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18–19 October | The Vox, Birmingham
Join us for two days, to learn, inspire, and share innovation challenges. At the InterSystems UK & Ireland Summit you can listen to the InterSystems community share their experiences and priorities on the path to being more innovative.
Hear how InterSystems technology and services are making digital transformation a reality, while enabling and empowering future innovation.
s I write this, the UK has just appointed its fourth Prime Minister in six years. Changes at the top of government tend to mean changes throughout –so anyone in the life sciences sector will have had a keen eye on the announcements of the new cabinet ministers responsible for health and business, energy and industrial strategy.
With long waiting lists meaning a huge backlog to tackle for the NHS, its important the new health secretary Therese Coffey is at least in post until the next general election. I became the editor of this magazine just over two years ago and she will be the fourth health secretary I will be reporting on whenever new technological adoptions in the NHS are a factor. She follows Matt Hancock, Sajid Javid and Steve Barclay in the post during a period of great political
Ofinstability.course, instability at the top of the department is not responsible for the millions waiting for treatment or the long hours in A&E but three different health secretaries in the space of just a few months and power vacuums are definitely not going to be helpful.
Adoption of new technology is likely to form a key part of the plan to help NHS get to grip with its current predicament – whether that’s to improve access to care or indeed to speed up time to establish a diagnosis and treatment. If there were to be mass technological adoption during this time, the effects it will have on the NHS for years to come will be profound.
The Office for Life Sciences sits under the Department for Health but also the Department for Business, Energy and Industrial Strategy, with Jacob Rees-Mogg now the secretary of state for the latter. At least this is one department that hasn’t seen so much change recently, and Rees-Mogg’s predecessor in Kwasi Kwarteng is now at the Treasury. One would think that Kwarteng is ideally placed to know any financial incentives that are required for the medical device manufacturing industry – whether that is via tax arrangements or direct investment from central
of broader challenges in this department that don’t just affect business
but everyone on a direct, personal level – notably the energy and fuel costs heading into the winter. But there are also the knock-on effects on the medical device sector with energy costs, of moving and sourcing materials and transportation – all of these are factors that government must consider when it comes to aiding the industry through a difficult time.
We saw at Med-Tech Innovation Expo in June that there is a great appetite for investment and new ideas coming out of our sector but, like everywhere else across supply chains in multiple industries, help and clarity will be required for success in the short and medium term. Ensuring that figureheads at the head of departments remain in place prior to the next general election – in what is sure to be a turbulent period – strikes me as valuable.
Right now, strong and stable (where have we heard that before?) leadership of government departments is what needed from this new administration rather than any rearranging of personnel going forward.
PainChek, an artificial intelligence (AI)-powered pain assessment tool, has reported sustained growth in market traction and 400% growth in its UK team, two years since its launch in the UK.
The company, which started out in Australia, has 8,500 beds in UK residential care homes now using the PainChek technology, over 1,300,000 pain assessments worldwide, and reports sustained growth in demand from UK care providers.Amedical device for use on mobile phones and tablets, PainChek uses AI (facial detection and analysis technology) and smart automation to detect and score pain in real time. The tool has regulatory clearance as a medical device in the UK, Australia, Canada, the EU, and New Zealand.
The company’s Tandeep Gill says PainChek is well positioned to continue its impressive growth momentum in the UK: government-funded“Through pilots, integrations with eMAR and care planning partners,
and a vision to move into new markets, our growth strategy is very much on track.
“Our ongoing expansion in the UK is a core part of PainChek’s plans for this year. We have recorded a surge in interest, enquiries, and uptake of PainChek from a range of care providers, from those with well-established digital systems as well as those looking to make the first entry into their digital journey. Indeed, with the UK government’s digitisation target front of mind, many care providers are realising the value, time and cost savings digital tools can bring.
“Worldwide, cases of people living with dementia are predicted to treble to 153 million by 2050. Timely detection and management of pain is integral to ensuring high quality care and quality of life for care home residents living with dementia, and this starts with accurate pain assessment for those unable to self-report theirPainChekpain.” has successfully supported pain assessment and management for thousands of adults worldwide living with
dementia, disability, or other conditions which impact their ability to reliably self-report pain. Building on this success and technology, the recently validated, world-first PainChek Infant app has been developed to ensure pain can also be identified in pre-verbal children aged one month to 12 months who have yet to learn to selfreport their pain.
The Infant app has received regulatory clearance in the UK, Australia, Europe, Canada, and New Zealand, and will soon be available for use by UK healthcare professionals in settings including clinical studies, hospitals, and GP clinics.
Healthtech start-ups
Certific and PocDoc have struck a partnership to tackle cardiovascular disease. The partnership will allow patients to remotely monitor blood pressure, BMI and quantitative lipid levels through the same user experience. This solution will be rolled out through several pilots, in conjunction with the NHS, across the UK, and eventually across Europe and globally.
PocDoc is an NHS Digital Health Accelerator backed healthtech company that recently announced its first in-house test for the 5 marker lipid panel. Backed by investors including MMC Ventures, Forward Partners and the founder of healthtech unicorn Ada Health, PocDoc won the MedTech Breakthrough Award 2022 and has also won multiple Innovate UK awards.
A new conductive silicone with graphene nanotubes has been approved for use in the European market.
Graphene nanotubes outperform other conductive materials for silicone rubbers used in skin-contact applications such as carbon black and silver particles. While silver-based additives have unresolved problems with mixing and processing, carbon black leads to skin contamination, as well as to degradation of the properties of silicone that are crucial for healthcare applications, such as flexibility and softness.
The use of graphene nanotubes, also known as single wall carbon nanotubes, allows silicone producers to combine functionality and
comfort in materials used in medical devices.
The growing requirements of the electrical massage devices industry resulted in a necessity for conductive silicone rubber that maintains high softness and flexibility. Graphene nanotubes became the solution for a Chinese silicone rubber compound manufacturer. Nanotubes make it possible to pass massage pulses through rubber to the human body, while maintaining the desired
original properties of the silicone.Adosage as low as 0.25% of nanotubes from OCSiAl replaces up to 40% of carbon black in a conductive HCR (high consistency rubber) silicone compound, ensuring stable volume resistivity of <100 Ω•cm. It shows no carbon release to the material’s surface and no contamination of the skin. The new silicone compound is used in the production of a serial line of electrical devices for massage treatment. Compliance of the nanotube compound with the EU RoHS Directive has allowed the manufacturer to enter the European market and further expand its line of products using the new nanotube silicone compound.
Certific was created by the co-founder of Wise Taavet Hinrikus, alongside Liis Narusk and Dr Jack Kreindler, and recently raised €7.4 million of investment to advance remote medical diagnostics, support product expansion and entry into new markets and has served over 150,000 patients so far. Certific recently partnered with Zapp, a convenience delivery app, so people could order test kits for Urinary Tract Infection (UTI) and Sexually Transmitted Infection (STI) screening and delivering fast
Certifiresults.c’s platform is testagnostic and can be used for multiple point-of-care tests including swabs, blood, and urine
Stevetests.Roest, CEO of PocDoc, said: “We are delighted to announce PocDoc’s partnership with Certific – they are a real digital disruptor in healthcare that we admire and have followed their success closely. They bring a wealth of experience, and our combined knowledge will empower patients to improve their heart health, helping prevent future heart attacks or strokes through home-based digital solutions.’’
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.
Returning for the 2023 running of Med-Tech Innovation Expo will be the Start-Up Zone, sponsored by NIHR, SBRI and Innovate UK who will also be returning after a successful 2022.
