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A new chapter FROM THE EDITOR
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ISSN 2046-5424
Since the last time I sat down at my desk to write my editor’s letter for the magazine, a lot has changed in the UK MedTech landscape. The general election on July 4th was a historic moment in UK politics, and with it came a new government, and more specifically, a new team in charge of the UK healthcare industry.
Wes Streeting, MP for Ilford North, was appointed as Secretary of State for Health and Social Care in Starmer’s cabinet, with Peter Kyle, MP for Hove, appointed as Secretary of State for Science, Innovation and Technology. Speaking to MTI immediately after the election results were announced, Chris Whitehouse, Director at Whitehouse Communications and an advisor to MedTech suppliers, chair of the Urology Trade Association, governor of the Anscombe Bioethics Centre, and regular contributor to the MTI website, said the election result “should be good news” for the MedTech sector.
Claus Andersen, Partner specialising in the life sciences and technology sector at national law firm Freeths told us: “The life sciences industry will certainly be at the heart of the growth strategy for the new government, and it seems that the sector will get a lot of attention over the coming months.”
Since the election, figures have been released by the Department of Health and Social Care that show just how much of a task there is ahead for the new government, as it revealed in July that the UK had a trade deficit in MedTech products of 5.4 billion GBP in 2023, after UK medical technology imports began to decrease post-2019. Now, moving on to this issue. For the cover story I had the pleasure of chatting to
Dr. Adnan Siddiqui, Professor of Neurosurgery and Radiology at UBNS, Director Canon Stroke & Vascular Research Centre at SUNY University at Buffalo, and CEO & CMO of the Jacobs Institute, about the IDE approval for Anaconda Biomed’s ANA Funnel Catheter.
We also have a very special feature for you in this issue, as we look at the work of some of the most trailblazing women in the MedTech industry.
In our regular features, Michael King of IQVIA writes about the future of quality and regulatory in MedTech for the regulation feature, and Jon Payne of InterSystems discusses the use of AI in wearables, monitoring and imaging for the digital health feature, as well as Rachel Duncscombe talking about why the future of digital health depends on it being open.
In sustainability, we hear from experts at Owen Mumford on how to clear a path to sustainability for single-use drug delivery devices.
We have two interesting articles in the testing feature, with insights from Broughton and Measurlabs. The adhesives feature sees Kevin Brownhill of Intertronics taking a look at common issues with industrial mixing for medical devices. Finally, in start-up scene, Yogan Patel of MHA draws on an international network to provide insights into how the UK start-up landscape is changing.
Oli Johnson, Editorial Content Producer
In this issue
06. COVER STORY
Editor Oli Johnson speaks to Dr. Adnan Siddiqui about Anaconda Biomed’s ATHENA study for its ANA Funnel Catheter and IDE approval.
09. REGULATION
Michael King of IQVIA talks about the future of quality and regulatory in the MedTech industry.
11. TESTING
Measurlabs Testing Expert Laura Ahola discusses how to perform medical device sterility testing by EU and FDA requirements, alongside Paul Hardman, Managing Consultant for Broughton explaining the route manufacturers can take to develop NGPs as approved medical devices in the UK.
14. WOMEN IN MEDTECH
Hear from some of the most important, trailblazing women in the MedTech industry about their roles in a range of different sectors.
16. SUSTAINABILITY
Owen Mumford’s Head of Insight Alex Fong, and Business Development Manager Olivia Houselander speak on how to clear a path to sustainable single-use drug delivery devices.
23. START-UP SCENE
Yogan Patel of MHA draws on an international network to provide insights into how the UK start-up landscape is changing.
26. DIGITAL HEALTH
Jon Payne discusses the use of AI in wearables, monitoring and imaging & Rachel Dunscombe talks about why the future of digital health depends on it being open.
PODCASTS
20. ADHESIVES
Kevin Brownhill, Head of Technical: Learning and Development at Intertronics discusses common issues with industrial mixing in medical device applications.
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COVER STORY
What’s the big IDEa
Oli Johnson speaks to Dr. Adnan Siddiqui about Anaconda Biomed’s ANA Funnel Catheter, its enrolment in the ATHENA study and IDE approval.
Anaconda Biomed, a medical technology company developing ‘nextgeneration’ thrombectomy systems, announced in summer 2024 that it had received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the ATHENA study of its ANA5 Advanced
Neurovascular Access (ANA) Funnel Catheter. The study will assess the safety and effectiveness of mechanical thrombectomy using the ANA Funnel Catheter in combination with a stent retriever. The ANA Funnel Catheter is designed to assist in neurovascular procedures by facilitating the delivery of other intravascular devices such as stent retriever devices and catheters. The device consists of a radiopaque Nitinol braid covered with a silicone coating to enable local flow arrest.
The company says that studies have shown that flow arrest during mechanical thrombectomy can improve revascularisation rates and clinical outcomes at three months, but the approach has been underutilised to date due to the limitations of current devices. The company says its ANA Funnel Catheter is uniquely designed to facilitate flow arrest during clot retrieval.
Speaking to MTI about the limitations of previous devices, coordinate investigator of the ATHENA
study Dr. Adnan Siddiqui, Professor of Neurosurgery and Radiology at UBNS, Director Canon Stroke & Vascular Research Centre, SUNY University at Buff alo, and CEO & CMO of the Jacobs Institute said: “There are two aspects to that. The fi rst aspect is that there is really good data to suggest that flow reversal during mechanical thrombectomy is useful, and that has been the biggest reason why we have a plethora of balloon guide systems in the marketplace. Even though we don’t have randomised data, and that’s not for lack of trying, the NIH has not
funded those proposed trials. There have been lots of proposals, but when you look at the overwhelming majority of real-world data, there’s a stark difference in the effectiveness with a balloon guide rather than without. So there’s a strong understanding that I think it makes a big difference.
I think there’s great clarity that comes with the IDE approval for the company, knowing that if you do this and you hit these metrics, your device will likely be
approved.
“Now the second thing that has happened in this space is that people are going with larger and larger and larger catheters inside the brain, but then you don’t have flow reversal in the neck. But when you put this garden hose in the middle cerebral artery, you essentially have flow reversal in the MCA, which is where you want it. That is being investigated in clinical trials right now, and we have had some presented recently, which looks very, very promising. But the issue is, driving a garden hose into the brain still remains a challenge. So the idea of Anaconda is, can you put in a smaller catheter, that has a funnel tip, which can expand to whatever diameter the vessel is, gentler on the vessel than say a traditional large catheter, but equally
effective, because the vacuum power of a clot is based on the cross sectional area that interacts with the clot. So the larger the cross-sectional area, the greater the effectiveness of the vacuum to suck it out. Anaconda’s premise is, you don’t need a garden hose, you can go with a smaller catheter, and it’ll work just as well.”
The IDE approval allows for a company, whether it is based in the U.S. or outside of the U.S., to initiate a clinical trial under the aegis of the FDA, a necessary step for medical devices. The approval means that the FDA has looked at the device, the background data, and considered it safe enough to be assessed in a rigorous clinical trial in the United States. It also means that the company has presented, and the FDA has agreed upon the specific markers of what would be considered a successful clinical trial. This is so there is complete alignment in terms of how many patients, what will be the control arm, as well as what are the safety endpoints, effectiveness endpoints and revascularisation endpoints.
Dr. Siddiqui said to MTI: “I think there’s great clarity that comes with the IDE approval for the company, knowing that if you do this and you hit these metrics, your device will likely be approved. Now, the FDA always puts in some language in there as a disclaimer that they reserve the right to not approve even if you meet those things, based on new findings or this that or the other. So they have that caveat, but they typically do not exercise that. So I think it’s a significant step forward for the company.”
