MediWales LifeStories Magazine 2023

ISSUE 8

THE SHOWCASE MAGAZINE FOR WELSH LIFE SCIENCE 2023

Connecting health and social care with industry and research in Wales Innovation and collaboration in NHS Wales

Success stories from the Welsh life science industry

Forward thinking health research

SHOWCASING ADVANCES IN WELSH LIFESCIENCE

Creative design that will give your brand the perfect lift-off

Creative design and communications for science, innovation and technology sectors

www.teamworksdesign.com

Contents 5-30 5-30

Innovation and collaboration in NHS Wales 6 Welsh Government innovation strategy: Wales Innovates: Creating a Stronger, Fairer, Greener Wales 7 Wearable cardioverter-defibrillators - national guidance published 8 Missing Boys Project recognised for successful social care innovation and collaboration 9 Revolutionising diagnostics for enhanced outcomes 10 The WeCare app - vascular intervention sparks bright future for patients 11 AI is changing prostate and breast cancer diagnostics in Wales 12 Wearable technology to address childhood obesity at Cardiff and Vale UHB

31-64

65-76

SHOWCASING ADVANCES IN WELSH LIFESCIENCE

13 Independent ultrasound clinic provides access to diagnostics for patients across North Wales 14 Helping patients regain mobility after joint replacement 15 CGI and Delta Wellbeing partner to improve health and social care in West Wales through digital transformation 16 Digital transformation of medicines and prescribing in Wales 18 From hackathon to a last year of life population dashboard 19 Welsh Patient Administration System links-up north Wales 20 Welsh Nursing Care Record transforming nursing in Wales 21 Pioneering QuicDNA project recognised at prestigious awards

22 Real-world evaluation of the NGPOD device 23 Trialling an innovative medication management device in Bridgend 24 Proactive care in reducing the risk of cellulitis recurrence 25 Tackling HCAIs by eliminating microbes from indoor air and surfaces 26 Better, faster, sooner – rapid-access palliative radiotherapy service in Wales 27 RITA – Artificial Intelligence Virtual Assistant responds to FAQs 28 Welsh Blood Service - blood and transfusion services for the future 30 From paper documents to state-of-the-art clinical decision support software

Success stories from the Welsh life science industry 32 Capital Law - Strengthening connections between the Welsh and Swiss life science sectors 33 Development Bank of Wales - Fuelling the growth of the life science sector in Wales 34 Afon Technology - Cutting-edge, non-invasive, realtime continuous glucose monitoring 35 AliveCor KardiaMobile® 6L receives second NICE recommendation 36 Alpha laboratories -The Faecal Immunochemical Test (FIT) is a quick and easy-to-use test 37 Ambrose Healthcare - Pioneering innovative approaches to clinical trials 38 Biodexa Pharmaceuticals PLC - Developing treatment of brain cancers 39 Biophys - Towards safe and accurate liquid drug dosing 40 Bloom Standard - Delivering big opportunities for tiny patients 41 Brainbox - Stimulating new markets at the cutting edge of neuroscience research 42 Collocco Consultancy - Helping companies to introduce safe devices to market 43 Creo Medical - Speedboat Inject cleared for upper GI use in Europe

44 DrDoctor - Integrating digital solutions in Welsh healthcare: A collaboration with DrDoctor 45 Eakin Healthcare - Advancing surgical safety and sustainability: The innovative CIMPAX smoke evacuation system 46 eg technology - Usability: eg technology provide 5 key considerations for product development 47 Frazer-Nash - EMPATH™ - Collaboration and innovative modelling at the heart of discovering optimal care pathways 48 Haelu - Empowering integrated care with a dynamic platform to address a divide between health and social care 49 ImmunoServ’s impact throughout the COVID-19 pandemic 50 inbio - Development of a novel ambient air sampling device for allergen detection 51 iq endoscopes - Working to improve the provision of sustainable endoscopy in Wales and beyond 52 Iterate - International collaboration to improve diagnosis and monitoring of neonatal sepsis 53 Fujifilm - Healthcare re-imagined: Meet Ultra-Portable Diagnostics 54 Llusern Scientific - Streamlining rapid molecular diagnostics

55 Magpie Concept - Advancing pharmaceutical asset management 56 Cellesce - Organoid expansion business outgrows incubator 57 NCL - Preventing unnecessary costs with Aternity Digital Experience Management 58 Objectivity - The importance of stakeholder engagement in bringing innovation to market 59 RedKnight - A new reality for digital mental health 59 Kooth - Continuing to innovate in digital mental health 60 Sony UK Technology Centre - nurturing innovation and resilience 61 Tamarnd - Revolutionising healthcare: humanmachine collaboration for enhanced patient outcomes 62 The Science Behind - Clinical trial for rare, progressive form of myoclonus epilepsy underway 63 Trakcel - managing, controlling and tracking Cell and Gene Therapy (CGT) products 64 UK Discovery Health – A new era in healthcare consulting

Forward thinking health research 66 Cardiff University researchers use video X-Ray to better understand how the spine works

70 Cardiff University Team reveals how SARS-CoV-2 changed and avoided detection

67 Innovation and collaboration in the fight against cancer

71 Diagnostic kit using a digital platform for the early detection of lung cancer

68 Cross-sector working supports paediatric medicines research in Wales

72 Exploring innovations in healthcare: Biomedical Engineering at Swansea University

69 ‘Hospital-at-home’ ultrasound test for older people at risk of heart failure

73 Energist Ltd: Building preclinical data for the NeoGen™ plasma system

LifeStories is produced and published by Teamworks for MediWales. www.teamworksdesign.com

The Maltings, East Tyndall Street, Cardiff CF24 5EA Tel: +44 (0)29 2035 1453 Web: www.mediwales.com

74 Training staff on low intensity psychological interventions for mental health conditions can cut workplace sickness 75 Welsh Wound Innovation Centre (WWIC) educational collaboration with ConvaTec 76 Pan Wales learning day in partnership with the Healthcare Technology Centre and Welsh Government

Gwyn Tudor, CEO: gwyn.tudor@mediwales.com

Katie Maxwell, Membership Manager: katherine.maxwell@mediwales.com

Debbie Laubach, Operations Manager: debbie.laubach@mediwales.com

Lee Gillum, Branding and Visual Communication: lee.gillum@mediwales.com

Ella James, Events and Engagement Manager: ella.james@mediwales.com

Thank you to our Partners

SUPPORTED BY WELSH GOVERNMENT

Welcome to Life Stories magazine, celebrating the vibrant Welsh health technology and life science sector. Published by MediWales and supported by Welsh Government.

As our regular readers will notice, Life Stories has expanded both in scope and depth. This issue is rich with an increased number of case study examples that highlight the remarkable advances in innovation and collaboration within the health and care sectors, industry, and research institutions across Wales.

The MediWales team is delighted to bring these success stories to you, showcasing them in a format designed to offer an overview of a diverse range of projects. These stories aim to spark inspiration, demonstrating how innovation and collaboration projects are creating tangible solutions to the complex challenges and exciting opportunities faced by healthcare professionals and businesses.

This edition of Life Stories is divided into three sections:

Innovation and collaboration in health and social care focusses on health and social care innovation and collaboration.

Highlighted within these pages is the Welsh Government’s ‘Innovation Strategy Wales Innovates: Creating a Stronger, Fairer, Greener Wales’, an ambitious blueprint for transformative change. We spotlight the ‘Missing Boys Project’, underscoring the urgent need for mental health support. Discover the latest advancements in diagnostics, and how apps, wearables, and mobile solutions are reshaping healthcare delivery. Experience how digital transformation and AI are revolutionising frontline services, diagnostics, and care delivery through effective data use. We also present two insightful examples of health technology assessment.

4

Success stories from the life science industry

Forward thinking health research delves into the world

begins by spotlighting the industry’s international ties, reflecting a global reach and impact. Key to the success of the sector is the Development Bank of Wales, a cornerstone in sector support. We delve into how digital, wearable, and mobile technologies are revolutionising health technology. We spotlight groundbreaking pharmaceutical developments from Wales, our trailblazing companies in neuroscience, and major advancements in endoscopic surgery. Discover how health technology is being delivered directly to patients, wherever they are. Our features include a case study on exemplary design practice and inspiring innovations from the largest and smallest life science companies in Wales.

of health research, addressing some of society’s most pressing health challenges. We explore innovative approaches to tackling the pervasive issue of back pain and highlight significant advancements in the ongoing battle against cancer.

Our focus extends to the critical area of paediatric medicine, where new treatments and methodologies are emerging. A recurring theme is the growing emphasis on home-based monitoring and treatment, reflecting a shift towards more patient-centric healthcare.

This issue also showcases the successful collaboration between universities and industry in Wales, a partnership that fosters groundbreaking research and excellence in training and education.

Innovation and collaboration in NHS Wales

SUPPORTED BY WELSH GOVERNMENT

5

Innovation and collaboration in NHS Wales

Welsh Government innovation strategy Wales Innovates: Creating a Stronger, Fairer, Greener Wales On 27th February 2023, the Welsh Government launched Wales Innovates: Creating a Stronger, Fairer, Greener Wales, an Innovation Strategy for Wales.

This strategy articulates a vision of how innovation can underpin the delivery of commitments made in the Programme for Government, extending across all devolved portfolio areas.

The core mission of the Strategy, specifically within health and wellbeing, seeks to forge a coherent innovation ecosystem. Within this framework, the health and social care sector intends to collaborate seamlessly with industry, academia, and the third sector, aiming to explore new and varied working methods, identify opportunities to bring additional value to patients, leverage further funding, and enable partners to innovate at scale.

The main vehicle for delivering the Strategy in health and social care is the £13m Innovation, Technology, and Partnerships programme (‘ITP Programme’). Confirmed in April 2022, the ITP Programme consolidated a range of innovation projects and programmes, initiated in response to system needs since 2014, and to address the challenges and opportunities presented by the impact of the Covid-19 pandemic on all services.

By the end of the current Welsh Government term in 2025, the Programme will demonstrate a variety of evidence-based interventions that support the development, dispersion, and adoption of innovation within and across NHS Wales organisations, Social Care, and wider Regional Partnership Board areas.

The Strategy focuses on three key priorities within health and social care: 1

Creating coherence across the Welsh innovation ecosystem, ensuring all partners comprehend their role.

2. Channeling innovation activity towards system priorities and needs, generating Innovation ‘Pull’.

3. Supporting the adoption of ready innovation, at scale.

To achieve the objective of the Programme and its funding, the following activities will be included: • Scale and sustain innovation for impact - the identification of ‘tried & tested’ innovations that can be accelerated as proven models of care.

• Harness a culture of innovation.

• Work in new ways with our partners, including Industry, to leverage our respective strengths to find the most impactful innovative solutions and bring them to the people of Wales that need them most.

• Influence cross cutting national and international policy including innovation, Value-Based healthcare, and life sciences.

Securing higher value for patients and service providers must evolve into the overarching goal of health and care delivery, uniting the interests of all stakeholders in the ecosystem, underpinned by the Well-being of Future Generations (Wales) Act. The ITP Programme supports a variety of organisations, programmes, and initiatives, such as: • Health Technology Wales • SBRI Centre of Excellence Wales • Regional Innovation Coordination Hubs • Bevan Commission • Intensive Learning Academies Wales

Innovating and developing sustainable working methods is a fundamental ambition of “A Healthier Wales,” the long-term plan for health and social care in Wales.

www.gov.wales

6

Wearable cardioverter-defibrillators national guidance published National guidance has been published

by Health Technology Wales (HTW), recommending the adoption of wearable defibrillators for adults at risk of cardiac death in Wales.

Wearable cardioverter-defibrillators continuously monitor heart rhythm and automatically deliver an electric shock within one minute when certain irregular heart rhythms are detected. They are worn like a vest against the skin and can be used as an interim measure during a recovery period or before further hospital treatment. The devices should only be taken off when the wearer is bathing.

Patients can take them home, meaning they do not need to stay in the hospital while waiting for medication to work or for the fitting of an implantable cardioverter-defibrillator (ICD).

HTW looked for evidence on the effectiveness and costeffectiveness of wearable cardioverter-defibrillators and has published guidance recommending the adoption of the device for some, but not all, adult patients who are at high risk of sudden cardiac death in Wales.

Professor Peter Groves, Chair of Health Technology Wales and a Consultant Interventional Cardiologist at the University Hospital of Wales, said: “We hope the publication of our national guidance recommending the routine adoption of wearable cardioverter-defibrillators will have a positive impact on the lives of people at risk of sudden cardiac death across Wales. This innovative technology will enable more patients to return home while awaiting further hospital treatment, which will improve their quality of life and provide added reassurance that their condition is being safely monitored.”

HTW Director Dr. Susan Myles added: “Our role as a health technology assessment organisation is to identify and appraise innovative health and care technologies with the potential to change lives in Wales, and cardioverter defibrillators are an excellent example of that.”

Health Technology Wales, which is funded by the Welsh Government and hosted by Velindre University NHS Trust, produces national guidance on the use of non-medicine health and care technologies in Wales. For health, this includes medical devices, diagnostic tests, surgical procedures, and psychological therapies. For social care, this includes

equipment or different models for supporting families, children, and adults.

During 2022-23, HTW considered more than 150 new topic referrals and published 10 new HTW guidance documents, as well as 71 Topic Exploration Reports. Looking ahead, it will be focusing on identifying topics for appraisal that address the six Ministerial Priorities announced

by Judith Paget CBE, Director General of Health and Social Services and Chief Executive of NHS Wales. HTW welcomes suggestions of non-medicine health and care technologies for appraisal, and anybody can suggest a topic.

www.healthtechnology.wales

7

Bwrdd Iechyd Prifysgol

Bwrdd Iechyd Prifysgol

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Aneurin Bevan Cwm Taf Morgannwg Innovation and collaboration in NHS Wales University Health Board University Health Board

Missing Boys Project recognised for successful social care innovation and collaboration Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Ymddiriedolaeth The Betsi Cadwaladr University Health GIG Prifysgol Felindre Board CAMHS (Children Adolescent Velindreand University NHS Trust Mental Health Services) Transformation and Improvement Team, with support from the Health Board’s Research and Development team, issued a national call to local, regional, and national partners to share ideas that would help improve the services offered to young people.

One of the projects submitted was the Missing Boys Project from the Young Persons Counselling Team at Denbighshire County Council. The pilot project provided increased school-based counselling services for young boys and men between 11-18 years old in Denbighshire, which helped reduce pressure and waiting times for CAMHS services. Early results from this project have shown that the young boys who engaged in the project now know more about how to access mental health support and when to seek help.

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG

Gwasanaethau This project has been recognisedAmbiwlans nationallyCymru Welsh Ambulance Services after winning the ‘Social Care Innovation NHS Trust through Collaboration’ Award at last year’s MediWales Awards.

“We are proud of the commitment and dedication shown by this fantastic team in delivering this very important project to support boys and young men. I’m delighted the team has been recognised by MediWales for their hard work and dedication in caring for our younger male residents. On behalf of the council and those they have given great support through the project, we would like to congratulate them and thank them for their professionalism and hard work.”

Councillor Elen Heaton Lead Member for Health and Social Care at Denbighshire County Council

The Young Persons Counselling team is planning to collaborate with the Health Board to extend this service in the area with the hope of improving male rates of engagement in therapy.

Llinos Edwards, Transformation Lead for CAMHS at BCUHB, added: “This call for innovation has provided us with the unique opportunity to collaborate with a wide range of partners who all share the same goal of improving children’s services in North Wales. This Denbighshire project is an example of offering support earlier for young boys who ordinarily find it difficult to reach out for help, ultimately reducing the need for more specialist intervention later in life. We’d like to thank all our partners for their engagement with this programme; we’ve had some fantastic ideas come through which we plan to explore in the near future.”

www.bcuhb.nhs.wales

8

Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Revolutionising diagnostics for enhanced outcomes Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Ymddiriedolaeth Robert Bonwick-Salisbury, a Senior GIG Prifysgol Felindre Biomedical Scientist at Betsi Cadwaladr Velindre University NHS Trust University Health Board, shares his personal journey, from conceptualising a novel solution to a recognised challenge to developing a new product.

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

Over the years, I’ve witnessed gradual advancements in immunohistochemistry (IHC). From the laborious process of boiling slides in acid, which took 4-6 hours to run tests, to the introduction of machines adept at swiftly handling intricate tasks. In addition, molecular diagnostics advancements are propelling healthcare towards tailored, personalised medicine, which imposes increasingly rigorous testing demands. The success of all of these advancements still depends on effective, rapid fixation.

A significant challenge we still face is achieving prompt fixation in cases with limited sample sizes. My primary concern has always focussed on breast pathology, where we are constantly wary of autolysis (cell death) altering a lesion’s staging and grading, potentially leaving us with insufficient tissue for molecular testing.

I conceived an idea with the hope of accelerating fixation without compromising patient samples, not only in breast pathology but across all surgical resection samples. My initial attempt at a ‘health hack’ event did not yield results, but it did connect me with the right people. I reached out to new contacts who could assist me in securing funding and finding the right experts to build a prototype.

After two years, I successfully obtained funding, engaged a designer and a patent lawyer.

Amidst the Covid pandemic, I persevered to find someone capable of manufacturing my prototype. After numerous online meetings, conducted from home, I eventually found a highly enthusiastic partner. Now, eighteen months into our partnership, we stand on the verge of christening this device.

Throughout this journey, I’ve gained invaluable insights into design processes, patent law, and the intricate steps required to transform an idea into a tangible device. My aspiration is that

this innovation will reshape the landscape of cellular pathology, reducing turnaround times and minimising the risk of false negatives in molecular diagnosis.

I am resolute in seeing this through to fruition.

Robert has received support from the R&D team at Betsi Cadwaladr University Health Board for his innovation, enabling him to bring his vision to life. As a department, the team is immensely excited about the prospects and potential of this remarkable project.

www.bcuhb.nhs.wales

9

Bwrdd Iechyd Prifysgol

Bwrdd Iechyd Prifysgol

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Aneurin Bevan Cwm Taf Morgannwg Innovation and collaboration in NHS Wales University Health Board University Health Board

The WeCare app - vascular intervention sparks bright future for patients Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Prifysgol Felindre Velindre University NHS Trust

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

Consultant Vascular Surgeon, Mr. Soroush Sohrabi has created an early version of an app called WeCare, the Welsh Mobile Application for Patient Care and Evaluation, to assist his patients, at Betsi Cadwaladr University Health Board, to completing a supervised exercise programme that is beneficial for patients with intermittent claudication (IC).

IC is the most common symptom of peripheral arterial disease (PAD) and is characterised by discomfort in the legs that is brought on by walking and relieved by rest. People with IC often have limited functional status and are at increased risk of cardiovascular morbidity and mortality. People often adapt by decreasing their level of physical activity, but evidence suggests regular exercise improves walking ability. People

with IC may be offered unsupervised exercise (USE) or supervised exercise programmes (SEP). The National Institute for Health and Care Excellence (NICE) recommends SEP programmes as the first line of treatment.

Invasive surgical or endovascular (stent, angioplasty) should only be offered to patients who have failed the exercise programme.

Soroush’s idea, which originated in 2018, came about because currently North Wales does not have an SEP programme, and only two out of four Health Boards in South Wales can offer hospital-based SEP. This is largely because of the cost of providing supervised programmes – because of the facilities and equipment needed, and the cost of staff needed to supervise sessions properly. Furthermore, published evidence demonstrates that not all patients with IC can attend SEP because of factors such as age; difficulty with patient transfer; lack of

SEP programme capacity to see all IC patients; and poor patient engagement. Without SEP, patients are told to conduct their own exercise regime, but it is then impossible for their clinician to monitor what exercise is being done and what is it achieving.

Soroush’s aim to develop a mobile application for remote supervised exercise programmes (RSEP), is particularly applicable to his own area of expertise in vascular surgery but could be useful across a number of clinical conditions. The app would be downloaded by a patient onto their SmartPhone or tablet. RSEP could replace physical on-site SEPs, which on average for any given patient could be done two-three times per week over a period of three months. Besides providing compliance with NICE guidelines, the app could show cost-savings to a Health Board in terms of more efficient clinician time management and savings on the use of hospital facilities.

www.bcuhb.nhs.wales

10

Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

AI is changing prostate and breast cancer diagnostics in Wales Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Ymddiriedolaeth

Artificial intelligence (AI) is changing GIG Prifysgol Felindre Velindre and University NHS Trust how suspected prostate breast cancer are diagnosed in Wales, with Betsi Cadwaladr University Health Board (BCUHB) leading the way. Funded through the Welsh Government’s Innovation Fund and supported by the Small Business Research Initiative (SBRI) Centre of Excellence, the AI tool automatically analyses digital images of pathology samples, classifying them through a traffic light system as having a higher or lower likelihood of cancer before a review by clinicians.

By classifying the images, the most urgent cases are prioritised, leading to improved patient outcomes through faster diagnosis and potentially fewer biopsies and additional testing. The IBEX AI platform is now undergoing further testing within six health boards with the ambition to make this technology a routine part of prostate cancer testing, supporting clinical teams and assessing its use in the diagnosis of additional cancers.

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services “By embracingNHS new technologies, Trust

we can transform how we interact with the NHS, find new ways to save lives, and increase performance across health and social care.

Innovative and effective use of datadriven technology, moving to digital healthcare, and exploiting new technology is vital if we are to meet the soaring demand and increasing pressures on our NHS. We are seeing how AI presents incredible opportunities to transform the way we interact and deliver NHS services. The benefits of using AI to help diagnose cancer have exceeded all our expectations, and it is fantastic that six Welsh Health Boards are undertaking further trials of this technology. The IBEX system has shown real promise, and the possibilities of what this type of technology can do and how it could be used in the future across a number of suspected cancers are an exciting prospect.”

Dr Muhammad Aslam, consultant pathologist and Betsi Cadwaladr’s clinical director of North Wales Diagnostic and Clinical Support Services, said: “I previously said the use of artificial intelligence for diagnosis and prognosis of cancers puts us ‘at the crossroads of an exciting new world’. I firmly believe this, and it is wonderful to see the use of what I like to call assistive intelligence being replicated across Wales. I’m proud Betsi Cadwaladr was the first health board in the UK to forge a path with its clinical use, with the help of SBRI funding. Early detection saves lives, and AI in BCUHB is improving prostate and breast cancer diagnoses. This is just the start, and it will lead to quicker diagnoses and more accurate predictions of prognoses for patients with various cancers. I feel very proud Welsh Government recognises our achievements and I’m grateful for its continued support for the work we are doing.”

The Small Business Research Initiative (SBRI) Centre of Excellence works with industry to develop innovative solutions that address unmet needs and improve the health and well-being of those living in Wales.

Eluned Morgan Minister for Health and Social Services

Following successful trials analysing prostate biopsies, which saw a 13% increase in cancer detection, the IBEX Galen AI platform is now also being trialed in suspected breast cancer cases.

The success of the IBEX AI project has been recognised at this year’s UK Innovate Awards, where it has been announced as a finalist in the Innovation Spread Category.

www.bcuhb.nhs.wales

11

Innovation and collaboration in NHS Wales Bwrdd Iechyd Prifysgol Caerdydd a’r Fro Cardiff and Vale University Health Board

ol

ty

Wearable technology to address childhood obesity at Cardiff and Vale UHB

ol

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

rd

ol

BwrddLives Iechyd Prifysgol The Active Families Active (AFAL) Hywel Dda team of Cardiff and Vale University Health University Health Board Board is dedicated to reducing childhood obesity rates through the implementation of a virtual ward app and wearable fitness watches. This initiative is part of the Bevan Commission Planned Care Iechyd Cyhoeddus Cymru Innovation Programme, funded by the Welsh Government. Public Health

rd

Wales

Leading this project are Dr. Sian Moynihan, Consultant Community Paediatrician and Clinical Lead for Cardiff and Vale CYPFH Weight Management Service, along with Hannah R. Williams, Research Officer at the Bevan Commission, as part of the AFAL team. Their research on children’s engagement with smartwatches revealed that children as young as 10 years old were eager to engage with these devices.

Research indicates that wearable devices can effectively contribute to weight loss and activity Previously, without the virtual ward interface, goals (Ringeval M. et al. 2020). The AFAL team is Ymddiriedolaeth GIG patient contact took approximately 10 minutes introducing the use of wearable fitness trackers Gwasanaethau Ambiwlans Cymru of professional time. Feedback indicated that integrated with an app, providing access to fitness Welsh Ambulance Services the non-interfaced watches raised awareness NHS Trust plans, activity challenges, recipes, and support of lifestyle changes, such as step count, but groups. The app also monitors data such as children lost interest quickly. With the introduction fluid intake, step count, and exercise. Patients of the virtual ward app, the interfaced watches will be encouraged to set personal goals, track are expected to better engage children and their their progress, and receive notifications to limit families in adopting an active and healthy lifestyle. sedentary time.

HS Trust

The next phase of the project involves trialling interfaced watches with a group of patients and their families. This digital solution aims to enhance the capacity to monitor outpatient reviews, improve team efficiency, and empower patients for self-monitoring.

The potential impact includes reducing hospital outpatient visits and decreasing waiting times for new patients.

After participating in the Spread and Scale Academy with the Dragon’s Heart Institute, the team has developed a plan to expand the project to similar services in Wales. This includes services for adults facing similar weight management challenges and tier 3 children’s services across the country.

“Already, I am witnessing the empowering effects of this project in terms of connecting with young people. It’s user-friendly for me as a professional, and I see young people engaging with it successfully.”

Dr. Sian Moynihan Consultant Community Paediatrician and Clinical Lead for Cardiff and Vale CYPFH Weight Management Service

Mark Briggs, Assistant Director of Innovation, said “It is truly encouraging to witness the fruition of this project, supported by Cardiff and Vale UHB and the Bevan Commission. Sian and her colleagues have worked tirelessly in recent months, overcoming practical challenges with their determination to make a difference in children’s lives by enhancing their fitness levels and weight management. I eagerly anticipate the next ‘Spread and Scale’ phase, where the team will use their knowledge and learning to support other child and adult groups similarly.”

The Bevan Commission Planned Care Innovation Programme (PCIP), funded by the Welsh Government, aims to reduce patient waiting times, address growing backlogs, and decrease overall demand on planned care services in Wales by supporting 18 innovative and diverse projects across all seven NHS Health Boards and two NHS Trusts.

www.cavuhb.nhs.wales

12

Independent ultrasound clinic provides access to diagnostics for patients across North Wales After more than five years of living and working in Australia, Dr. Tom Constantine has returned to the UK and opened a diagnostics company in his hometown of Colwyn Bay. Employing local sonographers, Coastal Medical Imaging aims to provide support from a new, modern facility.

Referred patients will receive their results within days, as Tom and the team use innovative technology and software to conduct non-obstetric ultrasound scans of musculoskeletal areas of the body, as well as the abdomen, kidneys, bladder, pelvis, blood vessels, and more.

