resulting in them designing apps that should be classified as medical devices. The Medical Device Regulation (MDR) defines a medical device as “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for specific medical purposes including diagnosis, prevention, prognosis, treatment or alleviation of disease”. Quite an all-encompassing definition and if your app does fall within the jurisdiction of the MDR, that involves significant time, effort and money. Also, beware - if at first your health app doesn’t fall within the MDR’s scope, as it is improved and later iterations released, it may then apply. Beyond the MDR there are issues to consider relating to data privacy as health apps can have access to highly detailed, personally identifiable and clinical information about the user. For example, NHS Digital has focussed its Digital Assessment around security on compliance with OWASP best practice guidelines for apps and web-based solutions. Whilst existing accreditation regimes such

as Cyber Essentials and ISO27001 are relevant, the need to demonstrate ‘security by design’ and suitable vulnerability testing is also becoming key. When ISO/TS 82304-2 is published, together with Part 1 it will provide requirements for the development of health and wellness apps designed to meet the needs of healthcare professionals, patients, caregivers and the wider public. It will contain a set of quality criteria and cover the app project’s life cycle through the development, testing, release and updating of an app, including native, hybrid and web-based apps, apps associated with wearable and other health equipment and apps that are linked to other IT Systems.


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TIME TO EMBRACE THE CHANGE Sandeep Chauhan, managing director of Definition Health, hopes the challenges in scaling approved digital health solutions across the NHS can tackle the age-old barriers to change.


s I write this article, the glow of being selected to be one of the 12 innovators to join the NHS Innovation Accelerator (NHS NIA) has started to fade. In its place is the realisation that, despite this accolade vindicating our hard work over the past three years to improve patient outcomes using digital technology, we may still face the same challenges we have always done when it comes to implementing solutions into hospitals. They are: providers believe they can build their own solutions; a lack of awareness of what already exits; slower decision-making processes; and hospital finance departments working in silos so all they see is the cost of a solution which may not have been budgeted for, and not the efficiencies that are likely to come. Sometimes, the barrier can also be the desire to be first. We hear a lot in the NHS about ‘first movers/early adopters’ yet rarely ‘second movers’. The advantages of being a second mover is you can adopt and adapt a tried and tested solution which means implementation is quicker and patients, staff and the hospital bank balance

will show positive outcomes sooner. But thank goodness for those brave first movers who believed in our digital health solutions. I salute the team at The Montefiore Hospital in Hove, which was the first private hospital to adopt our LifeBox digital patient preassessment app. By the time, COVID-19 struck last year, it had already digitised its entire patient pre-operative assessment service. Being an early adopter had unforeseen benefits in the face of a pandemic - while it became an NHS hub for clinically urgent surgery, The Montefiore was able to use the app to assess the requirements of its own cancer patients coming to its oncology unit, alleviating the need for 70% of hospital visits during the early stages of lockdown. South West London Elective Orthopaedic Centre (SWLEOC) was the first NHS hospital to start using LifeBox. During the lockdown phases, it used the digital app to pre-assess patients from their homes, ensuring they were ready for theatre when surgery could recommence. SWLEOC is now gradually rolling out this product to all four trusts within its

partnership which, I am sure, will be grateful to be `second movers’. Digital transformation in healthcare only works when teams collaborate. With all our hospital partners, we become one team, working together to adapt the digital solution to the hospital’s individual needs, with a commitment from both sides to drive a better patient experience and improve safety. This past year, the NHS has shown a huge ability to adapt quickly, especially making real strides in embedding digital approaches to patient care. We saw the adoption of our digital health solutions move forward by two years within weeks when the pandemic struck. It is a tragic irony that it needed a pandemic to push the NHS out of its comfort zone when it comes to embracing digital technology. But now that it has, we can’t go back to business as usual of lengthy face-to-face appointments and bringing patients into hospitals to fill in forms. The NHS Innovation Accelerator recognised this fact when it chose us to be one of the 12 innovators to address the key NHS challenges of restoring