Upon Institutional Review Board (IRB) approval the ATHENA study of the ANA Funnel Catheter will be conducted at up to 40 U.S. and international centres, enrolling patients experiencing acute ischemic stroke and treated within 24 hours of symptom onset. The study will
report acute reperfusion success after a single thrombectomy pass with three of the most commonly used stent retrievers, and on procedural safety between study arms.
Dr. Siddiqui spoke about how having the right kind of regulatory advice can significantly reduce the ‘headache and the heartburn’ and the delays that can be associated with a misguided or uninformed adventure. The doctor says that having the right kind of regulatory advice behind you can be a critical part of a successful passage of a process through the FDA.
Dr. Siddiqui told MTI: “There are people who have been doing this for their entire lives, rely on them to guide you, make sure you pick the right regulatory partners to be able to lead things forward. As far as the company is concerned, I think this is a tremendous milestone for them, because this is vindication that their device is considered
reasonably safe and effective for actual trial on patients in the United States.”
Dr. Siddiqui concluded: “What still remains up in the air is exactly what the results are going to be in this rigorous trial. And we’ll certainly wait to find that part out, but I think this is a successful combination of a rigorous regulatory process, and congratulations to the company.”
This is vindication that their device is considered reasonably safe and effective for actual trial
Allergic and autoimmune diseases are regarded as key global health challenges. The prevalence of allergic diseases is rapidly increasing across the world, and estimates suggest that as many as one in ten people may suffer from one or more allergic diseases, ranging from mild rhinitis to severe anaphylaxis or asthma. Autoimmune diseases are estimated to affect as many as one in ten individuals, with more than 100 different disease types identified to date.
As a leader in in-vitro diagnostics, our ambition at Thermo Fisher Scientific is to enable millions of people around the world to receive the right diagnosis for their allergic or autoimmune diseases. Here we discuss some of the challenges in this field and how we are working to overcome them.
Addressing the diagnostic complexities
Both allergic and autoimmune diseases can be challenging to diagnose. The sheer multitude of triggers of allergic diseases, and the fact that some patients may be sensitised to multiple allergens or allergen components of the same allergen, can complicate the diagnostic process. Similarly, autoimmune diseases often express similar symptoms in different conditions.
The heterogeneity and complex nature of these diseases mean that, even with a thorough patient history, diagnosis based on this alone can be difficult. In vitro diagnostic solutions can provide high sensitivity and specificity. Technologies and platforms, such as immunoassays, molecular diagnostics and mass spectrometry, can detect and measure the levels of specific antibodies, antigens, or other biomarkers in blood or other biological samples. These help to aid clinicians in the accuracy of their diagnoses and guide a patient’s optimal management and treatment strategy.
At Thermo Fisher we deliver products and solutions that enable our customers to push the boundaries of innovation for the diagnosis, treatment and follow up of allergic and autoimmune diseases. Our portfolio includes tests for a wide range of allergens and autoimmune biomarkers, which can help provide a comprehensive and personalised profile of each patient’s condition.
Our ImmunoCAP allergy portfolio is based on over five decades of research and development. We offer the broadest range of allergen specific IgE blood testing options worldwide,13 all designed to be fast, automated, easy to perform, interpret and report. While many people are familiar with skin prick testing for allergies, specific IgE blood tests offer many benefits over traditional methods. This approach increases the likelihood of making a diagnosis with greater specificity, while reducing risks to the patient due to possible cross-reactivity or clinical symptoms that do not match the sensitisation obtained in the laboratory.
Within our portfolio are ImmunoCAP Specific IgE tests, considered the gold standard in in-vitro allergy diagnostics, with close to 500 whole allergens and allergen mixes and
over 100 allergen component tests, which can be performed irrespective of a patient’s age, skin condition, antihistamine use, or pregnancy. Taking a serological measurement of allergen-specific IgE antibodies, using our ImmunoCAP Specific IgE tests, can provide the clinician with a measure of a patient’s allergic sensitisation profile. Tests display results with good precision, reproducibility and report down to 0.1 kUA/L limit of quantitation (detecting extremely low levels of IgE), based on proven assay technology.
Our EliA autoimmunity solutions include a portfolio of more than 50 clinically relevant, high-quality tests to aid in the accurate diagnosis of autoimmune diseases, such as coeliac disease, rheumatoid arthritis, anti-phospholipid syndrome, connective tissue diseases, and more. With an optimised balance of specificity and sensitivity, EliA tests help healthcare providers gain additional insight used to support disease-specific diagnoses and optimise patient management.
Bringing innovation closer to patients
Across Thermo Fisher, we are working diligently to make our diagnostic solutions and services more accessible in primary care.
Our ImmunoCAP Specific IgE tests are a convenient diagnostic blood test for all. In general, primary care providers can order the test directly, rather than through a specialist referral, which can help to optimise referrals and the diagnosis and treatment process. Additionally, ImmunoCAP Rapid test is a quick and user-friendly point-ofcare test performed in near-patient healthcare settings, such as doctors’ offices and nurse stations. Research suggests it can identify as many as 95 percent of symptomatic patients sensitised to any of the included allergens.
ImmunoCAP Tryptase assay, part of the allergy portfolio, measures transient tryptase level increases. It serves as a risk marker for severe anaphylactic reactions and, when continuously elevated, guides mastocytosis evaluation. Similarly, our EliA tests for autoimmune diseases can provide quick turnaround of results from a blood sample, helping physicians to rule in or out specific conditions and guide further testing or referrals.
Partnering
for impact
At Thermo Fisher, we proudly partner with other innovators, including research organisations, biotechnology companies, and digital health startups to co-create and co-deliver new testing solutions that help address unmet patient needs. Using intelligent services, such as AI, machine learning and big data analytics, we are developing and validating new biomarkers algorithms, and platforms that can enhance the performance, usability, and accessibility of the latest testing solutions.
By innovating and collaborating we believe we can seize the opportunities to meet our ambition, and, ultimately, help reduce the burden of allergy and autoimmune diseases on individuals, healthcare systems and societies at large.
REGULATION
The Future of Quality and Regulatory in the MedTech Industry
Michael King, Senior Director, Product & Strategy, Technology Solutions at IQVIA
Increasing numbers of regulations and standards are driving complexity in the MedTech industry. Within that complexity is the continuous evolution and divergence of global regulations, which, alongside the rapid adoption of technologies such as artificial intelligence (AI), including Generative AI (GenAI), present a challenging and interesting path forward for quality and regulatory teams.
In an ideal world, MedTech quality and regulatory standards would be harmonised globally, but that is not the case at present and is unlikely to occur any time soon when the drivers of politics and economics are considered. Therefore, the industry must find a way of successfully operating within a complex global landscape and look to ‘control the controllables’ that are truly within their influence.
EVOLVING REGULATIONS
The regulatory world is always in motion and can often step outside of traditional boundaries. This is due to the identification of new therapeutic
areas and the advancement of product solutions that often combine a range of product types, risk classes and steps across the medical device and pharmaceutical arenas. The complexity is further compounded by the need to meet global data and privacy requirements.
One of the biggest drivers seen over the last year is the advancement of regulation that targets the use of AI and other advanced technologies in MedTech. These inputs must be considered when products are being developed for both local and global markets. Consequently, regulatory experts within a company now have an important ‘seat at the table’ when it comes to both hardware and software design, defining the boundaries around regulation and relating those back to commercial imperatives and the ability to predictably define market access dependencies and timelines.
The era of connected devices also presents an opportunity to leverage intelligent automation through AI and GenAI. These technologies can significantly enhance and bring new capabilities to quality and regulatory operations by supporting the augmented user. They support activities such as the drafting of core documentation such
as regulatory submissions, audit responses or adverse event reports and the identification of signals to proactively assess product quality, production and safety trends. The tracking of product performance and production activities in real time, with AI supporting the augmented user, can greatly improve process and production controls and post market surveillance (PMS) activities to ensure enhanced compliance and optimised performance.
