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As it’s the last issue of 2022, it feels only right to do a piece reflecting on the year that has gone by, with a look ahead to the immediate future.
The start of the year had us feeling the aftereffects of a new COVID-19 variant with Omicron, the end of the year sees us potentially battling a newer variant and the NHS in the UK having to battle both a COVID and flu season –putting pressure on its already incredibly stretched resources.
It feels like that 2022 has been the time when some semblance of normality has returned. I am writing this editor’s letter on the eve of a trip to Germany, one of several international trips that would have been nigh on impossible just over 12 months before – and at this point I should say hello to those reading this at COMPAMED/ MEDICA – an event that was one of the first we could attend last year but I’m sure there’s a different feel to this year.
Getting in front of people and being able to talk about new innovations and how to tackle the challenges of today and tomorrow has been welcome.
But these challenges are big and potentially grave in many instances. As mentioned, there is the ongoing issue with health services being overstretched, other factors that are addressed in this issue include the pressure put on supply chains – whether that’s because of raw material scarcity or the geopolitical situation (or in some cases both), while many saw the pandemic as the opportune moment to pivot to more sustainable ideas, products and ways of running, if they weren’t already doing so before.
These factors are unlikely to go away in 2023. There will still be the issue of technological adoption within health services, barriers to entry, new regulations and how medical technology can
ultimately help those on the front-line tackle the challenges that have been exacerbated by the last few years. In the UK, at least, one would hope that some political turmoil can subside and effective governance can break out to offer the necessary measures that are required to help the life sciences sector thrive and help the NHS become the world class health service that politicians have repeatedly stated is the ‘envy of the world’.
This year might have been the year when things started to return to normal, but with spiralling energy costs and the multitude of challenges that have already been listed, 2023 could have a hangover of challenges brought about following actions taken in 2022. Another choppy period awaits, but we’ve all seen how resolute medical technology and its associated manufacturing industries can be – I’ve no doubt it can make the next 12 months a success.
The Government’s Department of International Trade has pledged to support Mid Sussex’s planned new Science and Tech Park, deemed as essential to the country’s future economic growth.
Dr Mike Short, chief scientific advisor, Department of International Trade, speaking at a Westminster launch event for Opportunity Mid Sussex, said that DIT “stands ready to help find investment and to build on adjacent company clusters.”
“Westminster knows science parks are the right way for future growth, and we also know some of science tech strengths in UK are really strong,” he told delegates.
Delegates at the VIP launch event in September, were shown details of the 49-hectare ‘Project Newton’ site which will have the potential to deliver up to 4,500 jobs, 1.3million sq. ft of commercial floorspace and 80,000 sq. ft of ancillary support
PolarSeal Tapes and Conversions is expanding into the United States of America with additional facilities.
This move allows PolarSeal to continue with its five-year expansion plan, including new market penetration, acquiring facilities to provide a higher-level service for its international customer base.
This new territory move opens up PolarSeal’s medically focused converting services to a wider audience within the medical device market. With decades of experience, expansive inhouse converting capabilities, and dedicated team members, PolarSeal look to meet a demanding market with quality, precision, and close collaboration.
As existing major players in the converting sector within the UK and EMEA areas, PolarSeal looks to the US medical arena as one of the first steps in its growth plans.
and amenity facilities, with between 40,000-50,000 people within cycling distance and 1,500 within walking distance.
Dr Short said Project Newton was ideally placed to succeed, thanks to its strong university links, a talent pipeline and investment, which will attract new tenants, combined
with its location – close to Brighton on the doorstep of London as well as the global gateway of Gatwick. He added that the park would enable the surrounding region to maximise the opportunities presented by its existing clusters, including those of life sciences and medtech.
“You have great opportunities to bring together the talent, investment and facilities to be a second to none science park.”
The Opportunity Mid Sussex launch event in Westminster attracted over 50 VIPs from the private and public sector, including Mid Sussex MP Mims Davies and Arundel and South Downs MP Andrew Griffith.
Cllr Ash-Edwards, leader, Mid-Sussex Council explained to delegates that the Science Park site was a key part of the authority’s wider development plans in the region.
He said: “Mid Sussex is seeing one of the most exciting developments in the UK today. With more than £2 billion of sites under delivery we are ready to welcome a new generation of business leaders to Mid Sussex as we grow our economy, create new opportunities for business and enterprise and boost infrastructure to ensure prosperity for all.”
Vectura has been granted planning permission for a new 10,000-square metre facility on Bristol & Bath Science Park in south-west England for its ‘Inhalation Centre of Excellence’.
The £58 million building, which is anticipated to complete in 2025, will allow the company to expand its operations, providing new career opportunities for research and development scientists and engineers in pharmaceutical and device development, as well as manufacturing and laboratory services. The facility also has a goal to achieve an ‘Excellent’ rating with sustainability assessors BREEAM.
Michael Austwick, chief executive officer of Vectura, said: “We are delighted that our plans to build a worldleading science facility have been approved by South Gloucestershire Council.
The new build will enable our already successful pharmaceutical company to continue and expand upon its vital work, providing innovative inhalation and other advanced drug delivery solutions that have the potential to improve the lives of patients around the world.
“For nearly 25 years, Vectura has been providing
a combination of formulation science, device technology and pharmaceutical development expertise, helping our partners and licensees develop products which are used by 10 million patients worldwide. This new facility will help us to build on this successful track record, increasing workspace capacity and attracting talent to the area.”
The presentations were packed and there was clearly a lot of interest. A good and healthy mix of innovators, experts and funders all in one place.
The UK and Ireland’s leading event for medical device manufacturing brings together leaders, engineers, innovators and manufacturers, connecting them with technology and innovation to facilitate the design and manufacture of life changing medical devices.
Visitors from the medical engineering and manufacturing community will be able to see the entire spectrum of advanced technology, materials and solutions on show including packaging, extrusion and moulding, 3D printing, automation, materials, electronics, medical plastics, design, sterilisation, components, testing and inspection, sensors, cleanroom tech, surface technology, manufacturing equipment & contract manufacturing services.
The event is further enhanced by a world class conference programme which is set to cover
every type of stakeholder in the medtech supply chain – from solving design and engineering challenges through to market access. The conference will also address key industry issues and bring together innovators, experts, thought leaders and government officials to deliver an exceptional programme. Speakers will have the opportunity to be part of the CPD-accredited conference at Med-Tech Innovation Expo, the perfect platform to share expertise and market knowledge, increase visibility of projects and research and start new conversations with stakeholders.
Ian Bolland, acting group editor of Med-Tech Innovation News and Medical Plastics News, said: "The industry is facing many challenges, but there are many great stories to tell that can provide inspiration to our audience at Med-Tech Innovation Expo. Whether that be the new ways of manufacturing, ongoing regulatory changes, or the sustainability agenda, speakers at Med-Tech Innovation Expo share new ideas to help the medical technology industry go from strength to strength."