services, meeting new care demands and reducing the backlogs caused by the pandemic. From remote patient monitoring and diagnostics to virtual clinical training for staff, innovation will be critical in caring for NHS patients and staff effectively and efficiently in this `new normal’. While the NIA recognition is fantastic for Definition Health, we still need to see more NHS hospitals adopt digital solutions to meet the pent-up demand in the system and to see more rapid decision-making. In our experience, it can often take six to 12 months from the point of first engagement to contract signature. That’s a considerable period of time for savings not to be realised and, importantly, for patient outcomes to be compromised. However, I take great hope in the wording within the NHS 2021/2022 Priorities and Operational Planning Guidance. In this document, it emphasises the need to `accelerate progress on digitally-enabled care’. As we start to restore services, the push to embrace digital health transformation may no longer just come from innovators like us alone, but hopefully from within the NHS itself.


Contract Manufacturing

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Viable Solutions:

A sustainable future for contract manufacturing PolarSeal has undergone new measures to ensure the business now has the ability to manufacture more sustainably for its healthcare focussed clients.


he growing demand for green practices within the medical industry is a result of many nations recognising the need for improved processes. The United Nations has created a collaboration that aims to deliver the Sustainable Development Goals (SDGs) in time for 2030. This shared movement focusses on the sustainable improvements that can be made to improve peace and prosperity for all people, and in turn practices that can improve the planet too. PolarSeal has chosen to focus on three main areas of this movement, with actions being committed to work towards the SDGs that ensure healthy lives, that build and promote sustainable industrialisation and also ensure they contribute towards responsible consumption & production methodologies. Whilst sustainability within contract medical manufacturing isn’t unheard of, it is difficult to achieve. The nature of the industry and the requirement for sterile equipment doesn’t lend itself to naturally promoting a circular economy where re-use is encouraged, so the business has worked on innovating the full manufacturing supply chain to

implement the change from start to end. To begin with, PolarSeal has reviewed its supply chain and reduced its carbon footprint by bringing additional manufacturing capabilities in-house to reduce unnecessary product travel miles. This decision has also led to the company being able to offer turnkey solutions for clients, reduced lead times and given the business ownership to implement more bespoke and sustainable packing solutions. The company can now optimise shipping for each client by using bespoke box sizes for the products ordered, reducing ‘empty space’ in product transit as well as pallet size/weight. This has been further supported by the reduction in waste generated as a business. PolarSeal is now working towards a zero waste to landfill objective and has partnered with an external third-party organisation who organises regular collections of the release liners used within medical manufacturing processes. This partner redistributes liners in industries external to healthcare for reuse where possible, or recycle the liners in a responsible manner – helping to ensure a closed loop for this article of waste and avoiding unnecessary landfill as a result. It has also implemented recycling procedures for both manufacturing sites and uses equipment such as box crushers to maximise efficiency when transporting recycling to larger facilities. To help reduce PolarSeal’s impact on climate change, the business now also powers over 45,000SQFT of manufacturing space including multiple cleanrooms by using only renewable sources of power. This helps the business reduce the need for carbon intensive, finite resources and provides a more secure energy supply for the future. This energy choice also gives the business the ability to stabilise costs. Internally, the business is also working towards providing a paperless environment for its employees. There


Investing in the future of sustainable contract medical manufacture, is quite frankly, vital, in order for us to grow has been a particular focus on this within manufacturing, with innovative systems being implemented which help contract medical manufacturers uphold regulation practices against ISO 14644:215. New technologies have been implemented in areas such as quality assurance and traceability records in a bid to streamline processes and ensure concise records for our clients. Matthew Rich, sales and marketing director of PolarSeal said: “Investing in the future of sustainable contract medical manufacture, is quite frankly, vital, in order for us to grow. “The business has invested heavily in ensuring our manufacturing processes reflect our desire to support change. Alongside this, we also uphold our ‘people first’ value with our charitable giving. We invest £100,000 yearly to charitable causes, who work towards promoting well-being for all ages. The charities range in focus, and it means we can support a multitude of areas which aim to improve life whether it be through cancer research, to removing homelessness all the way through to reducing poverty and beyond to.” Whilst PolarSeal is pleased with the changes it has managed to implement so far, it doesn’t mean that the business has completed its mission to become more sustainable. The business will continue to invest heavily in developing more sustainable products for the healthcare industry and is always open to collaborating with new partners on green projects moving forwards.

