MTI Issue 67

THE

CONTENTS regulars features

5. From the editor

Ian Bolland reflects on confidence in the medtech sector and the recent years covering the industry

6. MAKING MEDTECH

A round-up of the latest industry news

7. Expo News

What to expect from the conference stages at Med-Tech Innovation Expo 2024

12. On the cover PD-M outlines the cost benefits medical device companies consider as part of their plans to go green

18. DIGITAL HEALTH

MathWorks explores how digital twins are evolving healthcare

26. REAL WORLD MEDTECH

Ian Bolland catches up with DuPont following the launch of a soft skin conductive tape and soft skin adhesive at COMPAMED/MEDICA

9. Outsourcing

Broughton explains the benefits of outsourcing stability studies for inhalation devices

10. Ireland

The University of Galway explains more about its partnership with Medtronic

16. Regulation Medidata considers if regulation will be keeping up with the pace of technology in 2024

20. Industry 4.0

Foxmere outlines why OEMs need to automate high precision assembly

24. Micro and nanotech

Micrometric highlights the capabilities of laser cutting in small medical devices

26

group

+44

MED-TECH INNOVATION

5-6 JUNE 2024

Medtech | Devices | Digital HealthTech | Medical Plastics | Manufacturing | Software | Inspection and Metrology | Regulation | Design | Early-Stage | Innovation | Pharmaceutical

NEC | BIRMINGHAM | UK THE

Attend the UK and Ireland’s leading event for medical device manufacturing.

Back to the future? from The editor

W[

hen first putting together this issue of Med-Tech Innovation News, my Twitter (no Elon, I’m not calling it X) feed in the early days of January lit up with government cabinet ministers celebrating the great opportunity that awaits businesses in the UK joining the Horizon Programme. Sorry, rejoining.

I had earlier said in a piece on the website that it was a good move from government for the UK to be back in the Horizon Programme – a grown up move following several years of populist, childish squabbling. Yet it stuck in the craw a little when a substantial number of those who advocated for Britain’s withdrawal from the European Union, subsequently shifting the goalposts to claim a mandate to withdraw from any initiative or institution that had any variation of the word “Europe” in the title – were those celebrating this news.

It serves as a reminder of the uncertainty and lost time and talent that has been a signature of recent years because of playground politics. Speaking of which, it is an election year in the UK, with opinion polls suggesting the public will be voting for a change in government. If that is the case, one would hope that an ejection of the incumbents will see a return to sanity, allowing industry, and businesses such as in this sector to have a more certain environment to operate in and make it easier to trade with neighbouring nations.

That’s not to say a change in government will be the silver bullet to all the challenges facing manufacturers and other businesses involved in medical technology. There are challenging economic conditions still being faced, the manufacturing outlook in the UK is not exactly optimistic as one report indicated the sector shrank for the 17th consecutive month with optimism hitting a 12-month low at the start of January – and on a wider scale, economic statistics suggest the UK economy entered recession towards the end of last year.

On a separate note, this will be the last time I will be adorning these pages, so apologies to those who will miss my musings, but after the best part of four years editing this title, and five-and-a-half years at Rapid News, it’s time for a change from writing about all things medical technology in an editorial capacity.

It has been a great pleasure covering this industry. I knew close to absolutely nothing on Day One walking into this job – some of you may suggest I don’t know an awful lot now – but it has been an eye opener covering this industry during one of the most tumultuous times in human history with a pandemic and seeing how much a force for good the sector can be. It’s been, and still is, a really exciting time to be a part of it.

I’m sure the next editor will have loads of fun with you all, and I’m very excited for the journey they will be going on with you.

For those wondering if I’ll still be involved in medical technology. Yes, in a way, on the other side of the fence! You might well see me at Med-Tech Innovation Expo 2024. So, this might not be goodbye, just au revoir.

Medical devices spur growth for software and electronics firm

Embedded systems consultancy ByteSnap Design has announced robust sales in 2023, largely driven by hardware and software projects in the medical devices industry, which has led to the consultancy expanding its core team to 43.

ByteSnap Design has developed software and electronics for many healthcare companies and medical device developers. Healthcare experience coupled with indepth hardware and software knowledge saw ByteSnap Design secure several new projects.

Most of ByteSnap Design’s medtech contracts come from established medical companies that already have accredited product development teams, which ByteSnap works alongside to bring devices to market.

Clients the company has worked with include GCE Healthcare on portable oxygen concentrators, Hark’s new sensor technology for pharmaceuticals, and White Horse Scientific on lab monitoring equipment.

Some existing medical devices are close to obsolescence due to outmoded operating systems which no longer meet security criteria. Such devices require migration to newer supported operating systems. While Windows and Linux operating systems (OS) are selected in many industries, QNX is a robust choice of OS for high-reliability systems that ByteSnap can also offer help integrating.

Graeme Wintle, director of ByteSnap Design, said: “Given the volume of work that is coming our way through referral or repeat business, we are increasing our investment in the area and have taken on additional engineers. We’re a safe pair of hands for our medtech clients and can advise on the issues and pitfalls of designing and bringing their next generation of product to market. A large part of our project work includes extending the life of products that face the risk of obsolescence, thereby saving our clients the high costs of developing and bringing them to market.”

ByteSnap plans to grow its medical devices business by supporting a full choice of operating systems, from Windows 10 IoT Enterprise on ARM to Linux and QNX on a wider range of embedded CPUs.

Cambridge Cognition and Actigraph partner on central nervous system clinical trials

Cambridge Cognition, which develops digital solutions to assess brain health, is partnering with ActiGraph, a provider of wearable technologies for clinical trials. The partnership will deliver a suite of assessments to provide a fully rounded view of mental and physical capabilities.

ActiGraph’s

Accelerant partnership program is designed to advance the use of digital health technologies (DHTs) in clinical development by simplifying CROs’ and technology vendors’ access to raw data streams. As part of this strategic partnership, Cambridge Cognition and ActiGraph will combine their collective expertise in digital data collection to enhance assessment capabilities in CNS trials in areas where there is

a large unmet need, such as schizophrenia and dementia.  Cambridge Cognition offers touchscreen and voicebased digital assessments of cognition and other brain health indicators that have been based on over 30 years of work. The company’s suite of e-clinical technology solutions can be used at home or in-clinic.

Francesca Cormack, chief scientist, Cambridge Cognition, said: “CNS disorders are characterised by a host of heterogeneous symptoms which impact daily life, but

Health minister joins life sciences innovation event

Health minister Andrew Stephenson CBE MP joined the first life sciences event of Leicestershire Innovation Festival 2024.

Stephenson visited Charnwood Campus to join more than 100 delegates considering innovation as a potential solution to health disparities and inequalities. Attendees included senior representatives from the NHS, as well as clinicians, researchers, and life science business leaders.

The discussion event was designed to consider the impact on the physical and mental wellbeing, and life chances, of individuals in most-impacted groups and recognised the work and growth of the life science organisations clustered around Charnwood Campus Science, Innovation and Technology Park in Loughborough.