I was really delighted to be asked to come to the Med-Tech Innovation Expo conference. There were some very thoughtful questions from the audience.
Helena Zaum, Microsoft, 2022 speaker.
The conference grows in popularity every year, and attracts the brightest and best minds from across the medtech supply chain, from innovators and experts, to thought-leaders and government officials. Talks in previous years have included representatives from Microsoft, Deloitte and The Department for International Trade.
Just some of the topics being considered for the 2023 programme include the below. Please note that this is not an exhaustive list. We also kindly ask you to note that product pitches or sales orientated presentations will not be accepted.
● Supply chain strategy
● Growing adoption of minimally invasive devices
● New manufacturing practices
● Medical device outsourcing
● Overcoming manufacturing challenges
● Recruitment and retention of new skills and talent
● NHS market access
● Sustainability strategy
● Securing financial backing
● Manufacturing for miniature (smaller) medical devices
Global innovation will only achieve its fullest potential by embracing individuals from all backgrounds. We are calling on the entire medical technology industry to help ensure we have full representation and a diversity of voices for the programme in 2023.
Helena Zaum, social care lead at Microsoft, speaker in 2022, said: "I was really delighted to be asked to come to the Med-Tech Innovation Expo conference. There were some very thoughtful questions from the audience. This year is my first visit to the show and it’s just amazing!"
To submit your proposal to speak at Med-Tech Innovation Expo 2023, please email an abstract (maximum 200 words) and presentation title to Ian.Bolland@rapidnews. com and Charlotte.Chambers@ rapidnews.com.
Med-Tech Innovation Expo 2023 takes place on 7-8 June 2023 at the NEC, Birmingham. For more information, visit www.med-techexpo.com.
NEUCIN
Technologies, a UK company specialising in molecular diagnostics, is launching a new advanced subtyping kit for breast cancer, a huge step forward for precision medicine and personalised healthcare.
This new assay addresses several unmet
needs in current practice, including providing highly reproducible results, particularly for low HER2 expression.
This development comes in light of recent studies that have shown low HER2 patients are responsive to new HER2 targeting therapy, such as the antibody-drug
conjugates that target the cancer cells, e.g. trastuzumab deruxtecan (Enhertu).
The advanced technology of the Apis Breast Cancer Subtyping Kit provides higher accuracy of the Ki67 proliferation measurement, and significantly reduced time to result. It will be accompanied by validated software that enables automatic result interpretation.
stratification of HER2 expressing patients compared to classical methods like IHC. We are now able to provide a kit that delivers fast, accurate and reproducible results for the standard breast cancer biomarkers, including a faster HER2 result turnaround without the need for reflex testing when the IHC result is unclear.”
an RNA-based diagnostic workflow for detecting mRNA expression of standard biomarkers (ER, PR, HER2, Ki67) and novel proliferative biomarkers from preoperative core-needle biopsy (CNB) or resected formalin-fixed paraffinembedded (FFPE) breast tumour tissue and is available now.
Photo credit: APIS TechnologiesDr Ian Kavanagh, COO and co-founder of Apis Assay Technologies, said: “We are very excited to launch our new breast cancer subtyping kit, particularly since we are seeing links between the RNA expression and the
Apis Assay Technologies uses systems biology and big data to develop diagnostics tests that help direct clinicians to the right treatment faster and with higher precision, improving patient outcomes.
The new Breast Cancer Subtyping Kit is
Dr Kavanagh added: “Our strategy at Apis Assay is centred around developing technology for the reproducible detection of important cancer cell surface markers based on RNA expression, and in developing a suite of assays for supporting the stratification of novel Antibody-drug conjugates (ADCs)”.
Analysis by the life sciences industry association Medilink Midlands reveals it has helped the region’s life sciences companies to secure investment of £77 million.
Medilink Midlands’ CEO Simon Himsworth, says: “Our mission is to be at the forefront of delivering direct support to the region’s life sciences industry.
Working with companies in the sector to help them secure almost £80 million in funding since 2019, is clear evidence we are fulfilling this.”
Medilink Midlands’ analysis also reveals that it has been instrumental in the creation of over 190 new high-level jobs in the Midlands, 47 university
collaborations, 34 traineeships for life sciences businesses, and has engaged with 1,700 SMEs in the Midlands’ life sciences sector.
One of these is Dignio, which uses its integrated care platform with Bluetooth connected devices, and alerts healthcare professionals if they need to act. Already established in Norway, the company wanted to expand into the UK.
By working with Medilink Midlands and the West Midlands Academic Health Science Network, Dignio set up a UK base in Birmingham earlier this year. Its care platform is now used in multiple care settings across the UK.
Another is Spirit Healthcare, which develops products and services aimed to empower people to take control of their own health. It has combined its health and social care expertise with technological brilliance to develop the innovative digital health platform CliniTouch Vie, which is powering virtual wards and remote patient monitoring.
Warwickshire medtech business POWERbreathe International, manufactures a range of respiratory muscle training devices that strengthen breathing muscles that are often described as ‘a set of dumbbells for your lungs’. Support from
Medilink Midlands has included an introduction to Advena when POWERbreathe needed help with a regulatory advice issue for its operations manual and Polish distributor.
The past few years has seen many manufacturers experience disruption in their supply chains – it may have been sparked by COVID-19 and multiple lockdowns, but any subsequent backlogs illustrated by cargo ships waiting at ports and the geopolitical situation – such as war in Ukraine – means these have continued and may continue for some time.
MicroLumen may have had things better than most at the start of the pandemic, as the Florida-based tubing specialist manages to source its raw materials locally.
There are four noteable products in MicroLumen's offering:
● Polyimide: A thermoset plastic for thermal stability, chemical resistance, and tensile strength
● Reinforced: Braiding reinforced tubing for applications that require column strength
● PTFE/Composite: A process incorporating fluoropolymers with Polyimide –which the company says provides mechanical properties that are superior to conventionally extruded medical tubing
● Laser machined: Though outsourced, the laser machining process is offered to accomplish specific tasks such as precision holes for drug delivery or reduced OD to bond.
Krissi Heard-Slagle, technical sales at Microlumen, offered some insight as to who the company works with, describing their customers as the ‘heavy hitters’ of the industry.
“We sell to multiple industries within the medical industry. Some of these big companies have an orthopaedic division, a neuro division, cardiovascular. I would say the majority of our products go into cardiovascular type procedures and that could be anything like a blockage where we would go in and remove a blockage and then a stent would be inserted.”
Heard-Slagle also mentioned the work the company does with those who are looking to help prevent strokes.
Polyimide was MicroLumen’s main product line when the company started manufacturing tubing – a thermoset plastic which goes under the trade name Capton.
Explaining more about how it’s made, Heard-Slagle said: “Polyimide starts as a plastic, like a liquid, and then we cure it into a solid.
“We kind of use a core tooling and it goes through a cycle of dips, which is proprietary. We can control the idea of that tube due to our process versus extrusions.