An augmented user can use AI to combine and synthesise data from multiple sources into unified evidence packages for human review. GenAI can further streamline the process by generating high-quality regulatory documents such as submissions, reports and labeling content and, by reviewing precedent information within a company’s quality and regulatory ecosystem, it can highlight areas in the written document that need enhanced scrutiny. This not only benefits companies by saving time but also allows regulators to readily assess product functionality, performance data and real-world outcomes, saving them valuable resources.
ENHANCED SAFETY AND QUALITY
Patient safety remains the top priority, but MedTech operates under the concept of acceptable risk. Destructively testing every medical device before it is released to the public is clearly impractical as no product would be available for commercialisation. However, the use of GenAI can significantly improve patient outcomes by supporting both the generation of product risk documentation and the identification of product failure modes and associated risk mitigation plans.
One of the biggest drivers seen over the last year is the advancement of regulation that targets the use of AI...
Additionally, through analysing aggregated device performance and patient data, GenAI can build predictive models to forecast potential safety risks and device failures before they occur. Advanced technology can flag trends occurring at a rate outside of the threshold defined in the product documentation. Generative models can continuously scan published medical literature, clinical studies, social media and call center audio files to detect potential adverse events and product quality issues for medical devices in
REGULATION TESTING
real-time. These models accelerate post-market safety intervention and potentially reduce the impact of any needed regulatory field action.
IN CLOSING
As products become more intricate, managing go-to-market activities in a cost-effective manner presents a growing challenge. While automation and AI are poised to play a significant role, MedTech organisations recognise that AI has limitations for some quality and regulatory activities due to constraints like data, legal concerns regarding privacy of proprietary information, validation of the use of such AI driven tools and a company’s cost in using and maintaining such systems.
The excitement surrounding GenAI is undeniable, and prioritising feasible and practical applications over a onesize-fits-all approach is crucial. Success depends upon leading with a customer centric approach – (i) start with the quality and regulatory customer problem statement and/ or opportunity; (ii) identify what processes and decision points are mandated by global regulations and standards; (iii) pinpoint what data sets and data structures apply to these quality and regulatory processes, and (iv) begin solutioning in a way that best suits the organisation.
Effective outcomes stem from enhancing human-technology interfaces and utilising AI responsibly to augment quality and regulatory professional expertise. Strategic technology deployment, supported by robust processes, is the key to unlocking the full potential of AI in this domain. Ultimately, the use of AI to enhance human to human interactions improves the provision of safe and effective product solutions in all global markets.
How to perform medical device sterility testing by EU and FDA requirements
Laura Ahola, Testing Expert, Measurlabs
Ensuring that medical devices labelled as sterile are truly free of viable microorganisms is paramount for patient safety, and both the European Union and the United States have rigorous legislation in place to achieve this goal. In the EU, the main regulatory framework governing sterility requirements is the new Medical Device Regulation (MDR), while in the US, the Food and Drug Administration (FDA) requires information on sterility as part of the 510(k) Premarket Notification process.
subjected to sterilisation. Having experienced personnel plan the testing procedure and perform the tests is crucial for obtaining high-quality results.
HOW IS STERILITY DEFINED AND HOW ARE MEDICAL DEVICES STERILISED?
To be considered sterile, medical devices should have a sterility assurance level (SAL) of 10−6 or less, corresponding to a probability of one in one million for a viable microorganism to survive on the device during the sterilisation process. In the US, this requirement is outlined in the FDA’s guidance document on 510(k) submissions for sterile devices, while in Europe it is specified in the EN 556 standard series on the requirements for designating medical devices as sterile.
Medical devices are sterilised by exposing them to either a chemical sterilising agent, such as ethylene oxide or hydrogen peroxide, or a physical treatment, such as heating or radiation. The effectiveness of the sterilising treatment should be assessed at multiple points throughout the process by determining the presence or absence of viable microorganisms on the device.
STERILITY TESTING BY ISO 11737
As products become more intricate, managing go-to-market activities in a cost-effective manner presents a growing challenge.
Both frameworks adhere to the same international standards –primarily ISO 11737 – as the basis for performing sterility testing. The process is challenging and consists of multiple steps, including evaluating the bioburden of the device before sterilisation, establishing and validating the required sterilisation dose, and finally assessing the sterility of devices
ISO 11737 standards – Part 1 for assessing the bioburden of devices before sterilisation and Part 2 for assessing sterility after devices have been exposed to a sterilising treatment – are classified as harmonised standards for medical devices in the EU and as FDA-recognised consensus standards in the US. Effectively, these designations mean that devices that meet the sterility requirements outlined in ISO 11737 standards are presumed to comply with regulatory requirements on sterility. Additionally, ISO 11737 - Part 3 assesses the presence of endotoxins, which can resist sterilisation and thus must be considered independently if gram-negative bacteria may be present on the device before sterilisation.
TESTING
Bioburden testing is a necessary preliminary step for sterility testing, as it provides information on the type and number of microorganisms present on the device in a non-sterile state that need to be eliminated through sterilisation. A sterilisation method is chosen by accounting for the characteristics of the device and the microbes that should be eliminated during the process. The sterilisation method must be validated for the device through testing and the minimum sterilisation dose should be verified to ensure effective sterilisation of the device.
Sterility testing is performed next, starting with the selection of a representative sample. Generally, a minimum of three replicate samples are needed to ensure the reliability of the results. An appropriate testing method, chosen from the three outlined in ISO 11737-2, is then selected, again accounting for the characteristics of the device:
1. Direct immersion of the tested product in a culture medium.
2. An elution of microorganisms from the product.
3. Filtration of liquid products to capture the microbes in a filter, which will then be tested.
The direct immersion method is the preferred method and should be chosen if there is no rationale for selecting another method. If the direct immersion method cannot be used, the elution or filtration methods are appropriate. The elution method is used when a solid device cannot be immersed, for example, when it floats due to high
devices.
ISO 11737 REQUIREMENTS FOR NONSTERILE PRODUCTS
An important note is that not all medical devices are required to be sterile. The microbiological safety, however, must be assessed for non-sterile products as well. In this case, safety limits for viable microorganisms are determined based on the intended use of the device, and bioburden testing is used to evaluate the cleanliness of the device against the stated limits. All kinds of devices should be evaluated for their microbiological safety according to the manufacturer’s risk assessment and non-sterile products are no exception.
Microbiological safety and sterility testing are an important part of the risk assessment of medical devices and should be included in the market submission for both FDA and MDR. While the ISO 11737 standard provides a framework for ensuring microbiological safety, assistance from testing experts is recommended if having doubts about the suitable testing method to minimise the risk of having to redo any tests.
Microbiological safety and sterilty testing are an important part of the risk assessment of medical devices and should be included in the market.
Demystifying the MAA route for NRT devices
Paul Hardman, Managing Consultant for Product Chemistry
at vape compliance and regulatory specialist Broughton, explains the route manufacturers can take to develop NGPs as approved medical devices in the UK.
Vaping has become increasingly popular in the United Kingdom, with approximately 1 in 8 adults saying they vape, according to a UK Government survey. However, the popularity of disposables among young people has contributed to the upcoming disposable vape ban, which is likely to take force in 2025 — irrespective of the General Election result. It is important that next-generation products (NGPs) remain available to adult smokers wishing to quit combustibles and, with regulatory pressure mounting on consumer devices, certifying NGPs as Nicotine Replacement Therapies (NRTs) via the Marketing Authorisation Application (MAA) pathway could become more important.