The minister for health and secondary care said:

that are often inadequately addressed by existing treatments. Our partnership with ActiGraph represents an exciting combination of expertise in objective digital measures of actigraphy, speech and cognition that will help accelerate the development of treatments for patients and improve efficiency in clinical trials.”

Christine Guo, chief scientific officer, ActiGraph, added: “Digital health technologies give us the ability to collect data objectively during a patient’s everyday life. This is especially important in CNS disorders where conventional assessments are prone to subjective biases. We are excited about this partnership with Cambridge Cognition to provide advanced clinical insights to study teams conducting CNS trials.”

“Programmes like this are a fantastic opportunity to bring together government, industry and academia to collaborate, discuss and drive forward innovation. Embracing cutting-edge science and technology are vital to boosting our public services, improving people’s lives and making the UK a life science superpower.”

The Med-Tech Innovation Conference this year will include two high-end keynote sessions. With the programme now taking shape, we can give you some insight as to what you can expect on 5-6th June at the NEC.

After last year’s keynote on The MedTech Strategy, David Lawson the director of medtech at the Department of Health and Social Care will revisit the strategy a year on. On Day Two Lawson will reflect on the progress made to date against the four priority areas of resilience, innovation, enabling infrastructure and special market topics with a vision of right product, right price, and right place.

The health and wealth at Med-Tech Innovation Expo

The main conference stage this year will also include thought leadership on some of the most pressing topics in the industry, with seminars from the Department for Business and Trade, Medidata, Charco Neurotech, Symbiotex, Withers & Rogers covering international trade, diversity in clinical trials, human centred design, intellectual property, and innovative material use as part of

its extensive offering. In addition, an hour-long panel on sustainability will feature on Day Two hosted by PD-M International, who will provide insight along with guests on how to tackle particular challenges to reduce carbon footprint.

as important regulatory advice from consultancies. With many medical device companies grappling with the changing regulatory landscape, finding the right notified body, or tackling the approvals process amid MDR and UKCA transition processes, experts are on hand to help.

Not to be outdone, the Introducing Health-Tech stage will showcase the best from the show floor including new technological developments, sound advice and practices as well

After last year’s keynote on The MedTech Strategy, David Lawson the director of medtech at the Department of Health and Social Care will revisit the launch of the strategy a year on. On Day Two Lawson will reflect on the progress made to date

Other sessions feature aspects of testing for medical devices, material selection, dealing with the challenges and opportunities that have arisen because of artificial intelligence, securing funding for research and development, any many more.

For the fourth consecutive year, the content from the Introducing HealthTech Stage will be rounded off with PITCH@Med-Tech Innovation Expo, where companies from the start-up zone will participate in quick-fire pitches in front of our audience, including an expert panel of judges as this year’s start-ups look to add their names to the list of previous winners including SurePulse, Neuronostics and OxNNet.

Med-Tech Innovation

Expo takes place on 5-6 June 2024 at the NEC, Birmingham. To see the full, up-to-date conference schedule and to register to attend, visit www.med-techexpo.com

Why Live Data is behind successful NHS engagement

Ready-made, easy-to-implement, cost effective solutions with the most up-to-date and accurate healthcare data

Our compliant databases feature more than 430,000 senior management and healthcare professional contacts.

And breathe!

Outsourcing stability studies for inhalation testing

Malcolm Saxton, senior consultant for chemistry at Broughton, explores the benefits of outsourcing stability studies for inhalation devices.

Stability studies are a crucial step during the development of inhaled medicines to ensure the product maintains quality, safety, and efficacy for its entire shelf life. However, they can be resource, time, and space intensive, so outsourcing these studies to a trusted partner can streamline the process.

Inhalation therapy is the cornerstone of treatment for many patients with chronic respiratory disease, a global issue affecting around 450 million people worldwide. Due to the benefits of inhalation as a rapid drug delivery method with the potential for reduced side effects, researchers are investigating inhalation therapy for novel applications.

For example, with the advent of novel respiratory diseases, including COVID-19, researchers are considering inhaled biologics, such as monoclonal antibodies, as therapeutic approaches. Inhaled antimicrobial peptides and proteins are also emerging to target multidrug resistant bacteria.

When bringing inhaled medicines to market, a stability study is an essential body of work required for regulatory submission. Stability studies are designed and conducted according to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH offers guidance on the proposed length of the study, storage conditions, and sampling frequency based on the product and its intended shelf life, although some products may require custom conditions.

STABILITY STUDIES FOR INHALED MEDICINES

However, designing a stability study for inhalation devices, such as nebulisers, pressurised metered-dose inhalers (pMDIs), and dry-powder inhalers (DPIs), can be complex, and numerous devicespecific factors must be controlled.

For example, it is essential to ensure that particle and droplet size remains consistent as part of the stability study, as particle size can directly impact the rate of dissolution and bioavailability in the lungs, affecting product efficacy.

In addition, the orientation of pMDIs — whether they are stored upright or not — may impact the device’s effectiveness. DPIs also have stability study design considerations; they are often packaged in a foil overwrap, for instance, and so the study should include removing the product from the packaging to measure the impact on shelf life, quality, and efficacy against the drug product specifications.

Furthermore, as more large molecule drug products, like biologics, come to market, stability assessments must adapt accordingly. These molecules are more prone to degradation, typically requiring more complex analysis, additional parameters to measure, and/or the need for custom test conditions. Biopharmaceuticals, for example, tend to exhibit more unpredictable degradation pathways than small-molecule APIs and may precipitate during the test due to their concentration and/or low solubility. Study design may be more challenging as a result.

WHY OUTSOURCE?

Pharmaceutical companies typically outsource stability studies due to space, facility, and resource constraints. Stability testing and analysis is a specialist field — if a company does not have in-house experts for method development and validation, particularly when working with a complex drug product, outsourcing may be a good solution.

Some stability study providers will have broader expertise and can give you access to subject matter experts, such as analytical chemists and toxicologists, who can help complete test data

analysis, understand deviations, and troubleshoot problems. If the partner is also an expert in extractables and leachables (E&L), studies can be run in parallel, streamlining the route-to-market. In addition, a partner with an in-house regulatory team can help prepare everything needed for submission to the regulatory body.

HOW CAN A PROVIDER SUPPORT WITH DOCUMENTATION?

For stability studies, it is extremely important to document that test conditions were maintained throughout to validate the study. Pharmaceutical businesses, therefore, must ensure their stability study provider offers end-to-end quality-controlled processes for the receipt, management, storage, and disposal of samples. Some providers take this up a level, by offering real-time access to stability data through Laboratory Information Management Systems (LIMS), ensuring compliance with regulatory standards.

With over 450 million patients worldwide suffering from respiratory diseases, the market for inhaled medicines is growing. Regarding stability studies, manufacturers can save time, effort, and resources by outsourcing to a trusted provider. Doing so enables manufacturers the ability to focus on their core competencies.

Signed, sealed, delivering

After striking a €5 million signature partnership with Medtronic, president of University of Galway Professor Ciarán Ó hÓgartaigh, explains

more about the significance of the partnership

First, tell us about the significance of this being the first partnership between the university and industry?

The University of Galway and Medtronic Signature Innovation Partnership runs for five years.