“Our tubes are predominantly used like a guide lumen and then, the innards could be several other tubes of various
plastics doing different functions, like one could be a guide wire. One could be a channel where they're pushing saline. Another could be where they're sucking out material and catching it – so they don't have those free particulates of plaque floating around and causing a stroke.”
The company’s reinforced offering involves adding stainless steel wires onto their tubes creating a braid to make the tubing more robust for certain procedures.
Its PTFE and composite products aim to reduce friction and laser machining has been outsourced to specialists the company has strong relationships with for the last two decades.
Supply chain concerns for business started to amass during the outbreak of COVID-19. At this point, Microlumen felt well-placed deal with any issues coming their way.
“As things started opening up, everyone became concerned about supply chain and we weren't super concerned just because most of our materials that we purchased, and raw materials, are in the United States.”
As a supplier of materials for essential workers, MicroLumen remained open and manufacturing during the pandemic, and HeardSlagle acknowledges that a spike in demand might have been down to some panic purchases.
New supply chain challenges have followed as certain nations began to return to normality as more people received COVID-19 vaccines. One area in particular where MicroLumen is seeing challenges is for its reinforced offering.
“For example, the stainless steel braid wire from the braid and coil reinforced, there's shortages and precious metals globally. So, let's say it took eight weeks to get the material in, we're seeing some lead times as long as like 20 plus weeks.”
So, how is Microlumen looking to combat these challenges?
“We’re just trying to make sure we're ahead of the game. If we know we have certain demands from our customers that we stay on top of our raw material inventories, we try to buy a little bit of a stockpile in the event there is going to be a longer lead time.”
This isn’t limited to stainless steel. Some chemical companies are having to outsource their chemicals to other countries while others are finding necessary gasi n short supply – in part down to the ongoing conflict in Ukraine.
“Everyone's just doing their best and I think the best thing to do is we're just being very honest and upfront with our customers by asking for realistic forecasts so we can also prioritise who needs what allocating.
“Let's say we only have so much of a raw material, we have to allocate well. These are legacy parts. These are production parts that these are going straight into manufacturing and being delivered to the hospitals versus this is an R&D job where we don't know if it's going to go anywhere. You have to navigate each project case by case.”
Challenging times can also bring about opportunities. MicroLumen have been working for some time, even prior to the pandemic, on how to bring down lead times with certain material.
Summing up, Heard-Slagle said:
“One of our materials that we manufacture we have to process it in a manner that uses chemicals, and we don't do it in-house.
It's just not something that it's dirty, it's bad for the environment.
It's not
something that we couldn't control the lead times or the quality.
“Throughout the years, we've started dabbling and making that process in house so we can control the lead times we can control the quality, we can be cleaner about it. That's just one thing that we did, but that wasn't even because of COVID. That was just out of necessity and growth.
“We're also looking at if we had two suppliers for a particular item and let's say the lead time is 30-something weeks, we're looking at if a different plastic or a different component can solve the same problem but reducing lead times. These are conversations we have to have with our customers and with the engineers and regulatory - just to make sure that we try to stay smart, stay sharp, stay ahead. We don't really know what the future holds.”
I think the best thing to do is we're just being very honest and upfront with our customers
At Design Partners, designing medical-grade equipment for both the healthcare services industry and the consumer healthcare industry is a core pillar of our work. Because of the high-degree of risk involved with designing medical devices, and rigorous regulatory expectations, we have developed a proprietary Human Factors Engineering (HFE), to ensure the solution we are creating will deliver genuine impact to the users’ life.
In recent years I’ve noticed how much medical services design must learn from the consumer sector. Smartwatches, for example, have done healthcare providers a huge service by empowering people to monitor their own wellbeing and by normalising wearable tech –making caring for your health a fashionable trend.
With life expectancy increasing, the amount of people living with chronic or debilitating conditions is assumed to grow as well, putting intense ongoing pressure on healthcare systems. If we can get more people successfully preventing or managing long-term health conditions in tandem with their healthcare provider, this will provide relief to medical institutions around the world.
Health self-management, or patient empowerment, is not an entirely new concept. People with severe allergic reactions, for example, have been successfully using EpiPens for years. The same can be said for the use of inhalers with asthma sufferers. But few of these devices respond to that human desire for discretion and comfort or take the practical user experience into much consideration at all. They’re only focused on doing what’s required to get the data they need, or deliver the medicine required. If future
“at-home” medical devices cannot meet people’s new expectations, set by the consumer market, they will simply fail – causing more complications for healthcare providers relying on them.
Design can elevate human potential and create incredible ways to selfmanage care. By combining our expertise in healthcare, consumer and wearable technology design, we created a heart monitoring device concept that puts user experience at the fore.
Abnormal heartbeats are common, but they can also be the symptom of a more serious condition, such as a stroke. As such, effective heart monitoring is a common and important practice. Most healthcare professionals generally advise those suspected to wear a holter monitor vest for 48-72 hours.
Patients can take the device home, but it is incredibly cumbersome and uncomfortable, which is not only unpleasant for the user but, importantly, it could impact the accuracy of the data.
We wanted to create an ECG monitoring solution that would be as simple as putting on a t-shirt. You simply live your life while it captures accurate and reliable data, without compromising comfort.
The result is Viscero - an ECG vest that uses electronic ink to pick up the signal of your heart rhythm and provides medical-grade data to your healthcare provider.
Making Viscero required a rigorous innovation process of trial and error to create several breakthroughs. A big challenge was ensuring we could get an accurate data capture through the t-shirt. The traditional holter monitor uses “wet electrodes” that “contact” the skin through hydrogel. These can slip off over the monitoring period,
and healthcare professionals often need to reapply them.
With Viscero, we recorded heart rate signals from skin contact to the vest with “dry electrodes” which don’t need any hydrogel. These are situated beneath the fabric at points around the arm and waist which have been tailored as compression points. The points are integrated using lamination and double layer compression and are positioned away from the chest to more peripheral locations so consistent compression points are maintained.
After capturing the data, we had to work out the best way to collect it, filter it, and send it to clinicians. So, within the ECG circuit system we created a small pod device“the brain” - which includes a tiny accelerometer and gyroscope so that clinicians can get a fuller picture of recorded heart signals, while highlighting when there are changes caused by exercise, for instance. The brain can also be removed for charging and, importantly, washing the T-shirt.
The data gathered from the brain would be ideally sent directly to the healthcare professional’s dashboard on their computer. AI would then help filter the data to identify irregular patterns for clinicians, saving hours of scrolling through ECG recordings. An app, created for the patient, would serve as a go between for the patient and healthcare consultant so that they can be easily updated on results.
Leading cardiologists have described the signal quality of Viscero's ECG waveforms as “diagnostic quality data.” Having the trust and reassurance from medical professionals is encouraging; it suggests that there is an openness to new technologies and ways of expanding within their sector.