Supported by the Welsh Government, Tom began scouting locations in 2021. As an A&E registrar with more than 10 years’ experience in the Australian and UK health systems, he aims to “make a difference” for those living in uncertainty and pain. Close to 8,000 people in North Wales are on the waiting list for a non-obstetric ultrasound scan, as diagnostic units across the country cope with backlogs and strain created by the Covid-19 pandemic.

“While in Australia, we noticed a huge difference in the way their health service was supported by independent clinics in almost every community. Yet here in North Wales, there is nobody doing what we are doing, offering accessible and affordable ultrasound services in a welcoming, comfortable environment. I really want to affect change here, in the area where I grew up, and believe Coastal Medical Imaging will give GPs, Consultants, and other health professionals another option when referring patients for diagnostics. That’s what this is about: providing a choice and working in partnership with patients and clinicians, building confidence and trust that we are a high-quality center where they can refer patients and receive a quick and effective response.”

Dr. Tom Constantine

Tom has invested significant capital in the business, including a state-of-the-art ultrasound machine. He has used local suppliers and contractors to help create the 1,100 sq ft clinic.

Tom explains: “Of particular concern in North Wales is the 3,300 patients currently waiting over 8 weeks for an ultrasound, up from 2,600 a year ago, especially with the Welsh Government’s target of eliminating this by March 2024. Having fast access to diagnostics will have an impact on their capacity to see patients, and while the NHS is a wonderful system, it is under pressure – we can help to reduce that pressure significantly.”

He added: “My vision is to eventually open further clinics and increase the number of modalities we offer, such as CT and MRI, to eventually become a ‘one-stop shop’ for diagnostics in the area. We already have plans to introduce MRI in the nottoo-distant future.

“It is a long-term, sustainable option that will have an effect, so we look forward to forging new relationships and playing our part in lowering waiting times and being there for GPs and hospitals in the months and years ahead as they continue to work hard to provide the best care available to patients.”

www.coastalmedicalimaging.co.uk

13

Caerdydd a’r Fro Cardiff and Vale University Health Board

Innovation and collaboration in NHS Wales

ty

ol

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

rd

Helping patients regain mobility after joint replacement

ol

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

rd

HS Trust

Digital health, especially smartphone in Wales to introduce the mymobility® app to its Iechyd Cyhoeddus Cymru apps, is increasingly being used for remote patients undergoing joint replacement operations, Public Health and personalised patient care, improving empowering them in managing these major Wales the patient experience. Osteoarthritis is operations. the most common joint disease worldwide The app provides patients with educational and a leading cause of disability in older content about these operations, detailing Ymddiriedolaeth GIG adults. Joint replacement surgery helps expectations along their entire journey, from Gwasanaethau Ambiwlans Cymru improve patients’ symptoms, mobility, and Welsh Ambulance Services before surgery up until one year after surgery. quality of life. The recovery can often take NHS Trust It also offers prehabilitation and post-surgery several months or longer (up to a year) rehabilitation videos and instructional guides to and can be affected by factors such as age, ensure patients are optimised throughout their general health, fitness, and the condition joint replacement journey. The app also offers a of the joint and muscles. two-way communication channel (text messages, The Trauma and Orthopaedic department at photos, video consultations) between the patient the Princess of Wales Hospital, part of the Cwm and a multidisciplinary healthcare team to ensure Taf Morgannwg University Health Board, in appropriate and timely advice. It also allows the collaboration with the Value-based Healthcare healthcare team to monitor patient engagement team and Zimmer Biomet, was the first hospital and collect functional outcome scores (PROMS).

Project lead, Mr. Rahul Kotwal (Consultant Orthopedic Surgeon), explains “Many patients coming in for surgery have been deconditioned over the years and have poor muscle strength and mobility before their operation. The app has certainly helped improve patients’ muscle strength and general fitness pre-operation, which then also aids in early recovery following the major operation.”

The team has received very positive feedback about the app from patients. Patient compliance with app usage has been almost 90%. Age hasn’t been a barrier to app usage as it is very user-friendly. Almost 50% of patients used the communication feature on the app, which has reduced patient footfall in the hospital, saved costs, and also reduced the carbon footprint while improving patient care and experience.

www.ctmuhb.nhs.wales

14

CGI and Delta Wellbeing partner to improve health and social care in West Wales through digital transformation

Llesiant Delta Wellbeing, a Local Authority Trading Company owned

by Carmarthenshire County Council, provides assistive technology and proactive monitoring to support older and vulnerable people to live more independently in their homes for longer.

Delta Wellbeing is at the heart of health and care collaboration between local authorities, health boards and community partners and has become a centre of excellence for Technology Enabled Care (TEC). Since it was formed in 2018, the company has expanded its services across Wales using innovative technology to provide a range of solutions in the health and social care sector. It works closely with local and national health and social care partners to deliver both standard and new innovative technology services to support patients leaving acute settings as well as in the community.

Delta Wellbeing, has selected CGI as its longterm strategic partner with the award of a five-year contract to improve health and social care outcomes in West Wales. CGI is among the largest independent IT and business consulting services firms in the world. With 91,500 consultants and professionals across the globe, CGI delivers a portfolio of capabilities including strategic IT and business consulting to systems integration, managed IT and business process services and intellectual property solutions.

The initial focus of the partnership has been the digitisation of Delta Wellbeing’s telecare services in preparation for the upcoming analogue switch off in 2025. The new digital platform provides

round-the-clock monitoring through alarms, sensors, and wearable devices to remotely oversee health conditions, proactively supporting people to remain in their own home and retain a high quality of life. With a secure and seamless transition, CGI is helping to ensure that Delta Wellbeing and its partners continue to provide a high quality of care and are best placed to capture and utilise the very best that technology can offer those in the community.

“Delta Wellbeing’s vision of supporting people to live independently and to enable individuals to help themselves, is at the centre of our partnership with CGI. We share values, ethics and both of our teams are truly committed to supporting better outcomes for our service users who are the people in our communities who need our help most.”

Samantha Watkins Delta Wellbeing Managing Director

The project sees the successful integration of multiple systems, providing Delta Wellbeing with a cutting-edge platform to allow more proactive monitoring of clients and a more engaging and effective solution for service users. A first of its kind unique platform, it enables health and care services to become fully integrated allowing patients, families and professionals to work together as one team seeing the same information enabling a seamless transition between home and hospital services.

The new platform is specifically designed to allow Delta Wellbeing to expand the range of assistive technology products and telehealth services they provide, transforming the way health and social care is delivered through a ‘whole system’ approach, supporting the continuous provision of high-quality care across the region.

“We are very pleased to see the platform in action and are looking forward to continuing our work with Delta Wellbeing to further develop their offering. CGI is committed to supporting digital health and care services in the home and are pleased to be involved in establishing Wales as the national pathfinder in truly integrated health and care at home services through the adoption of this new integrated hybrid care capability. As health and care organisations across the UK continue to face unprecedented and unrelenting challenges, there has never been a better time to coproduce and expand collaboration to develop a ‘whole system’ approach to the continuum of care.”

Donna Kelly CGI Senior Vice President, South and Midlands

www.deltawellbeing.org.uk

15

Innovation and collaboration in NHS Wales Bwrdd Iechyd Prifysgol Iechyd a Gofal Bae Abertawe Digidol Cymru Swansea BayDigital University health and Care Wales Health Board

Bwrdd Iechyd Prifysgol Caerdydd a’r Fro Cardiff and Vale University Health Board

Digital transformation of medicines and prescribing in Wales Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Iechyd Prifysgol Making theBwrdd prescribing, dispensing, and Betsi Cadwaladr administration of medicines throughout University Health Board Wales easier, safer, more efficient, and effective for patients and professionals through digital means.

Bwrdd In line with the restIechyd of the UK, the NHS in Wales Addysgu Powys has faced enormous challenges in the wake of Powys Teaching the COVID pandemic.

These challenges have Health Board prompted a transformative programme of digital innovation by the Welsh Government, including the creation of the ambitious Digital Medicines Transformation YmddiriedolaethPortfolio.

GIG Prifysgol Felindre Velindre University NHS Trust

Many of Wales’ 3.1 million people rely on medicines as part of their daily routine to treat illnesses and improve well-being, with 81 million prescription items issued each year

by GPs alone. However, the way medicines are managed across primary and secondary care, primarily using paper processes, hasn’t changed significantly for decades – that is until now.

New streamlined digital services are set to be introduced for the prescribing, dispensing, and administration of medicines, for use across Welsh hospitals, GP surgeries, and community pharmacies. This large-scale change programme is being led by the Digital Medicines Transformation Portfolio (DMTP), working closely with stakeholders, including patients, clinicians, pharmacists, and system suppliers. The work will make services safer, easier, and more efficient for healthcare professionals and people across Wales.

The introduction of new technology-enabled services will improve the way patients, clinicians, and pharmacists access and manage the provision of medicines across the health system. This includes patients’ access to medicines, prescribing of medication by clinicians, and the assurance and dispensing of prescriptions by pharmacists.

16

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol The Portfolio, established in April 2022, brings Hywel Dda together four major national programmes and University Health Board projects that will deliver the benefits of a fully digital prescribing approach in all care settings in Wales. They are: Iechyd Cyhoeddus

Digital prescribing services are also good for the environment, reducing the 40 million prescription forms printed each year and the many thousands of medicines charts used and filed away in Welsh hospitals.

Ambulance Services l A SharedWelsh Medicines Record

“We want to make sure services deliver the best outcomes for citizens and are designed around how citizens and service providers want to use and manage those services…

This programme will transform prescribing in Wales, supported by a digital platform.”

l Medicines functionality within the

Eluned Morgan MS

Cymru l An Electronic Prescription Service Public Health (EPS) in primary care Wales

l Electronic Prescribing and

Medicines Administration (ePMA) in every ward in every hospital in Ymddiriedolaeth GIG NHS Wales Gwasanaethau Ambiwlans Cymru NHS Trust

NHS Wales App

Going digital in our hospitals will mean paper drug charts will disappear from the end of the patient’s bed. Instead, doctors, nurses, and health professionals will have information at their fingertips to inform vital clinical decisions, and digitising the process will improve safety.

This will be supported by the development of a Shared Medicines Record that will be easily accessed and shared when needed. The record will mean that for the first time ever, all medication information for a patient will be in one place, including current and previous medicines.

Patients will also be able to use the new NHS Wales App to access their prescription and medicines information, helping to change the way people manage their care and connect with health providers.

Hamish Laing, DMTP Senior Responsible Owner, said: “The work we are undertaking to introduce a fully digital service will have a massive positive impact for patients and healthcare professionals across Wales. Extensive and reliable information will be available on medication usage and effectiveness, and for the first time, a patient’s full medication record will be available wherever they receive care. We are making excellent progress across all of the Portfolio, and we will be moving into the exciting delivery of an e-Prescription Service in autumn 2023.”

Minister for Health and Social Services, said

The Digital Medicines Transformation Portfolio, hosted by Digital Health and Care Wales Primary Care Electronic Prescription Service (EPS) l

l

l

GPs and other prescribers will be able to send prescriptions electronically to a pharmacy of the individual’s choice without the need for a paper form.

Patients will no longer have to visit the surgery to collect a repeat prescription form.

Secondary Care Electronic Prescribing and Medicines Administration (ePMA) l

l

GPs and other prescribers will be able to sign prescriptions digitally, freeing up more time for care. l

Paper medicines charts and prescriptions will be replaced as prescribing and medicines administration across all Welsh hospitals moves to a digital system.

Medication records will be stored digitally and available to health professionals 24/7 at the touch of a button, with no time wasted searching for paper charts.

Patients’ medicines can be started or changed remotely, saving doctors’ time and delivering better and safer care.

Shared Medicines Record l

Building a single shared record of medicines for every patient in Wales that is easily accessed and shared when needed.

l

Health professionals will have a clear view of a patient’s complete medicines record.

l

Patients won’t need to reprovide medication details when they see a healthcare professional.

Medicines Functionality in the NHS Wales App l

Helps people manage their medicines using their smartphone, a tablet, or computer.

l

Provides useful information and medicines services, including: l

Ordering and managing repeat prescriptions.

l

Selecting the person’s preferred community pharmacy.

l

Notifications that a prescription is dispensed and ready to be collected from the pharmacy.

www.dhcw.nhs.wales

17

Innovation and collaboration in NHS Wales Bwrdd Iechyd Prifysgol Iechyd a Gofal Bae AbertaweDigidol Cymru Swansea Bay University Digital health Health Board and Care Wales

Bwrdd Iechyd Prifysgol Caerdydd a’r Fro Cardiff and Vale University Health Board

Bwrdd Iechyd Prifysgol Bae Abertawe Swansea Bay University Health Board

From hackathon to a last year of life population dashboard

Canolfan Gwerth mewn Bwrdd Iechyd Prifysgol IechydCaerdydd Cymru a’r Fro Vale Welsh Cardiff Value inand Health CentreUniversity Health Board

Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Digital Health and Care Wales (DHCW) takes a lead on data and digital services.

Part of DHCW’s mission is to drive Bwrdd Iechyd Addysgu Powys value through utilising the data held, Powys Teaching for example, within DHCW’s national Health Board data warehouse. DHCW’s information specialists routinely collect, curate, and analyse national health data and produce Ymddiriedolaeth interactive reports and dashboards.

GIG Prifysgol Felindre Velindre University NHS Trust

The NHS Wales Modelling Collaborative hosts two-day data hackathons each year, in which data and information specialists, from DHCW and beyond, are brought together with key decision makers, such as clinicians, service managers, and planners, with the aim of collaboratively developing solutions to tackle specific ‘problems’ or exploring service improvement opportunities.

At the event held in May 2022, DHCW teamed up with palliative care consultants Anthony Byrne (C&VUHB) and Idris Baker (SBUHB and the national clinical lead for palliative and end-of-life care) to explore opportunities to use routinely collected data to provide new insights into people approaching end of life.

The problem the palliative care specialists raised was not having sufficient information about people approaching end of life, especially at the population level, and as such they were unable to effectively assess the quality of care provided.

Gareth John noted: “The information specialists The team pulled together data about people were really grateful to Anthony and Idris for in their last year of life and presented this data ideasCyhoeddus in Iechyd an understandable, engaging, and insightful Bwrdd Iechydbeing so enthusiastic and open to ourIechyd Cyhoeddus Addysgu Powys Cymru and for making us feel that we were equal dashboard.

The first step was to create a cohort Cymru Powys Teaching Public Health Health felt that ofPublic Welsh residents who had died in a single Health Board partners throughout the process. We Wales Wales the experience provided a nice template for how year, 2021 was chosen. This was done using we, as information specialists, would want to death registration records from the Office for Ymddiriedolaeth GIG Ymddiriedolaeth GIG(ONS). These records wereYmddiriedolaeth engage and collaborate with other healthcare National Statistics Gwasanaethau Ambiwlans Cymru Gwasanaethau Ambiwlans Cymru GIG Prifysgol Felindre Welsh Ambulance Services professionals.” linked to other sources including ambulance, Velindre University Welsh Ambulance Services NHS Trust NHS Trust Trust 111, NHS emergency department, hospital admission The Welsh Value in Health (ViH) Centre, headed and specialist palliative care datasets, providing up by Dr Sally Lewis. Given this experience agreed a comprehensive view of interactions during the to take over the operational management of the last year of life. end-of-life dashboard, resulting in the launch The team used existing dashboard templates, in February 2023 and an ongoing development including the “patient on a page” visual which programme. resulted in a longitudinal view of an individual’s Anthony Byrne said: “The insights from the service encounters during their last year of dashboard give us huge opportunities to life with different bars representing different interrogate the services being used by our patients encounters, the length of those bars denoting and allows us to see where we can make really the length of the encounter, and different colours effective interventions.” representing different services. It was noted how the frequency of encounters increased Following the launch of the dashboard, there has in the run up to death. The team was able to been interest in developing the dashboard further quantify this increase in frequency, showing that and to carry out more in-depth research, which individuals spent around 12 times as many days would take into account the perspectives of the in a hospital or ambulance during their last year patients and their families, with the aim of better of life compared to a group of the same age and understanding the quality of services provided and sex and 25 times as many days during their last helping to design the services of the future.

3 months.

“Having received the brief from Anthony and Idris, we were able to recycle existing analytical and visual templates that had already been developed. It was then a case of tailoring these to palliative and endof-life care. This proved to be a good way of engaging the palliative care specialists, immediately giving them something to see, showing them the breadth of data that was available, and how it could be used.”

Dr Gareth John Head of Information Delivery, DHCW

www.dhcw.nhs.wales

18

Iechyd a Gofal Digidol Cymru Digital health and Care Wales

Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Welsh Patient Administration System links-up north Wales The WelshPAS, created and managed

by Digital Health and Care Wales, is the largest IT system in NHS Wales, managing more than 2.6 billion transactions a year.

Its many functions include recording and sharing patient information, such as appointments and treatments.

A huge programme of work has successfully linked up separate versions of the Welsh Patient Administration System (WelshPAS) in north Wales, bringing together all areas of the Betsi Cadwaladr University (BCU) Health Board into one single version of the WelshPAS. Before the system was merged, if a patient was seen in BCU East, but needed treatment in Central or West, their information would have to be transferred across, whereas now the patient information and interactions are easily accessible across the whole health board – saving on time, increasing patient safety and improving the patient experience.

For the final phase of the work, DHCW and BCU worked together to install and transition the systems.

Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth “This has been a hugeFelindre endeavour, GIG Prifysgol Velindre University NHS Trust involving multidisciplinary teams

Ymddiriedolaeth GIG Carl Davies, National Application Manager for Gwasanaethau Ambiwlans Cymru WelshPAS, explained that nothing happens for Welsh Ambulance Services long in a hospitalNHS without Trust a fully functioning PAS:

from different professions, across BCU and DHCW working as one. The whole project has been a fantastic example of collaborative working, great joint planning and a focus on a shared purpose. The go live weekend involved over 110 people and is one of the smoothest I have experienced in my 23 years as a CIO. A great achievement. Thank you to all the BCU and DHCW staff involved, it is already starting to make a positive difference to patients and staff.”

Dylan Roberts Chief Digital and Information Officer BCU

Work began on the project to create a seamless PAS across north Wales in 2015 – with much of the latter work taking place against the backdrop of covid restrictions, changing priorities and unprecedented pressures on the NHS.

“It manages the referrals, admissions, and outpatient attendances as well as a myriad of other functions such as interfacing to thirdparty clinical systems. Without the efforts of everyone from support teams, technicians, developers, infrastructure specialists, project managers, and business analysts to doctors, nurses, ward clerks, and trainers, this project would not have taken place, let alone been such a success.”

In some areas of Wales, next up for the WelshPAS will include developments such as an MDT (multi-disciplinary team) admin module. The module is the first patient administration module which will link all NHS Wales organisations together and allows professionals in one health board to book patients into another organisations’ clinics – joining up care, and enabling a quicker and more co-ordinated service

www.dhcw.nhs.wales

19

Innovation and collaboration in NHS Wales Iechyd a Gofal Digidol Cymru Digital health and Care Wales

Welsh Nursing Care Record transforming nursing in Wales The WNCR – led by Digital Health and Care Wales - is a digital system that is transforming the way nurses record, store, share and access patient information.

Rather than using paper documents, nurses can use digital devices (e.g., iPads) to capture information and store it securely, so that care givers along a patient’s healthcare journey have access to the same, up-to-date information.

This year marks two years since the Welsh Nursing Care Record (WNCR) went live. It has now been ,established across all seven local health boards and Velindre NHS Trust and is being used in more than 285 wards across 44 hospital sites.

The project began with standardising the nursing language used in documentation, improving accuracy and making it easier to share information. Healthcare professionals, and representatives from other agencies, joined together to work through their local records and forms and create standardised documents that could be used in the WNCR.

The WNCR team included nurses from every health board and trust in key roles from the start, as clinical leads on the project. The roles were then established as Chief Nursing Information Officers, and they continue to oversee the implementation of the WNCR into hospitals and clinical settings.

On wards where the WNCR has been implemented, many nurses are championing the system, and delighted with the difference it is making to their work: -

“It’s become such a fantastic way forward for nursing, in that it’s clear, concise documentation. There’s no room for error. It highlights all the risk assessments that we need.”

Christine Evans Ward Manager Swansea Bay University Health Board

Naomi Jones, Student Nurse, Cwm Taf Morgannwg University Health Board said: “It’s been a really useful tool for us all. I think all the nurses would agree that it’s really simple to use, and it’s really for us all to share information and work together.”

Peter Davies, Staff Nurse, Powys Teaching Health Board: “I like the way the assessments are graded in a traffic light scheme, so you can see which have been started, which are completed, and which need some work doing to them.”

Stacie Hall, Staff Nurse, Hywel Dda University Health Board: “It definitely saves time, and I think it’s better for patient care, because it means we can spend more time with patients, rather than completing paperwork.”

As well as continuing to integrate the WNCR into more adult wards, it is also expanding into paediatrics with the first WNCR In-patient paediatrics project board meeting held in July 2023.

The team have been engaging with clinical teams in paediatric units across Wales to discuss the paediatric WNCR and demonstrate how it will look and feel.

www.dhcw.nhs.wales

20

Pioneering QuicDNA project recognised at prestigious awards QuicDNA and its partners have triumphed at the Advancing Healthcare Awards Wales 2023, winning two awards for its transformative impact on healthcare in Wales and its potential for roll-out across the nation.

The cross-sector project won both the Overall Winner out of all shortlisted entrants across all categories and the Award for New Ways of Working, which celebrated its innovative approach to accelerating the treatment pathway through earlier diagnosis for lung cancer patients.

The programme is evaluating liquid biopsy testing in health boards across Wales over 18 months.

A liquid biopsy is a simple and non-invasive alternative to tumour biopsies done through a blood test. It can be collected early in the diagnostic pathway and provide genomic analysis, which is needed for delivering targeted treatments. It is hoped this will mean patients can begin treatment earlier, and ultimately provide vital evidence to allow liquid biopsy test to become the standard of care for all Health Boards in Wales.

QuicDNA has brought together partners including the All Wales Medical Genomic Services (AWMGS), multiple Welsh health boards, the Centre for Trials Research, Welsh Government, Health and Care Research Wales, Life Sciences Hub Wales, various industry partners including Illumina, and third sector funding and support from organisations such as the Moondance Cancer Initiative.

The Advancing Healthcare Awards recognised that its collaborative approach demonstrated the strong leadership needed to deliver system-level transformation in healthcare in Wales and improve outcomes for people living here. The project has also been driven forward by the inspiring fundraising efforts of patient advocate Craig Maxell – who has now helped to raise nearly £1 million to support its roll-out.

QuicDNA’s innovative approach was also highlighted through AWGMS’ pioneering approach to genomic testing, which is the only NHS genomics laboratory to be offering an in-house large gene panel liquid biopsy test in the UK.

“I am overwhelmed with gratitude that the QuicDNA Project is one of the finalists for the ‘New Ways of Working’ award at this year’s AHA Cymru Awards. I am so honoured to have QuicDNA recognised in this way. The QuicDNA project is a truly collaborative project between the NHS, third sector, pharmaceutical, industry and patients. We are grateful that the project which we are so passionate about also resonates with others.We hope that this recognition by the AHA Cymru Awards can serve as an inspiration to others within healthcare, and we’re proud that the project will allow cancer patients with lung cancer to access treatments faster in the future.”

Sian Morgan Consultant Clinical Scientist and Laboratory Director All Wales Medical Genomics Service (AWMGS)

www.medicalgenomicswales.co.uk

21

gol

Bwrdd Iechyd Prifysgol

Cwmcollaboration Taf Morgannwg Innovation and in NHS Wales University Health Board

oard

gol

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

oard

Real-world evaluation of the NGPOD device Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG

re NHS Trust

Ambiwlans Cymru Nasogastric feedingGwasanaethau tubes (NGTs) are Welsh Ambulance Services employed when patients cannot safely NHS Trust swallow food, liquids, or medication.

National guidelines mandate clinicians to verify the correct positioning of the NGT before each use. The current method involves aspirating a sample through the tube and testing it with pH strips. Accurate positioning is crucial, as misplaced tubes, often coiled in the upper airway or inserted into the bronchus, can lead to severe injuries or death.

It is widely recognised that the current pH testing method can be unreliable, time-consuming, and often necessitates X-rays to confirm results.

These methods can lead to delays in feeding or medication administration.

However, a Healthcare Safety Investigation Branch report by NHS England in December 2020 revealed that both pH testing and X-ray usage are error prone. The use of pH testing strips is potentially unreliable and underestimated in complexity. In 2016, NHSI explored alternative technologies to enhance NG tube feeding safety.

In response to this challenge, NGPOD Global developed the NGPOD, a two-part device comprising a single-use fibre-optic sensor and a reusable handheld reader that provides a clear indication of NGT positioning.

While NGPOD demonstrated the device’s effectiveness in laboratory conditions, the TriTech Institute was commissioned to conduct real-world evaluations of their product.

Two evaluation sites, Morriston Hospital in Swansea and Glangwili Hospital in Carmarthen, assessed NGPOD’s performance over a 5-month period.

The main findings can be categorised into three themes: Technology, Infrastructure, and People.

Technology: The NGPOD performed well, demonstrating accuracy with no major errors.

When used correctly, the technology was safe and effective.

Infrastructure: Common themes emerged across both sites, including time constraints, difficulties in identifying key personnel, challenges in obtaining approvals, and service oversight.

People (Staff Evaluation): Feedback was mostly positive. However, respondents suggested that pH tests should be available as a backup or alternative method. Additionally, there was a need for more training.

In conclusion, the NGPOD proved effective when used as intended and following the manufacturer’s instructions. The test takes the same amount of time as standard testing but reduces the reliance on X-rays in real-world settings.

“For an SME, they deliver things you can’t do; they possess knowledge you may lack, understand systems you might not, and are passionate about the mission. What TriTech brought to NGPOD included taking time to understand what you are doing and why it’s important; they take action rather than just talk; they contribute as well as receive; they open doors instead of merely pointing at them; they collaborate within the system; they are passionate about the mission; they remain committed, and they accelerate progress.”

Marcus Ineson NGPOD Global

https://tritech.nhs.wales/

22

Bwrdd Iechyd Prifysgol Bae Abertawe Swansea Bay University Health Board

Bwrdd Iechyd Prifysgol Caerdydd a’r Fro Cardiff and Vale University Health Board

Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Trialling an innovative medication management device in Bridgend Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Bwrdd Iechyd

Iechyd Cyhoeddus

Addysgu Powys Cymru A multidisciplinary evaluation of a taken, the tag can alert family members and the because of better community support. It’s also Powys Teaching Public Health medication device and associated alarm-receiving centre. The telecare service can Health Board Wales expected to reduce in-person domiciliary care wraparound care could help empower also send a mobile response unit for a welfare visits to homes. people in Bridgend to remain independent check.