The Start-Up Zone allows some of the promising companies in medical technology to showcase how they are aiming to address the health challenges of today and tomorrow.
Those featuring on the startup zone will be offered the opportunity to talk further about their innovations in the
third consecutive running of PITCH@Med-Tech Innovation Expo, which will take place on Day 2 in the afternoon on the Introducing Health-Tech Stage.
The last two winners of the competition were Neuronostics and JohnSurePulse.Terry,co-founder and managing director of 2022 winner Neuronostics, said: “It was a pretty amazing feeling. With 10 other start-ups, all working on great ideas and tech, the field was tough. When the panel chair was
Following the 2022 running of the event, Med-Tech Innovation News found out what a few of the speakers thought about the Expo following their seminars and participation in panel sessions.
Michael Watts, managing director of Blum Health Ltd, opened up proceedings on the Introducing Health-Tech
HeStage.said:
“I was delighted to feature in the Med-Tech Innovation Expo 2022. It was a current and accurate demonstration of the innovation occurring across the NHS and beyond, and the talent invited to speak enabled me to learn and be inspired. I was particularly impressed by the range of solutions that were exhibited, and the intimacy of the speakers which meant that networking was productive and exciting.”
Watts was followed Dr Simon Leigh, director of research at ORCHA, who added: "From organising the slot, to coordinating and then the actual presentation, it was a breeze. The presentations (not just mine) were packed and there was clearly a lot of interest. A good and healthy mix of innovators, experts and funders all in one place."
Helena Zaum, who opened proceedings at the Med-Tech Innovation Conference, said: “I was really delighted to be asked to come to a medtech conference and then to talk about social care. And also the very thoughtful questions from the audience.
“This year is my first visit, so I’ve had a look around and it’s just amazing – all the fantastic gadgets that are here! I’m really excited about that innovation”
giving feedback on what constituted a good pitch, I was mentally ticking off the aspects we’d covered. So, come the end I was thinking we were in with half a shout, but it was still amazing for Neuronostics to be announced as the winner.
“Whilst I’m the front of house, so to speak, it’s really a team effort and a great reflection of the hard work everyone is putting in!”
After picking up the prize in 2021, James Carpenter, CEO of SurePulse, said: “It’s always
gratifying and a huge honour to win an award. I felt proud for the whole team who are working away behind the scenes so hard and have had to face some real challenges.
“Also, I was delighted that the judges picked up on what is the essence of our vision at SurePulse, the importance of innovation from the very first moments of a baby’s life when every second counts. That sort of feedback really energises me and makes me want to get back to work to continue trying to make a difference!”
Bookings continue for the 2023 running of MedTech Innovation Expo as companies book early to avoid the disappointment of missing out.
After featuring on a panel session in 2022, RED Medtech will be on the show floor while some companies such as Qosina and ZwickRoell will be making their return in 2023.
Among the newer faces for 2023 having not been present the previous year include Nottingham Trent University, MasterFlow and Sierra 57
TheyConsult.join some of the familiar faces from 2022 who have rebooked for 2023 which includes Rapid Fluidics, Neucin Design, PolarSeal and many more.
Med-Tech Innovation Expo 2023 takes place on 7-8 June 2023 at the NEC, Birmingham. For more information, visit www.med-techexpo.com.
Closomat, the UK’s only manufacturer of wash and dry toilets for people with medical and clinical needs, exhibited its product range at REHACARE in presentedDüsseldorf.Thecompanyoneof its signature products, Closomat Palma Vita, combining the functions of a toilet, a bidet and a drier in one unit, which can be customised to meet both simple and complexSpeakingneeds.ahead of the show, Brian Hoare, managing director
at Closomat, said: “We are excited to exhibit at REHACARE in September and are looking forward to showcasing our innovative toilets supporting disabled in their day-to-day lives. We believe that the event will serve as a great platform for networking –with seven distribution partners across Europe, we are keen to further expand our international reach and distributor portfolio.“AtClosomat, we think that dignity
and independence are fundamental to a person’s well-being, and that everyone has the
right to live their best life – over the years, we have witnessed how our products help support
this, having received excellent feedback from users and care providers.”
Law firm Mills & Reeve, which has a specialist team dedicated to the life sciences sector, saw turnover rise 5.5% reaching £131.2 million.
The results follow a year in which the firm has achieved some significant milestones, including opening an office in Oxford, adding to its existing presence in Birmingham, Cambridge, Leeds, London, Manchester and Norwich. Other highlights of the year included:
• Improved client metrics in all key areas of the latest “Fearless Feedback” client survey –loyalty91%clientrecommendationclientandsatisfactionboth(+2%),andclient90%(+5%).
• A first ever ranking in the Thomson Reuters Top 20 UK Law Firm Brand Index.
• A best ever position (18th) in the UK 100 Best Companies to Work for list –featuring for an unparalleled 19 years running.
• 13 partner.promotedassociatesprincipalbeingto
• A top four spot for the sixth year running in RollOnFriday’s best law firm awards.
Justin Ripman, Mills & Reeve senior partner, said: “It is an important part of our culture that everyone shares in the financial success of the firm and our all staff bonus is a great example of this. We recognise the importance of the bonus and the way in which we calculate and allocate it differentiates us from many other firms.
“On behalf of every partner in the business, I am extremely grateful for the role that everyone has played in winning work, being a leader in client experience and pulling together to support each other and push the business forward. Being able to pay a bonus reflecting the performancegreatof the firm is pleasing.”really
S EHTA announcedhas it is partnering up with IVDeology to provide four workshops on regulatory framework for the IVD/Medical Device diagnosticdevelopmentfornew"WeIVDeologymanagingofdiagnosticsmoretherebacklogsthethewetoIVDeologyindelightedSEHTA,thecompliancetrainingregulatoryspecialistIVDeologysectors.providesqualityandconsultancy,andservicestoIVDIndustry.NeilRoberts,CEO,said:“Wearetobeworkingpartnershipwithinrelationtheseevents.Aslooktomanageconsequencesofpandemic,andtheithascreated,hasneverbeenaimportanttimeinforthistypeinitiative.”StuartAngell,director,added:arenowinalandscapethedesignandofinvitromedical
devices, it is critically important that all stakeholders are aware of the changes, and the impact on time, resources and budget. The workshop will offer a friendly and positive experience to discuss these thebepersonTheconsiderations.”firstfreein-workshopwillon‘UnderstandingEUIVDRegulation
for Investors - How the implementation of the IVD Regulation has impacted the time to market and what It means for investor
placeworkshopreturns’Thehalf-daywilltakeonThursday 20th October 2022 at 09:30 at The Joiners Shop, the Historic Dockyard, Chatham, Kent.
Jason McGlynn, commercial manager at industrial metrology specialist The Sempre Group, shares his thoughts on measurement in Ireland’s medtech market and explains how the company’s new Dublin facility will support local manufacturers.
There is a growing shift towards connected metrology systems, which provide manufacturers with a digital thread connecting initial product drawings right through to final quality reports.
Ireland’s medtech sector is expanding, and so is the spotlight on production processes.
Manufacturers may already have multiple measurement systems and software on site, but, if these are working in isolation, vital data can be misplaced. However, manufacturers can now integrate their various measurement systems and connect them with the necessary software, tying them together with one unified electronic quality management system (EQMS) that enables them to access the necessary data.