The new partnership has three major components:

• Health Technology Ecosystem

Pillar: A signature investment in the expansion of the University’s medtech ecosystem aimed at addressing gaps in translational and clinical trials infrastructure.

• STEM Education and Outreach

Pillar: Continuing and expanding Medtronic’s current programmatic support and investments campuswide.

• Research Pillar: Providing earlystage seed funding for new Medtronic-University research projects.

As Medtronic already had a presence in Galway prior to this deal, how big a coup is it for the area and the university to have this agreement in place?

The partnership is created as part of University of Galway’s Meitheal campaign, an initiative bringing together individual, industry and community stakeholders to advance our strategic priorities in the areas of medical technology, clinical trials, sustainability, innovation, and creativity.

In that context, it is hugely significant for the University. It is also symbolic of the scale of ambition and intent that University of Galway has as a researchled institution which places its work for the public good at the heart of everything it does.

This partnership aims to develop the medtech ecosystem, STEM and research – how will it go about this?

Our vision is to reinforce Galway’s recognised position as a global medtech research and innovation hub, transforming the lives of patients around the world by providing new solutions to address the world’s persistent healthcare challenges, and centred around the internationally recognised excellence of University of Galway’s facilities, faculty and students.

It is ambitious. Over the five years of the initiative, the University-wide partnership will significantly advance the existing collaborations between the University and Medtronic to further grow collective expertise.

It will also help to launch bold new initiatives that will have major impact not only for our two organisations, but also for Galway, Ireland, and the world.

The partnership will drive investments in translational and clinical trials infrastructure and research at the University by supporting two new University of Galway research institutes: the recently established Institute

It will also help to launch bold new initiatives that will have major impact not only for our two organisations, but also for Galway, Ireland, and the world

for Clinical Trials and the soon to be established Institute for Health Discovery and Innovation.

The aim of the creation of these two new institutes is to accelerate and heighten the real-world impact of our research in the biomedical engineering science and clinical trials domains.

By bridging the lineage and harnessing the outputs of basic, applied, and clinical research, we can transform our research into life-changing treatments and interventions for a range of medical conditions and improve patient outcomes in a meaningful way.

What will the new research institute that is due to be established offer?

The establishment of the two new research institutes by University of Galway will provide a seamless infrastructure that will bridge the gap from basic and translational research through to the prototyping and clinical trials of new medical devices and technologies, leading to life-changing impacts for patients.

Medtronic’s philanthropic investment will positively impact the creation of an integrated and comprehensive end-to-end infrastructure, and in particular, will contribute to the establishment of a new Prototype Hub and a new Clinical Accelerator Hub which are part of the two new Institutes.

The development of the Institute for Clinical Trials will drive expanded clinical trial activity in Galway benefiting patients across Ireland who will have exponentially increased access to cutting edge medical technologies and treatments.

What does this partnership say about both the strength of Galway and Ireland’s medtech sector as a whole?

Ireland is one of Europe’s largest medtech hotspots, home to over 300 medtech companies. Nine of the world’s top ten medical device manufacturers have operations here and Ireland employs the highest number of medtech personnel per capita in Europe. Galway is at the heart of this activity, a mix of medical technology start-ups, multinationals and research centres that employs over 8,000 people.

This critical mass presents a compelling case for companies to grow and diversify their presence in the region, allowing them to capitalise on new opportunities afforded by the Irish medtech ecosystem and ever closer partnerships with University of Galway.

Specifically, this new partnership will benefit industry by:

• Building on the strength of Ireland and the West of Ireland as the centre of the global medtech ecosystem

• Strengthening opportunities to attract and retain global talent and leadership to Galway and provide a talent pipeline for the sector

• Advancing and accelerating basic and applied medical technologies research at the highest levels

• Placing Ireland on the map as the destination of choice for global clinical trials by advancing and accelerating the University’s leadership in clinical trials design and delivery

• Expanding educational opportunities in the medtech field so the University can continue to produce highly skilled graduates and leaders for the medtech industry

• Unlocking significant new sources of funding for medtechrelated research projects, leading to future positive breakthroughs in the treatment of disease and improvements in human health

• Driving new and innovative startup companies through innovation training including support for the Bioinnovate programme and the University of Galway Ian Quinn Centre for Health Discovery and Innovation.

Anything else you’d like to add?

One of the largest corporate philanthropic investments in Ireland in recent times, this new partnership builds on the foundation of an already deep and mutually beneficial relationship between our two organisations. This is the first campus-wide industry partnership at this scale at University of Galway. As well as the benefits for patient care, for the medtech ecosystem and for the university as an institution, our students will also benefit hugely.

We have a robust teaching programme, enhanced by its significant contribution to the academic research ecosystem in Ireland. Through deep partnership with Medtronic and other select industry leaders, we can explore a shared vision and to produce and develop medtech’s future leaders.

The partnership will allow us to do the following:

• Expand education opportunities and access for students in the medtech field

• Expand opportunities for studentled joint research programmes at the masters and PhD levels

• Engage current students with industry expertise, bringing leaders from the medtech industry into the University teaching and research community

• Enhance our robust programmes in innovation and entrepreneurial skills, including the BioInnovate training programme and the IdeasLab Enterprise Challenge programme

• Provide a clear pathway from research and ideation to proof of concept and commercialisation.

A FULL CIRCLE:

HOW CUTTING CARBON CAN CUT COSTS

Richard Shaw, sustainability lead at PD-M, outlines the cost benefits medical device companies can consider as part of their plans to go green.

First, how would you define sustainability in the medical device sector?

It’s becoming a hot topic. For a lot of organisations, it’s totally new, but unlike Brexit and COVID, it’s not transient, sustainability will be a driving force across the sector for decades to come. Currently, we’re at the bottom of the S-curve, we’re through the literacy building and well into the ‘take action’ phase. We’ve seen an increasing desire to adopt a circular economy with medical devices through programmes such as ReMed and Design for Life (DHSC). Things are also moving in a systemic way and the NHS netzero roadmap has been the catalyst for this. When an organisation of that scale makes a net-zero commitment it puts the entire supply chain on the same journey. This domino effect has been felt over the last year and whilst it may feel like another burden to suppliers, sustainability represents a business opportunity. To see the opportunity requires a mindset shift, and that’s the hardest part to achieve. Once directors and senior leaders see sustainability as an opportunity then things can move quickly.

What should be considered when designing an environmentally friendly healthtech product?

It requires a shift in strategic thinking. It’s important to determine where the product sits in the care pathway. If the device can speed up diagnosis, reduce hospital visits,

or theatre time, this can yield the greatest carbon savings, way beyond switching to a bioplastic for instance. It’s an important aspect, and one that’s gathering interest as it builds on the existing valuebased healthcare approach.