Contract Manufacturing

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Laser focus:

Investing to maintain precision Lincoln-based firm Micrometric is continuing to expand its services in the medical engineering and manufacturing sector after investing in and identifying new uses for a high-precision laser machine, predominantly used to produce medical components.


ounded in 1981, Micrometric is a specialist in the laser processing of materials and uses laser manufacturing services to produce fine parts and precision components for customers in the UK, Europe and across the world. Micrometric provides subcontract manufacturing services to produce components that are used by businesses in the aerospace, automotive, energy, medical device manufacturing and electronics industrial sectors. The company invests in equipment to respond to enquiries and changing demands from customers, particularly in the medical sector, who require high-quality, high-capacity and reliable components. The company is committed to highlighting the importance of UK manufacturers and works with customers on each stage of the production process, from prototype to volume production, offering an all-inone service. Micrometric specialises in a range of laser manufacturing services including cutting, marking, drilling and welding as well as precision component machining. But to maintain its innovative approach to manufacturing, the firm has recently introduced Coherent’s StarCut Tube system to its range of precision cutting equipment. The fully automated machine, which is designed to laser cut, drill and mark tubular or flat metal components, is traditionally used by subcontract manufacturers to produce exclusive medical instruments with extremely high precision. This machine, coupled with the team’s expertise, means that Micrometric has the capabilities to cut, assemble and weld complex manufacturing devices including injection needles, small tubes and endoscopes as well as intricate parts

used for surgical equipment. To manufacture medical parts the company uses tube cutting to create small windows, slots, holes and spirals for different pieces of equipment such as cannulas and large tubes which form parts of innovative MRI machinery. It’s vital that products and components which are mass produced for the medical sector have full traceability, and Micrometric is able to laser mark medical products with clear Unique Device Identification (UDI) codes to ensure that every part can be tracked back to its source. Since investing in this equipment, Micrometric’s knowledgeable workforce has found new uses for this machine; the company has also been using it to produce a flexible range of tube components in large volumes as well as finer, more precise parts for a wide range of sectors in addition to the medical sector. Neil Main, managing director at Micrometric, said: “We invested in the StarCut Tube machine as we knew it could deliver the required performance for a wide range of projects and had a long, low-maintenance lifetime which is necessary for cost-effective operations within our working environment. “The machine’s versatility allows us to cut thinner tubes than our other

machines produce and extend our capabilities and the range of customers we can service.” Micrometric has already used the machine to cut, assemble and weld complex medical and aerospace components for companies which produce aerospace filters, automated injection needles, endoscopy components and MRI scanning equipment. Main added: “Thanks to this machine, we can produce components for different types of sectors, including airflow sensors, flexible protective covers, valves used for car suspension systems, industrial and medical endoscopy equipment, printing machines and food production. “We’ve always tried to address difficult tasks by investing heavily in our equipment and in staff training. This machine is perfect for customers looking to produce reliable components with extremely precise design criteria, as well as those using materials which are less common than sheet steel. “The equipment we produce for the medical sector is often extremely small and intricate - and as these devices are used to save lives, it is imperative that the processes used to make them from beginning to end assure their quality and reliability.” As well as providing different laserrelated processes such as laser cutting, marking, welding and engraving to produce life-changing devices, Micrometric’s laser machines are suited to cutting materials of varying thicknesses as well as materials including metal, plastics and glass.