Michelle Michelucci, head of international events at ABHI previews MEDICA 2022, including the first 'ABHI UK Pavilion Presentation Theatre’ for exhibitors at this year’s show.
Weare delighted that for the first time ever there will be an 'UK Pavilion Presentation Theatre’ at MEDICA, to give UK companies a platform to demonstrate their technologies to international audiences.
visitors from all over the world. It is pegged as a must for anyone wanting to experience tomorrow’s healthcare market live.
Today more than 5,600 exhibitors from more than 50 countries present in its 17 halls, each home to its own area of focus - lab technology and diagnostics, electrotherapy and medical technology, disposables and consumables, information, and communication technology (digital health) and physiotherapy and orthopaedic technology. Among the presented high-tech products, visitors also have the opportunity to attend top-class forums and conferences.
joining to showcase their industryleading health technologies to an international audience and network, and to engage with key businesses and decision-makers in the market.
From exciting product launches to world-first demonstrations, the exhibitors will be showcasing innovations in key areas such as critical care, non-contact diagnostics and surgical care, as well as demonstrating the latest gamechanging solutions to help hospitals become more efficient, achieve greater sustainability and become better equipped for providing top quality patient care.
Organised by the Association of British HealthTech Industries (ABHI) and the Department for International Trade (DIT) and co-sponsored by Welsh Government and the law firm Sidley Austin, the dedicated space aims to give exhibiting UK companies greater opportunities for partnership at the world’s largest event for the medical sector.
Whether you are a start-up or an experienced exporter, MEDICA is an extensive exhibition which represents the entire spectrum of innovations from devices, diagnostics and digital. That is why we wanted to give UK companies the chance to demonstrate their innovative technologies and solutions to the world-class international audience at the exhibition.
Presenting UK companies will have a unique platform to showcase their latest innovations to all markets.
Representing the Department for International Trade, Dr Neil Ebenezer, medtech and genomics specialist, will be presenting on a number of topics including potential future UK medtech regulatory framework, the UK medtech landscape and changes in IP since the end of the Brexit transition period.
MEDICA – which has expanded its horizons over the past 40 years –takes place annually in Düsseldorf, Germany, and is open to trade
Each year leading individuals from the fields of health, business, research, and policy grace this topclass event with their presence, to meet with national and international experts and decision-makers from the sector. Creating unrivalled opportunities for companies to connect with new global partners.
Once again, the ABHI will be supporting a range of UK companies with the opportunity to strengthen trade ties and together showcase the strengths of the UK’s world-class healthtech industry to European and international markets.
The joint ABHI & DIT Stand will bring together a diverse mix of UK companies, and national partners, who all supply a range of highquality and innovative healthtech and healthcare services.
Along with the promise of an enhanced programme of activity, this year's ABHI UK Pavilion will also double the size of last year’s –with some of the UK’s top innovators
Our partner, the Department for International Trade (DIT) will also be taking ten pioneering UK life sciences innovators with them to the exhibition in a bid to showcase UK expertise to key international buyers. All the UK companies joining the UK pavilion will benefit from a comprehensive suite of support before, during and after the event, helping them raise their profile, make valuable contacts, and drive forward their international ambitions. Companies can also benefit from one-to-one meetings with DIT officers, networking advice, pre-event market briefings, and attendance at key networking events.
The joint DIT & ABHI UK Pavilion stand this year will also provide an opportunity for innovators to join UK Government in showcasing the strengths of UK healthtech and innovation on the international stage.
MEDICA takes place from 14 – 17 November 2022 in Düsseldorf, Germany. Throughout the exhibition the ABHI & DIT UK Pavilion will be located in Hall 16, stand J48.
Boston Scientific gives Med-Tech Innovation News some insight into the areas they have identified to make the company more sustainable.
We were the first large medical device manufacturer to commit to carbon neutrality by 2030 (back in 2017) in our key manufacturing and distribution sites (scope 1 and 2 emissions). We have committed to net-zero carbon emissions across our entire value chain by 2050, by joining the United Nations Race to Zero, and Science Based Targets initiative (SBTi) Business ambition for 1.5 degrees C campaign.
68% reduction in greenhouse gas emissions since 2009 (Scope 1 and 2)
46% of Boston Scientific is independently certified for energy efficiency by industryleading bodies such as LEED for design and ISO 50001:2018 for building operations, representing 4+ million square feet
91% of solid waste diverted from landfills
74% of solid waste recycled
73% of electricity consumed generated from renewable sources, surpassing our interim goal of 50% by 2021
38% of energy from renewable sources, on track for our goal of 90% by 2027
WAS THERE A REVIEW OF HOW DEVICES WERE MANUFACTURED, AND MATERIALS SOURCED TO LEAD YOU TO TRY AND REDUCE ANY "CARBON FOOTPRINT" OR "WASTE"?
These are scope 3 emissions, and we are working with our suppliers to reduce the emissions outside of our direct control, such as these, as part of our previously mentioned commitment to netzero carbon emissions across our entire value chain by 2050, having joined the United Nations Race to Zero, and Science Based Targets initiative (SBTi) Business ambition for 1.5 degrees C campaign, who externally validate your submissions for Scope 3 reductions.
SOME COMPANIES ARE AT THE BEGINNING OF THIS JOURNEY, HOW DIFFICULT IS IT TO IMPLEMENT A PLAN TO ALTER PRACTICES TO MAKE THINGS MORE "SUSTAINABLE"?
Moving from a linear to a circular economy, where you re-use, recycle, remake, etc, versus previous linear economy of take, make, use, dispose, in the world of medical devices is not an easy, nor speedy, move to make.
We must pay attention to many simple things, such as correct waste disposal, extending the life of products, ordering, and opening only what we need, and getting to place where ‘just in time’ ordering moves to something more organised, before we immediately jump to ‘single use is bad, move to re-useable.’
We as manufacturers have a responsibility to ensure our products are both safe and effective, and they are manufactured of particular components, in specific formulations, to ensure such things as sterility, and reliability. What we can do, is look to how best to recycle specific components with lots of embedded carbon, such as precious metals, and look in the longer term to ensure our polymers are not mixed, for example (unless the properties of the product cannot be ensured any other way) and therefore are ‘possible’ to recycle.
We should look to other sectors who are ahead on this journey to advise, and not make assumptions!
This can be called the world’s biggest onion, as you peel back a layer and find unintended consequences everywhere. Hence, looking to simple things first like minimising waste, segregating waste correctly, slowing down deliveries, making less deliveries, etc.
"THE PRINCIPLES OF CIRCULARITY ARE YOU MAKE SOMETHING; YOU USE IT AND THE WAY THE HEALTH SYSTEM OPERATES IS THE OPPOSITE OF CIRCULARITY" - HOW DO YOU SQUARE THAT PARTICULAR CIRCLE WHEN IT COMES TO DEVELOPING AND DESIGNING NEW MEDTECH PRODUCTS THAT CATER FOR HEALTHCARE'S NEEDS WHILST BEING SUSTAINABLE?