One user of the device has shown a consistent and support them with medication Ymddiriedolaeth GIG It’s expected that the device will improve adherence raiseCymru of 89% since she was Ymddiriedolaeth Gwasanaethau Ambiwlans adherence.

GIG Prifysgol Felindre adherence, helping to better Welsh Ambulance Services medication provided with the Your Meds device in April Velindre University NHS Trust NHS Trust Making sure people take their medication is a manage health conditions and reducing 2023 and has reported that she is finding it growing challenge. People need to manage incidents such as falls. This could prevent much less over whelming to manage their prescriptions to stay independent and live people moving into residential her medication. The additional in their own home, but it’s thought up to 50% of care earlier, alongside limiting support from linking the device prescribed medicine isn’t taken as intended. Our strain on loved ones – which with the Bridge Link Telecare ageing population only exacerbates this: Age is being measured through Service has given her and UK estimates that almost two million people family feedback. her family assurance that over 65 take at least seven different prescribed she will be supported if It could also benefit medications weekly. needed. health and care providers by reducing She commented “I didn’t An innovative device to remind emergency department want to take all my tablets people to take their medication visits due to fewer because there was too whilst offering greater support medication mistakes, many for me to manage. through telecare is being trialled decreasing medication But now it doesn’t bother in Bridgend. The pharmacy team wastage and allowing me at all taking so many, and Bridgelink Telecare, part of earlier hospital discharge it’s like playing bingo.” the Bridgend Community Resource

Team, are working with Life Sciences Hub Wales to evaluate this device, with Life Sciences Hub Wales providing project management assistance. Cwm Taf Morgannwg University Health Board’s Value Based Health Care organisation is also supporting via £20k of funding.

Life Sciences Hub Wales’ horizon scanning helped to identify YOURMeds’ medication management device as the best solution for addressing this challenge. A numbered blister pack is inserted into a digital device called a tag, which is filled by community pharmacists and delivered to users. The digital tag sends medication reminders to users and sensors in the blister pack detect if medication is accessed. If medication isn’t

https://lshubwales.com

23

Innovation and collaboration in NHS Wales Bwrdd Iechyd Prifysgol Bae Abertawe Swansea Bay University Health Board

Bwrdd Iechyd Prifysgol Caerdydd a’r Fro Cardiff and Vale University Health Board

Proactive care in reducing the risk of cellulitis recurrence Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Dr Melanie Thomas, Clinical Director Lymphoedema Wales Clinical Network Bwrdd Iechyd Prifysgol Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board Cellulitis is a bacterial skin infection that, if not recognised and managed appropriately, can lead to acute illness, emergency admissions and sepsis.

Bwrdd Iechyd

During 2021-2022, cellulitis episodes Addysgu Powys accounted Powys Teaching hospital for nearly 75,000 of UK emergency Health Board admissions (NHS Digital 2023). In Wales this equated to over 5,000 emergency admissions, 32,000 bed-days and 200,000 GP events.

The annual cost is estimated at over £28 Ymddiriedolaeth Felindre one million (Humphreys etGIG al., Prifysgol 2023). Having Velindre University NHS Trust cellulitis causes a 10-50% risk of another episode. Importantly, many of the underlying risk factors (lymphoedema, obesity, immobility, skin conditions, and ulcers or wounds) can be managed to reduce recurrence rates as well as NHS costs and patient impact. Further, skin infections account for the second highest antibiotic prescriptions issued, nonetheless around 30% of patients are misdiagnosed cellulitis adding to waste, harm and variation.

The National Cellulitis Improvement Programme (NCIP) established in 2020 aims to ensure people in Wales with cellulitis receive efficient and effective care reducing their risk of

Hywel Dda University Health Board recurrence and improving outcomes.

The programme is multi-pronged to deliver quality and evidence-based patient centric care that improves outcomes, decreases waste, harm, Cyhoeddus for cellulitis variation and reducesIechyd re-admissions Cymru with: Public Health Wales

l Education strategies for Health Care

Professionals and patients including presentations, leaflets, media films and Ymddiriedolaeth GIG accredited education programmes.

ThisCymru Gwasanaethau Ambiwlans Welsh Ambulance Services included delivering in GP Practices with NHS Trust higher than average rates of antimicrobial prescription. l A proactive clinical service targeting all

patients with a past cellulitis related hospital admission as well as any self and GP referrals. A clinical appointment ensures patients are supported and empowered to self-manage any risk factors such as skin issues and lymphoedema, reduce weight, increase activity and ultimately improve their outcomes. l Developing and collecting cellulitis-specific

patient reported outcome and experience measures.

Since April 2020, over 23,000 people in Wales have received a cellulitis reducing the risk leaflet with nearly 6,000 completing the programme. During NCIP, patients are triaged before being offered a series of local in-person clinical appointments. Based on the first 3,500 people who have completed the programme:

46%

had untreated lymphoedema

57%

had a BMI over 30

55%

had wounds/skin conditions

46%

were classed as Vulnerable on the Frailty Score

Patients receive advice, skincare, exercises/keeping active, weight management and oedema/wound compression treatment. This innovation has considerably decreased repeated cellulitis episodes from 4,827 to 95. This equates to over £13 million avoidance costs, reducing the burden for patients and systemic pressure on Emergency Departments and inpatient services.

The CELLUPREM© data continues to be used as an initiative to develop quality improvement initiatives, whilst also ensuring patient feedback. So far, the results are impressive with many outcomes improving.

An ongoing collaboration with the GPs and Antimicrobial Pharmacists is now targeting patients who have received two or more antibiotic prescriptions in the last year, and they are now looking at those on long-term prophylactic antibiotics.

The innovation covers rural, suburban and urban communities; supporting some of the harder to reach communities and provides a platform for shared learning. As international interest in this work grows, Wales are leading the way in cellulitis care.

NCIP offers a model of care that can be replicated worldwide.

www.sbuhb.nhs.wales

24

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Bwrdd Iechyd Bwrdd Iechyd Prifysgol Addysgu Bae Powys Abertawe Powys Teaching Swansea Bay University Health BoardBoard Health

Iechyd Cyhoeddus Bwrdd Iechyd Prifysgol Cymru Caerdydd a’r Fro PublicCardiff Healthand Vale WalesUniversity Health Board

Tackling HCAIs by eliminating microbes from indoor air and surfaces Ymddiriedolaeth Bwrdd Iechyd Prifysgol GIG Prifysgol AneurinFelindre Bevan Velindre University NHSBoard Trust University Health

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Swansea Bay University Health Board are investigating the link between the indoor environment and Healthcare Associated Infections, otherwise known Bwrdd Iechyd as HCAIs, by Addysgu Powys evaluating hygiene technology previously Powys Teaching used by the military.

SBUHB Health Board hope that the intervention could lead to better clinical outcomes for patients as well as an improved working environment for Ymddiriedolaeth staff. Assisting them in the evaluation are GIG Prifysgol Felindre Velindre NHS Trust Public Health Wales andUniversity the Accelerate Healthcare Technology Centre from Swansea University.

Ymddiriedolaeth GIG Bwrdd Iechyd PrifysgolCymru Gwasanaethau Ambiwlans Taf Morgannwg WelshCwm Ambulance Services University Health Board NHS Trust

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

Within the United Kingdom, there are approximately 800,000 HCAI cases every year, of which 14,000 are front line staff. Other than adverse clinical outcomes, HCAIs cause an average of 9.6 excess bed days per case, around 80,000 days of absenteeism and an annual cost of some £2.7bn. In total HCAIs account for 7 million occupied bed days per year.

To support existing hygiene efforts within the hospital, the team at Vitec Microgenix have developed a system, which eliminates microbes from indoor surfaces and air. The system is a combination of a surface coating and an air scrubber, both of which use a “mechanical kill” to eliminate a broad range of viruses, bacteria, fungi and other microbes on contact. The surface coating is applied once a year, and the air scrubbers purify the air in the wards four times an hour. In laboratory conditions, the system leads to a 99.999% reduction in surface and airborne microbes.

Traditional hygiene methods such as deep cleans are often disruptive, however the system being evaluated is designed to cause minimum disruption. Following installation of the system, a study of the ward staff by the Accelerate Healthcare Technology Centre showed that 80% of those surveyed saw low to no impact

on the day to day running of the wards. The same study showed that 40% of staff also perceived a positive impact on the safety of the workplace environment due to the Vitec Microgenix system.

By installing the system in two pilot wards, Swansea Bay University Health Board want to establish whether reducing the indoor microbial load has a direct effect on the rate of HCAIs on those wards, and as a consequence reduce the reliance on antibiotics to fight HCAIs. SBUHB, in conjunction with Public Health Wales, will be monitoring the impact on HCAIs over 2023 to evaluate the efficacy of the system.

“Tackling HCAIs is major priority for us at Swansea Bay and collaborating with the team in the locally based Vitec Microgenix has been a very positive experience for us. I’m hopeful that the evaluation will demonstrate a positive direct effect on reducing HCAIs on participating wards so we can confidently explore deploying the Vitec Microgenix solution to other areas.”

Dr Richard Evans Project leader Executive Medical Director & Deputy Chief Swansea Bay UHB

www.sbuhb.nhs.wales

25

Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Iechyd Cyhoeddus Bwrdd Iechyd Prifysgol Cymru Aneurin Public Bevan Health University Wales Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Ymddiriedolaeth GIG Prifysgol Felindre Velindre University NHS Trust

Ymddiriedolaeth GIG Bwrdd Iechyd Prifysgol Gwasanaethau Ambiwlans Cymru Betsi Cadwaladr Welsh Ambulance Services University Health Board NHS Trust

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Innovation and collaboration in NHS Wales

Better, faster, sooner – rapid-access palliative radiotherapy service in Wales Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

With escalating pressures on the cancer and radiotherapy workforce throughout Wales, three cancer centres have collaborated to devise new working methods to deliver palliative radiotherapy treatment.

Approximately 30% of all patients in Wales undergoing radiotherapy – approximately 2000 patients per year – receive it with the aim of alleviating advanced cancer symptoms through palliative radiotherapy. This is administered either as an inpatient emergency or for home-based patients requiring prompt radiotherapy due to symptoms impairing their quality of life. The current target is to commence this treatment within 48 hours of the treatment decision, a challenging aim given the multi-step nature of the process and a workforce that is in constant demand.

The program’s objectives were to expedite patient access to clinical assessment and treatment, enhance experiences for patients and staff, and offer radiographers career development opportunities and premier training for radiographers and medical staff.

In Wales, palliative radiotherapy can presently only be requested, agreed upon, consented to, planned, and prescribed by clinical oncologists.

Due to a shortage of clinical oncologists and wider clinical pressures, this reliance on clinical oncologists can create delays in the pathway impacting on staff stress, how quickly patients are treated, and their symptoms improve.

The Southwest Wales Cancer Centre has introduced a radiographer-led clinic where selected patients are seen, consent is obtained, and treatment is administered with minimal medical input. The radiographers possess the requisite training to operate independently, including obtaining consent from patients, planning radiotherapy treatment, and prescribing radiotherapy.

The Velindre Cancer Centre established a similar clinic, spearheaded jointly by a clinical oncologist and a radiographer, capable of accommodating a broader patient demographic. Both radiographers and junior medical staff, such as oncology trainees, have utilised this opportunity

26

Ymddiriedolaeth to expand their skills and apply their knowledge GIG Prifysgol Felindre in practice. Each clinic seesUniversity typicallyNHS 3-5Trust patients Velindre per week, expediting treatment for patients and alleviating pressure on the limited clinical oncologist workforce.

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

In North Wales, Betsi Cadwaladr University Health Board’s third cancer centre focused on enhancing the skills of their radiographers through academic modules, empowering them to innovate in their clinical services with radiographers capable of assuming new roles thanks to their advanced skills.

Data reflecting the new working method has indicated that: l Palliative radiotherapy can be

delivered more swiftly than before.

l Patient satisfaction with the service

is notably high.

l Swim lane mapping has illustrated

that a radiographer-led pathway is more cost-effective than a medically led pathway.

l Training experiences for both

medical and radiographic personnel have been exceedingly positive.

The training component of this program is pivotal, as through the completion of advanced practice MSc modules, alongside valuable clinical experience, more independently practicing radiographers and consultant radiographers will be available to deliver palliative radiotherapy services and propel future enhancements.

The collaboration has successfully elevated the profile of palliative radiotherapy and its significance to patients, cancer, and NHS teams, as well as broader society. The team has engaged with the Welsh Cancer Network, the Clinical Oncology Sub Committee (COSC), and Healthcare Education and Improvement Wales (HEIW) to explore avenues to advance this vital work.

Links have extended beyond Wales into England and even Canada, allowing the team to glean

insights from regions with more advanced palliative radiotherapy services. The Canadian Palliative Radiation Oncology Group has provided invaluable support and advice.

In May 2023, a showcase event at the National Imaging Academy Wales highlighted the multiprofessional work on palliative radiotherapy accomplished through this project by the 3 cancer centres in Wales, underscoring the developed community of practice. The multi-professional team continues to convene to build on the collaboration already developed and to sustain focus on this vital area of cancer care.

Moving forward, the team is exploring potential wider benefits from a focus on palliative radiotherapy, such as amplified patient involvement in decision-making, enhanced communication amongst healthcare professionals, improved data collection (including data related to value-based healthcare), and strategies to diminish the burden of radiotherapy – encompassing environmental, financial, and broader societal impacts of the time/travel needed for a course of radiotherapy.

Funding for the program was provided through the Planned Care Innovation Programme, sponsored by the Welsh Government and managed through the Bevan Commission, and also supported a successful, multi-million-pound bid to the Moondance Foundation to facilitate future enhancements to radiotherapy across Wales via the ARC (Advancing Radiotherapy Cymru) Academy.

www.velindre.nhs.wales

Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Prifysgol Felindre Velindre University NHS Trust

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

RITA – Artificial Intelligence Virtual Assistant responds to FAQs RITA, developed by the Innovation Team at Velindre University NHS Trust, is a virtual assistant powered by artificial intelligence. She has been trained to understand and respond to users’ Frequently Asked Questions (FAQs), utilising natural language processing to learn from previous interactions and provide intelligent answers. Initially, the long-term goal was to train RITA to support oncology-specific queries.

However, following the COVID-19 pandemic, the original concept was refocused. RITA was developed to alleviate the administrative burden and some initial anxiety and fear around attending Velindre for the first time, enabling patients and their families to get answers to their queries at any time of day.

RITA’s name is inspired by a receptionist at Velindre who receives around 1,200 calls a day.

She has been designed to reduce the burden by providing the same helpful answers to patients

and their families through our online user interface – 24 hours a day, 7 days a week!

Launched on 4th February 2023 to patients and their families to coincide with World Cancer Day, RITA is available via the Velindre Cancer Centre website’s front page. Since then, RITA has witnessed over a 100% increase in monthly users to an average of 70 unique conversations.

The most popular areas of questioning relate to the support Velindre offers to patients, available facilities, and general outpatient appointment queries, such as how to change an appointment time and the process for the first visit.

RITA now also encompasses a “patient’s first visit to the cancer centre” scenario, based on a current total of 200 topics. These topics cover many of the FAQs that patients, carers, and families have about their very first visit to Velindre, along with the support services, facilities, and resources available to them.

Throughout the project, the Innovation Team worked with a variety of partners and collaborators to provide funding, content,

feedback, and support. These include an unrestricted educational grant and project support from Pfizer in Phase I, along with further funding from Wales’ Accelerate R&D support programme. During Phase II, the team also worked closely with the Tenovus and Macmillan charities for content and access to further testing from their patient groups.

Based on feedback received from patients during workshops, beta testing, and launch phases, the team has embarked on a subproject to produce a series of two-minute ‘Talking Head’ videos introducing individual Clinical & Healthcare staff and their roles. When a patient asks a question relating to a specific clinical area, these videos will be available as embedded media within the virtual assistant.

These clips will allow patients, family, and carers to understand the role of their key workers and clinicians and help ease the anxiety of attending Velindre for the first time and/or when meeting new key staff.

www.velindre.nhs.wales

27

Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Prifysgol Felindre Velindre University NHS Trust

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

Innovation and collaboration in NHS Wales

Welsh Blood Service - blood and transfusion services for the future In August, the Welsh Blood Service launched its new five-year strategy for 2023 to 2028. This strategy details the current status, the objectives for 2027/28, and the planned steps to achieve these goals. Crucially, it describes how the service intends to collaborate with staff, donors, patients, and communities to ensure a safe and enriching experience, contributing to the overall health and well-being of individuals and making a wider contribution to society. The strategy identifies strategic themes, with Theme 5 focusing on achieving excellence in research, development, and innovation to enhance outcomes for donors and patients.

The Blood service has 15 open projects across these 4 themes. Examples of recent projects include Advancing Kidney Transplant Treatments and Cold Platelet Storage:

Advancing Kidney Transplant Treatments Felicity May, Clinical Scientist at the Welsh Blood Service specialising in histocompatibility and immunogenetics doctorate research project investigated the response to desensitisation treatment in patients awaiting a kidney transplant.

Research, Development and Innovation (RD&I) The Welsh Blood Service plays a vital role in giving thousands of people across Wales a lifeline in their time of greatest need. But it’s not all about blood. The Service is also at the heart of cutting-edge research, covering a broad range of healthcare topics including the support of crucial trials during the Covid-19 pandemic.

The RD&I team supports researchers to conduct high quality and ethical research. Alongside their own independent research, they also work with academic partners and other organisations to help improve the entire blood supply chain and to advance care, for everyone, across the world.

Welsh Blood Service RD&I activity four main themes: l Donor - Donor recruitment, retention

eligibility and care and public health surveillance. l Blood components - Which

includes component product manufacturing, quality management, immunoheamotology, testing and the evaluation of equipment and materials. l Transplantation - Solid organ

and stem cell transplantation, histocompatibility and immunogenetics, and donor registry. l Cellular Therapies - Cellular and

other blood therapies

28

She explains: “On average a patient waits over 2 years for a kidney transplant. There is a greater demand for kidney transplants than available donor organs and not every organ is safe for every patient. When a kidney becomes available for transplantation, many clinical and laboratory factors determine which patient receives the donated organ.

“The immune system makes antibodies to help fight off illness, but this has the potential to cause problems for transplant recipients through rejection of transplanted organs. A proportion of patients on the transplant waiting list have high levels of antibodies and unfortunately high antibody levels reduce the likelihood of successful transplantation. Patients with high antibody levels can wait longer for a compatible organ or may even never be eligible for a kidney transplants.

“Treatments are available to reduce antibody levels in patients awaiting a kidney transplant.

One treatment known as desensitisation allows patients to be successfully transplanted with otherwise ‘incompatible’ organs. Desensitisation describes a range of treatments used to remove antibodies from donor patients. Some treatments target the cells that generate antibodies, and some target the antibodies themselves. However, desensitisation is not an effective treatment for all patients. The response to desensitisation treatment can vary.

“The treatment works effectively in some patients, but others do not respond as hoped and giving patients desensitisation treatment exposes them to unnecessary side effects if the treatment does not work. Due to this “knowledge gap”, clinicians cannot predict whether a transplant patient will respond to desensitisation treatment.”

is not possible to predict patient response to desensitisation treatment using antibodies alone the study looked at levels of cell signalling molecules, which have rarely been studied in transplant patients and she discovered some unintended effects of desensitisation treatment.

In some patients, the treatment increased cell signalling for antibody production! This is a surprising discovery that needs further exploration.

Felicity’s project is a step towards understanding why some transplant patients do not respond to desensitisation treatment. The research will aid further studies which they hope will minimise unnecessary treatment for patients and inform the development of future alternative treatments.

Ground-breaking work in the cold storage of platelets The demand for blood platelets has increased over recent years. Platelets are stored at room temperature and have a short shelf life of around a week. However, a growing body of research is now finding that platelets can be stored at lower

temperatures and these “cold-stored” platelets may have benefits over the room temperature platelets.

Chloë George Head of Component Development and a leading transfusion scientist at the Welsh Blood Service has led ground-breaking work on the cold storage of platelets which could mean a longer shelf life and safer transfusions.

Chloë’s work has been published in the journal Platelets, and will improve the quality, safety and efficiency of platelet storage for patients.

She has plans to lead a clinical trial in the future and is researching different environments and their effect on platelet characteristics. Her team in the Wales Blood Service, Component Development Research Laboratory are involved in several ongoing projects focusing on new and better ways to produce, store, monitor and use blood components for transfusion.

Chloë was awarded ‘Health Care Scientist Award 2022 when she impressed the judges with her ground-breaking work in the cold storage of platelets.

Felicity’s research project was designed and conducted to address this knowledge gap. Because it

www.velindre.nhs.wales

29

Iechyd Cyhoeddus Cymru Public Health Wales

Innovation and collaboration in NHS Wales

e NHS Trust

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

From paper documents to state-of-the-art clinical decision support software Many patients calling 999 do not require an emergency ambulance. The Welsh Ambulance Service (WAST) attends to more than 250,000 emergency calls a year, with remote 999 clinicians consulting with 60,000 patients annually, often without further clinical intervention required from WAST. This includes advising patients, referring them to alternative providers, and providing instructions for interim support. Therefore, ensuring that clinicians can consult patients remotely in an adequate, safe, and robust manner is key.

WAST has implemented new clinical decision support software in 999 call centres to assist nurses, paramedics, and mental health clinicians in remote patient consultation. The LowCode/ ECNS system employs reductionist, age, and gender logic across over 200 evidence-based algorithms, supporting clinicians working remotely via phone and video. It integrates with existing Computer Aided Dispatch Systems, offers text, email, and chat functionality, and includes a quality assurance programme named AQUA. LowCode boasts numerous operational reporting capabilities and comprehensive data export functionalities, enabling quality improvement techniques using software and statistical analyses to enhance clinician performance.

Prior to the implementation of the new system, WAST relied on 53 standalone pieces of paper to triage, assess, and refer patients who called 999 but did not require an ambulance. The paper method was not integrated with any digital system, solely utilised a paper-based audit system, and did not provide data.

LowCode enables clinicians to select various care options (GPs, Ambulances, Self-care, Pharmacy, Crisis teams) and consult patients using supporting algorithms in a manner that was not possible with the paper triage system.

Consequently, patients are now receiving more focused, tailored, evidence-based, and autonomous clinical triages than previously.

LowCode allows clinicians to send care advice, email links, and self-care instructions to patients, carers, and families to better support themselves and employs video functionality to further increase the number of patients who might not require an emergency ambulance.

The aims of this programme were: 1) To enhance, modernise, and safeguard the method of consultation, data sharing, and usability of clinical decision support software.

2) To introduce more technologically enabled care through video triage, integrated Directory of Services, Computer-Aided Dispatch Integration, and Information.

3) To enhance how clinicians are audited, tutored, and how feedback is developed and delivered to staff; and refine the method by identifying learning through themes and trends.

As LowCode’s data-sharing elements gradually become operational, patient data can be shared with the entire health community to further improve outcomes.

There are not enough ambulances to currently dispatch to all patients who call 999. While many patients do not require an ambulance or admission to an emergency department, many do. Remote clinical consultation and call closure, augmented by technology, have enabled evidence-based clinical decision support, allowing resources to be targeted towards those patients who clinically require them.

The number of consultations conducted by the Welsh Ambulance Service is expected to surpass last year’s 60,000, given the technological advantages brought by LowCode.

The Welsh Ambulance Service delivers remote consultation across four main sites, as well as other satellite sites and through home working.

Clinicians work pan-Wales on any call coming into 999, irrespective of their, or the patient’s, location.

This has wider implications for decarbonisation, reducing ambulance miles, while data sharing will enable primary and secondary care to work more seamlessly, possibly reducing further calls to 999 as GPs (for instance) can follow up on patients who have called 999.

www.ambulance.wales.nhs.uk

30

Success stories from the Welsh life science industry

31

Success stories from the life science industry

Strengthening connections between the Welsh and Swiss life science sectors Marlies Hoecherl, Swiss Honorary Consul in Wales and Corporate Partner at Capital Law Following closely on the heels of an inaugural Swiss-Wales event as part of the #WeAreSwitzerland UK tour in 2022, the second edition of the Swiss-Welsh Life Science Dialogue proved to be a resounding success, bringing together industry participants from our two nations.

We know that the Welsh life science industry is thriving. Currently employing more than 12,000 people in over 360 companies, the industry has an approximate turnover in excess of £2 billion.

World-leading academic expertise calls Wales home, and a central Life Science Hub helps catalyse innovation and collaboration between industry, health, social care, and academia.

However, there is still so much to learn. And, where better for budding Welsh life sciences businesses to further their knowledge and strengthen their ties than Switzerland? With a successful and innovative life sciences scene, Switzerland is home to some of the largest pharmaceutical companies and hundreds of medtech, biotech, and nanotech companies.

Attendees from across Wales, Switzerland, and England gathered in late June at the Banqueting Hall, Cardiff Castle, to participate in the SwissWales dialogue. After the successful inaugural dialogue in June 2022, the follow-up event was aimed at helping participants discuss the challenges that the sector is facing in both countries and learn from each other. Ambassador Markus Leitner, Embassy of Switzerland in the UK, and Gwyn Tudor, CEO MediWales, provided welcome remarks to open the dialogues.

Oswaldo Rodriguez, Head of Medical & Government Affairs, Roche Diagnostics EMEA LATAM, delivered the keynote speech, highlighting the perspective of a large Swiss pharmaceuticals company that is actively engaged in Wales.

What followed was an exciting panel session, moderated by Rodriguez and peppered with audience questions. The panel, consisting of Kevin Teburi, Managing Director of Genedata Ltd; Dr Patrick Dümmler, Manager of Health Tech Cluster Switzerland; Dr Sian Morgan,

32

Consultant Clinical Scientist/All Wales Medical Genomics Service and Laboratory Director; and Maireadh Pederson, Commercial Operations Director, SGS Quay discussed the challenges and opportunities of the life sciences industry in Wales and Switzerland. In particular, the panelists emphasized the need for organically grown clusters and the better exchange of and access to data and exceptional talent.

The evening concluded with a networking reception. Over Swiss wines and canapés, attendees built connections and shared good practices in access to talent, R&D, and financing.

Here’s to future collaboration on the horizon!

In March 2023, MediWales was delighted to be part of the UK delegation at BioEurope Spring hosted in Basel, Switzerland, a town and region recognized globally for its leadership in the life science industry and innovation.

Also in March, Gwyn Tudor, CEO of MediWales, represented Welsh life science on a UK Deep Tech mission to science and technology centers across Switzerland.