Vapes are recognised as a valuable smoking cessation tool as part of the UK’s Smokefree by 2030 objectives. For example, the Conservative Government committed 45 million GBP over two years to support the national “Swap to Stop” scheme, which provides a free
porosity. The filtration method, on the other hand, is applicable for liquid medical
vape kit and behavioural support to help people quit smoking. Meanwhile, the Medicines and Healthcare Regulatory Products Agency (MHRA) is encouraging the licensing of e-cigarettes and other inhaled NGPs as medicines, and aims to support companies to submit applications for this authorisation. However, the pathway requires a large amount of scientific evidence, data, and the completion of a lengthy regulatory dossier.
This means there are limited suitable alternatives available as Ayrton Saunders’ nicotine inhaler system recently became the only MHRAapproved NRT inhaler ready for commercial launch.
CONSUMER PRODUCT OR MEDICAL DEVICE?
If licensed as a medicinal product, e-cigarettes do not need to comply with the consumer Tobacco Related Products Regulations (TRPR) limits. They would be exempt from measures announced in the disposables ban, and instead subject to the requirements around the marketing and advertising of medicines. Products that receive an MAA marketing order under a General Sales license would be subject to the same sales restrictions as over the counter medicines.
Amidst a backdrop of media reports about non-compliant products, the medicinal product route will provide confidence to smokers that an e-cigarette has been developed, manufactured, and tested to strict medicinal standards.
APPROACHING THE APPLICATION
Approval via the MAA route requires a large amount of scientific data, including a pharmacokinetic study to compare the new product with an appropriate
reference medicinal product. An already approved inhaled nicotine product, such as the Nicorette 15 mg Inhalator, has been suggested by the MHRA as a suitable comparator, given the intended route of administration. The NGP will also need to be proven to be electromechanically safe — meaning it will require assessment by an approved body to receive the UK Conformity Assessment (UKCA) mark.
As medicinal products, vapes are currently categorised in the same way as pressurised metered dose inhalers (pMDIs) — meaning similar approval criteria is required.
However, the differences in technology — e-cigarettes are often coil and wick based and pMDIs are based on a calibrated pressurised cannister — means delivered dose uniformity (DDU) is more inconsistent with an e-cigarette.
If e-cigarettes are subjected to DDU on a per-puff basis, then most will fall short. To address this, the MHRA has set DDU requirements that are averaged over 10 puffs, rather than one, smoothing the approval pathway. However, products must still be designed to be as consistent with each puff as possible if they are to reach medicinal standards.
There are multiple ways of achieving this. Power delivery can be regulated with thermocontrols, which help ensure the same amount of vapour is being released with each inhale by setting a temperature limit that applies to the wick no matter the battery level of the device. Non-heated vape technology is another option, an alternative to traditional coil-and-wick devices that atomises rather than vaporises the e-liquid.
One example of a non-heated vape technology is those based on piezo-ceramic meshes. These work by generating ultrasonic waves to vibrate the piezo element, drawing the e-liquid through the mesh and atomising it. Piezo atomisers are already common in medical devices such as nebulisers, used to deliver asthma medication to the lungs as an aerosol. This approach may be favored since droplet size is uniformly predefined by the mesh dimensions and can be achieved with minimal energy input.
A PARTNER THROUGHOUT
Vaping has become increasingly popular in the United Kingdom, with approximately 1 in 8 adults saying they vape.
The MAA process provides an opportunity for manufacturers in the electronic cigarette market to diversify and enter the medical setting. For those branching out of the consumer technology space, the scientific and regulatory data required for an MAA application can feel like a huge challenge.
Therefore, it’s beneficial for manufacturers to partner with an experienced and knowledgeable scientific and regulatory compliance expert like Broughton at the earliest possible stage. They can support from product design through to regulatory approval to help navigate the process, providing the analytical testing and regulatory expertise required to get it right first time.
WOMEN IN MEDTECH
Hear from some of the trailblazing women in the industry about their roles in various sectors of the MedTech landscape.
Leeanne Baker CEO, IMed Group
Leeanne Baker, founder of IMed Consulting and CEO of IMed Group, guides the Group globally with her extensive experience in International Medical Device Regulation and Quality projects, supported by a solid grounding in Industry.
A highly regarded Regulatory and Quality professional and Senior Consultant, Leeanne has a strong belief in delivering value to clients combining regulatory industry experience with commercial nous. As a result, she’s built up an agile and flexible offering with a QA/RA team of trusted specialists, who share her desire to perform at the highest level for clients, giving regulatory advice that supports business growth and success.
Leeanne has a strong belief in delivering value to clients.
Laura Friedl-Hirst Managing Director, LFH Regulatory
Laura Friedl-Hirst, the dynamic Managing Director of LFH Regulatory Limited, is making waves in the regulatory consultancy sector. Based in Huddersfield, this woman-led UK consultancy specialises in medical device and In Vitro Diagnostic Regulations. Since its inception in 2019, Laura has dedicated herself to building an inclusive and forwardthinking company, reflecting her own values as a proud member of the LGBTQ community.
Under Laura’s leadership, LFH Regulatory Limited has thrived, setting a high bar for creating strong, long-term client relationships. The company’s success is built on its pragmatic approach to guiding clients through complex regulatory landscapes, ensuring they achieve their end goals efficiently and effectively. Laura’s vision for LFH Regulatory is rooted in fostering an open, approachable, and flexible work culture, promoting a healthy work-life balance for her team.
Passionate and driven, Laura remains as committed as ever to her founding principles. Her leadership style emphasises inclusivity and personal well-being, which has been instrumental in the consultancy’s ongoing success. As LFH Regulatory continues to grow, Laura is excited about the future and the potential for further achievements and advancements in the regulatory consultancy arena.
Her leadership style emphasises inclusivity and personal wellbeing, which has been instrumental in the consultancy’s ongoing success.
Preeti Choudhary Founder and CEO, Pro-Business Consulting
Pro-Business Consulting (PBC) is a forward-thinking consultancy providing regulatory and quality support to both Med-Tech and Pharmaceutical industry, led by its Founder and CEO Preeti Choudhary. PBC helps the manufacturers to get their innovative, life-changing and life-saving products from an idea (conception) to the market.
PBC was founded in September 2018 with a vision to establish trusted regulatory consultancy in MedTech and Pharma sector. In last 6 years, Preeti and her team created PBC a trusted and award-winning consultancy with a global and diverse client base including big MedTech, Pharma giants to start ups and spin outs. Preeti has been working to scale up the business and took PBC on international market with PBC International, focussing on health economics, market access and clinical trials.
PBC team has experienced consultants, who are passionate, committed and thrive off the challenges the MedTech world can bring. We are highly sociable, motivated and have become integral parts of our client’s teams. We endeavour to always fulfil our professional promises, provide realistic guarantees, and follow our business ethos of truth, integrity and honesty.
Kirsty Ostle Owner/Managing Director, Advena
For more than 25 years Advena, an established reputable medical device quality and regulatory consultancy, have been at the heart of regulatory compliance. Its team offers a comprehensive range of services including UK/EU/US technical documentation compilation, quality
management system implementation, eQMS software, UK Responsible Person Services, EU PRRC, Training and Auditing Services.
Kirsty’s journey with Advena began in 2011 after gaining a vast amount of knowledge and experience in regulatory and quality management with a small but successful sterile medical device manufacturer. Although she faced challenging times with Notified Body audits and file reviews, it was only when Kirsty joined Advena as a Consultant that she really began to understand the difficulties businesses faced with the complex and quite often challenging expectations placed upon them, especially for small businesses who typically do not have the expertise inhouse.
It was for this reason Kirsty set about developing Advena to offer services predominately to remove this pain by providing holistic, practical and clear advice and solutions to our clients. The company understands the burden of the ever-changing regulatory landscape so remain committed and focused whilst continuing to develop and broaden its services which makes Advena such a powerful and trusted partner to any medical device business.
Kirsty’s journey with Advena began in 2011 after gaining a vast amount of knowledge and experience.