The first thing to understand is what the product lifecycle looks like – the three main phases of production, use and end-of-life. This is important as sustainability gains can be made at almost every point in the process. During the creation, we can look at sustainable materials, low-energy production methods and reduced packaging. Then in use, does the product consume energy or other resources to function, and how can these be minimised? There is real momentum building around re-useable devices, but they aren’t a silver bullet, and we must look at the effects of reprocessing since washing and sterilisation has an impact too. Lastly, the end-of-life phase can vary depending on the nature of the device, as we know many are incinerated, some are

It’s only now the net-zero agenda is ramping up we’re seeing manufacturers start to look at this seriously. We knew we could reduce the carbon footprint of devices through design decisions, but this needs to be tied back to the cost benefit

designed to be re-usable, and others are a hybrid of the two. The NHS waste strategy features a target reduction of 50% in carbon emissions from waste by 2026. With high temperature incineration producing 15 times the emissions of recycling, it is clear which directions things are heading.

What are the main challenges in applying sustainable design to medical devices?

The biggest is probably the mindset shift that’s required to see sustainability as an opportunity. This isn’t unique to medical devices, but largely being a B2B product there isn’t the consumer demand for sustainability since patients have virtually no influence into the devices they’re treated with. It’s only now the net-zero agenda is ramping up we’re seeing manufacturers start to look at this seriously. We knew we could reduce the carbon footprint of devices through design decisions, but this needs to be tied back to the cost benefit. We’ve been taking clients through the carbon accounting process for their carbon reduction plans (CRPs) and once the correlation between cost and carbon becomes apparent, we see senior stakeholders more engaged, and want to probe further into reducing carbon and cost together.

One big challenge is with the regulations. Manufacturers design devices to meet them and if sustainability isn’t written into them, it can be a barrier. Bringing a device to market is fraught with risks, costs, and challenges, so to add a ‘novel’ material on top needs to be very carefully considered, so being smart and selective in the approach is critical. Also, used devices are often treated as contaminated waste and have regulations which limit recycling options. Things are changing however and the DHSC is working towards a framework to bring circularity into medical devices.

80% of a product’s environmental impact is determined during the design phase. A) How is this the case? and B) What can be done to minimise any detrimental impact?  During the design stage you’ve got to consider what materials the device is going to be made from, how it will be manufactured, assembled, the technical performance, even where and how it will be transported. Once a product is designed and moves into a manufacture phase, its production run can go on for years,

even decades. Making changes to a product already in the market for a sustainable improvement can be very hard to commercially justify, so it’s vital sustainability considerations are built in from the start.

Thanks to carbon footprinting tools you can assess the environmental impacts of a design in a comparative way, at the early stages. This allows you to refine the design and measure the impact of your decisions. It’s also at the design stage you begin to engage with manufacturers and material suppliers. Deciding who and where a product or component is going to be made can have a significant impact, particularly if there are components or materials are being sent by air freight. Typically, devices are manufactured and sterilised in different locations leading to a lot of shipping back and forth. All this transportation creates emissions, so shrinking the supply chain or bringing sterilisation in-house brings carbon and cost savings.

Does reducing emissions also reduce costs? Or is it more nuanced?  It can be that simple, the two are directly linked. In doing Green House Gas carbon accounting, you see the parallel with every invoice carrying a carbon cost. The increase in energy costs prompted a lot of organisations to look at energy efficiency measures. These will help cut costs, but also the emissions associated for instance in heating a building. These operational reductions fall under scope 1 & 2. It’s a common place to start because it’s quick to implement as it’s within the control of the company and brings a quick ROI. Making changes relating to products is usually part of a long-term strategy, they can be harder to achieve but could bring far more significant savings. Simple steps can be taken such as ‘lightweighting’ by stripping out material we can reduce the weight, cost, and carbon all together with minimal regulatory implications. Historically ‘sustainability’ hasn’t been a factor for medical devices so there is great potential for improvements, both to existing devices and those in development.

Adopting new, more sustainable materials can carry a higher cost, so a holistic approach is needed. By balancing several changes, we can deliver an overall net saving in cost and carbon.

CREATING OPENINGS:

Why Live Data is behind successful NHS engagement

Oli Hudson, content director at Wilmington Healthcare, explores why smart, accessible and accurate NHS customer data is vital for UK medtech.

In speaking to life science stakeholders about engaging their customer base, one phrase that comes up again and again is: the right message, with the right frequency, to the right audience.

It’s an easy thing to say. But in the complex, cross cutting world of NHS stakeholders, with a range of responsibilities, priorities, and needs, it becomes challenging to assess who is that audience, what message they need, and when.

From the other side, medtech has a range of communication needs. How do you assess who needs a regulatory notification about a product? Who are the procurement managers? Which stakeholders are involved in creating a new pathway for a new surgical technique?

The solutions all hinge on data. Data that has reach; data that’s reliable; data that’s up to date; data that is granular; and data that is compliant.

At Wilmington Healthcare, great care is taken to ensure that the five elements above are always in place for any data we distribute to our industry clients.

The NHS differs from many other healthcare systems. NHS personnel can be confusingly compartmentalised. It’s not always easy to discern who the players are in each pathway.

Wilmington Healthcare operations director Sarah Hawkins says: “Our global clients ask what would you do differently with UK data – and I would say: everything!

There are different structures, organisations, and decision-making units.”

In such a market Live Data, that is constantly updated and can be made to order, based on pressing client needs – give an immediate advantage.

FIVE REASONS WHY YOU NEED LIVE DATA

Below we outline five aspects of our Live Data – and why getting the messaging and data right is all-important.

1. Reach: The NHS is one of the word’s largest employers and keeping track of the right contacts within it is highly challenging. Our database of over 340,000 contacts is larger than anything else available in the UK market.

2. Reliability: Our data is scrupulously researched to ensure the right people, attached to the correct healthcare settings, are presented for your needs; we know their current reported roles and responsibilities and how they fit into wider teams and decisionmaking units.

3. Currency: Our datasets are regularly reviewed and updated to ensure that in the fast-moving world of the NHS customer, you are always dealing with the latest possible information.

Head of sales Andy Hart says: “Static Data goes out of date. Live data is living and breathing, and on demand”.

Sarah Hawkins adds: “We make over 37,000 updates to our

data every month. It’s a full-time operation with a dedicated staff – we invest in our data, so your company doesn’t have to”.

4. Granularity: The modern NHS has many overlapping, crosscutting and sometimes confusing organograms. It’s important to get to the heart of who you need to message; the disease treaters, the clinical networks, the payers, the commissioners or the influencers. Get your message across to the people who can most directly action it.

Wilmington is uniquely well resourced with data on payers and commissioners, so if you are building influence on systems and pathways above the level of individual clinicians and procurement departments, we can help.

5. Compliance: Above all, customer relationship management must be compliant. You need to make sure you can access and contact all your customers within data law and within industry guidelines - and send comms that are targeted and only go to those for whom its appropriate. Wilmington specialises in compliant data.

IN SUMMARY

If you’re launching a device or trying to get engagement with the NHS on a new technique or area of healthcare, you need to know who you will use it, who will procure it and which stakeholders will benefit from it. Here, success is based on the best possible customer data. Companies in the past have been obstructed by data that is outdated, unreliable and unrepresentative of the current NHS.

We can help and position you in your market with fast, accessible, cutting edge and accurate data –that is on demand, can work with your current CRM system, and can be tailored to your commercial, organisational and team needs.

If this sounds like something your business would benefit from, then we have ready-made solutions for you - easy to implement, costeffective and most importantly, healthcare market specific.