One example is 21 CFR Part 11 compliance. Quality engineers must ensure the manufacturing process is fully traceable and connecting their systems and software can help medtech businesses meet this standard. At our new Balbriggan site, we offer a wide portfolio of metrology systems as well as automated, real-time data collection software. Therefore, we’re enabling local medtech firms to improve their productivity and quality by helping them improve measurement accuracy and traceability.
What measurement challenges is the Irish medtech industry facing?
The main challenge is device complexity. Medical devices everywhere are becoming more sophisticated as designs evolve with functionality. For example, glucose monitors for diabetics, catheters and orthopaedic instruments all have tight geometries, which can make measurement a challenge.
The medical industry demands the highest standards, which can mean measuring down to nanometres.
Manufacturers can overcome measurement hurdles when working with bone screws, drill bits or any precise other components by finding an experienced metrology partner that can provide flexible support and help them find the right solution. This means understanding the specific measurement challenges and needs, and what it takes to remain compliant with the necessary standards.
What inspired Sempre to open an Irish facility?
What does it offer?
Ireland is one of Europe’s largest medtech hubs, so opening a site where we can support local manufacturers was a nobrainer. Medical device companies care about two things — speed and
getting their products to market. Unless they have a metrology partner nearby, manufacturers and quality engineers must wait for parts to be shipped so they can be measured. This means they can lose valuable time in transportation
Atdelays.thenew site, we provide local metrology support to help medtech companies speed up their time to market. We’re already getting a lot of demand for contract measurement because we offer quick turnarounds, and we’re continuing to grow our product
portfolio at the site. For instance, we’ve just introduced the RX Solutions EasyTom CT scanner, which is available for both purchase at an affordable cost and for contract scanning services.
Branching out into Ireland is a great opportunity to expand our global reach. A lot of companies here are US-based firms using Ireland as their manufacturing hub, and we can offer local partnerships like we’ve already been doing in the UK.
What do you expect the future of measurement in Irish medtech to look like?
Data integrity will be critical, no question. Measuring an implant or a particular instrument or component is one thing, but this information is only useful if the manufacturer can demonstrate validity and confidence. Is the data traceable? Who measured the part, and when? These are all questions that medtech companies must ask
Datathemselves.integrity is already a hot topic with the industry facing increasingly stringent regulations, and its importance will only increase.
The number one priority must be finding a reliable metrology partner that can support with a credible data collection platform, such as Prolink SPC Data Collection Software.
The first version of the guidance dates back to 1971 and though there were multiple revisions up until 2010, this was the year when everyone took stock on what the guidance should look like. The document has expanded over the years, from 16 to over 50 pages and was finalised in August 2022 by the European Commission. So, how does it affect medical device manufacturers?
Though it is a European guide for manufacturing, EU GMP Annex 1’s impact is global. As soon as a sterile medicinal product is imported into Europe having been manufactured elsewhere, the same practices must be adopted in these manufacturing facilities too.
What drives the spirit of EU GMP Annex 1 is Quality Risk Management and Contamination Control Strategy. Though it is mostly directed at the manufacturer of sterile medicinal products, it's also important to remember there's a lot of useful aspects for non-sterile manufacturing including prompts and recommendations.
The Annex 1 contains several major revisions with many references to the implementation of Quality Risk Management as a more proactive approach rather than reactive. The document also highlights the importance of a contamination control strategy and covers 16 different elements, including cleanroom design, qualification environmental monitoring and several other areas.
Section 4, concerning the facility, stipulates that the manufacture of sterile products be carried out in appropriate cleanrooms. The environmental monitoring of viable particles and cleanroom qualification is therefore essential. The focus in the EU GMP Annex 1 tends to be on Grade A cleanroom environments – the most stringent standards that sterile medicine products are manufactured, where in many cases the products cannot be sterilised.
The Annex 1 states that a manufacturer should use a combination of different methods, contact plates, settle plates and volumetric air sampling and not rely on merely one or the other method.
It also recommends that all Grade A monitoring must be continuous and capture the entire duration of operation –a full manufacturing shift. The air handling units in cleanrooms turn over significantly large volumes of air and therefore sampling merely 1 cubic metre is not truly representative and one of the reasons why the Annex 1 calls for continuous viable air monitoring, not sequential monitoring, or sampling miniscule volumes over an extended period of time. EU GMP Clement Myriam
Continuous viable air monitoring in the Grade A zone can strictly speaking be achieved only through volumetric air sampling. Whether passive sampling using settle plates delivers adequate monitoring is open to debate, but the door has been left open in the document. But bear in mind, it is the use of a combination of different methods that has been recommended.
The EU GMP Annex 1 specifically mentions that monitoring should be for the full duration of critical processing and also recommends monitoring cleanrooms even when operation has stopped.
The document clearly specifies that all interventions caused by the environmental monitoring operation be avoided at all costs. One of the most common interventions being the routine retrieval of impaction plates from volumetric air samplers to avoid dehydration. This is where the MD8 Airscan from Sartorius comes into its own. Paired with gelatine membrane filtration, cleanrooms can be monitored for a tested period of eight hours, typically the length of an entire manufacturing shift. By circumventing routine intervention, the technology is fully compliant with the requirements of the Annex 1 and stays true to its intended spirit.
It is also worth mentioning that both Grade A and Grade B cleanrooms must be requalified every six months with an aseptic process simulation repeated twice a year taking into consideration all human interventions that typically occur during production. Care has to be therefore taken in minimising all possible interventions, to avoid the introduction of contamination during sterile manufacturing. Routine interventions also typically lead to increased microbiological samples from personnel monitoring.
One of the other key requirements of the Annex 1 in terms of environmental monitoring is that the sampling method should not introduce the risk of secondary contamination. By being Vapour Phase H202 (VHP) compatible, the MD8 Airscan facilitates complete decontamination when built in line with the air flow path in advanced aseptic processing systems. Sterile and individually packed capacitywithmembranegelatinefilters,theretentiveofaHEPA
The EU GMP Annex 1 specficially mentions that monitoring should be for the full duration of critical processing and also recommends monitoring cleanrooms even when operation has stopped.
filter, are capable of retaining the smallest of viruses. The filters are hygroscopic in nature and prevents the desiccation of retained microbes by forming a protective capsid, enabling long-term continuous monitoring.
Though much of the guidance applies to pharmaceutical products, there is the effect on medical devices too.
Sterile integral drug delivery devices such as single-use pre-filled syringes, inhalers, transdermal patches can be considered as medicinal products that includes a medical device. As the principle intended action is achieved by the drug contained within the device, it is designated as a medicinal product and therefore falls under the guidance. Also implants containing medicinal products whose primary purpose is to release the medicinal product fall under EU pharmaceutical Thelegislation.European Medicines Agency (EMA) adopted in July 2021 a guideline for medicinal products when used with a medical device. This guideline considers the three different configurations of medicinal products (integral, co-packaged or referenced) and the addition of the impact of the device on the Critical Quality Attributes (CQA) and overall control strategy in the medicinal product dossier.