SUSTAINABILITY
Clearing a path to sustainable single-use drug delivery devices
Alex Fong, Head of Insight & Olivia Houselander, Business Development Manager, Owen Mumford Pharmaceutical Services
Traditionally, drug delivery devices have relied heavily on single-use plastics to ensure safe, effective administration of medication to patients. Recycled materials are not currently an option as material choices are limited to medical-grade options that have undergone rigorous testing for aspects such as biocompatibility with the drug, sterility and zero chemical leaching.
However, increasing pressure from regulators and consumers alike is leading to medical device manufacturers making environmental concerns a greater priority. The journey towards a greener, more sustainable future is turning the spotlight on singleuse devices for delivering drugs to patients.
But it’s a delicate balancing act – any move towards sustainability has to take into account tshe needs of patients and the financial pressures facing healthcare organisations. And, in the meantime, healthcare systems around the world need regular supplies of delivery devices and pre-filled syringes right now to meet clinical demands.
This means a transition plan is required to map out the pathway to sustainability – given that it will take the industry a number of years to move to truly sustainable alternatives that can be delivered at scale. Suppliers and buyers will need to adopt a collaborative approach to manage the transition and ensure the best clinical and patient outcomes.
The journey towards a greener, more sustainable future is turning the spotlight on single-use devices for delivering drugs to patients.
Research is well under way into potential substitute materials for petroleum-derived plastics used in most drug delivery devices. But there are no easy answers. Biodegradable options, for example, have been under consideration. But biodegradability can sometimes affect the stability of drugs in pre-filled pharmaceutical products. The focus has therefore switched to creating reusable drug delivery products that can be easily remanufactured, with a disposable element that can be easily recycled.
That is where ‘sustainability by design’ comes in – in the short term, it is likely to be the fastest route to environmental improvements. It involves building sustainability considerations into product design and engineering. Ease
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Non-Animal Derived Endotoxin Detection
Recombinant PYROSTAR™ Neo+ mimics the same cascade reaction as traditional LAL reagents that are derived from Atlantic horseshoe crab blood.
With three recombinant factors (Factor C, Factor B, and proclotting enzyme) and the pNA chromogenic group PYROSTAR™ Neo+ offers an assay with high sensitivity and endotoxin specificity.
Colorimetric method, can be used with an absorbance plate reader
Endotoxin-specific reagent eliminates the risk of false positives from (1-->3)ß-D-Glucan
Quantitative range: 0.001 to 50EU/mL
High sensitivity with less lot-to-lot variation
Stable storage after dissolution (4 hrs. at 2-8°C and 2 weeks at -30°C)
Find out more: www.alphalabs.co.uk/pyrostar-neo+
SUSTAINABILITY
of disassembly, for example, will have a major impact on recycling costs and methods. Creating a smaller, simpler device with less packaging will reduce waste and the impact of transportation. And having different products sharing the same raw materials and production methods will save on cost and waste, as well as giving more flexibility on the production line.
Careful consideration at the design stage can also help reduce the amount of single-use plastic associated with each treatment using a disposable device, without affecting safe and effective usability. And removing metal components from a design can also help reduce the carbon footprint, as the processing and shipping of metals has a greater environmental impact than polymers.
The key to success is approaching sustainable product design by examining the whole product lifecycle – not just the standalone product. That means thinking about everything from concept development, material selection, and design and engineering to manufacturing, packaging, transportation, sales, product use and end-of-life disposal. In each case, things like energy efficiency, environmental impact, material usage and recycling need to be evaluated.
The key to success is approaching sustainable product design by examining the whole product lifecycle - not just the standalone product.
But, even with sustainable design, most drug delivery devices are likely to need a disposable element for some time to come – to meet regulatory, safety and hygiene requirements. For connected devices, disposable electronics would not be financially viable or environmentally acceptable. So a simple interface is required between the two component sections to ensure functionality and efficacy are not impaired.
Biosimilar interchangeability also has to be taken into account, with the cost benefits of a change in drug formulation or drug delivery device weighed against the effects on the patient experience. The most straightforward option in these circumstances is likely to be a disposable device as this will avoid the regulatory complications of interchangeability status. But, of course, this is not the most sustainable choice.
With so many competing factors on the path to sustainability, collaboration between buyer and supplier will be needed more than ever to deliver optimised products that tick the desired boxes. It is a balancing act, but strong and transparent partnerships promote ongoing refinement, as we continue to innovate and find better solutions.
Life Cloud
e4life CEO Vincenzo Pompa speaks about the company’s devices and how they work to kill airborne viruses with electromagnetic waves.
Q: Can you explain what products e4life offers and how they work?
A: e4life is producing devices that are able to inactivate viruses in the air. The devices we sell work through electromagnetic waves, and create a resonance effect on the external shell of the airborne viruses. It’s possible because the frequency leverages the difference of charge present in a virus, positive internally, negative externally. The right frequency provides a bit of energy that starts a vibration that resonates the outer shell until it ruptures. Without the external shell, the virus is no longer able to infect.
Q: How did e4life begin? Where did the idea come from?
A: Our history started during COVID. Our parent company ELT GROUP, who owns 51% of e4life (remaining 49% is owned by LendLease), is an engineering company working in the defence arena. Its core business is electromagnetic microwaves, they produce electronic defence systems. During COVID, they read an article published by a medical equipment manufacturer in Taiwan, describing how viruses impacted by electromagnetic waves could change their shape. This was the starting point. From here, our parent company started studying how electromagnetic waves could change not only the shape, but also interact more with the virus.
Q: There’s two different sizes of the e4life device, one that fits in a shirt pocket, and a larger one that you can put on a table, what is the difference?
A: The small one, e4life personal, is designed and developed for being on your person, its completely safe, certified CE, and SAR. SAR certifies that it is completely safe to be on you for 24 hours a day. Because of the shape of the antenna, it creates a bubble around you to protect you, an electromagnetic shield, to protect you wherever you are. The big one, e4life ambient, is designed to protect up to 50 square metres, so a large room like an office, but of course, you can use more devices to cover a larger space, using WiFi to control all of them together in parallel.
Q: As you said, the company only started a few years ago, what’s the interest been like so far? How are things going?
A: The company was officially founded one year ago, after a couple years of research, and this was possible because of the experience of ELT in this field. We are currently selling the devices for B2B clients, corporate clients rather than consumer. Consumer is too much for a new brand, for a new technology, it’s too expensive to start from scratch. So we are working
towards entering the corporate environment first and then moving towards entering the consumer market. Entering the consumer market will help for the miniaturisation of the device, to make it even more portable. We hope to have a wearable device in a couple of years.
Q: Has MTI Expo been a successful show for e4life?
A: Yes. We have already signed contracts in Italy, signed contracts in the Gulf, Dubai and UAE. We are here in the UK to figure out if now we can enter the market in the UK as well. We are also here to start our collaboration with a public university to have a scientific support and collaboration in UK too.
Q: Is there anything else you would like to add?
A: This is already commercialised, and the price is quite low for the corporate market, so we really hope to contribute to reduce the risk of viruses. We are working on human viruses, and the OMS recently has talked about the avian flu as a new potential pandemic risk. We have done tests for the avian flu and swine flu too, and we are effective with more than 90% inactivation for these two animal viruses. This is not strange, because the structure of the viruses are quite similar to the flu of humans, so considering how we sanitise the air, the physical effects driven by shape and dimension, we are effective for these two animal viruses as well.
e4life ambient (left) e4life personal (right)
ADHESIVES
Overcoming mixing challenges in MedTech applications
Kevin Brownsill, Head of Technical: Learning and Development at adhesives supplier
Intertronics, discusses common issues with industrial mixing in medical device applications, and explains how to address them.