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Med-Tech Innovation Expo

For success in product development – start at square zero


Steve Green, head of design at Oxford Product Design, explores ways of maximising the chances of commercial success in technology-led product development.

hen it comes to the commercial success of a technology-led product, there are several factors that come into play along the development journey. Have the regulatory requirements been met? Can the design be produced at a viable cost? Is it possible to ensure the quality of the manufacturing process? The list goes on. Some of these can be foreseen, mitigated and controlled. Others must be discovered by taking what one believes to be the right path and allowing for the evolution of the original idea as new insights are gained. From experience, the most important factor is often the way product development begins. Technological innovation most frequently emerges from academia. Whether in a university or a commercial research lab, it’s arguable that the most revolutionary thinking comes from those exploring in the pursuit of knowledge. As technology becomes ever more complex, it’s only natural that it’s the people most able to invest the time and effort into diving deep into an idea that make the breakthroughs which lead to the products of the future. In the current age of spinouts and start-ups, ideas can be financed, and teams assembled in no time at all. But one of the challenges with projects that begin this way is that the product vision is often led by the exciting new technology, rather than by the needs of the user. So, we’re at square one: new technology discovered. On to step two: product development, right? In fact, in the long run, it can be more valuable to take a

step back from square one and look at the ‘why?’ that sits behind the new technology. Consider this - why did you buy the last product you purchased? Assuming it wasn’t a piece of art, you most likely bought the product primarily for the solution it provides to a problem you have. Like you, most consumers will base their purchasing decision on a combination of what a product allows them to achieve and the emotions they feel as a result of that achievement. Rather than progressing to step two at this point, consider going back to square zero. Below are some valuable ways we know of gaining insights that will give your technology-led product the best chance of commercial success. STAKEHOLDER ANALYSIS It’s often not enough to consider the needs of the product’s end user alone. In some cases, the person making the purchasing decision is not the end user of the product. There may be multiple users across different applications, or an additional stakeholder that is responsible for the maintenance of the device. Exploring a broad view of your product’s different stakeholders will ensure no critical insight is missed. USER PERSONAS Identifying stakeholders is one thing; understanding them is quite another. Taking the time to define the needs, responsibilities, pain points and other attributes of the stakeholders upfront allows you to capture a well-rounded set of user requirements. Note: it’s important to identify what is known versus what is assumed at this stage.

USER/TASK/ENVIRONMENT ANALYSIS In addition to the stakeholder perspective, it’s worth investing the time to investigate the user’s workflow. Outlining each step of their process, from setup to maintenance, will help to further refine the user requirements and identify any scope for further innovation that hasn’t yet been explored. USER REQUIREMENTS SPECIFICATION Not technical or product requirements, but user-focussed requirements. These will form a list of objectives that the product should achieve to ensure success. For example, ’the device should use a 400mAh battery’ is not a user requirement, but ‘four hours of runtime are needed between charges’ is. These requirements should express the ‘why’ of quantifiable technical requirements. Investing the time in this servicefocussed approach is key to ensuring the completeness of your requirements specification, and helps build an efficient development plan, which ultimately increases the likelihood of success. The resulting documentation also serves as a useful aid for onboarding new team members along the development journey and helps keep efforts aligned. Not to mention its invaluable input for your quality plan. As such, it’s important that this information is readily available and updated as new learnings are discovered. You can visit Oxford Product Design at stand B70K on Medilink Pavilion at Med-Tech Innovation Expo on 28-29 September at NEC, Birmingham. On Day 1 Steve will be speaking on the Introducing Stage at 2:20pm.


Catheters and Stents


How a catheter reduces trauma and stress Med-Tech Innovation News spoke to James Urie, sales and marketing director at Mediplus, who explains the benefits of its S-Cath system, and how it came together.