Please view the application note in full here: Continuous Microbial Air Monitoring in Clean Room Environments | Sartorius. www.sartorius.com
options.tobeanwholekepttheinfectionaend-productproduct.suitableandmanufacturinghelprequirements.towithItneeds.istakingavoidneededwhichprocesses.andrelatingitplentyforknowWhilstmoreonebudgetvolumetohasmanufacturingFindinginflsoanddemandingcostswalkenvironment.toughareanufacturersfacingatradingTheyregularlyatightropetokeepdownandsatisfyspecifications,arecurrentlydoinginahighlychallenging,ationarycontext.andselectingapartnerthattherequiredcapabilitiesproducequality,highcomponentswithinisadifficulttask,butthathasbecomeevenimportant.manymanufacturerswhatthey’relookinginasupplypartner,areunsurewhencomestospecificationstoclean,sterile,hygienicmanufacturingTodeterminecapabilitiesareforaproject,andtoover-spec,itisworthtimetoassesswhichmostappropriatetoyourcanbeusefultostartafewbasicquestionshelpclarifyprojectThesecanteaseoutwhichprocessescapabilitieswouldbeforaparticularForexample,isthegoinginsidepatientorwillitposeanrisk?Anddoesproductneedtobesterilethroughouttheprocess?ThisisnotexhaustivelistbutcanagoodplacefromwhichstartassessingdifferentARECLEAN
Wayne Matthews, sales manager at Tecman Speciality Materials, outlines what should be considered before embarking on a clean manufacturing process.
MMany people know what a cleanroom entails but it’s a little trickier when it comes to CMPs because they refer to a set of processes that sometimes vary from manufacturer to manufacturer, but can broadly be understood to involve:
theacontaminationsegregationhandlingcarefulandofrawmaterialstopreventtheofmaterialduringmanufacturingprocess.
The
The limiting of exposure time when sensitiveprocessingmaterialstoreducetheopportunityforcontaminantstocomeintocontactwiththeparts.
CMPs are suitable for many manufacturers, products and applications that require a degree of quality control, hygienic production, and traceability – some examples of which we have worked on include chemical indicator strips used in diagnostic devices and the production of airtight gaskets for use in bone cement mixing devices. These processes signify a risk adverse approach to manufacturing that still ensures a high degree of quality and safety, but without the price tag that can sometimes accompany cleanroom
Expertisemanufacturing.iskey in this field.
The thenumberofautomationsemi-processingtoreducetheoftimesmaterialsarehandledbyanoperator.
The wearing of PPE betweenthoseclothingprotectiveandbyinvolvedtopreventcontaminationpeopleandparts.
If you are unsure of the regulatory framework for your intended product, or which facilities would meet these requirements, you should seek regulatory advice.
Once you are clear on this, selecting a supplier who has the manufacturing expertise and experience to understand how your vision maps onto technical requirements will enable you to understand which method is best suited to your budget and
Youspecification.mayalready
be on the right track, but you could be overcomplicating and overpricing a straightforward project.
Peter Swanson, managing director of adhesives specialist Intertronics, discusses some of the latest formulations of UV curing adhesives used for assembling wearable medical devices.
UVcuring adhesives offer manufacturingsignificant productivity benefits, due to their fast “on demand” curing when exposed to the correct wavelength of UV light. Several new light-curable materials have come to market that can help medtech manufacturers assemble devices more efficiently, accurately, and safely.
Due to their benefits, UV curing adhesives are growing more popular for the assembly of medical devices. There are many materials available that have passed ISO 10993 tests. Once a material is chosen, establishing a UV curing process is relatively straightforward. Light curable adhesive processes are easy to measure, control, and validate — and process repeatability and robustness are important in such a regulated sector.
The use of diagnostic and therapeutic medical wearable devices has hit the mainstream, as consumers manage their health through monitoring, drug delivery and pain control systems. This includes the use of continuous monitors for sleep, glucose levels and vital signs. According to Gov.uk, more than 270 million units of earworn devices (from hearing aids to music ear buds) and 180 million units of wristwear devices (from blood pressure monitors to step counters) are forecast to be shipped in 2023.
Consumers will be using more wearable devices for communication and entertainment too, including virtual reality.
When assembling wearable devices, adhesives, encapsulants, and coatings are commonly used to bond components, protect the electronics from the environment, and to join or seal plastics or metals within the assembly. Typical applications
for light curable materials include electronics encapsulation, needle to hub bonding, component edge bonding, wire and flexible circuit staking, and battery reinforcement.
When designing a wearable device, the engineer must consider whether the specified materials could cause skin sensitivity. It’s also important that the device can survive repeated use, exposure to different environments and extended periods of time on the body. These factors make adhesive selection
Sometimes,critical.thechemical isobornyl acrylate (IBOA) is found in adhesives because it is useful as a diluent or plasticiser. However, IBOA is a known skin irritant — if an adhesive containing IBOA is used in a wearable device, it has the potential to cause skin sensitivity issues if it is not fully-cured and crosslinked. TPO easyflavailableaddition,andsoTheseagainstandincludingonThesensitisers10adhesiveslikeconcernspecifiadhesiveisDymaxskinlaunchingForandphosphine(2,4,6-trimethylbenzoyldiphenyloxide)isaphotoinitiatoramaterialofconcern.thisreason,manufacturersareproductsformulatedwithsensitivityinmind.Thenew2000-MWseries,forinstance,thefirstdedicatedlightcurableproductlineformulatedcallywithoutmaterialsofandcommonskinirritants,IBOAandTPO.Ideally,themustmeetISO10993-thatverifiestheyarenotskinwhenfullycured.seriesproducesstrongbondssubstratesusedintheindustry,lowsurfaceenergyplastics,dependableperformancemoistureandthermalshock.materialscontainnosolvents,environmentalimpactisminimisedworkersafetyisenhanced.InthereareformulationsthatincludeUltra-Reduorescenttechnologytoenableandclearprocessvalidation.
One challenge for manufacturers of medical tools like scopes, surgical instruments, dental equipment, and sensors, is ensuring the devices can cope with high heat, humidity, chemicals, and other environmental factors. The same is true of the radio frequency identification (RFID) tags, which are increasingly attached to instruments to aid inventory management and help keep track of them during procedures.
The adhesive used for RFID chip encapsulation must form extremely strong bonds to stainless steel and other metals that surgical instruments are made from, enable the tag to remain in place throughout a procedure, and to ensure safe instrument use and storage. For tools that must tolerate repeat sterilisation, the adhesive may also need to possess low water absorption properties. Instrument makers may need a product that meets certain requirements such as fast cure or certifications like ISO 10993-5.
Designed to be autoclave resistant for more than 100+ cycles, Dymax 1040-M is a UV cured adhesive that can be used to quickly bond, pot, or encapsulate RFID chips onto medical devices, tools, and vials. It features exceptional bond strength to stainless steel and aluminium substrates used in medical instruments.
As the medical device market grows and changes, manufacturers are introducing products that address the needs of specific healthcare applications. Bonding and coating challenges follow. Equipped with an understanding of the latest materials and technologies on the market, and helped with implementing these into their production process, medical device companies can solve common assembly challenges while improving patient safety.
PolarSeal Tapes & Conversions have teamed up with science-based technology giant 3M as well as coating & laminating experts FLEXcon to create wearable medical device adhesive solutions fit for a growing and demanding market.
With the surpassingtechnologywearablemarket$116.2billion
in 2021(1), and demand rising alongside this exponential market growth, global medical technology companies are realising the market potential and developing user centric solutions such as glucose patches and smartwatches to aid in the recovery and monitoring of human Conceptualisinghealth. and realising a medical monitoring wearable device requires disciplined project management, especially stickto-skin solutions, and several layers of external involvement. PolarSeal now looks to service this need by upgrading a medically focused converting service with the knowledge of material professionals 3M and coating specialist FLEXcon.