The medical device and pharmaceutical market requires the fast, homogenous mixing of materials for many applications, for example during drug development and delivery or when creating medical implants. Traditional contact mixing brings challenges for medical device manufacturers who must avoid contamination, meet stringent quality standards, and ensure patient safety to the highest levels. These challenges can be resolved with a noncontact planetary mixing technology.
Productivity is another challenge MedTech manufacturers may want to address with a new approach: increasing throughput or reducing waste.
Contact mixing, also known as mechanical agitation, can range from stirring with a stick, glass stirrer, electric stirrer with blades, impellers or paddles, or magnetic stirrer. However, when mixing liquids, pastes, and powders, medical device manufacturers may experience issues with this approach, typically variance between operators, difficulty validating the process, poor dispersion, or a high defect rate. Contact mixing offers a lack of traceability and process control that is undesirable for any medical device assembly process.
Productivity is another challenge MedTech manufacturers may want to address with a new mixing approach: increasing
throughput or reducing waste. A manual mixing process may have numerous weighing or decanting steps, as well as requiring mixing by hand. If there is a high filler content or heavy fillers in the mixture, the operator may risk repetitive strain injury (RSI) following long periods of hand mixing.
IMPROVING MIXING QUALITY
With contact mixing, quality and repeatability issues can occur when the paddle or stirrer introduces air into the mixture, mixing differs between operators, or contamination occurs between batches. Incomplete mixing can risk serious defects, particularly in adhesives applications where insufficient mixing
of a two-part adhesive can result in incomplete cure, and therefore a product that cannot withstand its intended environmental conditions.
Furthermore, it may be difficult to achieve a homogenous mix manually with certain material types. For example, combining materials with differing viscosities, or when adding solids such as conductive powders, catalysts, phosphors, fillers or even nanoparticles, into liquids or pastes.
Another challenge of contact mixing is that rollers, blades or propellors can cause physical damage to the components of a mixture. This can be a particular problem in applications where MedTech manufacturers are mixing delicate materials, such as enzymes or nanostructures.
PLANETARY CENTRIFUGAL MIXERS
One alternative to contact mixing is using a planetary centrifugal mixer. This is a non-contact mixing method that combines revolution and rotation within a set radius to achieve a fast, homogenous mix. Rotation is typically at ~1,000s of RPM, generating mixing forces of about 400 G. Users mix in their own containers (with sizes ranging from 12 ml to 20 litre), to mix, disperse, and degas materials in seconds to minutes.
Planetary centrifugal mixers can be programmed with different ratios of revolution and rotation —“recipes” — for example to add more rotation for the defoaming function or more mixing for a more centrifugal action. Altering the speed and mode can help with mixing difficult
materials, some of which may require a 10 or even 20 step program.
THE BENEFITS OF NONCONTACT MIXING
One of the key benefits in medical device assembly is that planetary centrifugal mixers are closed cup. Because mixing takes place in removeable containers, the cleaning process is straightforward, saving time, avoiding cross contamination, and making it easier for the technology to be repurposed for other applications.
Adopting a planetary centrifugal mixer can remove steps from a process compared with manual contact mixing processes, saving time and reducing labour costs. Material can be simultaneously mixed, dispersed, and degassed with minimal operator intervention, freeing up team members for more valuable work elsewhere. The technology can reduce process waste by reducing the risk of contamination, while the removed need for decanting reduces waste left in containers. The ability to repeat the process can reduce variation due to operator skill and improve product formulation.
Planetary centrifugal mixing is effective at controlling shear, and is usually quite benign to the products. Additionally, unlike machines that rely on the insertion of paddles or impellers into the material, no air is introduced; in fact, there is a tendency to remove it.
PROCESS TRACEABILITY
Planetary centrifugal mixers enable precise and repeatable control of the mixing process; process variables are
programmable. Some models offer data logging and PC connectivity, giving operators information on RPM, mode, and which recipe is being used. Mixers with communication functions can provide remote control and traceability functions — the user can start/stop operation and report abnormal stop information.
Manufacturers can collect data from their mixer to see the exact RPM in near real-time and validate that the correct program was used for a particular batch — useful for quality assurance and as a development tool. This level of visibility is useful to inform any technical documentation ahead of regulatory submission.
SELECTING A MIXER
There are various planetary centrifugal mixers available, some that purely mix, some that mix and degas, and some that degas to a high level under vacuum. Machine selection is normally based on two considerations, batch size and the required level of air removal. While many manufacturers opt for a larger mixer for higher volume applications, others operate multiple smaller machines to avoid a large upfront investment, prevent a single point of failure, and increase flexibility.
Some manufacturers may need to guarantee that all air is removed from a particular mixture. In this case, manufacturers can select a machine that mixes under vacuum, which can remove invisible micro bubbles.
PLANETARY CENTRIFUGAL MIXING MEDICAL DEVICE DEVELOPMENT
One example of the use of planetary centrifugal mixing comes from the Department of Automatic Control and Systems Engineering (ACSE) team at the University of Sheffield, which is developing a diagnostic glove that includes several flexible bioelectronic sensors. The sensors are formed from elastomers mixed with various conductive nano or micro particle compounds, like graphite, platinum, and silver, which are 3D printed onto the glove’s material. The process involved mixing nanoparticles into very viscous filled polydimethylsiloxane (PDMS) mixture to produce a graphite composite.
After trialling a THINKY Mixer, ASCE has removed the need for solvents as a mixing aid, removed a step from the process, improved health and safety, and increased repeatability.
Another interesting example comes from the University of Bern, Switzerland, where a team of researchers developing a microfluidic platform for the formation and maintenance of blood micro-vessels benefitted from planetary centrifugal mixing. One of the key production issues was the complete filling of all the microstructures with uncured PDMS. The team wanted to reliably prevent air bubbles becoming trapped in the PDMS. A THINKY Mixer was used successfully to simultaneously mix and degas the material.
A good supplier can address your challenge by doing laboratory evaluations and demonstrations with your materials. Based on previous experience, it can advise on the best mixer for your process.
Are you investment ready?
Thomas Averre, Founder and Managing Director of Tarleton Communications
Great technology is not enough to convince investors to line up and give you money.
The blunt truth is that thousands of companies have great technology.
So, what are investors looking for and what influences their decision making on which companies to back?
There are a couple of elements to this in my experience:
Momentum: this isn’t a risk at all!
Very few investors want to take wild risks. Most want what they call ‘calculated risks’ or what in reality are ‘de-risked’ opportunities.
This means that to be successful in attracting investment, you need to show investors that you have plenty of momentum behind you and are already on the way to success. If you can create the perception that you are making rapid progress and they can join in on that inevitable success, you’re halfway there.
Credibility: this is the real deal!
Investors active in the MedTech sector understand the trends and key issues well, but they are unlikely to be an expert in your specific technology or have a deep understanding of your key therapeutic areas.
It is for this reason that they look to others – independent, recognised authorities or KOLs – to evaluate the credibility of your offering and technology to help them make an initial judgement about whether it is worth pursuing a conversation.
Visibility: who are these guys?!
Investors need to read, see and hear about you regularly. This is important because building and refreshing memory structures helps them to start to recognise and remember your business, which in turn leads to action.
On a first pass, you probably won’t be noticed. On the second pass, the name might be become memorable. On a third or fourth pass, they’re probably thinking you’re worth investigating because you’re appearing so often that there’s probably something interesting happening!
How to
I run a public relations agency called Tarleton Communications. I am in the business of reaching and persuading people and have been since I started by career almost a decade ago in digital health, before moving through biotech and MedTech companies.
For many of our startup clients, attracting investors is their primary focus. Good, strategic PR is the best and most efficient way to do this…but I would say that wouldn’t I?
By securing industry, national and business media coverage for clients, we help them to reach investors, demonstrate that they have momentum behind them and prove that they are considered credible by those with sector authority.