MediWales is committed to maintaining and developing the relationships forged during all of these activities to form a lasting, valuable connection between the Welsh and Swiss life science communities.

www.capitallaw.co.uk

2 0 1 8

Fuelling the growth of the life science sector in Wales Wales is fuelling the growth of the life sciences sector as an increasing number of medical technology companies invest here. With financial backing from the Development Bank of Wales of nearly £15 million and private sector investment of almost £60 million, a remarkable £75 million has been injected into 19 different life sciences, medical devices, and associated healthcare businesses since January 2020.

Those benefiting include Deeside-based Reacta Biotech, which is quickly building a strong name in the global food allergy diagnostic market, Cardiff-based female health specialists Health & Her, and Antiverse, a biotechnology company developing a computational antibody drug discovery platform.

Halo Therapeutics was attracted to Wales following a £1 million seed investment by the Development Bank in May 2023. The biotech company is now based at Welsh ICE, Caerphilly, and has partnered with Cardiff-based CatSci on the development of pan-coronavirus antiviral nasal sprays that can be applied by patients themselves at home, irrespective of existing health conditions.

Dr. Daniel Fitzgerald, Halo Therapeutics, said: “Our self-administered and cost-effective antiviral treatments are a potential gamechanger in the treatment and prevention of coronaviruses, particularly with the emergence of new variants. However, we needed support to progress with pre-revenue research and development. As our lead investor, the Development Bank of Wales stepped up and convinced us why Wales has such a competitive advantage in the sciences industry - the agile approach, established ecosystem, high-tech infrastructure, and financial support available are second to none.

“Having a network of support around you in the early stages of building a business is so important, and we’ve definitely got that in Wales. The wider community is critical when

considering your supply chain requirements, including manufacturing, shipping, and distribution. Our business is all about finding solutions, so we value partners that have the same approach, and we’re certainly reaping the benefits of the biotech ecosystem here in Wales as we prepare to enter clinical testing.”

The Development Bank of Wales offers seed funding to start-up companies to help commercialise products or technologies and bring them to market. Entry investment ranges from £50,000 to £2 million and is designed to support start-ups, university spin-outs, and new companies.

“We’re here to support innovative technology and life science ventures, so it’s encouraging to see a growing number of life sciences and medical technology companies investing in Wales. As a nation, we offer a vibrant and prosperous environment that is an attractive proposition for early-stage businesses like Halo Therapeutics as they move towards global commercialisation from a base here in Wales.”

Dr. Mark Bowman Venture Fund Manager Development Bank of Wales

https://developmentbank.wales

33

Success stories from the life science industry

Cutting-edge, non-invasive, real-time continuous glucose monitoring Afon Technology, a small start-up based in Caldicot, South Wales, is dedicated to developing Glucowear™, a cutting-edge, non-invasive, real-time continuous glucose monitor (CGM). Led by Dr. Sabih Chaudhry and his committed team, they are on a mission to create the world’s first wearable non-invasive CGM, a technology in high demand among people living with diabetes worldwide.

Get FIT Non-invasive glucose monitoring has proven to be a challenging endeavour, but Afon Technology is making significant progress in this field.

They utilise ultra-low-powered RF/ microwave technology to track changes in blood glucose levels. Glucowear™ will be

worn on the underside of the user’s wrist and will connect to a companion app on their smart device, providing continuous glucose readings. Additionally, the device will include an alarm system to alert users to low or high blood glucose levels and offer a range of functionalities that provide valuable data for both users and their healthcare providers, aiding in the management and understanding of diabetes.

Compared to traditional finger-pricking methods for obtaining blood glucose readings, continuous glucose monitors (CGMs) represent a significant advancement, allowing users to monitor their blood glucose patterns throughout the day and facilitating selfmanagement. Current CGMs are minimally

invasive and have limitations, such as a limited sensor lifespan of 10-14 days, resulting in significant waste. An affordable non-invasive technology like Glucowear™ would be groundbreaking.

Glucowear™ underwent clinical testing at the Joint Clinical Research Facility (JCRF) at Swansea University earlier this year and they are currently planning further trials into 2024. Afon Technology is on track to secure the UKCA/CE mark for Glucowear™ by the end of 2024.

The company proudly received the European EIC Accelerator Award at the end of 2022, which will provide them with €2.4 million over the next two years to accelerate development and expedite the introduction of Glucowear™ to the market.

Diabetes is a global health concern, affecting 537 million adults worldwide. In the UK, a significant portion of the NHS budget for England and Wales is spent on diabetes, particularly for addressing complications arising from poorly managed diabetes.

Technology like Glucowear™ that supports individuals in managing their condition can lead to improved long-term health outcomes for patients and cost savings for the NHS.

www.afontechnology.com

34

2 0 1 8

AliveCor KardiaMobile® 6L receives second NICE recommendation AliveCor’s KardiaMobile® 6L has received its second recommendation from NICE and has become the first personal ECG device recommended for use in psychiatric services in England and Wales.

AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, recently announced the publication of the Early Value Assessment (EVA) Guidance by the National Institute for Health and Care Excellence (NICE), recommending KardiaMobile 6L as an option to measure heart rhythm disturbances in people who are either having or about to have antipsychotic medication.

With a growing clinical need for a more easily accessible and available method to detect cardiac abnormalities in NHS psychiatric services, as antipsychotic medications can prolong the QT interval and lead to a potentially fatal effect known as drug-induced sudden cardiac death (DI-SCD).

KardiaMobile® 6L is the first smartphone-based personal electrocardiogram (ECG) recommended by NICE as part of its Early Value Assessment (EVA) pilot project, aimed at facilitating earlier access to promising healthcare innovations for use within the National Health Service in England and Wales.

During the COVID-19 pandemic, the Tees, Esk and Wear Valleys NHS Foundation Trust (TEWV) introduced the use of KardiaMobile 6L to support patients in the community, allowing patients to be remotely monitored without having to visit a hospital setting, thereby reducing the risk of COVID-19 transmission for both parties.

The TEWV team, including Dr. M. Santhana Krishnan, Consultant in Old Age Psychiatry & Senior Clinical Director, and Lauren Bennett,

Innovations Coordinator, identified that the six-lead AliveCor device could be used to monitor patients on psychiatric medication, or those starting such medication, who need careful monitoring to detect potentially dangerous QT prolongation.

Compared to a 12-lead ECG commonly used in clinical practice, there is less need for patients to undress or apply gel, wires, or patches, potentially reducing their stress and anxiety.1 Moreover, patients can use the device themselves in the comfort of their homes. The entire process takes five minutes, and ECGs can be sent instantly and electronically from the Kardia app to a clinician’s secure NHS email address for immediate measurement and reporting of the QTc interval.

Timely ECG monitoring of patients on antipsychotic medication can save lives.

Having access to KardiaMobile 6L means that potentially vulnerable patients can now be monitored anywhere, including in the comfort of their homes, reducing their stress while ensuring that this essential monitoring is done at the right time. It’s encouraging that NICE has recognised the need for early access to this technology,” said

1 NICE. Diagnostic Assessment Programme. Early Value Guidance: KardiaMobile 6L for measuring cardiac QT interval in people having antipsychotic medication. 2022. Available at: https://www.nice.org.uk/consultations/2021/3/7c-kardiamobile-6l-early-value-guidanceconsultation-document-noacicdocx. Last accessed: August 2023.

NHS Long QT Syndrome. 2017. Available at: https://www.nhs.uk/conditions/long-qt-syndrome. Last accessed: August 2023.

Dr. Mani Krishnan, Consultant Psychiatrist and Specialty Clinical Director of Tees, Esk and Wear Valleys NHS Foundation Trust.

With support from NHSx, there are now 1,200 KardiaMobile 6L devices in use across community teams at TEWV NHS Foundation Trust and 40 in use across inpatient wards at Cumbria, Northumberland, Tyne, and Wear NHS Foundation Trust, with further expansion plans in India.

In addition to antipsychotic medication, there are other medications, when taken in high doses, that can trigger prolonged QT intervals, including antihistamines, decongestants, diuretics, antibiotics, and antidepressants. With various medications that can cause long QT, the opportunities to adopt the KardiaMobile 6L into existing pathways are varied. For example, KardiaMobile 6L is currently supporting oncology facilities for Breast Cancer medication monitoring and in the TOPHAT research study for Parkinson’s disease in Wales.

To find out more about the TEWV Remote ECG Pathway, visit ahsn-nenc.org.uk (The Tees Remote ECG Pathway - AHSN NENC AHSN NENC).

www.alivecor.co.uk

35

Success stories from the life science industry

The Faecal Immunochemical Test (FIT) is a quick and easy-to-use test The Faecal Immunochemical Test (FIT) is a quick and easy-to-use test, providing valuable assistance in managing and triaging colorectal cancer referrals in primary and secondary care settings.

Laboratories and service providers are working tirelessly to distribute these kits to GPs, clinics, and patients. Due to high demand, Alpha Labs has developed the next phase in FIT evolution: The Alpha Portal (TAP).

The Alpha Portal offers: l a snapshot of stock levels,

including lot and expiry information

l proofs and print-ready versions of

the kit component

l comprehensive product

descriptions

l a traceable ordering system l tailored reports to highlight usage

patterns

TAP offers a new perspective on the distribution of sample kits, catering to both direct-to-patient delivery and larger orders for GPs or clinics. It allows greater control over logistics and offers a traceable, efficient, and adaptable solution to meet varying demands.

The Alpha Portal has demonstrated a significant improvement in the workflow of sample distribution within laboratories. Southmead Hospital was among the first to adopt TAP and reported substantial enhancements in their FIT service: “The portal has greatly improved the FIT service at North Bristol NHS trust. It has freed up time for both lab staff and our busy stores department.

Feedback from users has been overwhelmingly positive, with kits usually delivered within two working days. Previously, issues with the Trust post room and Royal Mail delivery meant that deliveries could take up to a week or even longer.

The weekly report has greatly improved our ability to keep track of how many kits we are sending out to surgeries and how many we are getting back from them!”

This underscores how TAP benefits both laboratory and clinical teams, offering insights into return rates and facilitating a seamless and efficient

testing service, essential for supporting endoscopy resources and reducing waiting times.

How it Works: User profiles are categorised based on required access levels, determining the number of kits they can order within a specified timeframe (to prevent overstocking) and which reports they can run. Each login is customised, displaying only relevant kits and their components, stock availability, and print-ready files.

When placing an order, a pre-loaded list of delivery locations simplifies the process. Each login displays locations requiring a FIT-KIT delivery, with validity checks performed through Royal Mail software before adding to TAP. New sites can be added as needed.

Shipments are dispatched using Royal Mail Tracked 48 service or DPD Next-Day, depending on the quantity ordered, ensuring traceability and offering Proof-of-Delivery upon request.

Alpha Labs are committed to continuously enhancing the services they provide, and they have several solutions in the pipeline, which they hope to introduce online in the near future.

www.alphalabs.co.uk

36

2 0 1 8

Pioneering innovative approaches to clinical trials Toby Wilson Waterworth, CEO at Ambrose Healthcare, discusses the future of drug development for rare diseases In the wake of the pandemic, significant changes have occurred in the way people work and access healthcare services.

Remote work and online consultations with healthcare professionals have become commonplace. However, one area that has seen limited transformation over the past three decades within the life sciences sector is the development of new drugs.

Despite the emergence of novel modalities like anti-sense oligonucleotides and gene therapies, the fundamental approach to designing clinical trials and defining primary endpoints remains a formidable challenge. Adaptive trial designs offer some promise, especially when tailored to ageappropriate and disease-specific endpoints.

According to Deloitte, the average cost of drug development in 2022 surged to $2.3 billion, a $300 million increase from the previous year. In contrast, the average peak sales per drug declined from $500 million in 2021 to $389 million in 2022. This trend of rising costs and diminishing returns has prompted investors to question whether there exists a more balanced equation for drug development.

The predicament is particularly acute in the area of rare diseases, where over 10,000 such conditions have been identified, but just 600 treatments have gained regulatory approval. At the current pace of innovation, it is projected to take more than a century for each rare condition to have just one treatment, according to estimates from the International Rare Diseases Research Consortium.

In response to these challenges, there is a call for a more efficient model of drug development. This approach advocates for involving patient input at earlier stages, integrating AI where applicable, and establishing cost-efficient centers of innovation globally.

Ambrose Healthcare, recognising the vibrant life sciences ecosystem in Wales, has selected Wrexham in north Wales as a location for its global headquarters. Here, they benefit from an integrated healthcare system, clinical expertise, a supportive funding environment, and a collaborative ecosystem. However, recognising the need for diverse solutions, Ambrose Healthcare is also establishing regional hubs of innovation in the Middle East and the United States.

Traditionally, drug development has often relied on tools or endpoints from one condition and applied them to another or used outdated tools in the first place. The design of clinical trials is usually undertaken with the input of key opinion leaders, applying previously validated clinical endpoints for agreement by regulators. However, this approach does not work for clinical trials related to rare diseases, as 95% of them lack approved treatments and, consequently, validated endpoints.

To address the significant unmet needs of people with rare diseases, a different approach is needed.

Bringing in patient input much earlier, designing endpoints in collaboration that are important to them, age-appropriate, and disease-specific, is a much smarter way forward. Ambrose Healthcare is at the forefront of implementing such an approach.

Over the summer, there has been notable progress in adopting patient-relevant endpoints.

The European Medicines Agency approved stride velocity as an alternative primary endpoint to the established six-minute walk test for Duchenne Muscular Dystrophy patients four years and above. This critical change in endpoint took over 14 years of campaigning by patient groups and academia, with the pharmaceutical industry joining the effort.

Ambrose Healthcare is spearheading new collaborations in Wales and internationally, pioneering innovative approaches to address clinical trials and treatments for people with rare diseases.

www.ambrosehc.com

37

Success stories from the life science industry

Biodexa Pharmaceuticals PLC developing treatment of brain cancers Biodexa Pharmaceuticals PLC is a clinicalstage biopharmaceutical company based in Cardiff that is developing a pipeline of products aimed at primary and metastatic brain cancers. The company’s lead candidate, MTX110, is undergoing studies for aggressive rare/orphan brain cancer indications, including recurrent glioblastoma (GBM), medulloblastoma, and paediatric diffuse midline glioma (DMG).

MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables the delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumour, bypassing the blood-brain barrier and potentially avoiding systemic toxicity.

The currently available oral formulation of panobinostat lactate (Farydak®) is not suitable for treating brain cancers due to poor blood-brain barrier penetration, resulting in sub-therapeutic drug concentrations at the tumour site. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent glioblastoma (NCT05324501), paediatric DMG (NCT04264143), and recurrent medulloblastoma (NCT04315064).

Within these studies, MTX110 is delivered directly into and around the patient’s tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DMG and GBM tumour cells in in vitro and in vivo models. In a key study, it was the most promising of 83 anticancer agents tested in 14 patient-derived DMG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).

Biodexa Pharmaceuticals recently announced the completion of the enrolment and treatment of nine paediatric patients in the ongoing investigator-sponsored Phase I study of MTX110 in newly diagnosed DMGs (NCT 04264143).

All of the patients (age range 4-17 years) were

38

enrolled at the Columbia University Irving Medical Centre and received radiation therapy as per the institution’s standard of care. Each patient subsequently underwent surgery with the implantation of an intratumoral catheter and a programmable subcutaneous pump, and 8 out of 9 have received two infusions of MTX110 via convection-enhanced delivery separated by a period of 1 week. Concentrations of 30, 60, or 90 µM were delivered with no intra-patient dose escalation. No dose-limiting toxicities related to the study drug have been reported in the study.

Full study results are expected to be made public around the 1st quarter of 2024.

A critical component of the drug development process is the evaluation of the safety and efficacy of investigational medicines in clinical trials. Biodexa Pharmaceuticals relies on, and appreciates the role of, volunteers who enrol in clinical programmes, helping to build a better understanding of the potential benefits and risks of investigational therapies.

Biodexa’s newly launched reSOLVEtrials website aims to inform patients who might be considering enrolling in a clinical trial, allowing them to better assess what may be involved and their suitability for such a study, as well as providing details on the location of studies and their principal investigators. This will enable

patients to contact the sites directly or discuss this information with their treating physicians.

Currently open for recruitment at two US hospitals, in North Carolina and Florida, the MAGIC-G1 trial is a Phase I study investigating the safety of MTX110 in patients with recurrent glioblastoma (rGBM).

Glioblastoma (GBM) is the most aggressive and most common type of brain cancer. Previously referred to as glioblastoma multiforme, GBM is a malignant (cancerous) grade 4 tumour.

Recurrence is very likely to occur, and currently, there is no standard of care treatment, which is why most patients participate in clinical trials, seeking access to potential new therapies and aiding in the development of future treatments.

Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines: Q Sphera, Midasolve, and Midacore.

Biodexa’s headquarters and R&D facility are in Cardiff, UK.

www.biodexapharma.com

2 0 1 8

Towards safe and accurate liquid drug dosing How much is too much? Or not enough?

These questions become particularly important when measuring the correct dose of liquid medications. For many people, taking medicine is not easy, and for the person administering the medicine, it is not as simple as just measuring a spoonful of sugar to make the medicine go down more easily for their charge.

This is a reality that carers, nurses, and parents face every time they have to administer medication to people like Joe and Pippa (names changed). Joe is a gentleman with dementia, and Pippa is a two-year-old toddler who is prone to high fevers. In both cases, swallowing tablets is not feasible or safe, so any medication they take has to be in liquid form. Joe struggles to pick up pills, put them in his mouth, and then swallow them without coughing. He sometimes also forgets that his carers have already helped him take his daily dose of medication and attempts to take another dose. Pippa is not yet able to swallow tablets safely, and her parents find it difficult to ensure that the correct amount of medicine is measured out and swallowed by Pippa using a medicine spoon or a cup. Understandably, both Joe’s carers and Pippa’s parents are anxious to make sure that the correct dosage of medication is

given every time and that the possibility of over or under-dosing of medications is minimised as far as possible. This is where the Dose-Dr. comes in.

The Dose-Dr. is a first-in-class medical device that circumvents challenges arising from imprecise measurement markings on liquid formulation medicine dispensing instruments and prevents inadvertent or accidental overdosing on medicine. It is a cartridge and applicator system that is made up of a series of mechanisms requiring logical steps instead of force for a precise, pre-packaged, single dose of medication to be administered while minimising the potential for coughing or choking. The Dose-Dr. complies with all the Food and Drug Administration’s (FDA) requirements for safe packaging of paediatric medications stipulated in their Paediatric Exposure Limiting Packaging (PELP) guidelines. This makes it unique and a game-changer for safe and consistent administration of liquid medicine formulations.

and impactful medical device with the potential to improve the quality of life of people reliant on liquid medications and to prevent adverse events and associated healthcare resource use and costs.

With approximately 55,000 people predicted to have a dementia diagnosis in Wales by 2025, Biophys is looking forward to introducing the Dose-Dr. to the Welsh health and social care ecosystems, finalising the development of the device and creating new Welsh intellectual property (IP). Biophys is also passionate about creating circumstances that give children the best chance of thriving, in this instance, by minimising the risk of medicines-related adverse events.

Biophys Ltd has partnered with the inventors of the Dose-Dr., South African-based InventX Solutions, in an international partnership to take the Dose-Dr. through the next steps in its development and commercialisation journey. This WelshSouth African collaboration combines innovative, simple, and elegant design thinking in an easy-to-use

www.biophys.co.uk

39

Success stories from the life science industry

Bloom Standard delivers big opportunities for tiny patients The owners of Swansea Universitybased Bloom Standard started building their medtech company in the midst of a global pandemic that spotlighted how health systems respond to adversity. The health crisis also enabled an innovation pipeline that helped bring thousands of new lifesaving tools to patients when and where they were needed most. One of those tools was ultrasound.

“Ultrasound is one of those amazing, longproven technologies that has been underutilised for decades,” says Bloom Standard’s cofounder and CEO, Annamarie Saarinen. “COVID saw a massive uptake in the use of ultrasound to scan the lungs and hearts of impacted patients.”

No stranger to the power of medical imaging, Saarinen is the mother of a baby diagnosed with critical heart defects as a newborn. Her child survived multiple surgeries and is alive today thanks to an “early enough” diagnosis— one that included ultrasound of the heart, or echocardiography. Her daughter has had nearly 70 such scans at this point. Saarinen continues to be active in global health, and Bloom Standard’s team of 10 remains acutely aware of the lack of such technologies on the front line of care for babies and paediatric patients, where survival often hinges on where a child is born. In fact, delays in diagnosing lung and heart conditions are among the biggest contributors to infant mortality around the world, including the UK. With a multi-disciplinary support team around them in Wales, Bloom Standard’s engineers have been developing a low-cost, autonomous, hands-free ultrasound scanner, which can be used by almost anyone, almost anywhere.

Bloom’s EVA RAPIDscan technology makes ultrasound screening available to babies and children wherever they are, removing the need for highly skilled clinicians and large, expensive imaging machines—all of which are typically only available at the highest-level medical centres and not where most babies are born, and children are seen for routine care. “We’ll still be

getting these children to those more complete imaging exams and advanced specialists when they’re needed—just faster, safer, and more efficiently,” Saarinen explains.

Bloom Standard’s technology hardware and software utilise lower-cost, highly scalable core sensor technology for its “intelligent” self-driving scanning pod. Demonstrating the quality and resolution of their imaging sensors and ultrasound data, the company’s first cohorts of patients are now being used to develop and optimise robust AI algorithms that will provide a clinical decision support software layer that health staff need for rapid screening, triage, and spot checks.

Bloom Standard is a part of Minnesota’s Medical Alley—the world’s leading health tech innovation cluster. The company is also embedded in the

prestigious Hong Kong Science & Technology Park and within Texas Medical Center, which has an established “BioBridge” with Swansea University, but when the company looked to launch into Europe, Africa, and the Middle East, it landed in Wales. With the support of the Welsh Government and innovation acceleration partners such as Tritech, Life Sciences Hub Wales, ATiC, and MediWales, and the Swansea University Faculty of Medicine, Health & Life Sciences, Bloom Standard was able to quickly leverage Accelerate Wales funding through Swansea’s HTC centre to develop its iterative R&D pathway and clinical feasibility protocols. The team’s work was recently awarded a fully funded 3-year PhD from Swansea University, which will begin its clinical investigational work, and they will be applying for further grant funding through the UK Government. NHS Wales and local health boards are helping with testing to meet regulatory requirements, and the device is planned to be ready for production and initial distribution in 2024.

www.bloomstandard.com

40

2 0 1 8

Stimulating new markets at the cutting edge of neuroscience research Since its inception in 2010, Brainbox has emerged as a prominent and influential player in the field of non-invasive brain stimulation and imaging technologies, showcasing a remarkable journey marked by strategic alliances, market expansion, and a widespread global presence spanning more than 50 countries.

The trajectory of Brainbox’s success is highlighted by its commitment to fostering international relationships and developing new markets. Through market analysis and innovative strategies, Brainbox has propelled its products to the forefront of cutting-edge neuroscience research. The company’s portfolio boasts a comprehensive array of tailored and integrated non-invasive brain stimulation and imaging solutions, encompassing a diverse range of modalities including transcranial magnetic stimulation (TMS), transcranial electrical stimulation (tES), transcranial ultrasound stimulation (TUS), Optically Pumped Magnetometers - Magnetoencephalography (OPM-MEG), and an assortment of other pioneering techniques.

With decades of technical experience and academic excellence, Brainbox is uniquely positioned to offer customisable solutions that cater to the demands of even the most intricate non-invasive brain stimulation research studies. Beyond providing innovative technology, the Brainbox team distinguishes itself through its commitment to customer relationships. The company places great emphasis on expert hands-on training, ensuring that researchers worldwide are equipped to harness the full potential of their technology.

Within the last year, Brainbox has been celebrated, gaining the prestigious MediWales Innovation award for its contributions to export.

Over the past twelve months, Brainbox has achieved a remarkable increase in worldwide

export sales, expanding its presence in vital markets such as Japan, China, the USA, and Brazil, among numerous other countries. This growth trajectory has empowered Brainbox to establish further reference sites, fortify distribution partnerships, and establish its position as a market leader in delivering, training, and supporting cutting-edge, integrated solutions for global brain research.

Brainbox’s commitment to remain at the forefront of innovation is demonstrated by its continual exploration of novel technologies and techniques in brain stimulation and neuroimaging. A standout milestone over the past year was the establishment of a strategic partnership with the French startup MAG4Health, solidifying Brainbox’s presence as a pioneering force in the realm of OPM-MEG. This groundbreaking collaboration has brought forth a revolutionary technology that harnesses the potential of Helium4 at room temperature, expanding the horizons of MEG research and widening access to this methodology. Through its approach, Brainbox leverages the global market advantage to ensure that its products and services remain at the forefront of emerging research, catalysing advancements in the realm of neuroscience.

Elevating its commitment beyond commercial pursuits, Brainbox directly sponsors the Brainbox Initiative, a not-for-profit arm of the company standing as a nurturing platform dedicated to empowering early career researchers and giving back to the scientific community. The Brainbox Initiative organises an array of activities, including stimulating neuroscience webinars, interactive workshops, and an annual conference designed and focused on the aspirations of early to midcareer neuroscience researchers. By fostering knowledge exchange, collaboration, and training, the Brainbox Initiative underscores Brainbox’s dedication to shaping the future of neuroscience through a holistic and inclusive approach.

www.brainbox-neuro.com

41

Success stories from the life science industry

Collocco Consultancy - helping companies to introduce safe devices to market Collocco Consultancy Ltd provides companies in the medical devices and life sciences sector with expert quality, technical, and regulatory support.

Company Director Jill Rosser identified a need for high-quality, technical, and regulatory support within Wales and the wider area, leading to the establishment of the business. Their goal is to enable the introduction of safe devices to the market and ensure ongoing compliance throughout a product’s lifecycle.

Located near Swansea, the team of consultants has over 40 years of combined hands-on experience. Navigating the complex regulatory landscape can be daunting, especially when developing new devices or expanding into new markets. Compliance with evolving regulations is a continuous challenge for many companies.

Collocco Consultancy steps in to address these challenges.

In the five years since its inception, the company has built an impressive portfolio of clients, including medical devices and in vitro diagnostics companies, such as Hybrisan, Pelican Health, P3 Medical, Prima Dental, Huntleigh Healthcare, Abingdon Health, Nonacus Ltd, Eakin Surgical, LaproSurge, and global multinationals like Becton Dickinson and Stryker.

Here are some case studies illustrating their expertise: Due to a transition from the Medical Device Directive 93/42/EEC to the Medical Device Regulation 2017/745, Huntleigh Healthcare in Cardiff needed to update its Quality Management System. The project resulted in a successful external audit outcome.