The material and adhesive selection plays a pivotal role and is the starting point in this process. With over a century of innovation, 3M aid in many industry developments including its medical and healthcare contribution with newly designed materials for wearable devices. Matthew Berdahl, global converter channel manager with 3M’s Medical Materials and Technologies business provides some insight on 3M’s latest innovation in the extended wear adhesive space.
He said: "People deserve to live active lives without their condition – or a device meant to monitor it – getting in the way. Adhesives are more than a simple material. They have the potential to unlock longer wear times, slimmer device profiles, and more. We're excited about 3M Medical Tape 4576 and what it can offer device developers and real-time, proactive health monitoring as a whole."
3M Medical Tape 4576 is an acrylate-based adhesive intended for applications that require up to a 21-day wear time. The tape aims to
be flexible, conformable and with its adhesion to the skin, this new product can be used for devices that require continuous extended wear, both in and out of care facilities.
As part of 3M's medical adhesives, 3M Medical Tape 4576 builds was made possible through a collaborative, global effort. Further medical grade adhesives to consider for your application would include:
● Silicone adhesives – gentle and breathable with low trauma removal suitable for a variety of skin types.
● Acrylic adhesives – a Pressuresensitive adhesive (PSA) that is permeable to water vapor and breathable without leaving residue upon removing the device.
● Synthetic rubber adhesives –a strong adhesive designed for short term use due to the lack of breathability.
With a user-friendly and application appropriate adhesive material selected, PolarSeal use its contract manufacturing service and inhouse converting capabilities to design, develop, collaborate, and full scale manufacture the specified adhesive component for the wearable medical device.
All of PolarSeal’s ISO 7 cleanroom facilities operate under ISO 14644:2015 and ISO 13485 quality standards.
PolarSeal’s partner, FLEXcon, who provide label materials for all applications and industries bring Biocompatible Skin Coated Adhesives to the market with the intent to evolve the industry with high end and purposeful Jordanproperties.Smith, business process devices.forcompany’sintroducesmanagerimprovementatFLEXcontwoofthelatestsolutionsmedicalmonitoring
FLEXcon dermaFLEX materials are biocompatible and recommended for device attachment to the body. It contains three tiers of adhesion - Gentle Release, General Use, and Long-Term Wear as well as finished formats, including singlecoated, double-coated and transfer tapes.
dermaFLEX NNRU utilises FLEXcon’s H-566 adhesive, offering durable anchorage of devices and suitability for challenging skin types. The nylonreinforced urethane disappears in both sight and feel. It’s thin and flexible enough to conform to body contours and stretch with movement, but also return to its original dimensions without becoming baggy. dermaFLEX is a stocked product.
PolarSeal aims to partner with suppliers and like-minded companies so it can provide a range of PSA’s and medical grade materials to serve global medical technology companies. The company specialises in flexible material and adhesive tape conversion, with the aim of providing cost effective and performance-based solutions for the medtech market.
PolarSeal will be exhibiting at Med-Tech Innovation Expo on 7-8 June 2023 at the NEC, Birmingham. For more information, visit www.med-techexpo.com.
utoinjectors represent an important growth driver. Testing these devices can present operational challenges, which are coming to the forefront as the scale of autoinjector manufacturing and testing continues to Closelyexpand.related to pen injectors in basic design and function, autoinjectors are typically used for infrequent, single-dose medications that are for subcutaneous or intramuscular injections. Pen injectors are more commonly used for patients with chronic health conditions like diabetes. They are designed to be re-filled and used multiple times. Pens are typically used for medications that are injected
Thesubcutaneously.growthinthis market over the past three decades is likely to sustain itself for the foreseeable future with an ageing population and rising rates of chronic diseases and allergies. These devices were originally developed to support emergency self-administered dosing of liquid medications in applications such as: Epinephrine (adrenaline) injectors used to combat nerve gas in military applications, and morphine injectors used by emergency personnel requiring urgent pain relief.
Starting with FDA approval of the EpiPen in 1987, injection devices have rapidly become a frontline solution in a broader range of healthcare applications. Some early devices did function incorrectly, driving recalls—and the implementation of quality control standards employed today. As technological developments open new capabilities for these devices, autoinjector usage continue to climb.
These devices are increasingly becoming the standard delivery platform for injectable drugs, providing a self-administration solution for substances that cannot be administered as a pill or tablet. By ensuring a proper, precise dose every time, autoinjectors can increase safety for both supervised and unsupervised applications. They provide dose-sized storage, and instead of visibly inserting a needle into the skin, patients hold a device against their skin while it injects the medication.
Testing these devices after performing a final “fill and finish,” can be challenging. They need to be precisely engineered to perform reliably while meeting strict regulations for protecting patient health - the FDA is focused on ensuring safety and precise function. As companies handle ever-higher production and testing volumes, there is a more pressing need to streamline.
All medical devices require some extra quality assurance, but injection devices particularly stand out for their precise engineering needs, strict requirements for testing and manufacturing, and need to perform consistently and safely in an unsupervised setting.
When patients or healthcare providers use an injection device, they are counting on it to deliver a full, precisely measured dose of a potentially life-saving therapeutic; autoinjectors must perform their intended function every time.
Delivering the incorrect amount of medication can adversely affect patient health. Even patient comfort is at stake: injection time is a key testing attribute, intended to ensure patients do not need to
leave the needle in their skin for long amounts of time while waiting for the injection to fully dispense. Injection device testing leaves no room for error. Because of the standards for autoinjector safety, a single failed test could mean that an entire lot of thousands of devices is lost. Autoinjector testing operations must catch potential deficiencies while also minimising the risk of false positives that could impose immense costs. The number of devices from each lot that must be tested vary depending on the risk factors of the relevant drug, but heightened safety concerns generally necessitate larger samples compared to other industries.
Manual testing processes can slow down the pace of required work while many facilities are still using them. Traditional manual testing processes can limit testing throughput, and the ability to keep pace with rapidly increasing production volumes for
AZwickRoell examines why autoinjector testing after the final fill and finish can be so challenging.
autoinjectors, which can lead to human errors in specimen handling, measurement, and data recording.
Also, valuable but optional quality control tests may be skipped to save time. Fortunately, there are proactive options for streamlining autoinjector testing while reducing the risk of Anyerrors.testing
machine that can perform multiple tests without further handling or technician intervention can dramatically streamline testing. Integrated testing solutions reduce the overall need for hands-on supervision from technicians, minimise waiting times between tests, limit the need for additional costly testing solutions, and reduce the number of humanspecimen touchpoints where errors can occur. Some production line machinery providers can add ad hoc measurement devices as a custom attachment to the line itself. They are typically provided by manufacturing firms with little expertise in materials and component testing and have some important limitations. Most importantly, they are usually designed for specific autoinjector
problematic as new autoinjector designs are continuously coming to market. Where possible, the most effective testing solutions should use flexible handling systems that can work with current autoinjector designs while offering the versatility needed to future-proof testing for new platform developments. Rigorous daily checks are imperative to ensure testing equipment is working properly. Well maintained sensors are essential for ensuring precise readings, preventing false positives,
Automated autoinjector testing solutions can even provide automatic daily checks. For manual testing, technicians need to ensure that this requirement is followed strictly. While it is generally recommended that daily checks are carried out, other approaches such as performing a check at every shift change or product changeover may be viable.
For ensuring accurate testing results, recording/reporting of testing data is as important as taking the measurements themselves. Seamless documentation and execution help protect data quality and avoid costly mistakes.
The FDA is only increasing demands for meticulously documented, highly traceable testing results. This issue is even more complex for companies managing multiple sites for the same product.