We will need to get this right, patient safety is paramount. But we can do better when it comes to breaking down components and recycling them and reducing wasteful practices and habits in our health systems, looking through the lens of sustainability!
BUSINESSES MAY NOT HAVE DEVELOPED THEIR PRODUCTS AND IDEAS WITH SUSTAINABILITY AND REUSABILITY IN MIND - DOES THIS MEAN MANUFACTURERS LIKE YOURSELVES HAD TO LOOK BEYOND JUST BETTER MANUFACTURING PRACTICES... E.G CHANGE OF BUSINESS MODEL?
We have developed them with patient safety and reliability in mind. We now need to overlay that with a sustainability lens and see where we can achieve all three things. Patient safety first. We have to go through great regulatory and clinical evidentiary hoops to bring a product to market, you can’t just ‘change it’ overnight!
RECYCLING IS USUALLY THE ONE-WORD ANSWER WHEN IT COMES TO SUSTAINABILITY - WHAT EXAMPLES CAN YOU PROVIDE WHICH CAN ANSWER THIS QUESTION?
As well as what has been outlined, we can start to look as and industry to establish recycling best practice in healthcare as a start, looking to minimise precious metal and other components of great value and embedded carbon first. The whole system will have to work together to achieve this, and look to other sectors to advise, and regulations to adapt to allow it.
The NHS is the world’s first Health System to commit to Net Zero goals.
Those of us working here in the UK have a pathfinding place to move the needle, in a meaningful and safe way, in the world of medical devices. We will be working together with other companies and industry bodies such as the ABHI to find practical and meaningful solutions to safe and environmentally sustainable patient care over the coming years. We will all need to work together. None of us has all the answers, but we must show willing, and be prepared to try.
We can make immediate improvements! We can make a difference, and we foresee a level of cross-industry and cross-sector collaboration as never before to achieve this. The health system in the UK is responsible for 5.4% of the GHG emissions of the country, so it is vital that we do this!
We don’t pretend to have all the answers; remember, it’s the world’s biggest onion! However, we and other collaborators are full of good intent, and those working in this field, care, and want to make a difference, from all of the companies that we work with and discuss future possibilities with, in the world of healthtech.
We must pay attention to many simple things, such as correct waste disposal, extending the life of products, ordering, and opening only what we need, and getting to place where ‘just in time’ ordering moves to something more organised, before we immediately jump to ‘single use is bad, move to re-useable.’
Ian Bolland caught up with Clementine Auffray, group innovation and compliance director at STERIMED Infection Control about its new product POLYBOND CGP 85 – a new substrate for rigid packaging.
The aim of the new product, launched and showcased at Pack EXPO and COMPAMED, is to provide medical device manufacturers with environmentally friendly, sustainable products and packaging with less plastic content and a lower impact on the environment. Or to put it more simply, reducing plastic waste and becoming more environmentally friendly.
The material is water-based, has solvent-free coating technology, in addition to a share of a renewable raw materials, with the aim of making it a greener solution.
Its fibre mesh structure mixes cellulose together with a high content level of synthetic binders. Synthetic binders are used for optimal mechanical characteristic and cellulose contributes to breathability and efficient sterilisation process.
Auffray said: “For a medical device we significantly reduce the quantity of plastic which is used in the packaging and it's also important to note that STERIMED is working on the biodegradability and bio compostability.”
The approximate 70% reduction in plastic, and with approximately 80% of renewable material used in the project, not only makes it renewable, but the company also states there will be no extra cost for the product.
Explaining what else makes it different from other packaging solutions for medical devices, Auffray cited the company’s expertise when it comes to regulations and ISO standards, particularly surrounding standards which specifies for the packaging of terminally sterilised medical devices – including requirements for forming, sealing and assembly processes, and requirements for materials, sterile barrier systems and packaging systems.
“It's a unique project. It's really linked to our knowledge of regulatory affairs and the regulation on the Medical Device Regulation on ISO 11607.”
Auffray also highlighted a project that the company has been working on – when using a Class III implantable medical device – 100% plastic material would be used in the packaging, and
Sterimed feels it has been able to demonstrate that POLYBOND CGP 85 sufficiently maintains the safety of those devices.
“The goal of Sterimed to help the medical device manufacturer to be sure that we reach the target of the performances needed for the medical device.”
In terms of the devices that this can be used for, Auffray says it depends on both the weight and the shape.
The earlier that STERIMED is contacted in the development process, the earlier the company feels it can help use its POLYBOND packaging offering to suit the device in question.
“We classify the possibility to use POLYBOND depending on the medical device class and on the medical device weight. For example, we have some medical devices which are as a low weight, medium weight and high weight.
“It's very important for the customer to understand the performance that is required by the medical device. So, we look at the weight, we look at the shape, we look at the packaging, in fact how its packaged, what could be the transportation and the manipulation during the life cycle of the product. So, we need to help the customer to choose the good project, we need to understand the full life cycle.
It's a unique project. It's really linked to our knowledge of regulatory a airs and the regulation on the Medical Device Regulation on ISO 11607.
AI.
Innovation in technology is set to shape healthcare in the future and as we look to bounce back from COVID-19, we need to explore how we can harness the power of artificial intelligence (AI) to transform and personalise women’s healthcare.
The Government aims to put the UK at the forefront of the AI and data revolution in early diagnosis, innovation, prevention and treatment. We need to take advantage of this focus on AI to understand how it can facilitate identifying women at high risk of health conditions such as cancer, to ensure speedy diagnosis and access to treatment.1
Issues in women’s healthcare are not new, however the COVID-19 pandemic has accelerated the need for urgency in improving health outcomes for women, tackling health inequalities, and creating an improved patient pathway through personalised screening.
ONE SIZE DOES NOT FIT ALL AI has the potential to improve access to targeted and personalised diagnosis. While AI has been adopted in some cancer screening programmes, what we now need to see is a move towards a prioritised, risk
assessed screening system rather than a one size fits all approach.
Personalised screening will require the use of AI for risk stratification to identify high risk patients. We need to explore how to use AI to create a molecular profile to determine relative risk. For example, we know that women with dense breasts are at higher risk of developing breast cancer and that 40% of European women aged 40-74 years old have dense breasts.2 We need to ensure these women are identified early so that they can be prioritised for screening.
The PROCAS 1 and 2 study in Manchester has looked into the impact of creating a breast cancer risk score for women. The studies have found that there is patient demand to understand risk with 94% of those recruited wanting to know their risk score. The studies also found positive benefit of risk stratification as women were then inclined to act on the risk information.3
It is encouraging to see investment in AI for personalised diagnosis, as shown recently in a research study at the University of Strathclyde,
who are developing a new AI technology to calculate women’s risk of preeclampsia. The tool will look at large data sets of women who have participated in previous research projects taking into account a range of factors including ethnicity, socio-economic status and details of the woman’s current pregnancy.4
For AI to truly transform healthcare, datasets need to be inclusive, taking into account all risk factors and not focusing on one specific demographic.