Thomas Averre, Director at Tarleton Communications, a specialist life sciences public relations agency.

Gaining leads and INFLUENCING PEOPLE

“I don’t know who you are. I don’t know your company. I don’t know your product. Now – what was it you wanted to sell me?”

Sound familiar? The most common mistake I see companies making is the decision to ‘put off ’ a PR campaign, usually until they launch their new product or officially start raising money. This only kicks the can down the road.

If you want someone to make a decision, you need to start influencing them long beforehand.

HOW PEOPLE MAKE DECISIONS

Most decision makers are risk adverse. The fear of making the wrong decision far outweighs the benefit of making a great one. This applies to customers, investors, partners and just about anyone you want to influence.

So, what do you do? Reduce the perception that you are a ‘risk’.

If someone has read an article you’ve written and seen you in the media regularly, you are a lot more credible and trustworthy than if you arrive out of nowhere promising a revolutionary new solution (“If it was that revolutionary, I would have heard about it wouldn’t I?”).

In healthcare, the reputational and regulatory consequences of a mistake are much higher than other industries. This leads to a bias in favour of familiar and recognisable companies that are perceived to be less risky.

This is complicated by the fact that in many situations, particularly if you’re trying to sell into the NHS, there are different stakeholders influencing decision making. This means you need to be communicating with everyone who influences decisions, tailoring your messages to each audience.

Clinicians want evidence, so give them clinical studies and peer reviewed publications. Commissioners want efficiencies, so show them how you’re going

to save money. Policymakers want deep impact, so focus on population health messaging.

REACH WIDE AND START EARLY

PR is the most credible way of reaching large audiences, with a message they trust. Unlike advertising, it is not ‘tuned out’, cannot be bought and comes with a built-in credibility factor. It is a powerful tool for explaining problems, proposing new innovations, and attracting investment.

If you do no marketing at all, or you have a comprehensive marketing strategy already, PR should be part of what you do. Amid all the doom and gloom of dying publications and declining readership, it is still the most effective way of reaching huge numbers of people and getting them to pay attention.

I work with some of the UK’s most innovative start-ups to help them attract investors, and with larger organisations to help them raise their profile. Whether you’re looking to raise a Series A, gain more customers, build a personal brand for your CEO or influence government, PR is an indispensable tool in your marketing armoury.

Also, there is no mystery to it. Most editors put their contact details on their website – the days of ‘black books’ of contacts is over. So why bother with a specialist PR agency?

Because I could repair my own car, but someone else is better at it than I am. I pay them to do it properly and efficiently so that I can get on with doing the things I’m good at. Whether you’re running a marketing team or running the whole company, its very unlikely you have the headspace, time, or skillset to do justice to the outstanding work you’re doing – so

appoint someone who can. Many of the clients I now work with were once sceptical of the value and affordability of PR but are now complete converts. I’ve secured coverage for clients in Sky News, Fierce Healthcare, The Engineer, Drug Discovery World, UKTN, MedTech Innovation News (obviously!) and more.

This coverage, though nice for the corporate ego, has also helped these businesses succeed. By going wide (reaching everyone involved) and going early (so they are primed before they make a decision), it has directly led to new investor interest, new customer acquisition and changed the perception of others in the market in a measurable way.

I appreciate the irony of this being a ‘sponsored’ article, but frankly, what I have to say isn’t newsworthy. What you have to say probably is – that’s where I can help.

If you’re currently looking to raise investment, launch a new product or build a sales pipeline, the best time to start your PR campaign was 12 months ago.

THE SECOND-BEST TIME IS NOW.

If you’d like to pick my brains on how you can reach and influence others through PR, email me at thomas@tarletoncomms.com.

Fiona Maini, senior director global compliance and strategy at Medidata, a Dassault Systèmes company, outlines the challenges that regulation has with keeping up with technology in 2024.

Over the past decades, we have seen science and technology progress at a phenomenal rate which is a trend that continued throughout last year. Whilst these progressions are pushing innovation there is often a gap between innovation and regulatory frameworks which is often called the pacing problem. Regulators are on a constant learning curve with new innovations; and keeping up more than ever. The innovation offices now established at the regulatory authorities have created a win-win scenario. Here clinical stakeholders can discuss and work with the regulators, helping them to understand the innovations which will become a new normal for clinical research, while retaining their pragmatic and proportional-risk approach to approvals.

In this industry, success is often measured in regulatory approvals – so, what is being done to address this delay in approvals, and what progress can we expect in 2024?

IT’S ABOUT AI ADVANCING INTO BROADER CLINICAL AREAS

Artificial Intelligence was one of the hot topics for the industry in 2023 with the potential benefits of the technology becoming increasingly apparent across the sector, and we are already seeing the impact of AI in drug development, medical imaging, diagnostics and, more generally, across clinical research. At the heart of clinical trials is the collection, synthesis, and analysis of large volumes of complex data, and AI offers new solutions in the management of this data, creating new efficiencies and accelerating the trial process. AI can improve trial design by aiding the selection of trial sites and it can give

investigators and clinical staff the tools to support better patient care therefore improving the patient experience.

Regulatory frameworks allow the incorporation of these hightech solutions into trial design (and the healthcare sector more widely) in a responsible manner, ensuring the prioritisation of ethical principles at every step of the journey. Potential barriers to the adoption of new technology, such as the right to data privacy, must be rigorously evaluated to protect patients and maintain good healthcare outcomes. The associated challenge is the upskilling required to bring regulators and other stakeholders up to speed with the latest developments in as close to real time as possible,

all whilst ensuring they have a comprehensive understanding of the processes involved. Regulators need a good grounding in the latest technological advances to understand both the benefits and risks, and therefore produce informed, timely guidance to provide clarity for the industry and ensure patient safety.

This is no easy task, but the modernisation of regulatory frameworks to capture these innovations has been progressing at an impressive rate. For example, the EU AI Act, initially proposed in 2021 and updated in 2023, lays out the foundations for the use of ethical and trustworthy AI, and for validating and controlling algorithms via a risk-based approach. As with any new regulation, there are always

challenges to overcome and understanding the impact of any new rules regarding, for example, the current EU MDR will be vital for the successful implementation of new technologies. Ensuring that regulations are clear, and that there are enough notified bodies to certify new technology and devices and effectively support the industry, is instrumental for the timely approval of novel scientific and technological advancements.

KEEPING PACE – WHAT’S NEXT?

Over the past few years, there has been a significant increase in the number of innovation offices at regulatory authorities, allowing developers to present technology at an earlier stage. This helps to minimise the lag time before regulatory guidance can be developed. This open-door policy demonstrates an ongoing commitment from regulators to embrace scientific and technological change more than ever before.

However, keeping up with major breakthroughs in the industry requires forward planning.

That’s why a working group at

the European CRO Federation (EUCROF) is looking at the future of clinical trials and new technologies that may impact clinical research as well as the role of regulation within this. EUCROF regularly engages with a range of stakeholder groups across the clinical research space to build a well-rounded picture of the direction of travel. This type of work is vital to ensure that we have the right resources and people in place to accelerate approvals and promote the prompt implementation of these scientific and technological innovations, ultimately for the benefit of patients.

champion advancements in the industry, accelerating the speed at which these innovations can reach patients and healthcare professionals for the benefit of the sector more widely.