Technicians who may be working at different facilities on opposite sides of the world must follow precise, repeatable procedures for data entry. Semi-automated and automated testing solutions can provide integrated data reporting, with measurements automatically recorded and uploaded to the cloud.
If manual testing procedures are in place, technician training needs to be aligned across all sites and completed and kept up to date by all technicians.
The move toward automation in injection device testing is a necessary consequence of the need
for increased testing throughput alongside reduced human errors. But some companies are not confident true automated solutions are the right fit for their production facilities or budgets. “Semiautomated” machines are designed to provide a more flexible option. They offer many of the benefits of automation, like integrated data reporting and the ability to conduct many different tests on the same machine, while scaling back features like robotic specimen handling. This allows these solutions to be offered at a lower price point, and to fit into a broader variety of production facilities. Semi-automated solutions can cover a variety of required tests, and optional tests that can provide deeper data.
Semi-automation offers more flexibility than ever, but as testing volumes increase, the value proposition for automating as many aspects of the process as possible grows. True automated systems support capabilities including robotic specimen handling, 24/7 operation, and other key features designed to dramatically speed up testing while minimising the risk of human error. As injection device production continues to scale up, we expect to see true automated testing operations proliferate more widely.
All medical devices require some extra quality assurance, but injection devices particularly stand out for their precise engineering needs, strict requirements for testing and manufacturing, and need to perform consistently and safely in an unsupervised setting.
ZwickRoell will be exhibiting at Med-Tech Innovation Expo and promptly diagnosing testing issues if they do occur.
Shu Yang, senior associate and patent attorney and Sheri Jeyakumar, associate at European intellectual property firm, Withers & Rogers, comment on Internet of Bodies and the effects had on medtech.
The availability of more physical data has contributed to the medtech boom, as innovators harness the power of biosensors to monitor specific health conditions, and spot early warning signs.
Known as the Internet of Bodies (IoB), the integration of Internet of Things (IoT) technologies and medical care has led to a surge in patent applications for connected medical devices. Industry trends show that this rapid growth is set to continue - in 2020, 14,122 new European patent applications were filed for medical technology innovations overall, and this increased to 15,321 new applications in Many2021.of
these devices are designed to be worn, such as Fitbit, Garmin and Whoop. However, others are for internal use, and can be ingested or implanted, surgically or otherwise. Connected to the internet, these interoperable devices use data from biosensors to detect an individual’s vital signs or changes in their physiological responses.
Behind the demand for IoB devices is a growing interest in personalised medicine, which aims to tailor disease prevention and treatment to an individual’s genetics, as well as their environmental and lifestyle factors. Consumers have a natural interest in collecting data about their body and learning
more about their personal health. From a technological standpoint, advances in the miniaturisation of electronics have also made it possible to develop smaller devices that are more portable or suitable for internal use.
IoB devices take many forms, however, they are perhaps best known as wearables to monitor personal fitness. Other types of IoB device can be used to assist individuals with specific problems related to their sleep or walking, or to monitor a specific longterm health condition, such as heart disease or diabetes. Some IoB devices are used by clinicians, such as VivaLNK’s thermometer and dashboard which monitors a patient’s temperature and sends an alert if it becomes raised, whereas some are implanted surgically, such as pacemakers and cochlear Withimplants.many
more IoB devices expected to enter the market, innovators should ensure they are protecting their inventions at an early stage to minimise the risk of early disclosure and secure exclusivity rights ahead of their competitors. They should also keep a close watch on the market to identify areas of opportunity or threats that could undermine the commercial value of their activities. Once a patent has been granted, they should also be prepared to enforce their rights where necessary, to protect their commercial position.
In a recent example of IoB tech innovation for internal use, engineers at the Massachusetts Institute of Technology (MIT) have designed an ingestible pill, made from hydrogel with a sensor attached, that stays in the stomach for an extended period of time. The device can be used to spot changes and track gastrointestinal temperature.
Another example of an IoB device for internal use is an electronic gassensing capsule, capable of measuring gases in the gut.
Developed by engineers at Australia’s RMIT University and Atmo Biosciences, the device can be used to detect and measure gaseous biomarkers and aid the diagnosis of gut disorders.
Google has patented technology for smart contact lenses that contain sensors and microcircuits. While they look much like a standard contact lens, they can detect changes in the eye or eye fluid to aid the diagnosis of conditions that might require medical intervention.
Other IoB innovators are focused on the dynamic area of placetheyinnovatorsopportunitysoapparatusadvantageousEuropepatenteffectdemonstratebasedexample,technologies.commercialisewhenfaceinnovatorsopportunity,significanttechnologiesconnectedGrowingofthroughcontrolwhetherinClinicalforhelptechnology,computerimplantableisForneurocomputing.example,Synchrondevelopingbraininterfacewhichcouldtoimproveoutcomespatientswithparalysis.trialsareunderwayAustraliatodeterminepatientscandigitaldevicesthepowerthought.demandformedicalisacommercialbutIoBcouldchallengespreparingtotheirForcomputer-innovationsmustatechnicaltobeeligibleforprotectioninanditmaybetopatenttoo.Withmuchcommercialatstake,shouldensurehaveanIPstrategyinatanearlystage.
Behind the demand for IOB devices is a growing interest in personalised medicine, which aims to tailor disease prevention and treatment
Dr Francine Kaufman, endocrinologist who has served as president of the American Diabetes Association and Senseonics chief medical officer, outlines how medtech and digital solutions can alleviate the burden of diabetes management.
In recent years, a confluence of economic, technological, and demographic factors has given rise to a digital revolution in healthcare. Against the global context of a dwindling healthcare workforce, existing models of care are struggling to meet the demands of ageing populations. It is increasingly clear that digital solutions and a data-driven approach to healthcare are key to tackling these issues, to pave the way for lowercost, Harnessinghealthcarehigher-efficiencysystems.thepower
of data and digital connectivity is particularly important for chronic diseases that require expensive and constant selfmanagement, like diabetes. Approximately 537 million adults are living with diabetes globally, a number projected to rise to 643 million by 2030. In 2017, diabetes cost the US $327 billion, and while $237 billion of this was medical costs, $90 billion was due to lost productivity. Similarly, in the UK, the NHS spends around £10 billion a year on diabetes – 10% of its entire budget. If only to reduce unsustainable care costs, diabetes is a prime target for digital lifestyletreatmentglucoseContinuouslydiabetesalleviatesolutionstechnologyFurthermore,innovation.medicalanddigitalcanconsiderablytheburdenofself-management.monitoringlevelstoinformdecisionsandchangescanbe
demanding, not only for people with datadevicesLuckily,andfor(PWDs),diabetesbutparentscaregivers.today’sandthetheycapture provide exciting new possibilities for diabetes management and unparallel insights into each person’s condition.
This year, the 100th anniversary of the first insulin injection presents an opportunity to celebrate the development of several remarkable technologies that improve diabetes selfmanagement outcomes, strengthen interactions with care teams and enhance quality of life for PWDs. One of the most significant breakthroughs for diabetes since insulin was the development of Continuous Glucose Monitoring (CGM) Systems, which track glucose levels 24/7 through a tiny sensor, sending insightful data to an app.