Steve Monks – Director QRE Compliance, Huntleigh Healthcare said “Working with Jill at Collocco Consultancy was a pleasure. Amending the Quality Management System at Huntleigh Healthcare to accommodate the Medical Device regulation 2017/745, delivering training and assisting with technical file updates was never going to be an easy task but with Jills help on this matter made the transition seem relatively easy”.

Pelican Healthcare Ltd, part of the Eakin Group, had to update its Quality Management System and Product Technical Files due to the transition from the Medical Device Directive 93/42/EEC to the Medical Device Regulation 2017/745. Subsequent gap assessments and remediation work were successfully completed, resulting in an improved Quality Management System to support business growth.

Phil Morse – Head of Group Operations Compliance said “Providing timely support and

guidance with general compliance queries, in particular advising, delivering and supporting our EU MDR Device Regulation transition program.

The service has been professional and friendly providing valuable support”.

LaproSurge Ltd had to update its Quality Management System and various technical files due to the transition from the Medical Device Directive 93/42/EEC to the Medical Device Regulation 2017/745. Collocco Consultancy, led by Jill, provided clear action plans, explained requirements, and presented solutions to close gaps.

Denise Lane – QA/RA Manager, LaproSurge said “Jillian and her team (Betina) were able to provide clear and concise action plans, explain the requirements and present solutions to close the gaps and to work within the agreed budget, I was very impressed.”

In response to the COVID-19 pandemic, Collocco Consultancy collaborated with small Welsh company SurvivaWear to assist with Quality Management Implementation, Certification, and UKCA marking for a device under development.

The classification of the medical device changed from the EU MDR 2017/745 route to PPE under Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018: Great Britain due to government updates.

Collocco Consultancy have also established collaborative partnerships with various other businesses who can support their customers with research and development, design and development, manufacturing, and medical device servicing. The team and their partners are dedicated to providing expert guidance and support to companies navigating the complex landscape to introduce safe devices to the market.

www.colloccoconsultancy.com

42

2 0 1 8

Speedboat Inject cleared for upper GI use in Europe Creo Medical has announced that Speedboat Inject is now CE marked in accordance with the Medical Device Regulation (MDR) for use throughout the entire gastrointestinal (GI) tract, having received upper GI clearance.

Until now, Speedboat Inject, an advanced energy multimodal instrument designed for flexible endoscopy, has only been CE marked for lower GI tract use within European markets.

Clearance for upper GI procedures means that the device can now be used for endoscopic procedures throughout the whole of the GI tract, from the mouth down to the stomach (upper GI tract) and within the lower GI tract.

Speedboat Inject is already cleared, and used, in the US, APAC (Asia-Pacific) and other regions, for the cutting and coagulation of soft tissue using radiofrequency (RF) and microwave energy, in the full GI tract.

When used as indicated (for the cutting and coagulation of soft tissue), Speedboat Inject has been used to perform procedures such as: Oesophagus per-oral endoscopic myotomy (“POEM”) to treat achalasia (a swallowing disorder), where typically a heller myotomy (surgery) would be required; Gastric per-oral endoscopic myotomy (G-POEM) to treat delayed gastric emptying (gastroparesis); Z-POEM to treat Zenkers diverticulum, where a pouch or pocket that forms in the wall of the oesophagus,

affects the throat and swallowing process, and is a prominent procedure for ear, nose, throat (ENT) and foregut surgeons; F-POEM, a derivative of Oesophagus POEM, to reduce reflux – typically this has required an invasive upper GI surgical procedure; and Speedboat Submucosal Dissections (SSD) in the stomach and oesophagus, to endoscopically resect certain cancerous and pre-cancerous lesions.

Craig Gulliford, Chief Executive Officer of Creo Medical, commented “We are very excited by this extension to the clearance in Europe which

In regions that use FDA (US Food and Drug Administration) regulations, upper GI cases account for over 40% of global Speedboat procedures to date. Creo Medical already has a healthy pipeline of clinicians ready to use the device for upper GI procedures across Europe, with demonstrations, training and procedures already planned in.

will now see Speedboat used to treat a range of conditions in the oesophagus and stomach, building on its existing use in the bowel. We’ve already seen that have a really positive effect on a significant number of patients in the US and APAC, where clearance has been in place for some time. With European doctors often specialising in either upper or lower GI it also opens up our technology to a wider number of clinicians and we are expanding our European Pioneer training programme as a result.”

MDR represents a significant achievement for the Company and the team who have been working hard to secure this, building on the success we’ve already achieved in the US and APAC.” Dr. Zaheer Nabi, a frequent user of Speedboat Inject for upper GI procedures at AIG Hyderabad Hospital in India said “The advanced bipolar energy makes cutting and tunneling during POEM procedures very precise, providing me with improvements in efficacy and efficiency.

I’ve also found that the design of the device significantly lowers the risk of perforation during such 3rd Space Endoscopic procedures, with the microwave energy effective in minimising bleeds and thermal damage. The slimmer device in particular is excellent for performing upper GI procedures.”

Another prominent user, Dr. Jawaid from Baylor College of Medicine Medical Center in the US, added: “Speedboat is effective in POEMs in particular because

“Training doctors for Speedboat use in upper GI procedures has proven to be efficient

in the USA. With our Pioneer programme now well established, and with some of the world’s finest upper GI endoscopic practitioners championing the device and providing mentoring, we have great capacity now to transition doctors through our Pioneer training programme and for them to become high users with training opportunities in multiple procedures with many different types of patients.”

“I’m also delighted that this clearance has been done under the significantly changed regulatory framework (MDR) which has been a significant challenge for the team. This successful approval for Speedboat Inject according to the

it can speed up the tunneling process and prevents inadvertent thermal injury. It may also help with post-procedural pain.”

Dr. Yip, from the Division of Upper GI and Metabolic Surgery at the Faculty of Medicine, Chinese University of Hong Kong said “The Speedboat device is a new revolution to the field of third space endoscopy and advanced tissue resection. With the novel bipolar and microwave energy platform, upper GI ESD/SSD and tunneling procedures can be performed safely and efficiently, thus benefitting patients worldwide by enabling easier adoption of the technique.”

www.creomedical.com

43

Success stories from the life science industry

Integrating digital solutions in Welsh healthcare: A collaboration with DrDoctor The Welsh digital and data strategy, unveiled this year, places emphasis on the creation of bespoke digital platforms and the promotion of ‘digital-first’ services, thus setting the scene for a digital healthcare revolution. DrDoctor aligns with this digital-first vision, serving over 21 million patients across the UK, managing 100 million appointments, and facilitating 250,000 daily users. In the subsequent article, the partnership with Welsh Health Boards is discussed, exploring the success of waitlist validation tools and the incredible potential of digital Patient Initiated Follow-Up (PIFU).

Tackling the Waiting Game Prior to the pandemic, Wales had seen a consistent rise in the demand for outpatient services, with an average growth of 4% annually.

With a static capacity, this increasing pressure on services manifested in extended waiting times and inevitable delays in both treatments and reviews, only exacerbated during and after the COVID-19 outbreak. Addressing this was crucial for optimal patient care and system efficiency.

Redefining Waiting List Management DrDoctor has been working with four Welsh Health Boards to help validate their waiting lists. Using their Quick Question product, a mass communication tool that requires no integration, Health Boards have been able to contact thousands of patients with the click of a button. So far, the collaboration has enabled contact with 65,711 patients, and 2,321 have been removed from waitlists. But this is more than a numbers game; it’s about streamlining resources and ensuring patients get the care they deserve, when they need it. By reducing DNAs and enhancing patient experience, DrDoctor is

supporting Wales in shaping a more responsive and agile healthcare system.

A look forward: Digital PIFU Wales is primed to adopt and embrace advanced healthcare delivery practices, with the future of outpatient care centred around patient empowerment, aligning with Welsh Value Based Healthcare. As innovative ways of delivering services become standard, the goal is to maximise the use of alternative pathways to routine follow-ups, such as See-On-Symptom (SOS) and Patient Initiated Follow-Up (PIFU).

Both PIFU and SOS models empower patients to take control of their care, by initiating followup appointments based on their needs or symptoms. With an emphasis on discharging post-treatment as the default and offering virtual appointments, the SOS and PIFU models are set to reduce low-value contacts, release clinical capacity, and, in turn, cut down waiting times.

DrDoctor have been working in collaboration with Welsh Health Boards and are now positioned to help support and realise these national objectives with their digital PIFU product.

The Dr Doctor team explain: “Data from a recently commissioned report demonstrated that, by implementing digital PIFU pathways across the service, the NHS could prevent 1.6 million unnecessary appointments and save a staggering £167 million annually.

Simultaneously, these pathways could reduce waiting lists by 1.4 million appointments, further

shortening waiting times and enhancing patient satisfaction. Demonstrating its potential, the Trauma and Orthopaedics department at Guy’s and St Thomas’ NHS Foundation Trust reported a 70% reduction in follow-ups after implementing DrDoctor’s digital PIFU solution, forecasting considerable annual savings.”

DrDoctor’s Vision for Tomorrow Consistent with the ambitions of the Welsh government, the aspiration is for 20% of outpatient reviews to employ PIFU. The digital shift that we can see in the healthcare landscape, that DrDoctor is part of, leads to enhanced patient experiences, cost-effective care, and optimal clinician time utilisation. The result can be Improved patient engagement and better patient outcomes. As their collaboration with Welsh Health Boards strengthens, their shared objective is a healthcare future steered by innovations like Quick Question and digital PIFU. Projecting ahead, they are implementing AI models and tools that are not just about predicting missed appointments but could revolutionise how the NHS manages waitlists and validating those genuinely in need of care. The rise of clinically driven digital PIFU further emphasises this paradigm shift, allowing patients to actively participate and communicate their needs. By intertwining AI, waitlist validation tools, and PIFU, DrDoctor wants to be part of setting the stage for an NHS that’s more efficient, responsive, and, above all, centred around the patient’s unique journey and requirements.

www.drdoctor.co.uk

44

2 0 1 8

Advancing surgical safety and sustainability: The innovative CIMPAX smoke evacuation system Eakin Healthcare Introduces CIMPAX Smoke Evacuation System: A Closer Look The C-PURE 750 Smoke Evacuation System and the C-VAC Tornado smoke evacuation pencil are the latest offerings from Eakin Healthcare, aiming to address the management of surgical smoke in operating rooms.

The C-PURE 750 is presented as a compact and low-noise system that seeks to manage surgical smoke. It offers a variety of tubing and accessory options, along with customisable tips that can be adjusted depending on the specific surgical procedure, potentially offering a tailored experience to surgeons and patients alike.

In an eco-conscious move, the C-VAC Tornado claims to be the world’s first smoke evacuation pencil to be 100% free of PVC and phthalates. However, it will be crucial for hospitals to assess the tangible benefits and impacts of this on their sustainability goals.

The 3-port filter of the C-PURE 750, with its 4-stage filtration system provides an array of options to accommodate hospital or clinical requirements. While filters with RFID capability aim for consistent communication and control between the filter and the smoke evacuation system, this technology integrates with existing systems in a real-world setting.

A feature of note is the C-PURE 750 sensor, which can remotely operate the system and is designed to prolong filter life and manage noise.

The C-VAC Tornado integrates smoke evacuation capabilities into an electrosurgical pencil and tries to mitigate hazardous surgical smoke generated during procedures. Its triangular design and silicone cover aim to provide ergonomic benefits and a secure grip,

though user feedback will be pivotal to validate these ergonomic claims.

The device also includes a unique adaptor, intended to protect the main filter and ensure compatibility with various smoke evacuation systems.

Designed by CIMPAX A/S in Denmark and manufactured within the EU, the C-VAC Tornado and C-PURE 750 are Eakin Healthcare’s attempts at blending surgical safety, convenience, and sustainability into one.

Eakin Healthcare say that the arrival of the CIMPAX smoke evacuation system promises to usher in an era of enhanced surgical safety, precision, and eco-conscious practice within the healthcare sector, setting a new precedent for competitors and future developments alike.

www.eakinsurgical.com

45

Success stories from the life science industry

Usability: eg technology provide 5 key considerations for product development From point-of-care and therapeutic devices to surgical equipment and in vitro diagnostics, med tech innovation in the UK is acknowledged globally for saving millions of lives, as recognised by the Life Sciences Vision . The vision outlines a 10-year strategy co-developed by the UK Government, the NHS, life science companies, charities, and medical research.

Companies in the life science sector, driven by the pressing need for swift innovation and product development, often face challenges. However, prioritising speed to market might risk underestimating, or even completely overlooking, the crucial value of user-centred product design.

For many UK companies, integrating human factors into product development can be a daunting process, especially when the nessesary expertise is not available in-house. The human factors engineers at eg technology have compiled five key considerations for integrating usability into product development:

1. Integrate usability early into the product development process Product designs often prove most effective when usability is factored into development programmes from the outset. User and product requirements should mutually inform each other, guided by research and user insights gathered early in the development process to identify and mitigate risks, fundamentally working to maximise device safety.

2. Consider the full product development lifecycle Considering the iterative nature of product development, it’s vital to incorporate usability engineering at every stage, from concept generation through to transfer-to-manufacture. Early integration of usability might, in fact, expedite the route to market by mitigating the risk of recalls and costly redesigns, ensuring a smoother developmental pathway.

3. Understand the Context of Use It’s likely that more than one subset of user groups will need consideration.

Developing the right device and strategy, which satisfies both user and product requirement specifications, involves a thorough understanding of the context of use between user and product. Engaging in user research can assist design teams in challenging their assumptions and comprehending a wide range of user needs, preferences, and requirements, some of which might not be immediately obvious.

4. Identify conflicting usability requirements Some products, particularly medical devices, possess niche usability design traits that may not be intuitive but should not necessarily be altered.

Thus, understanding the target audience to balance usability with technical performance becomes crucial. Understanding how to translate perceived needs into actual requirements is key.

5. Benefit from External Expertise At eg technology, a refined design and development framework is employed, with usability and human factors fully integrated from the earliest phase. Many companies leverage this expertise and established processes to transform their innovations into successful and marketable products. A partnership with eg technology not only provides access to experienced engineers and a thorough understanding of the development pathway but also to an established network of partners, including regulatory experts, suppliers, and manufacturers. Flexible programmes offer an end-to-end solution, cycling through use-risk assessment and risk management phases. By prototyping and conducting initial test phases in-house, areas of highest risk can be assessed before moving towards the goal of a robust and fully tested pre-production design.

www.egtechnology.co.uk

46

2 0 1 8

EMPATH™ - Collaboration and innovative modelling at the heart of discovering optimal care pathways

Drilling down into the problem scope, priorities lay in the ability to be able to answer the following questions:

Overcrowding, 4 and 12 hour breaches, and average wait times are regular hot topics that are reported in the media with regards to Urgent and Emergency Care (UEC).

The initial stages focus on defining the problem with clients and what level of granularity is required, for example, through collecting data at an individual patient level.

As the UK population ages, the likelihood of being disabled or experiencing multiple chronic and complex health conditions increases.

Consequently, the UK is facing an unprecedented demand for both planned and unplanned medical treatment (National Audit Office, 2023). These metrics, along with the associated financial implications of missing targets, are of critical importance to the NHS and shift the spotlight directly onto simple questions with not-so-simple answers:

From here, a modelling solution is developed using their agile methodology, adding value to the specific areas of concern ensuring validation of the model results and iteratively fine-tuning to ensure that the most accurate forecasts are produced.

l What difficulties are faced in

dealing with the demand on UEC?

l What solutions are available in

a climate where resources are stretched to the limit?

These complex problems are well-suited to data modelling to capture, interpret and help inform decisions.

Frazer-Nash’s Approach to Modelling Solutions Frazer-Nash Consultancy’s approach utilises thier proven range of modelling approaches and expertise to support advisory engagements where collaboration and co-production with customers are key. Their experience with a wide range of evidence-based methods and tools helps then to solve complex and challenging problems such as these. The diagram shows the key stages of this approach:

Through this iterative approach, involving key stakeholders at each stage, important benefits can be realised in the form of robust evidence generation for given scenarios.

Frazer-Nash’s approach to care pathway modelling - EMPATH™: A Case Study A recent collaboration between Frazer-Nash and an NHS Trust in the South-West of England sought to support operational and strategic decision making, provoking a direct impact on elective recovery and Emergency Department waits. The resulting solution, EMPATH™, was developed in the form of a bespoke modelling tool for patient care pathways.

Frazer-Nash worked alongside the Trust through a series of workshops focusing on defining and capturing the hospital operations and a deep understanding of the patient journey, examining potential care pathways.

High-quality collaboration was of paramount importance, drawing on experience from roles including Chief Operating Officer, Management Information Leadership, Finance Director, and senior clinical and nursing staff members.

l What does the patient waiting list

look like over time? e.g., What will the (e.g., Orthopaedics) waiting list look like over the next ‘n’ months with current beds and staffing?

l What if the situation changes? e.g.,

What is the impact of increased demand (inpatient referrals)?

l How can we improve the situation?

e.g., How well does a planned increase to ward capacity improve the picture over time?

As a result, EMPATH™ was developed, representing flow paths that were rigorously validated against actual patient data, ensuring that the model performed as expected.

EMPATH™ modelling outputs provided business impact to the Trust by highlighting critical paths and quantifying system resilience to changes in patient volumes. This is currently helping to tackle Elective care waiting lists through data interventions that define Trust future operational trajectories over time. It has helped inform the planning of newbuild facilities, for example, the business case for new build theatres, and it is now supporting work in the Emergency Department to tackle Ambulance handover.

Senior leadership at the Trust have reported extremely positive results, noting an enhanced quality in both short and long-term predictions for operational trajectories. Frazer-Nash believe that this is only the beginning of what can potentially be achieved through the power of collaborative modelling solutions.

www.fnc.co.uk

47

Success stories from the life science industry

Haelu - empowering integrated care with a platform to address a divide between health and social care Every day, social care professionals have a unique opportunity to understand what matters most to individuals receiving care in the community. Working together to support their daily needs and provide much-needed person-centred care.

However, the divide between health and social care often means that when a person has a health need, social care can do little to support them besides escalating directly to secondary care.

While much is being done to integrate teams and enhance community health care accessibility, scaling early access to care is constrained by a lack of community data and resources.

Hywel Dda University Health Board (HDUHB) and the Welsh health-tech start-up, Haelu, identified a missed opportunity in the daily visits of care

visitors without clinical training to share insights that could alleviate pressure on both the NHS and social care by improving access to the right care at the right time in the community.

Through collaboration, Hywel Dda and Haelu have co-developed a digital integrated care platform designed to safeguard patient health closer to home by empowering care professionals without clinical training with a process for recording and raising concerns directly with health.

The core functionality of this platform has been carefully co-designed to provide structured, twoway actionable insights that make every contact count and enables holistic, data-driven decisionmaking at scale. Importantly, data-rich visit records will not only be accessible to professionals at the point of referral, but dynamic coordination features will also enable daily remote monitoring

of key signs and symptoms to manage risk while awaiting interventions and to monitor progress post-interventions.

Individuals receiving care and their families can easily access their care record, selfmonitor their progress towards personal goals, and have full transparency regarding any pending referrals.

The new model of care provided by this platform enables knowledge transfer across skill sets and services, facilitating a truly integrated approach to care delivery that is crucial for improving resource efficiency and scaling of value-based, preventative care in the community.

The first version of this platform will be launched with the NHS Care at Home team in Pembrokeshire, who have been key in the co-design and will support reablement and palliative patients. Collaborative co-design will continue as the model is adapted and introduced to integrated care teams and, ultimately, to support those receiving social care.

This collaborative partnership and project won the Wales Health Hack 2022, received an honourable mention at the MediWales awards 2022, and is a Bevan Commission Exemplar project. This approach to integrating care required collaborators who were ready to break the mould, be bold, and let their passion for improvement drive innovation. Haelu found this with their partners at Hywel Dda UHB and the local authority social services in Pembrokeshire, Carmarthenshire, and Ceredigion, all of whom have played a part in shaping this platform.

As part of the roadmap for this approach, Haelu is welcoming further collaborative partnerships.

www.haelu.co.uk

48

2 0 1 8

ImmunoServ’s impact throughout the COVID-19 pandemic Throughout the COVID-19 pandemic, ImmunoServ’s COVID-19 Immuno-TTM test has been performed on over 1000 patient and participant blood samples across multiple research studies.

The COVID Immune study, funded by Health and Care Research Wales and the UK Government, examined the effect of COVID-19 vaccination on both SARS-CoV-2-specific T-cell and antibody responses in cancer patients. This joint project, run by Cardiff University, Velindre NHS Cancer Centre, and the Wales Cancer Bank, utilised ImmunoServ’s COVID-19 Immuno-TTM test to measure SARSCoV-2 T-cell responses induced by COVID-19 vaccination in 68 cancer patients. Results published in the journal Immunology1 revealed that the vast majority of cancer patients do mount robust immunological responses following at least two doses of COVID-19 vaccination, regardless of tumour type, stage, or treatment.

The SARS-CoV-2 T-cell response test study, funded by Innovate UK and led by Dr Martin Scurr (Cardiff University, ImmunoServ Ltd.), developed a novel capillary blood T-cell assay for largescale population immunity assessments. Over 300 participants were recruited across the UK within 10 weeks at the height of the initial SARSCoV-2 Omicron wave. The results published in Nature Communications demonstrate that the magnitude of T-cell responsiveness to SARSCoV-2 is an effective correlate of protection against developing COVID-195. The study led to the successful commercialisation of the finger-prick version of ImmunoServ’s COVID-19 Immuno-T™ test6, primarily being used by immune-compromised individuals concerned about their immunity status.

COVID-19 Vaccine Response in People with MS studies, funded by the BMA Foundation for Medical Research and led by Prof Ruth Dobson at Queen Mary University of London and Dr Emma Tallantyre at Cardiff University, Cardiff & Vale NHS, utilised the COVID-19 Immuno-TTM test on blood samples obtained from MS patients recruited across five UK MS centres (Cardiff, Newport, Nottingham, Royal London Hospital (Barts Health NHS Trust), and Swansea). Two highly cited seminal studies7 have been reported that demonstrate the effect of MS treatments on COVID-19 vaccineinduced T-cell and antibody responses, revealing the potential protective effect of SARS-CoV-2-specific T-cell responses in seronegative subjects.

The COVID-19 National Core Studies Immunity program, funded by UK Research and Innovation, identified several areas where additional resources were needed to respond to urgent unanswered questions about COVID-19. ImmunoServ’s Immuno-TTM test was incorporated into multiple studies, including EVITE Immunity2, led by Professor Helen Snooks at Swansea University investigating the effects of shielding in Wales; Asymptomatic COVID-19 in Education (ACE)3, led by Prof Lucy Fairclough at the University of Nottingham - studying asymptomatic cases of COVID-19 in student populations to understand protective immunity; and Vaccine Response in People with Chronic Lymphocytic Leukaemia (CLL), led by Dr Helen Parry at the University of Birmingham - establishing the effectiveness of COVID-19 vaccines in people with CLL4. Together, these studies enabled the UK to use health data and research to inform government responses to COVID-19.

1 https://onlinelibrary.wiley.com/doi/10.1111/imm.13433 2 https://www.swansea.ac.uk/press-office/news-events/news/2021/03/new-study-to-evaluate-how-well-shielding-against-covid-19-works-.php 3 https://onlinelibrary.wiley.com/doi/10.1111/imm.13433 4 https://www.immunology.org/news/national-core-studies-immunity-programme-impact-report 5 https://www.nature.com/articles/s41467-022-32985-8 6 www.immuno-t.co.uk 7 https://onlinelibrary.wiley.com/doi/10.1002/ana.26251 / https://www.msard-journal.com/article/S2211-0348(22)00448-5/fulltext

www.immunoserv.com

49

Success stories from the life science industry

Development of a novel ambient air sampling device for allergen detection InBio has pioneered a new device for measuring aerosolised allergens.

Extensive documentation links exposure to environmental allergens with the development of allergic asthma and rhinitis.

As a result, allergen monitoring is becoming increasingly important for exposure assessment and intervention control. The majority of allergen assessment studies have focused on measurements derived from static dust samples due to the ease of sampling. However, since sensitisation to an allergen often occurs through inhalation, understanding allergen exposure in this context is crucial. Traditional methods for measuring aerosolised allergens are either passive or involve expensive and cumbersome sampling apparatus, adding complexity.

Recognising this knowledge gap, InBio developed Apollo: a user-friendly, lightweight, and quiet air sampler designed specifically to capture allergens using a specialised filter. Combined with InBio’s proprietary immunoassays and expertise, Apollo enables the measurement of aerosolised allergens in a simple and standardised manner. Since its launch in May 2023, Apollo is now being utilised in several key markets. For instance, Apollo is currently employed in two clinical trials by UK universities, focusing on environmental allergen exposure, and in occupational health settings to assess allergen control measures.

InBio collaborated closely with South Walesbased GX Designs during the Apollo’s design phase. As Apollo is intended for measuring

indoor environments in domestic and commercial settings, minimising noise was a priority to avoid disturbing those nearby, unlike most other available sampling devices.

Collaboratively, several design changes were implemented, including a new fan, grill design, and rubber feet, resulting in the device operating at under 40 decibels. Furthermore, usability was enhanced while contamination risks from handling were reduced by optimising the filter scaffold, allowing for easy removal and replacement via a slip-on design. Current projects with GX Designs are exploring the scaleup of device manufacturing.

In addition to scaling up, future efforts are focused on expanding the use of Apollo in the broader environmental testing market. Aerosolised microbial contaminants, such as moulds, viruses, and bacteria, significantly impact human health, as highlighted by the recent COVID-19 pandemic, and also pose major challenges in the food industry.

Identifying and monitoring airborne contaminants could help mitigate risks in these settings and open new and expansive testing markets. Currently, a Smart Partnership application with the Welsh Government is in progress in collaboration with a group at Cardiff Metropolitan University, which could potentially support research in this emerging field.

www.inbio.com

50

2 0 1 8

Working to improve the provision of sustainable endoscopy in Wales and beyond IQ Endoscopes is an early-stage medical device organisation located in Chepstow, South Wales. The company was established to address the current shortage in the capacity of endoscopy services across Wales and England. Their purpose is to create pioneering endoscopy technologies for the early diagnosis of diseases, helping people to live longer and healthier lives.

This is achieved by designing single-use endoscopes that offer a sustainable, sterile solution both inside and outside the hospital environment.

IQ Endoscopes’ single-use endoscopes are designed to mitigate the risk of cross-infection and enhance capacity, provide a cost-effective and safe alternative to existing technologies.

Eliminating the need for lengthy and sometimes ineffective decontamination, this approach makes the provision of endoscopy more streamline and economical.