BUT HOW?

Another development on the horizon is the finalisation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use’s (ICH) third revision of their Good Clinical Practice guidelines, which is expected soon. This framework will address key concerns regarding data governance, which is an important aspect for patient care within the wider use of data and AI in healthcare. The European Medicines Agency (EMA) has also published a draft reflection paper on AI across a medicine’s lifecycle. These developments in the regulatory space represent a drive to

Barriers to achieving and, crucially, maintaining this pace remain centred around resourcing and budgeting. As the science and technology continues to develop, new training schemes are required to ensure an understanding of the advancements, which places a significant burden on regulatory authorities in terms of the time and cost required. Using forward looking plans to ensure appropriate time and resource allocation in anticipation of major industry innovations will be beneficial in reducing any delay in regulatory approvals.

LEVERAGING REGULATION FOR INDUSTRY GROWTH

When new guidelines are released, there tends to be an increased confidence from industry to work in these areas; conservatism stems from not wanting to invest in something that regulators are yet to form an opinion on. Therefore, the ability of regulators to keep pace with the industry is not only imperative for the timely implementation of newly developed scientific and technological advancements, but also for promoting future innovation and ambition within the sector.

This is no easy task, but the modernisation of regulatory frameworks to capture these innovations has been progressing at an impressive rate. For example, the EU AI Act, initially proposed in 2021 and updated in 2023, lays out the foundations for the use of ethical and trustworthy AI, and for validating and controlling algorithms via a risk-based approach

Two of a kind: How digital twins are evolving healthcare

Dr Visa Suomi, medical devices industry manager at MathWorks, discusses how digital twins can improve overall patient outcomes and enable safer medical devices.

Today there are numerous devices that monitor and collect data on our physiological state: wearable smart watches and fitness trackers, medical imaging devices, digital health apps, thermometers etc. Similarly, these devices themselves are producing large amounts of data about their current operational environment and condition. But how can we comprehend all these data and get meaningful insights from it?

One possibility is to create a digital twin – a virtual representation of a physical object or a system across its lifecycle. This means the digital twin entails both up-todate and historical data about the state of its real-world counterpart. Incorporating these dynamic data into the virtual representation for different medical applications enables proactive decision making, process optimisation, and complete lifecycle management in healthcare.

PART 1: DIGITAL TWIN OF A HUMAN

To create a human replication, the patient must first have their vital signs monitored in combination with anatomical and physiological data. With a variety of wearables available, a patient does not have to be in hospital to collect this data as it comes from multiple sources.

For example, a smart watch can collect real-time information about the blood pressure, body temperature, pulse rate, sleep patterns, and overall physical activity levels of the patient. Similarly, when the patient visits a clinic or a hospital, the virtual patient model can be updated with the data from the laboratory tests and diagnostic imaging studies conducted during the visit. Genetic and behavioural data as well as social determinants of an individual can also be coded to the digital twin. When all these data are combined into a single virtual representation of a patient, a more complete picture of the medical

history is available to support decision making.

There are many potential applications for these virtual replicas of humans. For example, a digital twin of a patient together with AI models can be used in precision medicine to make proactive decisions about the right treatment options for the specific patient. A virtual human model could also be used for testing novel medical therapies and drugs that would otherwise be too risky or time-consuming if conducted on a real patient, as addressed by the U.S. Food & Drug Administration. For example, a selection of chemotherapy drugs could be tested against the genetics and physiological processes of the patient to identify the best treatment response. Virtual models of individual organs can also be used in developing and testing new medical devices, such as heart models for designing pacemakers. These studies are commonly known as in silico medicine, which can be used to support or potentially replace clinical trials in the future. For patients, digital twins mean better overviews and proactive management of fitness levels, chronic diseases, and overall health status. When patients have access to all data on their physical state, they can make more informed choices around personal health.

PART 2: DIGITAL TWIN OF A MEDICAL DEVICE

Digital twins of medical devices and medical technology can be created as a virtual representation of a device in operation. Here, the digital twin will capture the physical properties, environment, and operational algorithms, a combination of different signals from embedded sensors can be used to gather information about the current health condition, configuration, and maintenance history of the device.

For example, the chiller in an MRI scanner can provide data about the historical operation temperatures of the imaging device, which could directly affect the remaining useful life of its parts. In addition, a large variety of other types of signals, such as vibrations, pressures, fluid levels, and electrical voltages, as well as environmental parameters and device performance metrics can be collected to build an up-to-date virtual representation of a medical device.

Medical devices are often safetycritical, and their failure could put patient lives at risk. Therefore, health monitoring and maintenance of the device are crucial. Typically, the maintenance of a medical device is conducted either reactively or preventatively. In reactive maintenance the repair work is conducted only when the failure happens, which increases device downtime and might cause safety

A digital twin combining the historical data of the device operation with machine learning models can be used to investigate the cause patterns that lead to failures before they arise

risks to a patient. In preventative maintenance the parts are changed proactively before the failure, when they still might have useful service life left. This approach is safer to the patient but increases costs due to more frequent maintenance. A digital twin combining the historical data of the device operation with machine learning models can be used to investigate the cause patterns that lead to failures before they arise. Also known as predictive maintenance, this approach maximises the service life of device parts without compromising patient safety. Thus, a digital twin allows efficient and safe life-cycle management of a medical device.

PART 3: DIGITAL TWIN OF A HOSPITAL

On a larger scale, digital twins can be used to simulate entire medical facilities and reproduce their dynamic operations, improve safety, and optimise daily operations. Simulations of radiology departments, intensive care units, operating rooms and patient waiting areas can show the digital

schematic of their floor designs, equipment locations, and logistics.

A digital medical facility could also include operational data from hospital information systems such as staff schedules, administrative tasks, and financial transactions. If all these data were combined in a virtual representation, the optimisation of their operations could be achieved in a matter of days or weeks rather than after years of trial and error as in a physical environment.

Virtual replicas of medical facilities could be used to increase equipment utilisation rates and therefore their medical examination and operation capabilities. For instance, by visualising the logistics of patient arrival all the way to finishing the examination and departure, the processes causing the biggest delays

could be identified and optimised for faster patient turnaround times. This would result in shorter patient waiting durations and have a positive impact on customer and staff experience. Similarly, the staff schedules could be optimised according to the demand in clinical services. If the A&E department sees the highest demand for emergency care at certain times during the week, the personnel resources could be dynamically adjusted to better account for the demand. A digital twin of a hospital would allow smarter resource allocation and increased operational flexibility without compromising clinical safety. All these aspects together contribute towards more patientfocused medical care and datadriven decision making.

ACCELERATING DIGITALISATION IN HEALTHCARE

The field of digital twins is continuously evolving with more sophisticated virtual models being enabled by better computational capabilities.

Hospitals, clinics, and medical device companies are also collecting increasingly more data to incorporate into these models, which makes them more accurate representations of their real-world counterparts. Digital twins are a step towards more personalised and value-based healthcare for patients. For healthcare providers and manufacturers, digital twins allow efficient process optimisation and better product life-cycle management.