Researchers at Loughborough University recently announced a new study using AI to reduce risks faced by pregnant black women. Collaborating with the Healthcare Safety Investigation Branch, the team will review hundreds of investigations into adverse outcomes during pregnancy and birth. They will use machine learning to identify risk factors and as a result design ways to improve care for pregnant women and babies.5
Access to diverse data sets allows deeper understanding of how disease progresses
amongst different populations and is critical to ensure accurate and unbiased profiling of patients. The more data points you have, the bigger the database and the more accurate the AI.
While significant progress has been made in adopting AI to improve healthcare, as we build on innovations we must ensure collaboration between industry, clinicians, and researchers to unlock the full power of AI to radically improve women’s health and save lives.
1. GOV.UK [Internet] The Grand Challenge missions [cited 2022 April 22] Available from: https://www.gov.uk/government/ publications/industrial-strategy-thegrand-challenges/missions
2. Berg, WA & Vourtsis A, authors. Using education to overcome unequal access to supplemental screening for women with dense breast [Internet] DI Europe: 2020. Available from: dense-breastscreening-vourtsis-berg-febmch2020-1. pdf (densebreast-info.org)
3. Manchester Cancer Research Centre [Internet] PROCAS and BC-PREDICT Predicting the risk of cancer at screening. [cited 2022 July 22] Available from: https://www.mcrc.manchester. ac.uk/impact-case-studies/procas-andbc-predict/
4. University of Strathclyde Glasgow [Internet] Funding for AI technology used to calculate pre-eclampsia risk [cited April 26 2022] Available from: https://www.strath.ac.uk/whystrathclyde/ news/2021/fundingforaitechnologyusedt ocalculatepre-eclampsiarisk/
5. Loughborough University [Internet] New Loughborough research will use Artificial Intelligence to help reduce maternal harm amongst mothers from black ethnic groups [cited July 19 2022]
Available from: https://www.lboro.ac.uk/ departments/compsci/news/2021/newresearch-help-reduce-maternal-harm/
Wearable devices are becoming increasingly important in clinical settings and for monitoring our day-today health and activity. Given the sensitivity of the data, cyber resiliency of medical devices must be robust and account for various factors and settings that may impact the efficacy of security controls and data privacy. This is particularly important in the context of wearables, from smartwatches to continuous glucose monitors, that are reliant on proper use by the user for their software to remain up to date and for network security.
When discussing the cyber resiliency of medical technology, we must consider two crucial aspects: the level of security of the device, and the level of security concerning the transferring, processing, and storing of the data produced. In both situations, third-party suppliers are likely involved. Given these aspects are critical to protecting personal data, the way they are built and work as an ecosystem must be closely examined for potential threats to resilience. Protecting these value chains is as difficult, possibly more so, as dealing with other ‘stand-alone’ issues. Despite the risks, many companies do not prioritise the cyber resiliency of their supply chains or operational ecosystem.
According to the Cyber Security Breaches Survey 2022, 13% of businesses assessed the risks posed by their immediate suppliers, with 7% reviewing the
risks posed by their wider supply chain. This lack of visibility into third-party risks is concerning when fewer businesses control their supply chain in a way that might have been commonplace 30+ years ago - by owning every step. The fragmenting of the market into numerous smaller, specialist players have been notable and makes it more critical for companies to take supply chain resilience seriously.
Organisations must elevate their approach to cyber risks to avoid damage to their operation.
1. Define clear ownershipA dedicated team to evaluate and reduce third-party or supply chain risk tends to be more successful – ensuring visibility isn’t lost, and less potential weaknesses arise.
2. Prioritise suppliersConsider risk exposurebased factors when prioritising suppliers, including:
● The products or services they provide
● Access to data
● Which regulatory requirements apply
● If they have direct connectivity to systems
Highlighting the missioncritical suppliers is a crucial step. Take a riskled approach to your supply chain, ranking suppliers in terms of the impact it would have on
the business if something went wrong and prioritising interrogating and building resilience around them first. Companies need to orchestrate an internal discovery process to assess which third-party products exist within their environment, how they are produced and identify what aspects of the business they support.
3. Think ahead - Examine whether current contractual clauses are fit for purpose for the risk environment, not only for current regulatory compliance. Partners also need to be sought out to help anticipate future risks. Onboarding specialists can do this with continuous third-party risk management services.
From a resiliency point of view, the environment in which devices operate is a second major factor; for example, gadgets like "smart" hospital beds or radiology equipment function in a highly-controlled medical environment. However, technologies such as continuous glucose monitors or smartwatches are used in largely unmonitored dayto-day settings. Context is essential when evaluating these devices' resiliency and determining where legislators should focus on regulation.
Given many outside factors can generate gaps in security or privacy, device manufacturers have pushed back against being wholly liable for the resilience of their products. This
brings the question of who is accountable for the security of medical technology. Medical device manufacturers must ensure that their devices perform in a specific manner within certain prescribed use parameters. They then need to recommend the conditions under which the buyer can most securely use the device. By leading this way, clinicians, users and eventually regulators will demand minimum standards or implement them de-facto.
This picture will become even more complex when developers integrate ML and AI deeper within these devices. The necessary increase in connectivity and data transfer between devices and edge or core systems will create more potential weak points. Whilst many are already cautious about medical data being pooled for the sake of analysis, research, and in time personalised health recommendations, devices with ML and AI embedded in them are inevitable. We must implement systems to account for this instead of playing catch up.
Resiliency can only be assured once those involved fully understand the risks. A vulnerable supply chain can cause a ripple effect of damages and disruptions. Therefore, clear strategies to protect the "crown jewels" of patient data and critical systems are needed. Failure means delays in adopting digital health which embeds advanced medical devices, and worsening public-health outcomes as a result.
Abel Archundia, managing director, global life sciences & industrials, ISTARI provides advice for medical device companies on cyber resiliency.
Robert Donald, innovation and licensing officer at Medovate explains how the company navigates the IP landscape having secured 40 patents in four years.
We identify key points of the invention, what makes it new and inventive over the current state of play and prior art. During this initial review we look over the prior art and general IP landscape using various patent databases. These documents are reviewed internally and considered against the technology we’re looking to protect. This helps shape how we consider drafting the application to account for any prior art, as to successfully see a patent through to grant there is the requirement for it to be novel and gives an overview of the commercial landscape and our freedom to operate in the market.
We work closely with our external patent firm, who manage the drafting and filing process on our behalf. Throughout the drafting process we review the drafted material to ensure that we fully capture the idea and potential other iterations to broaden the scope, working closely with the inventors and engineering team. Once we have a robust patent specification this would be typically filed at the UK Intellectual Property Office as a priority application.