Founded in 2015 by Dr. Patrick Ward-Booth and CTO Andrew Miller, IQ Endoscopes stems from Patrick’s background as a community service endoscopy provider, which highlighted to him issues such as limited access to endoscopy and the absence of a diagnostic service. Recognising the significant impact, a single-use endoscope could have on global service provision, Patrick’s motivation to enhance patient pathways in endoscopy, coupled with Andrew’s automotive engineering expertise, led to the implementation of an innovative approach to endoscope design, resulting in an early-stage prototype with promising results. The design was granted a patent in July 2020.

In just three years, the company has experienced significant growth. Securing £5.2 million in Series B funding to support the development of their initial products, IQ Endoscopes expanded their team from four members to twenty-two. As a startup, this marks an exciting phase as they navigate the regulatory process and finalise the design of their

product for market release, bringing them one step closer to their mission of designing and deploying high-quality, sustainable single-use endoscopes.

Sustainability is a core focus for IQ Endoscopes, integrated into all aspects of their business, from operations to product development. They are committed to delivering a product that positively impacts the environment. Efforts to measure and reduce their carbon footprint, from manufacturing to end-user, are ongoing.

IQ Endoscopes are proud to have received funding from the Cardiff Capital Region Challenge Fund, which supports their journey towards effective sustainable endoscopy provision. They are set to

enter Phase 2 of their grant with Cardiff & Vale UHB to further explore how their single-use endoscopes can enhance the patient pathway in endoscopy services.

IQE is also delighted to announce that it has received UKCA regulatory approval on its first product, the Q Vision G-100 Gastroscope. This approval is the first step in IQE’s regulatory strategy to bring a range of clinically acceptable, sustainable single use endoscopes to market.

www.iqendoscopes.com

51

Success stories from the life science industry

International collaboration to improve diagnosis and monitoring of neonatal sepsis Maternal and neonatal sepsis are significant contributors to global morbidity and mortality, with an estimated 500,000 deaths each year attributed to maternal and neonatal sepsis. Most of these cases occur in low-and middle-income countries (LMICs).

While South Africa has experienced a gradual decline in the neonatal mortality rate, from 20 per 1,000 live births in 1990 to 11 per 1,000 live births in 2019, the current biomarkers and haematological indices commonly used in clinical practice have limited value due to their low sensitivity. Moreover, results are often delayed in less-resourced settings. This delay leads to the unnecessary use of antibiotics, contributing to challenges with antimicrobial resistance. To address this issue and further enhance neonatal sepsis outcomes, the development of improved methods for detecting neonatal sepsis is crucial. In LMIC markets, these methods must be robust, easy to adopt, and, critically, affordable for healthcare providers with limited resources.

Building on innovative technology developed at the University of Oxford, Seroxo Ltd has created the Leukocyte ImmunoTestTM (LITTM) as a portable, rapid near-patient test for immune dysfunction. This ten-minute test utilises a finger-prick sample of whole blood (requiring no sample preparation) and measures the results using a portable handheld luminometer. The assay works by measuring Neutrophil Function, a parameter that clinicians often want to assess but was previously tedious and time-consuming, requiring an expensive laboratory instrument and three hours of a technician’s time. With LITTM, this measurement is available in just ten minutes, facilitating better clinical decision-making.

In collaboration with clinical partners at Gazi University Faculty of Medicine, Ankara, Turkey, a clinical evaluation was conducted to compare LITTM in adult patients with infection (but not sepsis) versus adult patients with sepsis (N=276 total). The results indicate that LITTM provides comparable results to C-reactive protein (CRP), a common marker for sepsis.

This presents several major advantages: Test Time: LITTM delivers results in just 10 minutes at the bedside, whereas CRP tests often take hours in a laboratory.

Accessibility: LITTM uses a portable handheld reader, while CRP tests typically require bench-top instruments located in a laboratory.

Onset Time: LITTM exhibits rapid responsiveness, with an increase starting almost immediately and peaking in only 2 hours, compared to CRP, which has well-known delays with a 4–6-hour onset and 36–50-hour peak.

Despite LITTM demonstrating significant advantages over CRP for sepsis detection, the current test format involves several manual steps, including incubating the reaction mixture using a separate heating block from the reader. As a result, it is not currently suitable for widespread use in all healthcare settings, particularly for detecting neonatal sepsis in LMIC settings.

Funded by Innovate UK, ITERATE Design and Innovation Ltd collaborated with Seroxo Ltd and the Department of Paediatrics and Research Centre for Maternal, Fetal, Newborn, and Child Health Care Strategies at the University of Pretoria, South Africa.

Together, they adopted a planet-centred design approach to develop a new product design for LITTM (LITTM Mk-II), with a specific focus on

improving usability for diagnosing and monitoring neonatal sepsis in South African healthcare settings.

This project encompassed four main steps, involving input from groups of clinicians at each stage: Foresight: Initial research was conducted to establish considerations when developing a product for LMICs. Market trends and competitor products were analysed to gain a deep understanding of user requirements and the usage environment. A particular emphasis was placed on identifying ways to make the product design planet-centred, minimising its overall carbon footprint.

Concept: Multiple visual design concepts for both the cartridge and reader were explored through digital sketching. Usability research was collected through a focus group of clinicians who evaluated each product design proposal and responded to a comprehensive questionnaire. This provided quantitative and qualitative feedback to inform a refined design direction.

Detail: After reaching a preferred design consensus among international partners, a 3D CAD model was prepared. This model allowed for the creation of early-stage rapid prototypes to assess the overall form and usability. The CAD model also considered the assembly of internal electronics, touch screen display, manufacturing processes, and the fit and function of mechanical plastic components.

Prototype: The final phase focused on constructing a demonstrator model using additive manufacturing technologies. This prototype facilitated the validation of key user interactions, including the insertion and safe removal of the sample cartridge into the reader. Additionally, an animated video was produced to illustrate the use of LITTM Mk-II. The successful completion of this project has improved Seroxo’s ability to communicate its product offering to potential investors and funding bodies. This will enable Seroxo and ITERATE to finalise the product development required to bring this vital in-vitro diagnostic product to market.

In doing so, it will contribute to improving clinical outcomes for neonatal sepsis in South Africa and other low- and middle-income countries.

www.iterate-uk.com

52

2 0 1 8

Healthcare re-imagined: Meet Ultra-Portable Diagnostics Healthcare is under pressure, with growing waiting lists for appointments and diagnoses, higher emergency service times, and A&E departments under more pressure than ever due to the influx of admissions of patients who could be diagnosed and treated in their local communities.

For nearly 90 years, Fujifilm has been innovating in the primarily medical imaging market. Their latest innovation is the Ultra-Portable Diagnostics Solution Car, designed to meet the ever-changing needs of patients and healthcare professionals and to help address inequalities in healthcare across different communities. The Ultra-Portable Diagnostics car features products from across the company’s range of solutions to aid in the diagnosis and assessment of patients, wherever they are.

Enabling patients to be treated in their homes and local communities not only removes the burden from hospitals but also introduces true community-based diagnostics.

All of Fujifilm’s products within the car are designed to be ultra-portable and include: l FDR Xair, a lightweight, portable x-ray system weighing just 3.5kg, with a built-in lithium polymer battery and offering over 100 images on a single charge. l FDR D-EVO III, the world’s first glassfree digital detector, a lightweight, flexible film-based TFT detector that offers the highest quality images with low x-ray dosage, and is waterproof and dust-proof. l DRI-CHEM NX600, a point-of-care blood analyser offering highthroughput with up to 128 tests per hour and results in as little as one minute. l iViz Wireless, a pocket-sized wireless ultrasound with both convex and linear probes, offering 3 hours of continuous scan time, storage capacity, and short start-up times. l SYNAPSE 7, a picture archiving system that supports clinical collaboration across divisions.

Supporting this portfolio of solutions are key partners who are located in the car or in the cloud, including RWG, AWS, Primeshare AI Platform, Gleamer, and Lunit, offering a world-first multiagency partnership. Working in tandem across all of the partners and solutions allows Fujifilm to offer on-the-spot assessments and diagnoses, along with the ability to report back to the site in real time. By working with partners, Fujifilm has created a cloud-based, vendor-neutral datasharing solution, allowing for the diagnostic data captured by the equipment in the vehicle to be integrated with hospital information systems, such as PACS and LIMS, to facilitate diagnosis and decision management, thus improving patient pathways and ensuring continuity of care.

Through Amazon Web Services (AWS), images can be circulated via Primeshare to utilise AI platforms such as Gleamer and Lunit for assisted diagnosis.”

Allan Elborn, General Manager of Fujifilm Healthcare UK; “With the investment in Community Diagnostic Centres and Virtual Wards, we are seeing the NHS moving services away from

large Healthcare Centres and closer to the patient.

We believe that the Ultra-Portable Car, with its range of diagnostic solutions, could be a real benefit for this type of service. We worked hard to come up with a solution that enables a range of equipment, supported with market leading AI providers, and seamlessly connected to a Trusts IT systems. All of which we believe can ultimately support clinicians in deciding what the best course of action is for the patient, without having to bring them into hospital. Our hope is that a solution such as the Ultra-Portable car, can reduce the number of avoidable attendances to hospital, allowing patients to remain at home, reducing pressure on hospital beds and A&E departments.”

Huw Shurmer, Strategic and Government Relationship Manager, Fujifilm Healthcare UK says, “We’re delighted with how this project has come together, and to be able to provide innovation where it’s required, helping to address backlogs in the NHS and lowering unnecessary admissions to hospitals for patients, ultimately reducing healthcare inequalities in our most remote communities.”

www.fujifilm.com/uk/en/healthcare

53

Success stories from the life science industry

Llusern Scientific - streamlining rapid molecular diagnostics Llusern Scientific specialises in providing affordable, easy-to-use, and rapid molecular diagnostics, specifically designed to be used at the point-of-care in diverse settings. The technology they have developed is aimed at addressing an urgent, unmet health need – the diagnosis of Urinary Tract Infections (UTIs).

Currently, no reliable point-of-care test exists for UTIs, forcing clinicians to make treatment decisions with minimal evidence of specific infection. Llusern’s technology aims to improve patient outcomes and enhance antibiotic stewardship for this common infection.

UTIs are among the most common infections worldwide, affecting >150 million people annually and causing approximately 5,000 deaths per year in England and Wales alone.

Treatments for UTIs account for 10-20% of all community antibiotic prescriptions. However, in the absence of appropriate diagnostic tools, over half of these antibiotics are prescribed either unnecessarily or inappropriately, contributing to the spread of antibiotic resistance. Despite this, health professionals continue to depend on slow, and frequently inaccurate diagnostic tools for this significant disease.

Prior to spinning out from the University of South Wales, they had been developing their technology with Public Health Wales (PHW) and Cwm Taf Morgannwg University Health Board (CTMUHB). The collaboration was extended through agreements with CTMUHB and Tritech, and by co-leading a project with CTMUHB focusing on the development of their UTI test. The Bevan Commission funded this project.

The Llusern team first became interested in UTI diagnosis out of a desire to prevent overdiagnosis (antibiotic prescribing in the absence of true infection). However, as they engaged with the UTI patient community, they realised that under-diagnosis (missed infections) is an equally pressing issue, with many thousands of women across the UK silently suffering from recurrent and chronic complications. UTIs are also a leading cause of hospitalisation and sepsis in the elderly, where diagnosing actual infections is even more challenging. Llusern is focused on ensuring that the needs of these patients are met through the application of their technology.

Their work with the NHS has recently resulted in two poster presentations and abstracts published in JACAMR that have been co-authored

by Joanna Diggle, an Associate Practitioner at PHW. These abstracts vividly demonstrate the need for better UTI diagnostics and the inadequacies of current testing methods. With more collaborative studies planned to be published in the near future, Llusern hopes to play a transformative role in the way this substantial healthcare burden is managed by health services in the UK and beyond.

In December 2022, Llusern was awarded the ‘Partnership with the NHS’ award from MediWales. They have worked with the NHS since the start of their journey in 2016.

www.llusern.co.uk

54

2 0 1 8

Advancing pharmaceutical asset management Navigating through the dynamic landscape of the pharmaceutical industry demands efficient and compliant management of product information and assets. GWELO, an online platform developed by Magpie Concept, addresses this requirement effectively. It provides pharmaceutical companies with a comprehensive solution to streamline the management of product SmPC (Summary of Product Characteristics), enhancing compliance and offering notable time and cost savings for regulatory, medical, and marketing teams.

In an industry that thrives on innovation, maintaining up-to-date, accurate, and accessible product information presents a substantial challenge. Traditional management of SmPCs and associated assets involves complex coordination between various departments, which often leads to delays, errors, and increased expenses. The advent of GWELO by Magpie Concept signals a significant shift in this approach.

GWELO serves as an efficient tool for pharmaceutical companies to centralise the management of product SmPCs and related assets.

This intuitive online platform enables regulatory, medical, and marketing teams to collaborate effectively, ensuring the product information utilised is accurate and consistently updated. Features include the ability to add, update, track, and manage SmPCs in under 60 seconds and generate unique QR codes and links for both printed and digital assets.

Adopting GWELO brings various advantages, notably surpassing conventional methods. One of its prominent benefits includes the substantial time and cost savings it avails to pharmaceutical companies. By refining processes and reducing the need for intensive coordination, GWELO enables teams to allocate resources more optimally, thereby boosting productivity. Its capability to update SmPCs in under 60 seconds demonstrates the platform’s commitment to enhancing task efficiency.

Ensuring compliance with pharmaceutical industry standards is crucial, and GWELO diligently addresses this challenge. The platform assures that product information and associated assets consistently meet regulatory standards, mitigating the risk of inaccuracies and potential legal repercussions. This improved compliance supports a more sturdy regulatory framework, assisting companies in confidently navigating through the complex industry landscape.

Moreover, GWELO impacts positively on the final artwork results of pharmaceutical assets. By centralizing asset management, the platform reduces the probability of errors and discrepancies in printed and digital materials, enhancing the overall aesthetic appeal and maintaining consistency in branding and messaging, thus reinforcing the company’s professional image.

In a period where technology is altering industries universally, the pharmaceutical sector has to keep pace. GWELO by Magpie Concept shows how innovation can address challenges and modify operations. By adopting this platform, pharmaceutical companies can leverage the benefits of automation, real-time collaboration, and enhanced compliance, carving out a stronger competitive presence in the market.

As pharmaceutical companies persist in operating within a fast paced, ever-evolving landscape, the necessity for efficient asset management is paramount. GWELO introduces a transformative solution that not only economises time and expenses but also encourages collaboration, compliance, and consistent branding. Several pharmaceutical companies have initiated the adoption of GWELO, witnessing the beneficial impact it has on their teams and operations first hand. These teams can attest to the efficacy, precision, and velocity with which GWELO enables them to manage SmPCs and associated assets.

GWELO, developed by Magpie Concept, emerges as a noteworthy innovation within the pharmaceutical sector. Its capability to centralise and streamline SmPC management, enable real-time collaboration, enhance compliance, and deliver time and cost savings, marks it as an important tool for the industry. As pharmaceutical companies strive for excellence in a competitive landscape, GWELO paves the way for a more efficient, compliant, and successful future.

www.magpie-concept.com

55

Success stories from the life science industry

Organoid expansion business outgrows incubator A company specialising in expanding organoids at scale is preparing to leave its Cardiff Medicentre base.

Cellesce, a spin-out from Cardiff and Bath Universities, has been a tenant at the Medicentre since 2017. Having originally leased a laboratory and an office, the business now occupies five units in the Cardiff biotech and medtech incubation hub. From there, it uses its unique bioreactor technology and proprietary bioprocess to expand organoids at scale. Organoids are 3D miniaturised versions of human organs that can be cultured in the lab from human tissue.

They can be used to represent patients in drug discovery and biomedical research.

In December 2022, Cellesce was acquired by Molecular Devices - one of the world’s leading providers of high-performance bioanalytical measurement systems, software, and consumables for life science research. With staff numbers having doubled since the acquisition, Cellesce is now set to move into custom-built lab facilities in the Welsh capital.

Victoria Marsh Durban, CEO of Cellesce, said: “We’re entering a period of huge change for the company after five years developing our team and our services at the Medicentre. We’re excited to be graduating from business incubation and delighted to have joined forces with Molecular Devices. Together, we are moving forward with a

shared vision to enable 3D biology and end-toend workflows for our customers, particularly in the field of pharmaceutical and biotherapeutic development.”

Organoids are a new, disruptive technology that enables the wide application of 3D biodiscovery, primarily by pharmaceutical companies. But it’s Cellesce’s ability to grow standardised, reproducible organoids at scale that has really captured the attention of medical research, drug discovery, and toxicology specialists all over the world.

“Derivation and culture of organoids require technical skill and experience. It is performed in highly specialised labs and the process is laborious, timeconsuming, and costly. Manual culture typically results in small quantities of organoids of variable size range and quality, limiting their widespread commercial use. We have the technology to manufacture reproducible batches of bespoke organoids on an industrial scale for commercial use in therapeutic compound screening and other high throughput applications.”

Elizabeth Fraser Strategy Partner, Cellesce

This work will continue from Cellesce’s new home, with opportunities for further expansion and diversification. Molecular Devices is part of the Danaher group, a global science and technology innovator that accelerates research and develops pioneering products to further the understanding of science and medicine.

Speaking of the company’s time at Cardiff Medicentre, Victoria Marsh Durban said: “The Medicentre gave us the perfect start – a supportive environment, a great location, and room to develop and grow. The time’s right to move on, with solid foundations and a hunger to take the business to the next level.”

Rhys Pearce-Palmer, Innovation Manager at Cardiff Medicentre, said: “It’s been a privilege to have had the Cellesce team at the Medicentre and to have supported them along the way. Their work is hugely important, paving the way for a better understanding of cancer and other diseases, and providing a greater choice of therapies and improved outcomes for patients. We wish the team all the very best and will be keeping a keen eye on their continuing success.”

www.cardiff.ac.uk/medicentre

56

2 0 1 8

Preventing unnecessary costs with Aternity Digital Experience Management Cardiff-based Managed IT Services company Net Consulting Ltd. (NCL) have been working with the NHS over the last few years and have helped them with projects ranging from cyber security and root-cause analysis, through to creating operational efficiencies. In recent months however, it’s NCL’s Digital Experience Management service, powered by ‘Aternity’ from Riverbed, that’s had the biggest impact.

Health Boards across Wales have been looking for a solution which helps with the following priorities: l Improved quality of IT services; l optimised Service Desk operations; l and most crucially, a reduction

in costs

“Having worked closely with these organisations, it’s clear they’re battling the challenge of maintaining a high-level of patient care, while also improving staff and clinician digital experience, all while trying to reduce costs at the same time”, says Jamie Sheppard – Senior Account Manager at NCL. This is a seemingly impossible undertaking, and the IT departments we work with are often the teams who are tasked with finding a solution. This is why we’ve been delighted to introduce them to our Digital Experience Management service, underpinned by Aternity. With our support, these IT teams now have the capability to address these challenges all in one SaaS solution.”

Jamie Sheppard Senior Account Manager at NCL

Jamie explains that through using Aternity, Health Boards have been able to reduce the ‘Blue screen of Death’ (BSOD) across devices and improve the stability of critical applications used across the industry.

“It’s also helped reduce IT support tickets and escalations as well as improving the meantime to resolution (MTTR). Furthermore, the solution has helped avoid significant costs by extending the life of existing devices. This was done by identifying which of them were at risk of being unnecessarily replaced through a blanket refresh, even though they actually have plenty of life left in them.”

While the benefits of Digital Experience Management are broad-ranging and in some instances, sit in isolation, they all share a common denominator – a saving in either time or money, and more often than not, both.

One Health Board that’s using NCL’s Digital Experience Management service to great effect is Cwm Taf Morgannwg University Health Board.

“At a time when identifying and eliminating inefficiency is more important than ever, Aternity has helped us manage our assets and make better

use of what we already have.” A representative from the Health Board said.

“One simple example here is how the tool can help pinpoint idle equipment – machines that are just left on standby. By being able to identify this, we can make sure they’re turned off when not in use. Clearly this helps cut electricity cost, but it also helps us in our commitment to becoming Net Zero by 2030. We’re working very closely with Net Consulting and learning how to make the best use of Aternity and unearth other areas within our Health Board to be more efficient. In terms of Digital Experience Management their knowledge is second to none and they went above and beyond in helping us get this very valuable IT solution up and running.”

With Cwm Taf Morgannwg University Health Board leading the charge, other Health Boards across Wales are also realising the impact Digital Experience Management can have in their organisation, not only on general IT performance and user experience, but crucially on cost avoidance and budget saving too.

www.netconsulting.co.uk

57

Success stories from the life science industry

The importance of stakeholder engagement in bringing innovation to market Regardless of the innovation challenge or ‘problem to solve’, multi-level stakeholder engagement is a common driver for implementation, acceptance, and adoption, all of which are vital in the deployment of new technologies.

Overlooking, or trying to ‘short-circuit’, engagement at any point in the process means risking or limiting the success and sustainability of the outcome.

Objectivity is a software solutions provider specialising in bespoke innovation developments for healthcare organisations. Objectivity operates a strong stakeholder engagement model from the start of each project. The team makes a concerted effort to sit with clients and partners to really get to grips with and understand the requirement, with projects never being ‘off the shelf’. All projects start life from a deep understanding of what the challenge and solution really means for every stakeholder. This may be the commissioner of a service, the patient, the care team, the family, and the wider community.

As a data-driven solutions provider, Objectivity instinctively builds in the right metrics to ensure delivery within budget, on-time, and with maximum impact. But looking beyond these standard metrics, the most meaningful definition of success for the Objectivity team is being able to see the positive, day-to-day impact on patients, families, and health teams.

Objectivity worked on the Little Hearts at Home project; developed with Alder Hey Innovation under the leadership of Dr Phuoc. The company’s UX and analytical experts engaged with families and carers to ask them what they hoped to see from a remote monitoring system. Their early participation in the project was critical to achieving confidence and support.

“We know that early and regular engagement ensures that we are on the right path towards building a system or technology solution that is collaborative and user centric. However, our engagement activity doesn’t stop here — it’s a continuous process throughout delivery, implementation, adoption, and technical support.

This allows us to support the client in framing what the solution needs to look like over time (or evolve into) as the project progresses and new requirements organically occur.”

Andrew Smith Healthcare Services Director Objectivity

Objectivity argues that effective cross-sectional engagement depends on striking a balance between the shared objectives of the collective, the external directive (guidelines, regulatory, governance), and the personal drivers of each individual involved.

The technology must be easy-to-use and adopted as an augmentative (not distractive) everyday practice for all end users, including patients, families, clinical and non-clinical care teams, integrated care systems (interoperability and data exchange), and other non-clinical support agencies.

Improving health equity and reducing inequalities is one of the top priorities for the NHS and health systems globally, and digital health will play a critical role in this objective.

Objectivity is committed to representing entire patient populations when conducting a ‘Discovery’ or research phase of product development. This multi-level stakeholder approach mitigates the risk of introducing products or solutions which could create further equity divide, particularly when digital inclusion factors have not been considered.

To ensure a project (which is already demonstrating early outcome improvements) can continue to deliver with longevity, scale, and sustainability, Objectivity also engages those who are measuring the value, efficiency, and ROI of the development.

These are crucial metrics for a financially overburdened health system.

In conclusion, stakeholder engagement is one of the most imperative, integral activities when developing digital health solutions. From building in the opportunity for the right evaluation of data to sustaining new services and digital pathways, to enabling clear outcome improvements, access, and inclusion for entire patient populations, all these elements are crucial to delivering real value through technology innovation.

www.objectivity.co.uk

58

2 0 1 8

A new reality for digital mental health RedKnight is delighted to announce that it has supported SyncVR Medical UK Ltd (SyncVR) and South London & Maudsley NHS Trust (SLAM) in their successful application to the Innovate UK Mindset Extended Reality (XR) For Digital Mental Health competition, securing the consortium a grant of £185,000.

The project, titled “Auxilium”, aims to develop the world’s first mental health application for virtual reality headsets, designed to support at-risk patients awaiting mental health care. This innovative application will incorporate mindfulness and dialectical behavioural therapy (DBT) skills training components. Both techniques have been proven effective for patients in crisis and those suffering from mood instabilities.

Ari Billig from SyncVR states, “The UK has such a significant need for mental health support that it’s absolutely imperative we empower users to take control of their mental health. They should learn actionable skills to better their own lives.” In 2021-22, over 1.2 million people in the UK were on a waiting list for community mental health care, an increase from 1.08 million the previous year.

SyncVR is committed to enhancing healthcare with its groundbreaking XR technology, encompassing both virtual and augmented reality. The company has already developed several successful mindfulness-focused applications currently in use in over 100 hospitals, including 10 NHS trusts. These applications assist patients in reducing pain, anxiety, and medication dependence. Additionally, the platform offers medical staff development through XR training.

“Auxilium” aims to equip patients with valuable coping and mood management tools, enabling them to better handle their emotions during waiting periods for therapy. It also prepares them for the therapeutic process and aims to enhance their overall healthcare experience.

www.redknightconsultancy.co.uk

Kooth - Continuing to innovate in digital mental health Kooth has been providing online mental health support in the UK for over 20 years and in Wales for over a decade. Children and young people can access Kooth.com, which offers a variety of support, from self-help and a pre-moderated peer community to professional 1:1 support from counsellors and emotional wellbeing practitioners.

A major development at Kooth has been the introduction of the first measure to specifically look at the effectiveness and impact of single-session therapy, known as the Session Wants and Needs Outcome Measure (or SWAN-OM).

Data and studies have shown that attending a one-off session only is a common pattern of usage for people attending mental health services. This is also the case for Kooth service users, who often drop in for a single session or periodically drop in for one-at-a-time sessions.

However, despite this common pattern of access, outcome measures for mental health services are traditionally symptom-specific and/or designed to look at changes over a period of time or course of therapy. Such measures do not lend themselves to single-session therapy, hence why the SWANOM was developed alongside young people and clinicians, resulting in a more relevant outcome measure.

The Kooth Theory of Change, developed in consultation with service users, practitioners, and academics, provided a matrix of common wants and needs. This included those identified via dropin single-session online chats. This matrix allowed Kooth to scope a measurement tool that could do two things: first, help identify what a service user wants to achieve from a single session and second, encourage reflection after that session on whether they achieved what they wanted.

An iterative, phased approach was used to develop the SWAN-OM, which maximised the participation of service users and practitioners in the design and testing of the new measure. Useracceptability testing, trials, and workshops were undertaken to develop and refine the tool. Once the final design was completed, measurement validation was carried out. Kooth worked closely with the Child Outcomes Research Consortium (CORC) to develop and validate the measure as well as involving other organisations in testing the measure to understand its suitability within different services.

The Kooth team is continuing to work with partner organisations to trial and implement the measure and are open to developing new partnerships.