FIRST OF ALL, TELL US ABOUT THE NEED S-CATH ADDRESSES? Patients requiring long term bladder drainage are often managed with an intermittent catheter, indwelling urethal catheter or suprapubic catheter - a hollow flexible tube that is used to drain urine from the bladder. Urethral catheterisation is associated with a number of issues, including high infection


rates (CAUTI), encrustation, urethral trauma. For patients they can also lead to discomfort and make sexual intercourse harder to achieve. With a suprapubic catheter, the risk of urinary tract infections is significantly reduced, and patients often find them more comfortable and easier to look after, resulting in higher quality of life. Because it is

inserted into the bladder through a small cut in the abdomen (rather than the urethra), sex is simpler, and the technique also minimises traumas and tissue damage. S-Cath makes the procedure safer. The system, which is a complete insertion kit, enables suprapubic catheterisation using the Seldinger technique. As a result, more

Catheters and Stents

patients can be managed with a suprapubic catheter, so we can help to reduce infection rates. In the UK & USA, the combined cost saving figures are in the hundreds of millions of pounds per year. HOW DID YOU GO ABOUT DEVELOPING IT? The S-Cath system was developed in close collaboration with Bristol Urology at NHS Southmead Hospital Bristol. Our company has always had a good relationship with Bristol Urology (including Roger Feneley, an Emeritus Consultant Urologist to the North Bristol NHS Trust who pioneered the development of new types of catheter). Bob Urie, founder of Mediplus, had watched some SPC insertions with the “blind” products, which led to the usual, “there must be a better, safer, simpler way of doing this” question. Bob approached Roger and started discussing the issues and challenges clinicians have when inserting a foley catheter suprapubically. This instigated ideas for what a new product could look like and what issues we would need to “design out” of the procedure. WHAT ASPECTS DID YOU IDENTIFY TO REDUCE TRAUMA AND TISSUE DAMAGE RISK? Firstly, in terms of locating the bladder, “blind” insertion products are used with local anaesthesia. You take the needle out before inserting the trocar, meaning you have little to no idea of what depth or what angle you went in, thus heightening the risks of hitting tissue that has not been affected by local anaesthesia, which can be very painful for the patient. With S-Cath, suprapubic catheters are placed using the Seldinger technique: you insert the needle and anesthetise the tract, take the syringe off, insert wire down the needle to locate the bladder, then take the needle out. The trocar with its sheath is fed over the guidewire and into the bladder, and when it is

correctly positioned the guidewire and trocar can be removed, leaving the sheath in place, so at no point do you lose the tract into the bladder. This technique uses a patented three-stage guidewire in place of a traditional guidewire to place the catheter (traditional guidewires can kink and cause injury to the surrounding tissues). This provides greater control and accuracy, making catheter placement more precise than blind insertion and reducing the risk of bladder or bowel injury. The guidewire is made up of a ‘floppy’ tip, a more rigid central section and a third, solid section with two reference marks printed on it. The floppy tip helps prevent injuries to the posterior wall of the bladder, and the central section gives resistance, which allows the user to work out its location. The reference marks on the solid section help with device placement and allow the trocar (a hollow tube with a pointed end) to be safely inserted. WHAT MATERIALS DID YOU CONSIDER WHEN DEVELOPING IT? AND WHY DID YOU CHOOSE THEM? All the components are standard materials as we felt introducing new ones could make the product too expensive. We focussed on the procedural steps and designed each element of the kit to make sure we could make it as simple as possible for the clinician to use. For example, S-Cath has an integrated balloon (unlike most Foley catheters, in which the balloon is mounted on the outside of the catheter shaft). This is because traditional Foley catheters have a tendency to ‘cuff’, an effect in which the catheter balloon creases or forms ridges when deflated. This can make it more likely that the