Our filings and claims are directed to the technology as a whole, potential disposable and component elements, and consider therapeutic applications and, in the US, methods of treatment. From that core filing, and as the technology evolves through development, we typically look at the improvements being made and consider further patent filings thereby widening the scope of our protection away from the core patent.
We look to file as early as possible for that core IP to cover risk during development. Any further patent filings are when we feel comfortable that we have significant material to support them.
We consider several factors when deciding on territories; first are our key markets over the lifetime of the patent, where our first positions in the market will be, and weighing the value of downstream territories.
We consider the competition, identifying where key players are, their core markets and manufacturing bases. We consider this as a defensive strategy but providing the potential to align with a partner downstream and increase the opportunity value.
With all our patents we go through the normal prosecution route from priority application to Patent Cooperation Treaty on month 12 which allows us to simultaneously seek protection in multiple territories.
The pandemic has slightly impacted the timelines for prosecution through to grant; there is a backlog in many patent offices worldwide meaning that although the initial formalities process of priority through to PCT to national phase is set, the examination phase during the nationals can be slightly drawn out, though I understand that the UK IPO have recently cleared theirs.
Costs overall are pretty stable, the only addition is the consideration for further overseas defensive patents to account for the competition in the Far East which can push up costs significantly with general legal, formality and translation fees.
There are some incentives that make the process worthwhile commercially for any organisation to pursue patent protection; in the UK we have the Patent Box which allows companies to apply for a lower rate of corporation tax from any profits arising from patented inventions.
MD Stuart Thomson and I have extensive background in the management and commercialisation of IP. IP is at the core of our business; giving us control and understanding of our portfolio, opportunities to expand this, prosecution decisions, the IP landscape that we’re moving in, and strategic commercial opportunities.
It’s important for the IP strategy to fit in with the work of all other departments within the company. Our main consideration is during the development phase of any project and working with our engineers to ensure that any refinements fall within the patent specification, and that improvements are captured for potential further filings.
Find a good patent attorney with expertise in your area, potentially even the market (who is pragmatic with advice) to ensure that you take the right path when drafting and through the prosecution.
Early-stage companies should put in place a process that identifies new innovations and have a protection strategy. This could be through an innovation disclosure form for the development team.
Regular structured meetings with the steering group have been vital to review the company IP progress, new filings, and prosecution of patents, potentially bringing in the patent attorney also, to have a constructive plan of action.
Finally, monitor and review the patent landscape for competition. There are several good databases that are free to use including espace.net and lens.org.
Leon Birch, principal scientist at life sciences contract research organisation Broughton explains navigating regulation to approve inhalation devices.
Handheld nebulisers based on ultrasonic/ piezo technology have the potential to overcome many of the challenges of traditional nebuliser technology.
Inhalation therapy involves using a device to administer drugs to the throat, lungs, or oesophagus. The ability to deliver therapies into the alveolar spaces of the lung results in rapid absorption into oxygenated blood, allowing inhalation therapy to achieve efficacy with a lower dose than via tablet or intravenous injection, potentially reducing the risk of side effects and adverse events.
There are several types of inhalation therapy devices: nebulisers, pressurised metered dose inhalers (pMDIs), soft mist inhalers (SMIs), and dry powder inhalers (DPIs). Nebulisers atomise a liquid into a mist using mechanical action and are considered easier to use than inhalers; the user simply places the mouthpiece over their mouth and breathes normally. They are therefore commonly prescribed for young children, older or more frail patients, patients experiencing an asthma attack, or patients with comorbidities such as arthritis or visual or hearing impairments.
The development of handheld nebuliser technology overcomes some of the traditional limitations of nebulisers — in particular, making them more portable.
Applications of handheld nebuliser technology include the nicotine industry as a way of developing e-cigarettes to be offered on prescription to patients as part of a smoking cessation regime. This brings advantages over traditional e-cigarette technology by improving repeatability and
control, and potentially reducing levels of harmful and potentially harmful constituents associated with traditional heater coil systems.
A handheld nebuliser marketed for nicotine delivery can achieve regulatory approval for the consumer market via the European Tobacco Products Directive (TPD). In the UK and EU, handheld nebuliser technology for medicines will go through the marketing authorisation application (MAA) route to market, as well as achieving either CE mark for European use, or UKCA marking for the UK market.
If nebulisers containing nicotine are to be available on prescription as medicinal products, the MHRA guidance suggests that the pMDI route should be followed. This means that part of the regulatory approval process involves demonstrating delivered dose uniformity (DDU). Unlike other inhalation therapy devices, products for nebulisation are not typically subject to DDU testing per inhalation and are instead measured on drug delivery rate and total drug delivered during a treatment time period. However, the guidance also states that a dose can be considered as ten inhalations. This takes into account the drug delivery rate over ten inhalations whilst giving allowances for potentially greater variability between individual inhalations.
DDU is typically measured over at least ten inhalations, from the beginning, middle and end of the product’s life, with at least three containers from two different batches tested. In the EU/UK, DDU specifications are 9/10 doses within
25% of the mean and 10/10 doses within 35% of the mean. The test setup typically involves firing the device into a sampling apparatus, where a filter collects the dose of active substance, which is then analysed, typically by using highperformance liquid chromatography (HPLC).
However, discussions are needed about whether these technologies should be classified as a pMDI or a nebuliser, as this would impact the EMA's Committee for Medicinal Products for Human Use (CHMP) requirements for DDU and drug delivery rate.
There are simple things the manufacturer can do at the design stage to create a device that delivers acceptable DDU. Handheld nebuliser technology can be optimised (in terms of its vibration frequency, mesh size, and formulation characteristics) to control the particle size distribution of the resultant aerosol and hence influence the efficacy and drug delivery. For example, the frequency determines the amount and size of particles in the aerosol and can be fine-tuned to the viscosity and density of the formulation. Optimising a design at an early stage gives manufacturers the best possible chance of meeting regulatory criteria.
Navigating the route to market for novel inhalation therapy devices can be tricky. Working with a partner experienced in product development services, including regulatory applications, test methodologies, and product optimisation maximises your chances of efficiently bringing a new inhalation therapy to market.
Sean Hägen, principal, founder, director of research & synthesis, BlackHägen Design explains why contextual inquiry (CI) is beneficial in medical device design.
With the rapid expansion of advanced technologies to enhance medical device designs for both in-home and clinical environments, it’s more important than ever to involve proven methodologies to ensure user and regulatory acceptance of new or improved devices.
One such method is contextual inquiry (CI), a structured observational approach to gaining valuable insights into behaviours between end users and the products they interact with. Trained observers view, in realtime, what users typically do, day to day, revealing exactly how they interact with the devices and systems being considered for redesign or reinvention.
A sub-set of the human factors engineering (HFE) process, CI is most valuable when deployed early on in the development cycle. The knowledge gained from this research is subjected to rigorous data analysis to identify user patterns and behaviours. Insights from CI research provide the foundational guidance to inform the design of a final product that meets the criteria for safety, usability, market strategies, and regulatory approvals.