They continue to utilise the data gathered through

The SWAN-OM has been in place as a routine measurement tool at Kooth since 2021. Within services in Wales in the last year, there have been 1,180 single sessions attended by children and young people. A significant 74% of service users have had at least one positive outcome, where they answered ‘Agree’ or ‘Strongly Agree’ to the outcome statements they had chosen as important to them to achieve within the session. The most common areas chosen included ‘Exploring how I feel’, ‘Feeling better’, ‘Feeling listened to’, and ‘Understanding my feelings and or behaviours’.

services to improve responses for people looking for immediate, responsive mental health support.

www.koothplc.com

59

Success stories from the life science industry

Sony UK Technology Centre - nurturing innovation and resilience Located in Pencoed, within the county borough of Bridgend, Wales, is the Sony UK Technology Centre (UK TEC), a division of Sony Europe B.V. For five decades, this company has been at the forefront of innovation in Wales, manufacturing high-specification Sony broadcast and professional camera systems and offering collaborative manufacturing, service, and refurbished businesses. Sony UK TEC has played a significant role in supporting

Prioritising the health and safety of its workforce, Sony UK TEC introduced extensive precautionary measures during the pandemic, such as thermal testing, designated work zones, one-way systems, and strict hygiene practices. The increased demand for the Raspberry Pi4 8GB computer, influenced by the global shift to remote work and learning, highlighted the facility’s adaptability.

Sony UK TEC’s work with the Raspberry Pi was critical in developing medical ventilators and virus tracking technology, demonstrating the significant role of technology in tackling global issues.

essential services, fostering innovation, and encouraging growth.

In contract manufacturing, Sony UK TEC has a dynamic and adaptive approach. With a history of engagement in medical technology production and collaborations with partners like MediWales during trade shows, the facility showcases its versatility and commitment to serving various markets.

Resilience beyond the pandemic

“I am proud of our team’s contributions during these challenging times. Their integration of new safety protocols during the pandemic, coupled with the rise in production volumes, particularly of the Raspberry Pi 4, shows our commitment to technological progress and adaptability. Our journey represents resilience and progress, with a focus on continuous innovation.”

Gerald Kelly

Moving forward Continuity remains crucial, and Sony UK TEC’s professional service centre consistently provides essential support for high-end Sony products, including medical printers, cameras, and broadcasting equipment. Across Europe, various establishments depend on UK TEC’s expertise for seamless operations.

Professional Services Director Sony UK TEC

Sony UK TEC’s dedication to the Welsh and UK economies is unwavering, reflecting Sony’s commitment to supporting key industries.

Sony UK TEC is known for its tenacity and innovation. Understanding the vital role of technology in medical advancement, the facility adjusted operations during the COVID-19 pandemic, ensuring the supply of crucial technology to the medical and broadcast sectors.

Manufacturing Raspberry Pi computer models, which have been globally recognised for their contribution to medical technology, UK TEC continued to support essential services during challenging times.

www.sonypencoed.co.uk

60

2 0 1 8

Revolutionising healthcare: humanmachine collaboration for enhanced patient outcomes

In an industry embracing the rapid evolution of technology, the very nature of human interactions within the healthcare ecosystem is shifting, creating a synergy between humans and machines that is transforming how medical care is perceived, accessed, and received.

Traditionally, healthcare has been characterised by face-to-face interactions between patients and medical professionals. However, the emergence of technology has ushered in a new era where human interaction with machines is becoming increasingly prevalent. This transformation is evident through the utilisation of smart devices, wearable sensors, and health monitoring apps, empowering individuals to take an active role in managing their health.

Tamarnd Applied Sciences is harnessing the power of technology, by leveraging artificial intelligence (AI) and smart interaction mechanics, to enhance the healthcare experience. Unlike conventional systems, Tamarnd’s approach does not solely focus on medical diagnoses and treatments; it looks to actively involve patients throughout the care cycle. This approach intends to bridge the gap between patients and care providers, allowing for both to receive the best possible insight into a specific case.

At the heart of Tamarnd’s innovation lies its flagship, AI-driven platform “Nebula”, which gathers and analyses data from a number of sources. This encompasses medical history and diagnostics as well as lifestyle factors, social determinants, and patient-reported outcomes. By unifying these diverse inputs, Tamarnd seeks to create a comprehensive profile of the patient’s health journey, enabling care providers to make better clinical decisions. This contextual richness provides medical professionals with the ability to tailor treatment that aligns with the patient’s lifestyle, preferences, and medical needs.

What distinguishes Nebula is its emphasis on collaboration over replacement. The platform does not seek to substitute human care providers with machines; rather, it serves as a support system, enhancing the capabilities of medical professionals.

This synergy is apparent in Nebula’s ability to offer personalised treatment recommendations that

are not only medically sound but also aligned with the patient’s unique circumstances. By actively involving patients in their care, Tamarnd seeks to foster a sense of ownership over one’s health, promoting a proactive approach to well-being.

Tamarnd suggests that through this approach patients could feel empowered by personalised insights, rendering them more engaged in the management of their health. Consequently, this will lead to better adherence to treatment plans and healthier lifestyle choices. Furthermore, Nebula’s collaborative nature could strengthen the doctor-patient relationship, transforming it into a partnership centred around shared decisionmaking.

Tamarnd is but one such entity in a field of innovative companies and technologies. The rise of companies looking to employ intelligent technology in healthcare today, demonstrates the potential of this collaboration, showing how technology can enhance clinical outcomes while promoting a patient-centric approach. The integration of technology into healthcare should prioritise the active involvement of patients, and Tamarnd looks forward to leading that charge.

www.tas.wales

61

Success stories from the life science industry

Clinical trial for rare, progressive form of myoclonus epilepsy underway Cardiff based neuroscience research services provider, The Science Behind, is working closely with clinical stage biotechnology company Autifony Therapeutics Limited (Autifony) to support a clinical trial of their AUT00201 compound, a novel Kv3 modulator, in progressive myoclonic epilepsy-7 (EPM7).

The Phase 1b clinical trial is being conducted in partnership with the Hospital of the University of Pennsylvania and enrolled its first participant in May 2023. It follows the designation of AUT00201 as a drug for a ‘rare paediatric disease’ and orphan-drug designation for the treatment of EPM7 by US FDA. The trial is a randomised, double-blind, placebocontrolled, crossover study in patients with Myoclonus Epilepsy and Ataxia due to Potassium (K+) Channel Mutation (MEAK aka EPM7). Its primary aim is to provide additional confirmation of safety and tolerability following a successful First-in-Human study completed in 2020. The study also aims to provide proof of mechanism in this patient population using transcranial magnetic stimulation electro-diagnostic-markers (TMSEDM) and other neurophysiological measures.

MEAK is an extremely rare seizure disorder caused by a recurrent de novo heterozygous mutation (c.959G>A, p.Arg320His) in the KCNC1 gene which codes for the Kv3.1 protein. The Kv3.1 channel is a voltage-gated potassium channel found on interneurons in the brain. Dysfunction of the Kv3.1 channel causes reduced cortical inhibition and leads to hyperexcitability in the motor and sensorimotor cortex of the brain – the areas responsible for movement and physical senses. This hyperexcitability essentially causes the rhythmic myoclonic activity in MEAK and progressive ataxia observed in these patients.

A targeted therapy, AUT00201 is a potent and selective modulator of Kv3 ion channels. Positive modulation of the channel allows for faster and more regular firing of the interneurons and thus reduces the cortical disinhibition. This precision medicine approach aims to reverse the impact of the genetic mutation.

Patients usually present with myoclonus (brief shock-like jerks of a muscle or a group of muscles) and/or ataxia (unsteadiness and difficulty in co-ordinating movements) in childhood, between the ages of 3 and 15 and get progressively worse over time. In some cases, patients also experience generalised tonic-clonic seizures. By the time

patients are in their late teenage years they often need to use a wheelchair and other assistive devices.

In many cases, patients have difficulty with daily activities and are mostly dependent, although in adulthood seizures are less frequent and the disease stabilises. There is currently no specific treatment for MEAK or the relief of myoclonus or ataxia in these patients. Therapy typically involves anti-seizure medications for the symptomatic relief of seizures.

The technology of TMS-EDMs allows probing the excitability of the motor cortex and directly and objectively measure with reliability and reproducibility whether the candidate drugs of pharmaceutical and biotechnology companies are in fact facilitating or inhibiting cortical excitability – a key aspect in understanding the physiological effects of novel compounds.

As a specialist in providing tailored neuroscience research solutions for early phase clinical trials, The Science Behind team of neuroscience and research scientists designed and developed the TMS-EDM and EEG-Auditory Chirp protocols in close collaboration with Autifony to measure key endpoints in this study.

Working with technology partner, Brainbox, The Science Behind developed the specific combination and integration of neuroscience devices and coded the stimulation and data acquisition parameters of the protocols and ensured the correct installation and training was provided to the study team at the trial site.

Once all participants have finished the study, The Science Behind’s team of neuroscientists will lead the analysis of the data and support Autifony during the interpretation of the findings.

Tonia Smreczak, Managing Director, The Science Behind says - “This is an exciting study for The Science Behind to be involved with. Trials in rare diseases are often some of the most challenging and under supported and the success of this study has the potential to lead to a treatment that will have a significant benefit to those who live with MEAK. For us to be part of that story is a tremendous privilege.”

www.thesciencebehind.com

62

2 0 1 8

TrakCel - managing, controlling and tracking Cell and Gene Therapy (CGT) products Founded in 2012 in Cardiff, UK, and with offices in the USA, TrakCel was the first provider and remains the marketleading developer of integrated Cellular Orchestration Solutions (COS) that manage, control, and track Cell and Gene Therapy (CGT) products through the supply chain.

TrakCel boasts the highest number of live clinical trial and commercial therapy deployments worldwide. Their driving principle is that ‘there is a patient at the end of everything they do’.

Many therapies TrakCel assists with are personalised for each patient. Receiving the incorrect batch could have fatal consequences.

Therefore, TrakCel’s OCELLOS software solutions help safeguard patients by recording the intended recipient through a Chain of Identity (COI) and detailing who has managed the cells via the Chain of Custody (COC) log.

OCELLOS is a leading and proven orchestration platform. It’s the choice of cell and gene therapy developers globally to compile supply chain data into a reportable, electronic format. This provides full real-time audit trails for each patient. Data is simplified for users who are often managing multiple therapies, into user friendly dashboards with notifications of required actions.

TrakCel support a broad range of therapy types and classes, including Autologous, Allogeneic, and Personalised Cancer Vaccines; helping to keep therapies for critically ill patients moving through the supply chain by securely and automatically communicating with partners such as labs, healthcare centres and couriers.

At the end of 2022, OCELLOS 3.0 was recognised in The Scientist Top 10 Innovations for its contribution to safety and quality in the supply chain and for upholding COI and COC to data

regulatory standards. 2023 promises further platform advancements for the company.

What’s next on the horizon for TrakCel?

Their vision positions TrakCel at the centre of the CGT ecosystem. They have bold plans for 2023, including launching an Advanced Scheduling module for optimising manufacturing slot allocation and introducing OCELLOS Core – a straightforward, cost-effective COI and COC solution from the initial human trials. Their list of integrated partners has expanded to encompass couriers, therapy manufacturers, labelling solutions, and patient hub service providers.

In the near future, they continue to hone and broaden their product suite to meet the demands of the burgeoning CGT sector. The number of therapies entering clinical trials in recent years has increased and diversified in terms of indications targeted and scientific techniques used.

These integrations are critical to keeping a seamless flow of information between essential supply chain partners, ensuring live cells are expediently managed to maximise treatment efficacy.

The year has been exciting and has seen TrakCel in a drive to recruit fresh talent with a new graduate programme which has brought skill, diversity and new viewpoints into the team.

This industry growth must be supported by supply chains to bring these ground-breaking therapies to patients. Recently, there has been more research into personalised treatments of solid tumour cancers that impact huge patient populations globally, so the industry must prepare to deliver these therapies on massive scales once they have been approved.

Technology has always been key to scaling processes up quickly and cost-effectively and TrakCel are looking at how the latest technologies can be combined with what has been learned about best-practice in the industry over the last ten years to help to offer more patients safe access to these treatments when the time comes.

www.trakcel.com

63

Success stories from the life science industry

UK Discovery Health – A new era in healthcare consulting UK Discovery Health is a pioneering, independent consultancy providing strategic direction and market access for SMEs in the Life Sciences, MedTech and Digital Health Tech sectors. UK Discovery Heath was founded in 2022 and is consultancy based in Wales with the aim of specifically offering a new approach to consulting. Bringing new innovations to market in a rapidly changing landscape requires a nuanced approach, no two innovations are the same.

“The UK can seem a complex market to enter. We aim to help simplify some of that complexity, enabling innovative Welsh, wider U.K and Global companies to successfully launch in the UK”

Victoria Wilbraham-Mitchell Founder and Principal Consultant UK Discovery Health

As a senior healthcare executive with over 25 years of product launch experience within the Digital, MedTech, Devices and Pharmaceutical industries, Victoria has seen the UK and global healthcare markets grow and change over time. With the UK healthcare market transitioning to a value-based approach, it is imperative to build a market access strategy with this at the centre. Having direct, real-world experience of successfully bringing innovations to market, Victoria is keen to help companies navigate this complex landscape to launch successfully in the UK and beyond.

The NHS is constantly evolving, as such we must move along with it. At UK Discover Health we work with 3 pillars, clinical, value and patient.

One question we regularly get asked when partnering with innovative companies is ‘how can we demonstrate value to the system, where there is no precedent?’. It is imperative that these questions are explored, and an appropriate strategy developed. The danger of ending up with a great innovation, with no evidence of how it would fit into the system ultimately delays successful launches. In some cases, unfortunately this leads to products and solutions never making it to market. Building the overall system value, including service and pathway redesign and health

economics can prove challenging. Precedents in this area is heavily relied upon to build successful submissions. Innovation, by definition, is a new method, idea, or product, and as such, introducing novel innovations to any healthcare system requires thinking outside the box. UK Discovery Heath helps guide clients who find themselves in this situation.

We are very humbled by our first year of trading, we have been nominated and selected as finalists for a variety of Welsh awards. We have found the Welsh healthcare ecosystem incredibly welcoming and helpful. Regardless of an individual’s starting point, whether working for the NHS, an innovator, investor, or company, everyone is working towards the same outcome, a successful NHS, where patient care is pivotal.

We have the daily pleasure of working with forward thinking, passionate clients, who believe in their solution. Our role is to partner strategically with innovative companies to support them on their journey in realising their products market potential. The ultimate goal is to enable patients to have access to the best products, services, and treatments. Ensuring that the great innovations being developed, see the success they truly deserve.

www.ukdigitalhealth.com

64

Forward thinking health research

65

Forward thinking health research

Cardiff University researchers use video X-Ray to better understand how the spine works In the UK, many millions of people suffer from back problems and back pain. The spine is a complex structure comprising vertebrae, discs, nerves, joints, ligaments, and muscles, about which we still have much to discover.

Professor Cathy Holt and Dr. David Williams at Cardiff University are conducting a novel research project focused on the movement of the spine, with funding awarded by the Engineering and Physical Sciences Research Council (EPSRC).

The £1.2 million, three-year project, in collaboration with the University of Exeter, aims to improve our knowledge of the function of the spine and, importantly, how it deals with the load stresses placed upon it. The innovative study’s goal is to use data collected from living participants to develop a tool that predicts the forces within the spine during daily activities.

Abnormal forces are linked to various back issues, such as manual handling injuries, disc degeneration, and pain. The research aims to better understand the forces our spines experience, ultimately assisting in the future prevention and treatment of back problems.

Measuring forces directly in the spine is too invasive, so current science predicts forces in the spine using mathematical models. For these models to be truly accurate and clinically useful, they need to include information about individuals’ unique anatomy and tissues, as well as the way they use their spine, as every one of us moves differently. The absence of this ‘subject-specific’ data is the key to this new ‘Image-Driven Subject-Specific Spine Models’ (IDSSSM) research project, involving a multidisciplinary team of engineers, physicists, and specialists in computer modelling.

The research is ‘image-driven’ as the team in Cardiff is collecting data using bi-plane fluoroscopy or video radiography, which delivers highly accurate imagery similar to a mini X-ray movie of the spine as it moves. This is possible due to the unique Fluoroscopy laboratory in the Musculoskeletal Biomechanics Research Facility at Cardiff University School of Engineering.

Human volunteers undergo an MRI scan at the University’s CUBRIC imaging centre and then undertake activities representative of daily life, including bending and lifting small

weights. Motion capture technology records their movements using skin-placed markers, EMG (Electromyography) collects muscle activity data, and two X-ray machines positioned on either side of the spine take a series of quick pulsed X-rays, recording exactly how the structures within the spine move as the volunteer undertakes activities.

This image data is being combined with specific tissue property data from lab specimens subjected to force experiments and material properties generated from specimen MRI models generated by the Exeter team. Once combined, the data will deliver a 3D model demonstrating what is happening to the spine and the surrounding tissue as it moves.

This unique 3D model can then be tailored to individual patients for the first time, and the researchers hope that in the future, applications of the model for surgical planning and spine implant devices may be possible.

www.cardiff.ac.uk

66

Innovation and collaboration in the fight against cancer Cancer remains one of the biggest areas of investment in research by the Welsh Government, supporting the delivery of clinical trials, personal awards, and the development of key research infrastructure, such as the Welsh Cancer Research Centre, funded by Health and Care Research Wales.

Health and Care Research Wales is committed to developing innovative and ambitious cancer research studies to continue improving outcomes for people and communities in Wales.

CReST – Wales’ Coordinated Cancer Research Strategy In July, the first-ever national coordinated Cancer Research Strategy for Wales (CReST) was published, bringing together the entire research community in the fight against cancer.

The strategy was developed by Health and Care Research Wales, the Wales Cancer Network, and the Wales Cancer Research Centre, along with groups across Wales dedicated to improving cancer diagnosis and treatment. This includes patients, members of the public, and cancer researchers. It also builds on key strategic advice from a panel of external experts.

CReST focuses on six priority areas, including precision and mechanistic oncology, immunooncology, and clinical trials, where there is already a track record of excellence in Wales, with the intention of developing them to be internationally leading.

Professor Mererid Evans, Director of Wales Cancer Research Centre, said, “The CReSt Strategy is helping the talented research community across Wales and beyond to work together to improve the way we detect, prevent, and treat cancer and to build on the amazing research that is already happening across the country. As well as discovery science taking place within universities, clinical studies funded by non-commercial organisations or industry partners and delivered through the NHS are giving patients early access to promising new treatments. It is through these joined-up efforts to gather robust evidence that we can help current and future cancer patients to receive the best care.”

Professor Alex Tonks of the Division of Cancer and Genetics at Cardiff University

Developing “Gold Standard” Cancer Treatments Health and Care Research Wales also continues to fund groundbreaking individual cancer studies.

One study into the role of a key protein found in one of the most common types of leukaemia, Acute Myeloid Leukaemia (AML), could pave the way for “gold-standard” lifesaving treatments in the future.

The research team, led by Professor Alex Tonks of the Division of Cancer and Genetics at Cardiff University, observed that the protein, NFIC, appeared to be significantly higher in blood cancer cells of AML patients than in non-cancerous cells, and that NFIC is required for those cells to survive.

Professor Tonks said: “We would be the first to understand NFIC’s role in how AML develops.

Once we have that understanding, we can create treatments to tackle it.”

This precision therapy has already been used to great effect in treating Chronic Myelocytic Leukaemia (CML).

Professor Tonks explained: “Research developed a treatment for the cancer-causing protein in CML, and the survival rate went from approximately 10% after five years to above 90%. That’s the gold standard we want to achieve for all the other different blood cancers.”

Key Industry Partnerships Partnerships with industry form a key component of this collaborative approach in several areas of cancer care.

Professor Richard Adams, Director of Cancer Trials at the Centre for Trials Research at Cardiff University, said, “We are currently developing partnerships with companies such as Biontech and Moderna to develop new vaccines that may increase cancer cures. We are also already opening new studies for patients within Wales.

“The QuicDNA study has recently been launched as a Welsh clinical assessment of liquid biopsies, a type of blood test for cancer, in partnership with multiple industry partners. This study is exploring the role of an NHS-based blood test performed in the All Wales Genomics Laboratories in Cardiff to speed up the identification of patients with lung cancer so that they can start tailored treatment more rapidly. In this collaborative study, we aim to recruit patients from across Wales and the Centre for Trials Research, collecting data to help us understand how this technology can improve patient care and by how much.

“Clinical research allows us to explore new treatments and care pathways for patients with cancer, and collaboration brings the best science and the best people together to deliver efficiently and effectively.”

www.healthandcareresearchwales.org

67

Forward thinking health research

Cross-sector working supports paediatric medicines research in Wales In children, 50 percent of medicines are used off-label or off-license, a figure which rises to 80 percent for the neonatal population. Legislation in both Europe (including the UK) and the USA requiring trials, where relevant, to be conducted in the paediatric population has stimulated research in some areas of paediatric need.

Conducting these trials requires collaboration between various stakeholders, including industry, healthcare professionals, and most importantly, the patient and their families. In 2017, the Children and Young Adults’ Research Unit (CYARU) - the only paediatric clinical research facility in Wales - was officially opened at the Noah’s Ark Children’s Hospital for Wales, to allow children across the country to participate in research.

Starting with a team of two, Dr. Phillip Connor (Clinical Lead and Health and Care Research Wales Specialty Lead for Children and Young People), and Rhian ThomasTurner (Research and Development Lead at Noah’s Ark and operational lead for the unit), CYARU now employs eight full-time members of research staff, the most recent of which is an early-phase oncology research nurse funded by the Paediatric Experimental Cancer Medicines Centre (ECMC). The ECMC is jointly funded

by Cancer Research UK and the Welsh Government.

“We’re delighted that the Noah’s Ark Children’s Hospital for Wales was able to participate in such an important study, as this vaccine has the potential to protect many young children from serious respiratory disease.”

CYARU has placed cross-sector working at the heart of its operational model. Rhian ThomasTurner emphasised the importance of working alongside colleagues in industry and the charity sector, including LATCH, the children’s cancer charity, which has provided invaluable support, allowing CYARU to establish an early-phase oncology service, which has led to it becoming part of the Paediatric ECMC for the first time. The research unit has also received support from the Noah’s Ark Charity, which has funded essential equipment, vital in ensuring that studies can be delivered in Wales.

Rhian added: “We also work with our industry colleagues in other ways, most recently in an initiative to promote the involvement of adolescents in adult clinical trials.

The group, hosted by EFGCP, a Belgian non-profit organisation, recently published a decision tree that could support those designing trials to facilitate adolescent inclusion (EFGCP_Adolescent Inclusion Decision Tree_FINAL.pdf).

“We also recognise the important of our industry colleagues in the integration of technology in clinical trials, something that could revolutionise clinical trials for the paediatric population; I’m also grateful for everything that I learned during a six-month secondment at Welsh health tech firm Aparito.”

CYARU has opened up numerous opportunities to bring innovative and often life-changing treatments to children in Wales. “We have been involved in many important studies since CYARU opened its doors,” Dr. Connor said. “Recently, we participated in the HARMOINE RSV study, which showed that a potential vaccine – Nirsevimab - reduced hospitalisation in 83 percent of infants who participated in the study. www.healthandcareresearchwales.org

68

‘Hospital-at-home’ ultrasound test for older people at risk of heart failure A researcher has received funding from Health and Care Research Wales to explore whether an at-home ultrasound scan could improve the quality of care for older people at risk of heart failure. Dr. Emma Rees, Associate Professor of Healthcare Science at Swansea University and a member of the Health and Care Research Wales Faculty, is researching the impact of nurses adding a focused scan of the heart and lungs during their home visits to older people in the Neath Port Talbot area.

Around 30% of people over 70 experience breathlessness, which can be linked to reduced quality of life and more frequent use of health services. Heart failure is a common cause of breathlessness in older people and is an important reason for being admitted to hospital.

However, lung disease and other long-term conditions can also cause breathlessness.

Currently, individuals may need to attend several hospital appointments to determine what is causing their breathlessness so that effective treatment can be started. This can be particularly difficult for older people who may be frail, have mobility problems, or who are living in care homes.

Dr. Rees’ research examines whether adding a focused ultrasound scan to the existing examination done during a home visit improves a clinical practitioner or nurse’s ability to accurately determine the cause of breathlessness.

The research will also discover whether any improvement in accuracy leads to better decisions about the most appropriate next steps for each patient.

This research is a collaborative effort between Dr. Rees, PhD student Sophie Moosavi, and an Acute Clinical Team from Swansea Bay University Health Board. The research program has included developing a training and assessment program for nurses, measuring the accuracy and reproducibility of the nurse-led scan, and performing a small feasibility study in the homes of older people referred to the team. The results

reduce the number of people being rushed to the hospital because they are critically unwell. This could help to relieve some of the burden on A&E services and ambulances.”

Annette Davies is the lead advanced clinical practitioner in the Neath Port Talbot Acute Clinical Team. She and three other clinical practitioners were trained to undertake the point-of-care ultrasounds as part of the study. She said feedback from patients was “very positive”: “This is an extra tool in our toolkits to confirm a diagnosis. You can see so much more detail and examine parts of the heart that you can’t normally.

“We saw around 30 patients, and they were all very positive about taking part. They all appreciated being looked after in the community and being able to have the test at home.”

suggest that adding the test to the home visit is acceptable, feasible, and likely to improve patient care. A larger trial is planned for the autumn and will comprehensively assess the value of adding the scan to the existing care pathway.

Dr. Rees said: “Testing and diagnosing patients with heart failure tends to be done by specialists in hospitals rather than in the community. We know that a diagnosis of heart failure is often made quite late, at a point when a person is admitted to the hospital. There is also a national recognition of the need to transform the way we provide care for the increasing number of older people in society who have a higher risk of heart failure.

“Hand-held ultrasound scanners are already used in hospitals to provide useful information at the bedside in emergency medical settings.

We believe that clinical practitioners or nurses could use this technology with older people in community settings to make better decisions about whether heart failure is the probable cause of the breathlessness. A more timely diagnosis of heart failure, with early specialist advice and treatment for those who need it, may help to

Dr. Firdaus Adenwalla is a consultant physician with the Neath Port Talbot Acute Clinical Team. He also believes the study demonstrates the benefits of such at-home testing: “Shortness of breath can be for a variety of reasons. Being able to do this investigation at home is very useful to rule in or rule out a cardiac problem. You are then able to refer a patient earlier and in a more targeted fashion.

“This study will go some way in reassuring colleagues in primary and secondary care that this sort of technology can be used safely in the community. I would like to see advanced clinical practitioners taking on more of these techniques and using them to further develop hospital-at-home services.”