The integrated balloon makes the dilator smaller, meaning less pressure is required to insert the catheter, granting more control

patient feels pain or discomfort as the catheter is removed. With S-Cath, the integrated balloon makes the dilator smaller, meaning less pressure is required to insert the catheter, granting more control, which in turn is safer for the patient. Also, when the catheter is changed, the balloon “cuffs” less and so removal is more comfortable. WHAT OTHER CHALLENGES DID YOU COME ACROSS IN ITS DEVELOPMENT? The main challenge was ensuring that all the components worked in harmony to make sure the users had the best possible product they could have at their disposal. The key has been creating a product that clinicians can use confidently to improve patient safety. IS IT SOMETHING THAT CAN BE FURTHER DEVELOPED, OR REFINED? We believe that there is always the ability to refine products. There are a few things we are working on. WHAT’S THE RESPONSE TO THE PRODUCT BEEN LIKE? In a word, fantastic. S-Cath is a truly breakthrough solution that reduces the risk of harm to patients, and we have been so proud to see it become the standard of care in the UK, while also enjoying rapid adoption in the U.S. market. The device is recommended by NICE and approved by the British Association of Urological Surgeons (BAUS). We were particularly proud to win the Queen’s Award for Innovation in 2017. Many clinicians say it offers them greater confidence in inserting the trocar into the bladder, and it also offers hospitals huge savings in terms of money, time and resources.


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Meet the start-up


Med-Tech Innovation News spoke Ross O’Hanlon, co-founder of BioLiberty, which has developed a robotic glove to help people with motor control deficiencies live independently.

FIRST OF ALL, TELL US ABOUT HOW BIOLIBERTY STARTED? BioLiberty started off with an observation. My auntie suffers from MS and at the early stage of her diagnosis she began to lose motor control of her legs. Several innovative technologies existed to combat this issue, such as crutches, wall rails and mobility scooters. However, when the MS attacked her hands, there was no technology available which addressed the issue of reduced hand strength. This is when I came up with the idea of a robotic glove which strengthens grip. I formed a team of engineers with experience in the medical device industry to tackle this problem. We have been working on the product for around a year now. HOW DOES THE GLOVE AID THE USER? The glove bridges the gap between orthosis and rehabilitation. The idea is that the glove can strengthen the hand for both flexion and extension, whilst also developing natural hand strength. In assistive mode, the glove monitors the position of the user’s hand, and when the user attempts to grip an object, the glove responds by amplifying their grip. We have also built a digital therapy platform around the glove. When in rehabilitation mode, the glove and digital therapy platform guide the user through tailored exercises which help restore

Hands are just the starting point. Our goal as a company is to design products which make independent living possible for everyone

natural hand strength. We wanted to create a product which not only assists grip in the short term, but also puts the user on a path to improved natural hand strength in the long term. PATIENTS WHO HAVE MS, MND AND CARPAL TUNNEL SYNDROME CAN USE THIS, CAN OTHERS? The exciting part of our technology is its versatility. Initially, target conditions will include post-stroke, post-surgery and arthritis, with an aim to create a portfolio of products which are specifically designed to tackle conditions such as MS, MND and carpal tunnel syndrome. Once we have our portfolio of gloves on the market, we aim to apply this technology to other parts of the body. This could include ankles, elbows and knees. Hands are just the starting point. Our goal as a company is to design products which make independent living possible for everyone. CAN YOU TELL US WHAT HAS GONE INTO MAKING THE GLOVE? The glove can be analysed as a system with an input, process, and output. The input of our system is electromyography. Electromyography is a technique which uses electrodes to measure muscle activity when the user intends to grip. The system then uses our sophisticated algorithm to send a signal to our actuators which creates an assistive force to strengthen the user’s grip. This force works for both flexion and extension of the hands. The algorithm uses Machine Learning to characterise that individual’s muscle activity, and in turn increase the reliability of the glove. HOW SIGNIFICANT IS THE SUPPORT FROM THE EBS INCUBATOR? The support from Edinburgh Business School (EBS) Incubator has been key to our success so far. The BioLiberty team is made up of engineers so having access to the EBS Incubator has