Tom Cash, director of Siemens parts supplier Foxmere, explains why OEMs need to automate high precision assembly.

From parts to perfection

The manufacturing of micro medical devices, with their increasingly complex geometries and tiny dimensions, presents unique challenges to manufacturers. When the final product is only millimetres wide, the internal minuscule scale of the components involved must be manufactured at the microscale, often being invisible to the naked eye.

Early this year, researchers at the Brigham and Women’s Hospital developed a grainsized implant called The Micra, a heart-implanted pacemaker.

The implant delivers nano doses of anti-cancer drugs directly into a patient’s brain tumour, which enhances and reduces invasiveness, with the size of the pacemaker being that of a vitamin capsule.

The iStent inject, one of the world’s smallest medical implants, is also inserted during cataract surgery and remains within the eye to alleviate intraocular pressure.

This device offers a minimally invasive option for managing eye pressure, and is particularly beneficial for conditions like glaucoma, ensuring ongoing relief and improved patient recovery.

However, manufacturing micro medical devices with intricate geometries, like the world’s smallest pacemaker, the Micra, requires specialised approaches because of components as small as millimetres and wires at .002 inches.

MATERIAL SELECTION

Assembling microdevices goes beyond the dimensional accuracy of parts. As objects diminish in size, micro and nanoscales introduce substantial changes in surface-to-volume ratios, altering chemical and material properties. Consider microelectromechanical systems (MEMS), which are crucial components in biomedical applications. At these minute

scales, MEMS face challenges such as heightened friction, shifts in thermal conductivity and increased sensitivity to external forces.

These transformations directly impact the reliability of MEMS, particularly in applications like microfluidic components, implantable drug delivery devices and neurostimulators.

To tackle these challenges, manufacturers must meticulously choose materials and employ microfabrication techniques. Photolithography, etching, and electroplating are all processes used to shape and structure materials accurately on a minuscule scale, making them ideal for microdevices.

SPOTTING DEFECTS

What’s more, the medical device industry is governed by stringent quality standards and regulations, such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, to ensure devices are safe and effective for their intended use.

Adhering to rigorous

standards, the manufacturing of micro medical devices covers all stages of production, spanning from the initial design to the final part inspection.

Here, quality management systems must guarantee that every minute component aligns with required specifications and tolerances, ensuring precision and quality for all medical applications.

For example, Ultra-HD cameras capture detailed images that use AI and advanced algorithms analyse irregularities or specific attributes in real time.

The use of highly sensitive sensors, such as micro-scale cameras, accelerometers, or pressure sensors, can also be integrated into medical devices to monitor and detect micron level defects.

ROI

Techreviewer states that robotic process automation in healthcare helps to reduce operational costs by nearly 50%, while helping to recover costs in a short period.

This interests manufacturers because assembly usually

stands out as the most financially demanding phase in bringing a device to market.

The expenses involved in manufacturing and assembly is often underestimated, especially given the intricacies of working with micro components that are often invisible to the human eye.

Therefore, it is essential that manufacturers partner with a reliable automation parts supplier that has expertise in high precision assembly to navigate their way through the complexities of microdevice manufacturing.

Parts suppliers not only help to ensure cost-effective, high precision assembly for microdevice manufacturing, but their expertise will help manufacturers to mitigate risks and reduce expenses associated with intricate assembly processes.

This is the case with innovations such as Micra and the iStent inject, which, in a sector that demands accuracy, quality and adherence to industry standards, requires the right expertise to automate for a customised approach.

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a cut above

Laser cutting experts Micrometric outlines its capabilities for small medical components.

Laser-related processes, including cutting, marking, welding, and engraving, are just some of the processes that are used by Micrometric to produce life-changing devices in the medical sector.

The Lincoln-based company produces fine parts and precision components for customers in the UK and international markets. It specialises in services including cutting, etching, drilling, and welding as well as tube cutting and precision component machining; producing medical products which meet the demands of one of the most vital sectors.

Commercial director Chris Waters said: “Lasers are at the heart of everything we do, and we have the relevant capabilities and laser equipment to cut, assemble and weld complex manufacturing medical devices including small tubes, injection needles, and endoscopes and intricate parts required for surgical equipment.

“We have built up a reputation for our personal approach with customers as we want to fully understand our customers’ laser cutting requirements. We’re committed to providing exceptional, customised services that help our customers achieve their

goals faster and with greater precision.

“The equipment we produce for the medical sector is often extremely small and intricate, and as these devices are used to save lives, it is imperative that the processes used to make them from beginning to end assure their quality and reliability.”

Waters continued: “Our laser machines are suited to cutting materials with a wide range of thicknesses and can cut a range of materials including metal, plastics, and glass. We offer micro laser cutting capabilities that allow small parts to be cut to tight tolerances +/-0.05mm to +/0.02mm across a variety of materials including stainless steel, titanium, copper, brass, and ceramic.

“To manufacture medical parts, we use our tube cutting service to create small windows, slots, holes and spirals for different pieces of equipment such as cannulas. Our laser machines offer high-resolution cutting to ensure high-speed dimensional accuracy, precision and stability which are required when producing medical tube components. We also make large tubes which form parts of innovative MRI machinery.

“We are AS9100 qualified and can supply process sheets, certification, first

article inspection reports or similar inspection regimes to clients, as required.

“We use several CO2 and state-of-the-art fibre laser cutting systems which precisely cut materials with minimal heat and excellent edge quality to produce components quickly, efficiently, and costeffectively.

“In 2018, we invested in the Coherent StarCut tube-cutting machine which is fully automated and is designed to laser cut, drill and mark tubular or flat metal components and is traditionally used by subcontract manufacturers to produce exclusive medical instruments with extremely high precision.

“For example, it can cut stents and cut tubes from 0.5mm diameter up to 30mm diameter.

“Our Bystronic 4kW ByStar machine allows us to cut tubes in a range of thick metals ranging from 20 to 300mm in diameter and up to 2m in length.”

Since investing in this equipment, Micrometric’s workforce has used the machines to cut, assemble and weld components for companies which produce automated injection needles, endoscopy components and MRI scanning equipment.

Micrometric’s lasers and experts can weld a range of

parts to deliver solutions.

Waters added: “Laser welding offers the benefit of welding while minimising heat input which is critical when welding components with temperature-sensitive items inside them or minimising any distortion due to heat.

“We can also weld autogenously or with wire feed. Depending on the metallurgy of the parts, it is possible to add different alloys as wire to adjust the weldability of the component. The wire feed can be fully automated within the welding machine. For some welds, such as titanium, a helium atmosphere is required, and an enclosed helium welding system is used.

“A variety of materials can be laser welded dependent on the metal composition and design of the product. We have experience in welding a variety of different tube sizes for different applications including medical, aerospace, and other industrial applications.

“We understand the importance of having full traceability when massproducing for this sector and can laser mark medical products with clear Unique Device Identification (UDI) codes to ensure that every part can be tracked back to its source.”

