Non-invasive Medical Devices


These compelling case studies highlight the journey of two innovative health technologies from scientific discovery to clinical application, showcasing the impact of interdisciplinary collaboration and industry partnerships.

These stories from two distinguished clinical academics at the University of Manchester illustrate how dedication to patient benefit, integration of diverse expertise, and long-term vision can drive advancements that significantly improve healthcare outcomes.

The Innovators and their innovations

Professor Jacky Smith
Jacky Smith is a Professor of Respiratory Medicine at the University of Manchester and an Honorary Consultant at Manchester University NHS Foundation Trust. She runs a multi-disciplinary research team whose focus is on understanding mechanisms underlying pathological cough. She also setup a regional clinical service seeing patients with refractory chronic cough. She is Director of the NIHR Manchester Clinical Research Facility, Respiratory Theme Lead in the NIHR Manchester Bioemdical Research Centre and an NIHR Senior Investigator.

A novel cough monitoring system to test new treatments for chronic cough

Jacky's innovative work focused in developing a cough monitoring system using sound recordings and signal processing to enhance respiratory treatments.

With this collaborative project between the University of Manchester, the Manchester University NHS Foundation Trust (MFT) and industrial partner Vitalograph, the team has developed the first accurate system to quantify coughing. The VitaloJAK, built with their algorithm technology has been used in >50 clinical trials to date, increasing the number of studies evaluating cough treatments. It was the first cough monitor approved for use in regulatory clinical trials in Europe and the US and has facilitated the development of the first licensed treatment for refractory chronic cough (Gefapixant).

Impact: The cough monitoring technology is now used to understand the causes of chronic cough and to test new therapies. By providing accurate and objective data on cough frequency, this system also has the capacity to help clinicians make better-informed decisions and improves patient care. This case study highlights the importance of interdisciplinary collaboration in advancing medical technology.

The Pharmacogenetics to Avoid Loss of Hearing (PALOH) study

John’s work focuses on the challenges of applying genomic medicine in everyday healthcare, highlighting a breakthrough project on ultra-rapid genetic testing to prevent antibiotic-induced hearing loss in newborns.

The team, has developed a world-first genetic test to establish if a newborn baby is vulnerable to deafness if treated with a commonly used antibiotic, which has been conditionally recommended by the National Institute for Health and Care Excellence (NICE) for use within the NHS.

This follows research led by Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust (MFT), The University of Manchester and Manchester-based firm Genedrive Plc on the Pharmacogenetics to Avoid Loss of Hearing (PALOH) study. The team has recently been awarded further funding to test the technology across the UK (PALOH-UK)

The pioneering, rapid bedside genetic test which was piloted at MFT in 2022; using a cheek swab, the test can identify in 26 minutes whether a critically ill baby admitted to intensive care has a gene change that could result in permanent hearing loss if they are treated with a common emergency antibiotic, Gentamicin. While Gentamicin is used to safely treat approximately 100,000 babies a year, one in 500 babies carry the gene change that can lead to permanent hearing loss when given the drug. The new test means that babies found to have the genetic variant can be given an alternative antibiotic within the ‘golden hour’ which could save the hearing of 200 babies in England every year.

Impact: The implementation of this technology in neonatal intensive care units has the potential to prevent hearing loss in newborns, demonstrating the profound impact of integrating rapid genomic testing into clinical practice. This case study exemplifies how translational research can bridge the gap between genetic research and real-world healthcare applications.

Dr John McDermott
Dr John McDermott is an NIHR Academic Clinical Lecturer at the University of Manchester and a Clinical Genetics Speciality Registrar. He was appointed as the UK’s first Academic Clinical Fellow in Genomic Medicine in 2016. Working at the Manchester Centre for Genomic Medicine (MCGM) his research focuses on the application genetic and genomic technologies in the acute and everyday healthcare settings.