CGM sensors are rapidly evolving, with new innovations providing PWDs with an ever-expanding range of options. For example, we recently launched the Eversense E3 CGM System, alongside our partner commercial Ascensia Diabetes Care. This is a system entirely tailored to the needs of PWDs. Our approach to CGM at Senseonics is unique, with a fully implanted sensor lasting six months, a removable smart transmitter that
provides Wewithtovibratoryon-bodyalertsandanappallowingyousharedataothers.stronglybelieve in this disruptive technology but recognise that all CGM systems offer different features and optionality is key. No person’s diabetes is the same and it’s vital that care providers recognise this.
These daily.PWDsmonitoringactivedecisionsofdanceelaboratereplacecanTheseinsulinautomaticallyaninsulinCGMthetechnologiesDeliveryaspancreas.referreddeviceswhichinnovativetheRecently,devicesinteroperabilityatHowever,caredigitallyandinnovationstechnologicalarelife-changing,theecosystemofenableddiabetescontinuestodevelop.toofferservicesscale,increasedbetweenandappsisneeded.therehasbeencommercialisationoftechnologiestakeinterconnectedtonewheights–toastheartificialAlsoknownAutomatedInsulin(AID),thesecloseloopbetweensystemsandpumpsviaalgorithmwhichadjustsdoses.systemseffectivelythedosingandglucosethatendure
To offer services at scale, incresed interoperability between devices and apps is needed
As we enter the digital age, we are witnessing a paradigm shift in diabetes care.
A data-driven approach to healthcare and an ecosystem of interconnected digital solutions are unlocking a future for PWDs in which diabetes management is no longer a burden. Companies, healthcare systems and regulators have shown they have the unprecedented ability to transform the lives of PWDs and their families; I am honoured to have been part of this journey.
Elaine Gemmell, head of regulatory affairs, InnoScot Health, writes about the need to implement comprehensive measures with the increasing prevalence of microbial contamination.
Since the COVID-19 outbreak, two key questions have arisen – how does it spread and how can we help to stop it?
The potential for transmission of disease by contamination in clinical settings has since been placed under the spotlight.
During care, medical devices and instruments will encounter infected patients. With a lot of patients requiring advanced care during a pandemic, meaning one device could be used multiple times in one day.
To prevent transfer, reusable medical devices must be sterilised or thoroughly disinfected between use, particularly point of contact devices that are used at the
Thebedside.Medical Device Regulation replaced the Medical Device Directive in Europe in 2021, which reflects the importance placed on contamination control. The definition of a medical device now includes products specifically intended for the cleaning, disinfection, or sterilisation of devices. These were previously considered accessories. It is anticipated that this definition will be incorporated in new UK
I devices don’t usually require assessment by a notified body unless they have a measuring function or are sterile. The new regulation requires a notified body assessment of the processes required to decontaminate reusable surgical instruments. Future UK legislation is expected to mirror these
Partrequirements.oftheapproval process considers the safety of devices with respect to microbial contamination. The extent of contact with the body and the invasiveness of the
device will determine the level of cleanliness required. For instance, a device which is intended to contact intact skin is required to be clean whereas a device which is invasive and enters the body though a surgical incision will be required to be sterile. Devices intended to be reused will be reprocessed in accordance with validated processes provided by the manufacturer.
There are several measures designed to heighten cleanliness and identify contaminants:
This detects the presence of microbial contaminants and may include identifying bioburden levels, presence of endotoxin, and methods for sterility assurance.
The manufacturer is required to provide reprocessing instructions to return the device to its original condition. This includes precleaning processes and packaging to maintain the cleanliness level of the product. This process must be validated. The device must not be damaged by the process and continue to perform as intended by the manufacturer. In some cases, degradation of materials due to the cleaning process may limit the lifetime of the product.
The type of decontamination required depends on the risk to the patient. High risk devices which are introduced into sterile body areas or contact a break in skin or mucous membrane require sterilisation. Medium risk devices which contact intact mucous membrane or are contaminated with virulent or readily transmissible organisms require disinfection. Low risk devices which only contact intact skin or do not come in direct contact with the patient require cleaning.
Cleaning can be achieved by mechanical or chemical processes. Mechanical cleaning requires a cleaning fluid and mechanical action. The action can be friction e.g., rubbing, brushing or ultrasonic agitation. Fluid is required to remove debris loosened by the mechanical action. Chemical cleaning requires detergent with added enzymes to break down proteins, fats, or starches.
Sterilisation may be achieved in several ways. Steam sterilisation uses high temperatures to kill microorganisms. Autoclaves are steam sterilisers and operate at temperatures more than 121°C.
Ethylene oxide sterilisation disrupts the cellular metabolism and reproductive processes of microorganisms. It is used when other methods of sterilisation are not appropriate since it does not expose devices to excessive heat, moisture, or radiation. Devices can be sterilised in final Gammapackaging.orelectron beam
sterilisation effectively kills microorganisms and will not leave residue. The amount of radiation received depends on the type of product and its dose Therequirements.marketfor detection and destruction of microbial contamination is growing, but devices also need to be tested and approved – a big challenge for medical devices with compliance needing to be rapidly achieved amid stringent regulations.
The pandemic has underlined the need for rapid detection of microbes and of releasing products faster and is an undoubted area of future opportunity.
Itoro Udofia, director, Medical Health Service at TÜV SÜD, a global product testing and certification organisation, outlines the challenges for medical device manufacturers with AI when it comes to regulation.
Regulatory requirements in the European Union (EU) and other major medical markets do not currently address the unique and complex characteristics of medical devices incorporating artificial intelligence (AI) and machine-learning (ML) technologies. This gap between advanced technologies that are currently available and existing regulations poses a myriad of challenges to medical device manufacturers that are seeking device approval.
By leveraging advanced algorithms and vast amounts of data generated through their routine use, AI-enabled medical devices and software as a medical device (SaMD) can quickly adapt to new information and changing conditions, as well as optimise their performance in real-time. These advantages can lead to improved treatment outcomes for patients, resulting in reduced costs and substantial gains in the overall quality of healthcare everywhere.
Although medical technologies with integrated AI capabilities offer significant potential for improving the quality of healthcare, they also present some important challenges when it comes to assessing safety. The greatest challenge comes from the singular advantage that AIenabled technologies offer - their ability to adapt their prediction to reflect accumulated data.
Traditionally, the assessment of the safety of medical devices has been based on predetermined and clearly defined risk assessment principles and practices, and ISO 14971 provides medical device developers with a detailed
However,roadmap. many algorithms and data models used in certain AI-enabled medical technologies are not “locked” but instead continuously
learn and adapt their functionality in real-time to optimise performance. These technologies may well present one risk profile during the initial product development process and a different risk profile after the device has been deployed for use with patients. Unlike static program code which can be evaluated line by line for its suitability, assessing AI functionality is a less transparent
evaluation of AI functionality is largely dependent on an assessment of both the quality and quantity of data since these factors directly impact how well AI algorithms and models perform. Key aspects affecting data quality can include hidden biases in the selection and collection of data, or errors in data labelling.
A more problematic issue affecting data quality involves the overfitting or underfitting of data, in which data sets either align too closely or not closely enough with the data models being used. Factors to be considered in assessing the quantity of the data required to validate AI models include both the complexity of the AI algorithm and the complexity of the problem that the model is tasked with solving.
Another challenge in the development and assessment of AI algorithms is the difficulty in explaining specifically how the algorithm drives the functionality of the medical technologies. AI models are generally based on a highly nested and non-linear structure, making it difficult to determine which specific input data has determined device function. Given this lack of transparency, it is often difficult to validate the basis or the appropriateness of the model’s process
There are at present no harmonised standards that specifically address the unique
performance aspects of AI technologies. At most, current regulations in major jurisdictions around the world address only specific aspects regarding the assessment of software. Organisations developing medical technologies with integrated AI capabilities should strongly consider taking a more expansive approach in assessing the safety of their products. Such a holistic approach would address every aspect of the product planning and development process and extend beyond the initial product release date to include rigorous postmarket surveillance activities.