An isolated press release does nothing to achieve this, by the way. Proper investor communications are about creating a compelling narrative and using a variety of tactics – whether news stories, op-eds, features or something else – to reach, influence and persuade sophisticated, sceptical individuals.
This requires messaging to be spot on, positioning to be disciplined and a clear and thoughtful strategy to be put in place. Without these, businesses are often rudderless and hop from one opportunity to the next at the whiff of a quick buck.
Everyone but them can see this, and it has a detrimental impact on their perceived investability. This is terribly sad, as many of them have fantastic technologies that don’t get the funding they need in order to commercialise and make those innovations a reality.
Great investor communications is about being distinctive and memorable, demonstrating how your innovation is different and how you are uniquely placed to commercialise it. This can be done on a budget, but it needs to be strategic and executed by someone who understands the sector and the way the media operates.
If you really do believe that you have something special and you’re serious about investing to attract investment, you should bring in an agency with experience and a track record. You should be happy to be constructively challenged, to be advised to shift course and most importantly, you should start putting the work in before you need the investment, not when you’ve already exhausted every avenue.
Thomas Averre is the Managing Director of Tarleton Communications, a specialist life sciences public relations agency based in Harrogate. You can contact him via thomas@tarletoncomms.com
START-UP SCENE
BEYOND
THE NHS: Why start-ups are looking to international markets
Yogan Patel of MHA draws on an international network to provide insights into how the UK start-up landscape is changing.
The NHS is a global brand in healthcare. It is synonymous with high standards, best-inclass training, innovation and much more. This has helped position the UK as a leader in medical technology and helped many of the companies supplying the NHS to internationalise at speed.
When international healthcare providers come across UK companies, they are attracted to those who supply the NHS. They are perceived as trustworthy, high quality and value driven. This has led to many medical technology start-ups taking an NHSfi rst approach to growth, that sees them establish a successful track record in the UK before leveraging their NHS case studies to venture into international markets.
By their very nature, start-ups are dynamic and agile.
However, this NHS-fi rst strategy has been changing over the last decade. Although still an eff ective approach, it is increasingly being seen as a slower route to growth.
MHA is part of the wider Baker Tilly International network, which gives us access to valuable market insights in 146 countries. We are increasingly working with UK start-ups who are either exploring, or planning to explore, internationalisation much earlier on in their corporate journey.
The reasons for this are complex, but there are several common threads that include a mix of push and pull factors. This trend hasn’t been confi ned to MedTech either; we
START-UP SCENE
have also witnessed similar trends with gene therapies and rare disease therapeutics.
One of the main drivers of this trend is the recent increased availability of international funding sources for UK start-ups. The value of estimated inward life sciences foreign direct investment (FDI) was 1.9 billion GBP in 2021, coming behind only the USA in terms of value; this is a signifi cant uptick from 574 million GBP in 2019.
A signifi cant proportion of this funding came from overseas investors, especially from the US and Asia, who are attracted to the UK’s strong reputation for research and innovation. This means startups are being exposed to international stakeholders earlier on in their journey, which can be extremely positive as securing international funding can open up new networks and partnerships and attract investors with market expertise.
Another driver is the growing demand for solutions to health challenges that are truly global in nature. Medical devices focused on addressing ageing populations and chronic diseases are especially popular, and regulatory pathways to accelerated access are being simplifi ed to help get solutions to market. The FDA has taken a pragmatic approach to regulation as it seeks to outmanoeuvre the MHRA, which combined with the more commercial outlook of many US providers, is making the US an increasingly attractive market for early-stage companies.
Another important factor is that many start-ups feel it takes too long to break into the NHS. Investor pressures, and the realities of cash fl ow management, mean many MedTech companies are having to generate revenue more quickly. This is forcing them to make tougher commercial decisions and be more realistic about how quickly opportunities may crystalise.
The adoption of new technologies varies across the UK too, as many ‘Test Bed’ sites and ‘Innovation Hubs’ are accessed at a local level – complicating market access. Health clustering is strong in regions like Cambridge, Leeds and London but in other areas of
the country it can make accessing the NHS harder.
There is no doubt pursuing internationalisation has its challenges. Companies must navigate complex regulatory frameworks, protect intellectual property, manage cultural barriers and understand complex fi nancial and accounting rules.
As a result of these challenges, early-stage companies are having to transition from being research-led to a becoming more commercially focused earlier on. As my US-based colleague Mario Prohasky pointed out recently, this requires a clear strategic vision on how to achieve operational scale while staying true to the fundamental focus on breakthrough science.
But many start-ups are simply adapting to the challenges in front of them and fi nding solutions by building a team with the experience, expertise, knowledge and capabilities to help them exploit new opportunities. Where this isn’t possible, they are adopting a strategic approach and seeking expert advice from industry associations and professional services fi rms.
Start-ups are now taking a personalised approach to growth and going where the opportunities for them to make the biggest difference exist.
By their very nature, startups are dynamic and agile. They are living out this ethos by adapting to the changing circumstances around them and seeking to get innovation into the market as quickly as possible. Traditionally, the mantra was to grow gradually in your own market before considering exporting - but that approach is dying out. Startups are now taking a personalised approach to growth and going where the opportunities for them to make the biggest diff erence exist. All the better for patients.
Patel attending a session at the Baker Tilly conference in Auckland, NZ.
www.pbc-uk.com
DIGITAL HEALTH
HEALTHTECHS FACE MANY DATA CHALLENGES WITH AI – HERE’S HOW TO RESOLVE THEM
Jon Payne, Director of Sales Engineering and Education at InterSystems
The use of artificial intelligence (AI) in wearables, monitoring, and imaging is forecast to save hundreds of thousands of lives, and billions of pounds by helping individuals make healthy lifestyle decisions and physicians to detect disease early.
A 2023 study by Accenture in the US estimates generative AI could automate 28% of work time in healthcare and augment another 11%. An earlier study by Deloitte estimated the combined effect of eight AI applications could save 400,000 lives annually across Europe, deliver 200 billion EUR in annual
savings, and free up 1.8 billion hours of healthcare professionals’ time.
Yet AI poses specific challenges for the HealthTech industry and on its own it cannot fuel success. Companies seeking to incorporate AI into their product portfolio will only realise its potential if they surmount the hurdles related to data acquisition, interoperability, data cleansing, and privacy.
OVERCOMING THE CONSTRAINTS OF THE TRAINING MODEL
This is necessary because AI is only as good as the data used for its modelling. AI in medical applications must also go beyond the bounds of its training model to aggregate data from external sources of clinical and non-clinical data. That could be as many as ten different EHR environments, along with next-generation sequencing labs, patient questionnaires, and other sources. This data has to be cleansed, labelled, and rendered interoperable through conformity with a standard such as HL7 FHIR, so senders and receivers understand the information in the same way. The data must also be protected in line with all regulations and privacy laws that apply in any territory.
While an AI application can sift through masses of
research or clinical data it remains constrained by its model and will not have the full context. This means, for example, that AI can only assess a patient for risk of stroke based on entered patient data.
AN EXAMPLE FROM IMAGING DIAGNOSTICS
Take the increase in diagnostic imaging, for example. A study in the Journal of Digital Imaging suggested nearly 60% of radiology orders had no mention of important chronic conditions despite the increase in their prevalence. There is an obvious need here to include contextual medical record information within diagnostic imaging workflows. Imaging AI and ML applications can ease workloads and cognitive burdens on radiologists by analysing curated clinical data. However, to do this they need to bridge siloed imaging data and disparate picture archiving and communication systems (PACS) that use proprietary technology.
Achieving this requires knowledge of healthcare data and systems, and interoperability with the approaches of companies such as Epic, GE Healthcare, 3M Health Care, INFINITT, Guerbet, Ricoh, Canon Medical, and Roche Diagnostics. Compliance with the full range of healthcare protocols and standards is necessary to facilitate information flows across the imaging data silos and sources.