CI provides a deeper and richer understanding of the potential use of the new or re-engineered device in the environment where it normally will be used. This means considering environmental constraints or disruptions like crowded rooms, noise, multitasking, or other potential distractions.
Direct observation, identifying problems, characterising them, and user interactions that influence these scenarios reveal opportunities for a new device design. It’s a “show me, don’t tell me” approach where the observer views what the users are actually doing and what they need versus their recollection of what they are doing or think they need; in other words, filtering out biases that would occur with an interview or survey.
Specific expectations for the desired outcome of a CI study keep a project on target. Certain deliverables should be specified: cog Spoken and unspoken needs, challenges, and aspirations of all stakeholders
cog Characterisation of use-case challenges, work-around patterns, and implications
cog Potential use errors/use-related hazards
cog Development of detailed and robust device requirements
cog De-skilling a procedure, making it easier and safer to use
cog Discovering new opportunities —from new features to more efficient workflows to business acquisition strategy
CREATING A CONTEXTUAL INQUIRY PROJECT
A CI project includes planning and logistics, fieldwork scenarios, data visualisation and analysis, and finally, translation of the information learned.
Sample size may vary but as the methodology studies behaviour and not opinion, it can often be a small set of observations. Assuming the participant types are homogenous in nature and represent appropriate use scenarios, a pattern or trend in behaviour can be realised in samples as small as six, though more often it is closer to 12.
For example, if researching a device used in both private hospitals and teaching hospitals, observations are going to require an additional sample of the same size for each type of hospital. This is because the context of care between these two types of hospitals is different, and the nature of the clinical teams varies greatly between these two types of clinical environments.
Once the data has been analysed, workflow maps can be generated reflecting metrics imperative to product development:
cog Characterising user types into personas
cog Current tasks and their order
cog Criticality of tasks
cog Tools required per task
cog Emotional association to particular tasks
cog General time to complete tasks
cog Usability challenges
cog How users overcome usability challenges
cog Implications of usability challenges, both commercial and efficacious
All interrelationships of the interaction points are recorded as well as those of the user experience. The recordings may be written/logged and/ or demonstrated on video. This information
provides a proven foundation for generating specific recommendations for design or re-design.
Some medical device development teams consider themselves ‘experts’ in device use and design parameters. But over time, when perspectives on how users interact with devices evolve, design teams may not consider how users have created workarounds to overcome design discrepancies.
Therefore, the “why” the device is being used in a non-prescribed way is not always communicated to the manufacturer. Most design projects start with the “what” is going to be designed and not the “why.” This is when a CI approach is valuable as it specifically provides the “why” basis for the need and an understanding of real-world behaviour with direct observation and interaction with the prospective end users. It’s the “show me, don’t tell me,” advantage.
A CI study can add cost to a project depending on the team size and the scope of the project, i.e., domestic or global. CI may not be the best approach if there is
limited time and budget, or if there is very high confidence that only a limited set of specific details need to be captured from the context of use.
However, there is a strong case for a CI methodology, particularly as it relates to discovering unmet needs related to the efficacy and safety of a product design. The aim of any product design program is to ensure that the device is useful and commercially viable. A proven methodology in the HFE process, CI ensures that developers are gaining the knowledge of human behaviours and the ‘why-behindthe-what’ that will assure the value and safety of the final product.
In fact, regulatory agencies worldwide encourage these types of contextual immersion studies throughout the feasibility and discovery phases. CI studies can determine the benefits to the end user which leads to market acceptance and the foundation for regulatory approvals.
CI provides a deeper and richer understanding of the potential use of the new or re-engineered device in the environment where it normally will be used
Inevitably, claims of being a “world-first” can lead to some dispute – but GlucoRx has stated it is the world’s first multisensor device, acknowledging that there are some other devices that have been developed but have yet to come to market. The multi-sensor approach is what the company says is unique.
Nilesh Nathwani, CEO of GlucoRx, said: “I think that historically people have always used just one technology to measure glucose, and haven't used this approach. The idea with using multi sensors is that you can compensate and modulate for the artifacts and improve the accuracy. That's why we believe this is the first.”
The multi-sensor approach is used alongside Radio Frequency (RF). One of the main challenges that Nathwani outlines is getting all the sensors into something weighing 14g and measuring 42mm in diameter by 7mm for the user to wear.
“What we've done is we've taken the learnings from the last clinical study on the Gen 3 device and created a design to manufacture product. We’ve included the human factors with the understanding of what the market requires for a product like this.
“We've reduced the size and added a full array of sensors in the device. You've got your RF sensor, a near infrared stroke PPG sensor, a bioimpedance sensor and all three of those are capable of measuring blood glucose. In addition to that and to improve the accuracy, we have a 9-axis accelerometer, barometer, temperature sensor humidity sensor, pressure sensor and an ECG sensor.
“We managed to get all these sensors into a device which is so small and discreet. The challenge if you ask me has been to encompass all those sensors and all that technology into a form factored product which can be suitable for commercialisation.”
The device works for 2-3 days alongside a companion app for ease and convenience for the user to act upon its readings and will take up to 30 minutes to charge.
Nathwani was full of the praise for the team behind the product which involved a significant redesign because of supply chain difficulties. The initial sensor that was designed had few sensors in it than the one the company hopes to bring to market at some point in 2023, following submission in the first quarter of next year for CE and FDA approval.
Pressures on the supply chain meant longer lead times and the company couldn’t acquire the components required for the initial design –meaning a redesign was required.
Despite all the additional sensors that now feature as part of the product, Nathwani has stressed a simple point to it.
“It is a blood glucose monitoring device. It's just that when we put all the other sensors in there to improve the accuracy. We know that we can use those sensors to measure activity, heart rate variability, respiration rate, SPO2, ECG, temperature and so on. The device measures a lot of parameters, but primarily it is a blood glucose monitor.
“When people open this up, and we've obviously had other industry experts look at the design, they all say “wow, how have you managed to do this?” They've been absolutely amazed.”
In recent years, the company has focused on research and development in a bid to develop something that gives a clearer picture of glucose measurements to make it more affordable and pain free. Nathwani says they have developed something they feel is the future of blood glucose monitoring –particularly in relation to measuring immediate blood results as opposed to interstitial fluid glucose.
“With that in mind, you can do a lot more. It can become a preventative behavioural tool.”
With sustainability a key focus across many sectors, GlucoRx are keen to highlight what it feels are its green credentials. Rather than being disposable after a period of up to a fortnight, this is a rechargeable device – much like consumer devices including smartwatches – and can last for up to four years.
When the product eventually comes to market, the company envisions a subscription model, with the aim of making it as affordable as possible.
After announcing the intention to launch what it says is the world’s first non-invasive continuous glucose monitor GlucoRx BioXensor, Ian Bolland caught up with the experts at GlucoRx and Cardiff University to explain more about the innovation.
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