To assist developers and manufacturers in evaluating these processes, the Association of Notified Bodies for Medical Devices in Germany (IG-NB) has issued a comprehensive “Requirements Checklist” for assessing the safety of AI-enabled medical technologies. Compiled with the assistance of TÜV SÜD, the IGNB checklist does not prescribe requirements for AI-enabled medical technologies. Instead, it details a process-oriented approach that considers all the relevant processes and phases of the product development life cycle. The criteria presented in the IG-NB checklist provide a comprehensive assessment of the risks associated with the application of AI in medical technologies throughout the entire product lifecycle.
It is important to note that, in situations where a manufacturer outsources key aspects of any of these processes, the specific recommendations of the IG-NB checklist are applicable to these outsourced activities as well.
Until appropriate standards and regulations can be developed and implemented, the IG-NB criteria provide a critical intermediate pathway for the approval of AIenabled medical technologies.
Ziv Peremen, CEO, X-trodes, explains the thinking behind its product and the trends that led them there.
1. TELL US ABOUT WHAT MADE YOU DEVELOP X-TRODES. We developed our Smart Skin solution having recognised that, with the general trend towards homecare, there was clear need to bring medical-grade monitoring capabilities into the comfort of patients’ homes.
The technology was developed following more than a decade’s research at the Center for Nanoscience and Nanotechnology at Tel Aviv University by Prof. Yael Hanein. Her academic publications drew widespread interest from researchers and entrepreneurs looking to utilise it for research in various disciplines or to develop different types of products. This led us to realise the potential for such a disruptive technology in simplifying the use of traditional electrophysiology and opening new possibilities that are not currently available due to confinement to a laboratory setup.
As a sensor, Smart Skin was only the foundation. Developing an end-to-end solution that supports the idea of seamless electrophysiological monitoring in a natural environment is an endeavour beyond the scope of academia. For me, it addresses an important need of bridging a gap of thousands of academic studies in this field, often poorly translated, into applicative products for daily use. Once I saw the potential for a DeepTech solution to bridge this gap I was fascinated by the chance to lead a paradigm shift in this field.
and require a trained technician or expert to administer and adjust the devices. Traditionally, sleep disorders are diagnosed in sleep laboratories, which are often not conducive for encouraging good sleep. Meanwhile, other wearable technologies are based on accelerometers, thermometers, and heart rate monitors that provide indirect and, therefore, often inaccurate correlations to direct monitoring of brainwaves.
X-trodes’ technology is the first to allow a full stage sleep analysis by monitoring patients’ brainwaves in their own homes. The Smart Skin’s dry printed electrodes conform to any part of the body to capture accurate signal readings, providing a more costeffective solution for multi-night measurements than those offered by traditional sleep labs. Unlike alternative at-home solutions, that generally focus solely on sleep apnoea, X-trodes’ medical-grade technology can provide insights for additional sleep disorders, including narcolepsy, bruxism, RBD, insomnia and restless leg syndrome.
First, we demonstrated the feasibility of the new materials and the contact of our Smart Skin technology with the human body. This took several years in a long development cycle of testing new materials, compounds, and manufacturing process until we found the right combination of sensor that is dry, soft, flexible, and able to maintain high-quality signal acquisition while attached to a human body.
Next, we developed the necessary electronics that could integrate five different signals (EEG, EMG, ECG, EOG and IMU) on a micro system. We initially tried to use
existing devices but found they could not meet the accuracy required for our purposes. This led to us building an entirely new device designed specifically for this purpose – collecting high quality signal across five modalities that is smaller than a pair of EarPods and weighing less than 20 grams.
We then developed an analytics layer that could take the signals that the system acquires when we measure in a normal environment and extract the excess background noise to identify the meaningful physiology information needed for the clinical uses.
The final stage involved understanding our users and to optimise the system for ease of use and to best suit their requirements. We have provided a medical-grade solution, but are also aiming to provide a consumer experience that is seamless, easy to operate and an enjoyable experience for our users.
We have been working with leading companies in the fields of printing and adhesives, as well as sleep monitoring and analytics. We also work with leading hospitals and research centres in Israel and the United States. We have been able to set up an advisory board of internationally recognised experts committed to helping us bring this mission to life.
Our technology complies with all the safety requirements to pass an Institutional Review Board (IRB) for research purposes. We are currently in the process of submitting the technology for 510(k) clearance with the FDA.
Ian Bolland spoke to Dave Pearson an engineer at EDF Energy whose hobby developed a medical device that can be used via Amazon’s Alexa, which recently won the Health Champion prize sponsored by Nuffield Health.
The idea of the solution came about because of Pearson’s father-in-law who lives with dementia as he struggled to communicate with the wider family.
MindMinder uses the artificial intelligence provided by Amazon Alexa to develop a personalised relationship with people with dementia to provide active stimuli and reminders while also developing a long-term assessment dataset that can be used to monitor and inform care providers and family regarding rates of mental stability and/ or Pearsondecline.explains:
“MindMinder was just a hobby of mine really which has grown legs and to get me off things like Facebook – and to try to redevelop that spare time to be more productive and exercise a few brain cells along the Manyway.”people
with dementia have good and bad days at varying points and can sometimes be increasingly harder to predict. Pearson was trying to use any data at his disposal to allow for more predictability when it came to his father-in-law’s condition.
“I figured if you could give a day-by-day analysis of someone's state, but also introduce links between that data and the environment and other knowledge about their lifestyle; it might be able to inform a wider understanding of dementia in a research setting as well.”
The draw of using Alexa was, in part, the accessibility of the technology. The objective is to help mentally stimulate someone living with dementia in a way that isn’t so question and answer focused – or to present examlike questions – but to allow people to recall their own experiences, and remember anecdotes or individuals.
“To move away from a clinical assessment tool to something that has a bit of banter woven into the story allows someone to be a bit more
engaged with it, and they don’t find it quite as threatening, or clinical.”
The objective is that is it allows someone to have a little more resonance with the story and allows them to trigger certain thought Pearsonprocesses.outlined
three things that he feels this approach can achieve:
“The first one is helping people live independently for longer in their own homes. Part of it will include things like reminders, including take medication or a drink of water, go and do a bit of exercise, a reminder to put the bins out. So, from a family member point of view, it gives peace of mind about a relative that they can live independently for just a little bit longer.
“The second thing is providing a reliable, consistent source of dementia assessment information that can be used to engage with clinical people and doing that in a way that isn't resource dependent on clinicians or nurses and home visits and all those other things.
“It will move away from needing day-to-day NHS resources to deliver assessments reliably at an individual level. The third thing I think is building on the wider context is if this can be
embedded in a wider population to support in the field, the NHS or another organisation, then across a huge population of people, you can also develop a data set that you know is not unique to an individual.”
Examples include the weather and environmental factors which could allow for a broader understanding as to what may make dementia worse or improve a person’s quality of life with the condition.
At the time of our conversation, Pearson explained that this idea only started out in February and was still in development, with the technology about to go through its first trial, having received support from the Nuffield Health Partnership and Ingenuity Programme Competition. He said that he plans to use the funding at his disposal to try and accelerate the product to market.