Once achieved, this puts the right information in front of radiologists at the right moment and eliminates the need for complex searches in the electronic patient record to retrieve specific patient data. Clinicians have an accurate presentation of current diagnoses, doctor’s notes, wearables data, and even genomic information prior to reading a study.
THE MULTIPLE CHALLENGES OF MAKING DATA USEABLE IN AI
Multi-source datasets of the type we are discussing here depend on interoperability and compliance with multiple data standards within the healthcare sector. An AI application may be able to exploit the full potential of HL7 FHIR but may also need to work with legacy standards such as HL7 V2 and non-standard, or even non-clinical data sources. Relying on a single standard is unlikely to gain a new application or device widespread adoption because in the real-world, older, long-standing systems are always in use, generating a flat file or other non-standard format.
The requirement for comprehensive, aggregated data means that HealthTechs face real challenges in training on very disparate types of data for whatever purpose. Data pulled in from a wide range of sources, including devices or systems with legacy messaging standards, previously had to be cleaned and checked for errors by data scientists, because it is rarely
in structured tables. This preprocessing and labelling transforms data into a format that is suitable for use in AI applications.
The challenges of data preparation for AI applications are often underestimated, but the single platform approach is how they are best overcome.
Robust machine learning algorithms commonly used in AI, such as neural networks, can automate much of this. They can take care of some of the necessary preprocessing and cleaning through interpreting patterns in the training data. This is especially helpful when the data includes natural language text or other datatypes that are challenging to deal with programmatically.
AI APPLICATIONS NEED TO BE BUILT ON A SINGLE DATA PLATFORM
The full range of onerous preprocessing requirements, however, can only be fully resolved through a single platform approach that normalises all sources of data and provides the connective tissue with other devices and systems.
It is an approach designed for the challenges of the HealthTech industry, providing a patient-centric model that is ready for analysis. A platform can include numerous, trusted pipelines that aggregate data from across sources’ formats, complemented with AI-based techniques.It will take care of labelling, which is critical for training supervised machine learning models. A platform should also track data lineage,
allowing developers to use subsets to train predictive models, keeping the link back to the full dataset to ensure context is retained.
With encryption at rest and in flight, this approach is what HealthTech companies need for all-round success in the health sector when they incorporate AI into their solution. New applications benefit immediately from easier and more streamlined deployments, with the ability to develop the solution rapidly to achieve the genuine scalability on which commercial success depends. The challenges of data preparation for AI applications are often underestimated, but the single platform approach is how they are best overcome.
“The only limit to the height of your achievements is the reach of your dreams and your willingness to work for them”
Michelle Obama
DIGITAL HEALTH
THE FUTURE OF DIGITAL HEALTH DEPENDS ON IT BEING OPEN
Rachel Dunscombe, CEO of openEHR
International
With healthcare systems so pressured for time and clinical capacity, we need a digital health future that enables fast and precise decisions about a patient’s care.
Most agree the future of digital health largely rests on making joined-up data available. Integrated data is also going to play a vital role in propelling tech innovations forward. And, as we are hearing and experiencing from all corners of the industry, we need to leverage AI to unlock its full potential. The consensus is getting effective data foundations firmly in place is a prerequisite to support these types of innovations, while recognising there
As we are hearing from all corners of the industry, we need to leverage AI to unlock its full potential.
return for an additional 3.4 billion GBP investment for digital transformation in the spring Budget.
Traditionally, to risk stratify a patient, health professionals rely on hundreds of transposed data sources. This is an incredibly complex undertaking which is costly, time consuming, and difficult to scale up. I have experienced the complexity while being a chief information officer (CIO) and I have big reservations that continuing with the same approaches will undoubtedly delay progress, despite it being imperative that the NHS expediates digital programmes to relieve current pressures. It’s time for a new approach using architectures that are built differently to solve the mounting capacity issues.
are some barriers to work through first.
NHS England shares the same views. The Operational Planning Guidance released in April places a key emphasis on implementing strong digital foundations. Just weeks before that it agreed to increase productivity in
A CITIZEN-LED APPROACH THAT BENEFITS EVERYONE openEHR enables healthcare systems to move away from organising records around systems to data that is centred around the person. The powerful architectural concept accelerates digital transformation by securely separating patient data without the frictions of disparate data silos. The result is one consistent longitudinal patient record that improves care coordination, outcomes, and population health.
Health and social care systems are realising that the longitudinal record or digital twin is the key to getting
DIGITAL HEALTH
healthcare right for the individual and the population. The development of the NHS App has encouraged citizens to start thinking in this way, too. They expect to have access to their data, and they want to receive it in a unified way.
EVERGREEN GROWTH AND STANDARDS CO-EXIST
openEHR is the best standard for data persistence and provides a platform for evergreen growth. What is recorded today will be data that health and social care professionals can still use in 10 or 100 years to risk stratify and manage longterm conditions through a person’s lifetime.
My observations as a CIO were that systems weren’t evergreen because the data was hardcoded. With every new application, we had to start again with the data or rescue bits and put in a new data layer, causing huge frictions and costs to the trust’s overheads. openEHR is far more costeffective because it is additive and can accommodate future technologies, but underneath, the data will remain valid and useful.
There are many data standards in use across healthcare and they must work together to provide a functional system. I used them together as an information practitioner, such as FHIR, SNOWMED, and OMOP. I feel quite passionate about this area, and we’ve been doing lots of work to make improvements. For instance, openEHR International has been working closely with HL7 on a number of FHIR projects including connecting smart FHIR and openEHR data sources together to surface in patient/clinician-facing apps. In a recent joint announcement with Chuck Jaffe, CEO of HL7, we signalled our ambition to align some of our standards and specifications for the global good. We hope this will enhance the choice and power of available software. In the spirit of the two open communities, we’re looking forward to the discussion this signalling of intent will bring.
SUPPORTING ADVANCED HEALTHCARE SYSTEMS IN EUROPE
Europe is leading the way with the use of openEHR. The interesting theme is that advanced healthcare systems are adopting the open approach because they are able to separate their data more easily and leverage it.
Catalonia is a flagship example of a bi-directional regional unified record. The region has taken a semi-academic approach looking at the target architecture and how they should use it. Academics from around the world collaborated to review the outcomes and openEHR was chosen as the data layer. Now there are future plans to implement openEHR in other Spanish regions as well. It’s been a rigorous process, but rather than a reflection on the pain of fragmented systems and data, it’s a reflection on what suitable architecture should be, and it’s been a pleasure to be part of it.
In the Nordics, there is a long tradition of openEHR, which is growing with lots of vendors. Seven regions in Sweden are using it, and the Karolinska University Hospital has published a framework with an open approach. It’s steeped in the country but with a variety of approaches and other regions are set to embark on their own transformation journey with openEHR.
Slovenia has been using openEHR for nearly 13 years, and the most recent country to follow suit is Greece, which has signed an agreement to implement a shared care record for the entire country.
OPENEHR IN PRACTICE ACROSS THE UK
Closer to home, we’ve been able to facilitate integrated care through read/write care coordination across OneLondon using the Better openEHR-based digital health platform. It amounts to a footprint covering approximately 10 million people, 5 Integrated Care Systems, 1400 general practices, over 40 NHS Trusts, and 33 local authorities.
There are some really exciting things happening in Scotland and Wales too, where they are using openEHR for various use cases at a national level. Certainly in the UK, we are seeing an increase in people moving towards openEHR and hearing more senior people within the NHS talking about architectural patterns for openEHR and the advantages based on experience.
It’s encouraging to see this shift in conversation at a time when the NHS is nearing breaking point and services need rapid transformation. openEHR is the fastest approach to achieve it and put digital health on the path to a sustainable and promising future.
“Hope lies in dreams, in imagination, and in the courage of those who dare to make dreams into reality”