provided us with important training to develop the commercial aspect of our business. The EBS Incubator has also provided us with access to their network of leading experts in the medical and robotics industries. The incubator is based at Heriot-Watt University, which is home to the National Robotarium, meaning we have had an incredible opportunity to connect with pioneering roboticists working in social care. The incubator is also providing us with desk space which we hope to operate the business from as soon as COVID-19 restrictions are lifted. In the meantime, we will continue to work and be supported remotely. DO YOU HAVE ANY FUTURE PLANS YOU CAN TELL US ABOUT? We aim to create a world which is no longer restricted by limited mobility, allowing all people to live a longer, healthier life independently. Our immediate goal is to get our product into the hands of the people who need it the most. Our technology is extremely versatile, and we plan to develop products for a range of body parts and conditions. We want to help transform social care using innovative technology and empower therapists by giving them tools to monitor and treat their patients more effectively.


A DESIGN FOR LIFE? Ian Bolland spoke to Lee McCormack, CEO of MyGlobalHome, to discuss the vision of a digital health ecosystem within the home.


he vision of the company originally came from McCormack’s Orrb wellness device, a pod to deliver health and wellness to individuals within open plan environments, but this iteration has been scaled up for the home – and in the last couple of years has seen the idea gain traction. This includes the award of two Innovate UK grants, and a research partnership with the University of Surrey which has allowed the company to build its innovation centre. Summarising the idea, McCormack said: “It was really about how you can empower the occupant. The mission is to have a home that can look after the occupant not the other way around.” This isn’t about just caring for those later in their life, this applies across the spectrum. The company is investigating clinical studies that connect air quality with cognitive performance. “Air quality in the home is typically up to four or five times more polluted than outside. There’s not enough fresh air in the house and that has a massive impact on our ability to live well and learn,” McCormack explains, “and with older adults there’s a direct relationship showing between air quality and longevity of life.” MyGlobalHome’s technology looks at understanding the environment within the home and helping to manage ventilation – considering factors such as air quality, pollutants, humidity and allergens. The fragmented nature of the medical sector allows for the company to enter


the market. It also highlights that anyone who’s managing conditions in the home through a device or monitor can have it integrated into its system. C

McCormack said: “What we’re able to say is while you’re doing that, why not have that connected to the environment within the home where you are actually living? You can start to have a broader and deeper understanding of what’s happening in and around you, which may then be reflected within the diagnostic equipment. “What we’re trying to do is have the home as non-intrusive and non-reliant on the occupant being engaged as much as possible. Once a person gets onboarded into their own profile, it understands the type of needs they may have and if they already have specific healthcare needs those parameters are built into their healthcare profile from the very beginning. “You can have 10 different pieces of equipment with 10 different parameters of how they want to engage with the patient. Out of those parameters, what we’re saying is that all of that information can be harnessed in a central repository and that can then be coupled with the information about the environment and how the person is maybe moving around the home, how much water they might be consuming, whether they’ve been static for two days in bed, whether the air quality is polluted. It can then take on board all of those different bits of data, plus the environmental data and actually have some level of understanding of what to do with that.” This goes a long way to explaining the objective to designing a digital health ecosystem within the home. Recently,








MyGlobalHome struck up a partnership with Oxford University spin-out Oxford Immune Algorithmics, which also works with the NHS, specialising in blood tests. McCormack also said that a new partnership was in the offing with a respiratory care technology manufacturer – another part of the jigsaw of this particular ecosystem. “When you have respiratory technology on one hand, and blood diagnostics on the other they can actually both tap into that environmental understanding and correlate with each other in a way where it’s no longer fragmented, there’s some joined-up learning everybody can benefit from – especially the occupant.” The thinking appears to be based upon it’s where a person spends the most time, and so much of your activity supports your living needs, and this tool can be an additional aid. Summing up the vision, McCormack said: “What we see is that our platform will be developing in such a way that will facilitate that mutual benefit for everyone involved, and ultimately for the benefit of the occupant.”



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