Dr. Firdaus Adenwalla Consultant physician Neath Port Talbot Acute Clinical Team

www.healthandcareresearchwales.org

69

Forward thinking health research

Cardiff University team reveals how SARSCoV-2 changed and avoided detection As the COVID-19 pandemic unfolded, the race was on to try and understand how effectively our body’s immune system recognised SARS-CoV-2 – the virus that causes COVID-19 disease. Part of this immune system are T cells, a powerful and critical arm of our defence against these invading viruses. T cells can recognise new invading viruses which humans have never encountered before and work to drive the virus out of our body and limit disease.

Vaccination, or previous infection with SARSCoV-2, induces both protective antibodies and crucially protective T cells. Importantly, once T cells have seen and responded to a virus or vaccine, they generate immune “memory”. If we reencounter the same virus, our T cells are already primed and ready to quickly work to eliminate it.

So, if the virus changes over time, as we have seen with the waves of variants that have emerged across the world, is the virus now invisible to the immune system? A team at Cardiff University, funded by a Welsh Government “Sêr

Cymru – Tackling COVID-19 award”, have been working to try and answer such questions.

As the pandemic progressed, the virus began to mutate and change – most significantly the Omicron variant which emerged in late 2021. The team observed that two of the virus antigens that T cells could recognise were mutated and changed from the form of virus that people were vaccinated against. These changes were significant enough that the T cells within the blood of the vaccinated test group could no longer respond to the altered mutated forms.

Further experiments at Diamond Light Source enabled the researchers to determine just how different the mutated Omicron variant antigens were in their presentation to T cells. Crucially, they showed that one single and seemingly innocuous change within Omicron was sufficient to drastically alter the way an antigen was presented. This explained why the T cells’ immune memory built up by vaccination could no longer “remember” this part of the virus. This demonstrates just how sensitive our T cells are

to change and how we need to design vaccines which generate immune memory to the most stable and unchangeable parts of viruses.

The team in Cardiff are now using similar approaches to describe T cell immune responses to other viruses and in cancer. Having received a Health Research Fellowship from Health and Care Research Wales, Dr. Bruce MacLachlan is working to describe the peptide antigen that targets cancer-recognising T cells. Prof.

Andrew Godkin is using the knowledge gained to design the next generation of vaccines to protect against both viruses and for treatment of patients with colorectal cancer.”

When a person is infected with SARS-CoV-2, our immune cells digest and chop up the virus particles into small chunks called peptides. These peptides are shown or “presented” to T cells which may then initiate an immune response.

The team conducted experiments at Diamond Light Source, the UK’s national synchrotron facility, which shines intense beams of light in the form of x-rays onto the minuscule molecules involved. They were able to visualise in tiny molecular detail exactly how certain SARS-CoV-2 antigens are presented to T cells.

Combined with testing whether COVID-19 vaccinated donors could recognise these SARS-CoV-2 antigens, the researchers deciphered which virus antigens vaccination generated immunity to as well as what these antigens “looked like” to the T cells.

www.healthandcareresearchwales.org

70

Diagnostic kit using a digital platform for the early detection of lung cancer

Life Science Group (LSG), in partnership with Aberystwyth University, Highfield Diagnostics, ProTEM Services, Valley Diagnostics (VDX), and Professor Keir Lewis, a respiratory specialist at Hywel Dda University Health Board (HDUHB), aims to develop a rapid, cost-effective diagnostic kit using a digital platform for the early detection of lung cancer.

This project intends to address the challenges posed by current screening programs by creating a pre-test to swiftly identify individuals most likely to benefit from scanning.

Lung cancer affects approximately 48,000 individuals a year in the UK, claiming more lives than any other cancer and costing the NHS over £2.4 billion annually. Diagnosing the disease in its early stages is challenging, as clinical symptoms only manifest when the tumour is quite large or has spread beyond the lung. Surgery is an option for only about one in eight individuals, with the majority receiving treatments to manage their incurable disease.

Through research conducted at Aberystwyth University, the goal is to develop a multiscreen test kit capable of detecting minuscule chemicals (cancer biomarkers) present in urine.

These six biomarkers can diagnose lung cancer with 90% accuracy, even in its earliest stages, before clinical symptoms emerge. Once the test is fully developed, it is envisioned that it could be utilised in GP surgeries or at home.

The test is user-friendly and employs the lateral

flow method that gained familiarity during the Covid-19 pandemic.

This collaboration between Welsh academics, UK commercial partners, and several hospitals in Wales is currently seeking funding from Innovate UK to develop this diagnostic kit and ultimately manufacture these kits at scale in a new facility in south Wales.

The team in Aberystwyth has already identified biomarkers in urine that can diagnose various other cancers and diseases. The hope is that a range of these innovative diagnostic tests could be developed in the years ahead to diagnose and monitor the progression, location, and treatment effectiveness of various diseases and cancers. This could facilitate rapid, cost-effective, and accurate diagnoses of numerous conditions. consequences.

www.lifesciencegroup.co.uk

71

Forward thinking health research

Exploring innovations in healthcare: Biomedical Engineering at Swansea University Swansea University is internationally recognised for its dedication to research excellence and its significant contributions to many fields. The Biomedical Engineering department stands as a testament to this dedication, concentrating on the use of engineering principles to address complex medical issues.

Led by a dedicated team of faculty members, the department provides a range of degrees and opportunities for those keen on the convergence of medicine, biology, and technology.

With a multidisciplinary approach, students and researchers engage in projects spanning medical imaging, biomaterials, tissue engineering, biomechanics, advanced computational mechanics, data science and beyond. This diverse pool of expertise fosters an environment for innovation, where new ideas are brought to fruition.

Inspiring the Next Generation of Biomedical Engineers A Biomedical Engineering degree at Swansea prepares students for a successful career in both academia and industry. Undergraduate and postgraduate degree courses give a solid foundation in the fundamental principles of biomedical engineering, whilst also allowing students to specialise in their areas of interest.

One of the department’s unique strengths is its focus on experiential learning. Students have the opportunity to work on real-world projects, often in collaboration with external partners and stakeholders in the NHS and Industry, gaining experience in cutting-edge engineering practice.

This hands-on experience not only enhances their technical skills but also cultivates critical thinking, problem-solving, and teamwork – qualities essential for success in the field.

Notably, alumni have embarked on fulfilling roles at esteemed establishments such as Renishaw, Calon Cardio-Technology Ltd, Olympus Surgical Technologies, NHS, GE Healthcare, and the Royal Navy.

Research within the department focuses on three main themes Bioanalytics, Biomaterials and Biomechanics. From data modelling and statistical analysis, through to developing novel therapeutics and the experimental and computational study of biomechanical systems – the department’s breadth is impressive.

One great example of this is their project looking at the multi-analyte prognostic and diagnostic screening in blood and skin for Alzheimer’s disease with the MRC (UK)-AMED (Japan) grant and the Tokyo University of Agriculture and Technology.

Furthermore, they are part of the multiinstitutional worldwide project In Utero, using computational and mathematical modelling to highlight pregnancy risks.

Biomedical Engineering Simulation and Testing (BEST) Lab The department prides itself on modern facilities, including cutting-edge laboratories fitted with the latest tools for manufacture, instrumentation, imaging and testing. Our BEST

lab forges a synergy of computational and experimental expertise to deliver fundamental insight, novel technologies and translational healthcare solutions.

Current research projects within the lab include the advancement of lung mechanical measurements, next generation armour development, optimised surgical training devices, novel biomaterial phantom production and computational modelling of cardiovascular adaptions during heat stress.

The Future As the field of biomedical engineering continues to evolve, institutions like Swansea University’s Biomedical Engineering department will play a pivotal role in driving innovation and progress.

Through their commitment to cutting-edge research, multidisciplinary collaboration, and hands-on education, they are shaping the future of healthcare, one breakthrough at a time. Whether it’s the development of advanced medical technologies or the training of the next generation of biomedical engineers, this department’s impact is felt far beyond the walls of the university, reaching patients and communities around the world.

www.swansea.ac.uk/biomedical

72

Energist Ltd: Building preclinical data for the NeoGen™ plasma system Research to develop a quick, painless, and drug-free treatment option for patients living with chronic acne.

Energist Medical Group, based in Swansea Enterprise Park, is the first and leading global provider of nitrogen plasma technology to the medical aesthetics industry, with more than 20 years’ experience in design, manufacture and distribution of innovative aesthetic, dermatological, and surgical energy-based devices.

The company’s NeoGen™ Plasma devices are non-invasive, clinically proven and cleared for treating antiageing cosmetic and dermatological conditions including acne scars, actinic keratosis, facial rhytides, non-facial rhytides, superficial skin lesions, seborrheic keratosis, and viral papillomata.

A collaboration between Energist Ltd, Swansea University Medical School’s Healthcare Technology Centre (HTC), and the University of Wales Trinity Saint David’s (UWTSD) Assistive Technologies Innovation Centre (ATiC), was established through the former Life Sciences Hub Wales-led Accelerate Wales programme, co-funded by the European Regional Development Fund (ERDF) through Welsh Government.

Porcine skin samples inoculated with a common bacteria associated with the pathophysiology of acne, were treated with Energist’s innovative nitrogen plasma technology. This research provided evidence the NeoGen™ Plasma device can be used to treat chronic acne conditions.

The work included a study of user comfort and fatigue for clinicians during procedures, and review and capture current treatment methods to understand the issues around over and under treatment, to provide a better experience and outcome for patients.

In addition to the bacterial research study, HTC used its team’s expertise to investigate the diffusion rate of specific molecules through skin samples in response to the plasma treatment.

The novel technology and practices the project developed are among the first in the world, highlighting the expertise concentrated in Swansea and positioning Wales as a leader in this field.

The use of Franz cells and high-performance liquid chromatography quantified molecules diffusion rate and demonstrated the potential advantages of using the NeoGen™ Plasma device for increased skin absorption of topical products leading to enhanced clinical outcomes.

ATiC’s role within the project was in two distinct areas – a research study into capturing treatment areas, and user experience (UX) and ergonomic evaluation.

Using its team’s expertise and the UX research laboratory, as well as mobile eye tracking and prototyping facilities, ATiC conducted an in-depth UX study to investigate the ergonomics and controllability of the NeoGen™ Plasma device.

“Energist was delighted to collaborate with HTC at Swansea University Medical School and ATiC, UWTSD on such a meaningful project. Acne is estimated to affect nearly 10 per cent of the population globally and can lead to physiological and psychological complications for those suffering on a severe and prolonged basis.”

Simon Jones President Energist

As part of the research project with HTC and ATiC, Energist looked to innovate further by developing new equipment and practices for use in the treatment of chronic acne. Chronic acne has traditionally been treated using drugs, which can have longer-term health effects on patients.

HTC undertook an in-vitro study to validate the use of the unique nitrogen plasma technology for the treatment of acne. The work was undertaken in the Microbiology and Infectious Disease Laboratory within Swansea University Medical School.

www.neogenplasma.co.uk

73

Forward thinking health research

Training staff on low intensity psychological interventions for mental health conditions can cut workplace sickness Psychologists at Swansea University and Cardiff University have examined how training a workforce about treatment strategies for mental health problems can significantly reduce staff sickness and stigma.

Common mental health difficulties account for a large proportion of work absences. Many people may be needlessly embarrassed or ashamed of their mental health problems so either do not seek help or report that they have a physical health problem instead.

The research team devised a workplace intervention programme called Prevail to help people cope with their problems and reduce stigma. Priorities for improvement were common conditions depression, anxiety, stress, and distress caused by bereavement, divorce, debt, housing problems or friendship issues.

Analysis following the trial showed that Prevail had been well received and had reduced stigma related to mental health problems. Also, the number of sick days taken was reduced by around 22 per cent in those that took part in the programme while there was an increase in the number of sick days taken by the group that did not receive the intervention training.

“Mental health problems are often hidden and therefore get worse over time without effective intervention.

Prevail teaches people evidencebased psychological techniques for the treatment and management of these conditions. It also aims to reduce stigma by providing evidence that these problems are common and can happen to anyone. People who are struggling should seek appropriate help, just like they would if they had flu or a broken leg.”

Professor Nicola Gray Swansea University

Head of HR at the DVLA Helen Davies said: “The DVLA is committed to helping its workforce to be healthy and happy.

Our investment in developing the Prevail programme to help promote better mental health in our workforce has been worthwhile and many staff have commented on how Prevail has helped them overcome their mental health difficulties, and even helped them to help other people by teaching them the techniques they have learnt.”

Professor Robert Snowden, from Cardiff University, added: “We are delighted that Prevail has been shown to be effective. We hope that other organisations will also want to support their workforce within the area of mental health and support them to learn evidence-based techniques to improve emotional functioning and mental wellbeing.”

The aim of the research is that it will be used to help inform other major employers and have a long-term impact on how managers care for and support their staff.

A randomised control trial involving staff at Swansea’s DVLA evaluated the impact of Prevail on the findings of the research have been published in BMC Public Health.

Rather than identifying staff who may need help, Prevail aims to give all employees training on psychological interventions and coping techniques they can use if they experience mental health problems themselves and also how they can recognize and better understand if colleagues, friends or family have issues.

Through this, the programme also addresses unnecessary stigma surrounding mental health.

DVLA staff and managers involved in the study were divided into two groups - one taking part in sessions delivered by specially trained colleagues which taught psychological techniques for treatment of common mental health conditions and basic mental health literacy. The other (control) group did not attend the sessions.

www.swansea.ac.uk

74

Welsh Wound Innovation Centre (WWIC) educational collaboration with ConvaTec In 2021 ConvaTec, the advanced wound care and ostomy care company with large manufacturing sites in north and south Wales, celebrated 25 years of the production of the Queen’s Award winning hydrofibre dressing AQUACELTM. To celebrate this achievement ConvaTec donated an educational grant to the Welsh Wound Innovation Centre (WWIC) with the goal of educating 250 clinicians worldwide in recognition of the widespread use of the wound dressing by healthcare professionals. ConvaTec were not involved in the development or delivery of the program.

The initial aim was to educate 250 healthcare professionals within twelve months, however over 20 days WWIC had educated 631 nurses (152 from outside of the UK). More than doubling the original intended number. Delegates attended from 12 countries (Australia, Hong Kong, India, Ireland, Italy, Jordan, Latvia, Malaysia, New Zealand, South Africa, United States of America and the United Kingdom).

The course was delivered using the medium of English apart from some of the patient stories which came from Finland, France, Italy, Czech Republic, Switzerland and the UK. Where necessary English subtitles were used. The course was delivered through Microsoft Teams.

WWIC generated an online application system for delegates to book the days. They could repeat any days if they wanted to refresh their knowledge. The days had different start and finish times to accommodate delegates from Asia, Europe, and the Americas The course started in March 2022 and was designed using a four-day format that was repeated in April, May, June and October 2022.

Topics included wound assessment and wound healing, pressure ulcers/injuries, leg ulceration and hard to heal wounds. They started with an introduction to the course during which ConvaTec were thanked for their support that allowed the delegates to access this educational program free of charge. This was followed by live lectures in the morning by WWIC staff and

in the afternoon the delegates watched video clips of patients and clinicians and healthcare organisations sharing their experience of chronic wounds. This generated discussion among the delegates either live or in the chat facility within Microsoft Teams. The day ended with the delegates completing a unique WWIC designed online multi-choice ‘knowledge checker’ on the subject for that day. After completing the ‘knowledge checker’, the course facilitator went over the answers with the accompanying rationale for the correct and incorrect responses.

During, and following completion, of each day of the course delegates were asked to provide feedback using the WWIC hashtag #wwicliveelearning and they were also sent an electronic feedback form to complete and, on its return, received a certificate of attendance.

Feedback to date from the participants has been exceptionally positive and this resulted in a rapid spread of awareness about the courses both through direct sharing with colleagues and social media postings.

The courses were considered valuable for five key reasons; the high standard of the content; the live delivery of the content by

WWIC personnel; the unique format of the course; and the efficient administration of the course including the application process and dissemination of post-course resources.

During the planning of the course ConvaTec identified that it wished to have a legacy from the educational grant and developed a WWIC/ ConvaTec Alumni. A two-hour session including two new topics each month that are of current relevance to the field of tissue viability. Each topic will be introduced to explain the rationale for its inclusion then two live sessions one on the science behind the topic and the other on its clinical relevance/applicability followed by a general question and answer session (ask the experts) with WWIC staff. The first Alumni day was held in June 2023. Delegates attended from Austria, China, Chile, Croatia, Hong Kong, Italy, Malaysia, Saudi Arabia, South Africa, The Netherlands, United Arab Emirates and United Kingdom.

The collaboration between WWIC and ConvaTec on this educational program has been a great success which exceeded the initial target of 250 nurses by an additional 281 participants and has established an ongoing an Alumni legacy.

Feedback received:

“It was a fantastic eLearning online course.”

“I would highly recommend this to anyone.”

“Well done and thank you, it was an amazing and knowledge-based session. Keep it up!”

“Another fantastic day, I have learnt so much and look forward to attending more in the future.”

“This course needs to be compulsory to all health organisations!!!”

www.wwic.wales

75

Forward thinking health research

Pan Wales learning day in partnership with the Healthcare Technology Centre and Welsh Government The team within HTC Accelerate delivered a learning day to stakeholders from across health and social care in Wales, including Welsh Government, Public Health Wales, the Bevan Commission, Social Care Wales, and the Welsh Ambulance Service Trust (WAST), which was held at the Swansea. com stadium. The purpose of the day was to disseminate outcomes generated from seven mapping reports conducted over the past two years to assess research, innovation and improvement activities and assets for health and social care held by the seven regional partnership boards across Wales.

The reports involved extensive desk-based research and qualitative investigations with stakeholders across Wales, amounting to 164 units of data. Synthesis of the data from each of the seven regions was then conducted to achieve a ‘Pan Wales’ overview of opportunities to strengthen research, innovation and improvement efforts in accordance with Government policy for Wales.

The report was shared with Welsh Government, who invited the team to organise and deliver a dedicated learning day to share the outcomes and recommendations to over 30 stakeholders across health and social care and to engage them in a discussion about how best to move innovation for health and social care forward.

One of the objectives was to facilitate networking and greater coordination between stakeholders so attendees were given the opportunity to share a contemporary example of innovation that they had supported, while highlighting opportunities for scale and widespread adoption by other regions.

The learning day was a great success and was a first step towards achieving a more collaborative ‘Pan Wales’ approach to health and social care.

www.swansea.ac.uk

MEDIWALES THE WELSH LIFE SCIENCE AND HEALTHTECH SHOWCASE

THE LIFE SCIENCE NETWORK FOR

Communication Support & Skills Opportunity Collaboration

76

NHS COLLABORATION CONFERENCE

CEO LOOK FAMILIAR? STRESSED, LONG HOURS, CASHFLOW, INVESTMENT, PROFIT, GROWTH...

WHEN IT’S TIME TO GROW YOUR TEAM

HERE ARE MY TOP THREE TIPS

I’ve spent the last 25 years working with business owners of all sizes in many sectors, from micro-startups to brand leaders. You won’t be shocked to learn that the most successful of these are talented, driven, and passionate individuals.

Over the years, I’ve seen what works and what doesn’t - and the mistakes that business owners make. So here are my top 3 considerations you should have in mind when you’re looking to bring the right person into your business.

What might surprise you is how many of them will readily confess that they found the growth phase of their business remarkably stressful, particularly for SMEs or fledgeling businesses. It’s easy to start feeling overwhelmed by trying to keep an eye on cash flow, regulatory changes, maintaining or developing relationships with bankers and investors, updating business plans, and developing new strategies.

1. YOU DON’T NEED “ANOTHER YOU”

THERE’S NO TIME LIKE THE PRESENT It’s also usually the case that many people leave it a little late in the day to bring on a new member of the senior team to help.

Part of that delay is the natural reluctance to “let go” of what’s been your baby, but there’s also often a paralysis caused by either not knowing the kind of talent you need or - most concerning - making a bad decision.

WHAT YOU WANT VERSUS WHAT YOU NEED Sometimes, you can be the worst person to see what you actually need, versus what you think you do!

An MD client called me one evening, panicking and desperate for help. The business was growing, and following a board meeting that afternoon the decision had been made to scale up. The board were pushing for growth and time was of the essence.

When I met with them the next morning, I not only got a good insight into the experience they needed but most importantly, the personality type and cultural fit that would work. It was also clear to me that what they needed wasn’t a full-time FD - the job spec actually meant a part-time solution was perfect!

This is a trap I’ve seen plenty of people fall in to. Lots of founders have a very narrow vision of what they think the ideal recruit will look like, often based around their own traits and experience. The key here is to step back and think about what kind of individual will complement you. The best teams are fully rounded, with a variety of strengths and experiences, each member bringing something to the table that wasn’t there before.

2. IT’S NOT ALL ABOUT THE MONEY Just putting up an attractive salary isn’t enough to help you attract the right people. With low unemployment and a candidate-driven market at the moment, you need to think beyond basic salary in order to attract the right people.

I’m seeing more businesses thinking outside of the box here, beyond salary, car, and share options. What is your competition offering? What about flexible working? How about extending employee benefits to family members? Take a critical look at your office environment and culture to see if you can make some small, simple tweaks that will add up in your favour.

3. DON’T JUST ADVERTISE Your time is valuable - do you really want to be wading through CVs and applications? Recruitment is not a “numbers game”, so avoid the many companies who use algorithms or don’t personally vet candidates. Getting the right person is the most important criteria for successful recruitment, so work with someone who understands you, your culture and your personality and is looking for the most suitable person.

WHICH AREA OF YOUR BUSINESS REQUIRES NEW EXECUTIVE TALENT TO DRIVE YOUR GROWTH? LET'S CHAT ABOUT THE PEOPLE YOU WANT IN PLACE TO HELP YOU GROW IN 2023/2024

CONTACT SUE REES BY PHONE OR EMAIL

Oxford: 01865 477000 Cardiff: 02920 290663 Expert C-Suite Search Specialist supporting Biotech, Pharma, Med-Tech and Life Sciences

suerees@suerees.co.uk

CONNECT WITH US sue-rees-2b8b73

77

Forward thinking health research

labspace at the maltings

A uniquely vibrant bioscience clean laboratory and collaboration space

● Preparation &

Support Laboratories

● Collaboration Space ● Clean Environment

A proposed new development creating a shared bioscience laboratory preparation and collaboration space within Cardiff’s historic Maltings building. This new and exciting development will provide smaller businesses with access to laboratories together with auxiliary preparation and office spaces.

SEEKING INPUT This project is at the concept design stage. The project team are actively seeking input from industry experts into the specifications and requirements needed by potential tenants.

78

labspace at the maltings

The Maltings is a Grade II listed Victorian Malthouse situated in the heart of vibrant South Cardiff. Combining serviced offices, rental offices, meeting rooms, and co-working space. The Maltings is a unique space with real character. From the red brick exterior to the ultra-modern facilities within, it offers everything a business needs to thrive.

Nearly a quarter of those working at the

Onsite, we have 130 offices, 95% of which

companies research, develop, and

are occupied by approximately 630 people working in over 100 companies. The team is always seeking ways to develop an environment that fosters a real community of companies. That’s why we have two gym facilities, a Kin & Ilk Coffee Shop, an onsite Barber, and a complimentary shuttle bus that

Maltings are employed by bioscience and medtech businesses. A sector that’s thriving due to substantial growth in demand and an abundance of innovation. Local, Welsh and UK governments, along with private investors, actively support biotech and medtech businesses through various funding initiatives and grants. This assistance helps

framework for pharmaceuticals, diagnostics and medical devices, ensuring safety and quality standards are met. Collaboration between the public and private sectors is common, spurred on by the Covid-19 pandemic, where companies have adapted to address challenges such as diagnostic testing and remote patient monitoring.

Given the 12 years of experience the Maltings

commercialise their technologies.

team has gained from hosting medtech

Partnerships between academia and

Concepta Diagnostics, Medi 2 Data, and of

industry often lead to breakthroughs, making the environment for bioscience start-ups perhaps the best it has ever been. Wales boasts highly skilled scientists and engineers,

regularly runs into the city.

and the UK has a robust regulatory

PREPARATION & SUPPORT LABORATORIES

WRITE-UP & COLLABORATION

The clean laboratory space can be dedicated to individual user groups for extended periods or provided for short-term (daily) use. These laboratories will be managed and equipped with basic laboratory equipment and consumables.

Specific client needs can then be accommodated, and secure storage can also be provided within laboratory spaces.

The laboratory area is complemented by a range of temporary workspaces, allowing users to access write-up space adjacent to the laboratory areas. These local write-up spaces are further supported by existing building services, such as dedicated office areas, breakout and meeting rooms, self-service and commercial refectory provisions, and a collaborative working environment.

The cleanroom facility is to be a centrally managed space, allowing for clean work to be carried out either within the sterile environment or within dedicated cleanroom isolation cabinets.

The facility has been designed to offer a contemporary Cluster Support Hub to bioscience companies currently operating in the South Wales Region. The facility is expected to attract further investment in the

SEEKING SECTOR EXPERTISE / INPUT

The project is currently in the concept design stage, with Stride Treglown Architects leading the initial phases of design development. The project team is actively seeking industry input into the specific requirements for the new hub, including:

Shared equipment resources.

Level of management support required.

Access and security requirements.

companies like Lextox (now Synlab), course, MediWales, the Maltings management is aiming to support more businesses in this sector.

area by providing a flexible and collaborative workspace within the already successful Space 2B facility at the Maltings.

The final specification of clean environments is currently being developed with industry input to ensure the clean spaces align with the needs of current and future facility users. Currently, it is aligned with the requirements for DNA, blood sampling, sterile sample handling, and process testing to comply with ISO 18385:2016. The laboratory will have direct access through a suitable changing area to allow for both personal access and specialist equipment installation.

GET IN TOUCH

We would be keen to hear from experienced operators in the sector with any valuable insights to help shape the future of our proposed bioscience hub. In the first instance, please contact:

Gareth Oram gareth.oram@themaltings.co.uk or Andrew Walker Andrew.walker@resource.org.uk T: 029 20 462045

Supporting office and welfare requirements.

Type and containment level for clean spaces.

79

Forward thinking health research

TURNING BRILLIANT IDEAS INTO COMMERCIAL REALITY AT GX WE FIND PRACTICAL WAYS TO BRING A DESIGN IDEA TO LIFE Alongside major manufacturer of consumer electronic products Sony and skincare IIAA (International Institute for Active Ageing) we developed EVENTIS. A skin analysis imaging device that gives skin professionals the ability to visualise, analyse and monitor any change in their clients’ skin. GX designed the product from concept through to commercialisation and product approval.

Find out how we could help you develop your next product.

MECHANICAL ENGINEERING

ELECTRONICS

INDUSTIAL DESIGN

SOFTWARE DESIGN

REGULATORY SUPPORT

LIFE SCIENCE

www.g xg ro u p.co m +44(0)1291 673437

80

info@gxgroup.com claire.ricketts@gxgroup.com