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EProtecting medical device PCBs from electrostatic discharge

lectrostatic discharge (ESD) poses a serious yet invisible threat to the printed circuit boards (PCBs) powering critical medical devices like patient monitors, infusion pumps, and pacemakers. According to a study in Semiconductor Reliability News, an estimated 60% of device failures are caused by ESD and electrical overstress (EOS), costing the electronics industry millions annually in damaged and degraded parts. As electronic devices become faster and the circuitry gets smaller, sensitivity to ESD is increasing.

By proactively addressing vulnerabilities through cleaning and grounding protocols, medical device manufacturers can enhance reliability and achieve efficiencies by preventing device failure related to ESD. This ensures dependable performance throughout its targeted product lifecycles, reinforcing the importance of patient safety.

ESD RISKS IN MEDICAL ELECTRONICS

ESD is the sudden flow of electricity between two electrically charged objects caused by contact, an electrical short, or dielectric breakdown. In PCBs, ESD can be detrimental and cause, what is known as, ‘catastrophic’ failure, immediately damaging the electronic components.

However, catastrophic failure is often detected through performance testing. The PCB ceases to function entirely, and the damage is apparent, often necessitating replacement or extensive repair.

The problematic form of ESD is ‘latent’ failure, which is less obvious and manifests over time. Latent damage occurs during an electrostatic discharge, but its effects may not be immediately apparent during initial inspections or testing. The damaged PCB may pass the initial checks and seem functional, but it is prone to malfunction or failure later in its lifespan.

In medical device production, the primary driver of ESD events stems from technicians performing standard assembly and test procedures. Walking between rooms or workstations can generate up to 35,000 volts of static electricity. Any employee movement ranging from garment adjustments to reaching for tools produces further static build-up. Without mitigations in place, inadvertently touching a medical device PCB can transmit enough voltage to damage sensitive components. Compounding trouble spots in production include non-grounded machinery, synthetic surfaces, clothing, and compressed air discharges during cleaning routines.

CONTROL ESD RISKS

While complete electrostatic discharge elimination is impossible within manufacturing environments, actions to reduce risks are achievable through ESD control protocols, for example:

1. Mandate technicians to wear anti-static wrist or heel straps connected to a grounded line while handling sensitive PCBs.

2. Use conductive floor mats to discharge static build-up from technicians’ shoes.

3. Enforce the use of anti-static clothing and shoes, reducing the likelihood of static charges accumulating during the manufacturing process.

4. Ensure the grounding of all worktables, floor mats, and wrist straps, creating an interconnected grounded environment to mitigate static risks.

5. Maintain humidity levels between 40-70% in the production area, an effective preventive measure against static build-up in the air.

6. Remove unnecessary items, such as notepads and pens from the work area.

7. Package electronic devices in static-controlled containers.

ADDRESSING ESD RISK THROUGH CLEANING

Work surfaces and tools integral to PCB assembly and testing often carry static charges, posing an ESD threat. Wooden workbenches, metal racks, synthetic floor mats, and even seemingly innocuous tools like soldering irons can all contribute to ESD.

Mitigate these risks by systematically wiping tools and surfaces with pre-saturated ESD-reducing cleaning wipes. Specifically formulated to remove dirt, grease, and fingerprints, these wipes maintain cleanliness without introducing lint or static charges.

Opt for static dissipating PCB cleaning tools to counter the hazards associated with some metal flux removers and cleaning fluid cans, which can generate up to 12,000 volts of ESD. Using a static-zapping dispensing tool that replaces the plastic straw will further reduce any ESD, minimising it to a harmless fifty volts.

Enhance safety measures by considering the use of a controlled static-safe flux remover dispenser. This system offers precise control over the application of flux remover, reducing wastage. Both the dispensing tool and brushes carry ESD charges to the ground, significantly minimising the threat to PCBs and sensitive components.

Addressing ESD at its source is crucial in PCB manufacturing to prevent potential compromises in production output, PCB quality, and overall device reliability. PCB fabricators should develop robust strategies, focusing on controlling the work environment and implementing effective cleaning tools.

REDUCE THE THREAT OF ESD

While eliminating electrostatic discharge in production environments is impossible, medical device manufacturers can significantly mitigate its risks through ESD control protocols and cleaning practices.

Elizabeth Norwood, senior chemist at MicroCare, outlines ways that medical device manufacturers can prevent electrostatic discharge with printed circuit boards.

Making things stick

Following the launch of its new Liveo soft skin conductive tape and soft skin adhesive at COMPAMED and MEDICA in Dusseldorf in November, Ian Bolland spoke to Jennifer Gemo, global marketing leader – healthcare, DuPont to find out more.

Liveo Soft Skin Conductive Tape technology 1-3150 is intended for use as a skin dry electrode in biosignal monitoring applications to enable long-term patient monitoring with stable data quality and high patient comfort.

The new conductive tape is intended to be used as a skin interface for electric biosignal monitoring that requires good skin conformability, no drying over time, and repositionability with gentle adhesion and atraumatic removal. It can be used in single electrodes for short-term monitoring and is best suited in medical wearable patches for long-term monitoring lasting seven or more days.

Gemo explained that DuPont has been moving into the digital health and wearable space in recent years, and having a presence at MEDICA as well as COMPAMED was symbolic of that.

“We’ve been present in the digital health space for the past three years so this time it was really a launch year.

“In addition to our Liveo Soft Skin Conductive Tape we offer Liveo a medical grade soft skin adhesive, the MG 7-9960. This is a medical grade of skin adhesive that we are positioning for medical applications such as

advanced wound care but also smart wearable patches that bring a good compromise between gentleness to the skin, conformability to the skin and long wear.

“This is the higher adhesion version of our range and we’re trying to reach the limits of high adhesion and long wear.”

Liveo Soft Skin Conductive Tape 1-3150 is intended to complement the soft skin adhesive that can be used for longer-term patient monitoring, for example with ECGs or EEGs, or anything that needs a biosignal tracked via an electrode.

“This is a really novel technology that is built on the backbone of a soft skin adhesive. It will softly adhere to your skin to ensure good contact which is critical for signal quality and patient comfort.”

Gemo explains that the technology is based on silicone chemistry that is resistant to its environment whilst not being irritant to the skin.

Typically, technology that is used as a skin adhesive are acrylic based that build adhesion over time. Gemo identifies this can be quite aggressive on people’s skin, particularly sensitive skin, while the soft skin adhesive technology developed by DuPont doesn’t develop skin traumas.

“For example, if you have a wound dressing and you made a mistake, you can reposition it without trauma. This is very different from acrylicbased pressure sensitive which can be traumatic to the skin and cause irritation. We know that 5-10% of the population is allergic to acrylic so that’s the beauty of this silicone chemistry that is the backbone of our products.”

The tape and adhesive are targeting the more traditional medical device space as well as the more ‘fashionable’ and contemporary end of wearables and smart devices, with DuPont aiming to expand its portfolio to meet the specificities of the markets and its customers.

“It’s an inert chemistry so it will be resistant to the environment; whether it’s humidity, mechanical stress and it’s non-irritating and non-sensitising also brings this high-quality performance.”

This is a really novel technology that is built on the backbone of a soft skin adhesive. It will softly adhere to your skin to ensure good contact which is critical for signal quality and patient comfort

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