Words of Advice

We have recorded a podcast with Jacky and John talking about their experience on translating these devices and innovations into the clinic. In the podcast, both John and Jacky delved into the intricacies of regulatory approvals, the critical role of industry partnerships, and the non-linear pathways of translational research. Both emphasised the importance of multidisciplinary collaboration, effective leadership, and a shared vision in advancing health technologies from the lab to clinical practice.

John and Jacky also provided a words of advice for those starting in health technology research and innovation: persistence is essential! Initial problems can be discouraging, but finding alternate routes and sticking with the problem is crucial. It's also important to maintain a long-term strategy, considering the entire translational pathway and thinking ahead about aspects like commissioning and assessments.

While it's challenging, focusing on the potential market for innovations is critical for achieving impact, despite the tendency of academics and clinicians to overlook financial aspects.

You can listen to extracts from John and Jacky's podcast below, a link to the full podcast will be provided on this page once released as part of the Health Care Matters Podcast Series from the Christabel Pankhurst Institute.

"My experience in involving industry early has been a very good one and crucial to the success of what we have done"

Prof Jacky Smith

Professor Jacky Smith talks about the importance of business engagement and industry partnerships for the translation of healthcare technologies

Both case studies underscore the critical role of industry partnerships in translational research. Collaborating with companies early in the development process provided the necessary resources and expertise to navigate regulatory challenges and bring these innovations to market. These partnerships not only facilitated the development of the technologies but also ensured their successful implementation and impact on patient care. Hear directly from Jacky in the clip below.

Dr John McDermott explains how his team has overcome unexpected regulatory challenges when translating their technology

Navigating the regulatory landscape is a significant aspect of translational research. Both projects faced regulatory hurdles that required careful planning and collaboration with regulatory bodies. The experiences of these teams highlight the complexities of this process and the importance of seeking expert guidance and support from industry partners. In the clip below John explains how his team obtained approval from the Research Ethics Committee (REC), but later encountered issues with the Human Tissue Authority (HTA) which required support from legal experts.

"When you're developing an idea or a project, do really try to think about the long-term strategy."

Dr John McDermott

Professor Jacky Smith highlights the importance of co-creation and capitalising market opportunities

A key element in the success of these projects has been the co-creation process, where researchers and industry partners work closely together from the outset. This collaborative approach ensures that the technologies developed are not only scientifically sound but also meet real-world needs and market demands. By involving industry partners early, the projects benefited from their market insights and regulatory expertise, which helped in shaping the final products to be both effective and commercially viable. This synergy between academia and industry is crucial for translating innovative ideas into practical solutions that can be widely adopted in healthcare settings. Listen to the clip below to hear from Jacky how collaborating with industry early was a key to the success of the project.

Dr John McDermott emphasises the Importance of Health Economics and Value Proposition

Understanding the economic impact and value proposition of new health technologies is essential for their successful adoption and implementation. Health economics plays a crucial role in evaluating the cost-effectiveness of these innovations, ensuring that they provide value for money and improve patient outcomes. By incorporating health economic assessments early in the development process, researchers can identify potential financial barriers and work towards solutions that make the technologies more accessible and sustainable. This approach not only supports the economic viability of the projects but also strengthens their case for funding and adoption by healthcare providers and policymakers. In the clip below John explains how working closely with the health economists has ensured the successful development and adoption of their genetic test.

"Persistence is the key. It's very easy to feel like everything's going wrong and you're not going to solve it. But a lot of it is about just being persistent and sticking at the problem and looking for different ways around your roadmap."

Prof Jacky Smith

Professor Jacky Smith explains the chosen exit strategy and business model

Developing a clear exit strategy and business model is vital for the long-term success and sustainability of health technologies. Both case studies illustrate different approaches to commercialization. For instance, Jacky's project involved licensing the developed algorithm to an industrial partner, ensuring continuous support and revenue through royalties. This model allowed the technology to be used in commercial studies and facilitated ongoing collaboration for further improvements. Similarly, John’s project leveraged a spin-out company to bring the rapid genomic testing device to market. These strategies highlight the importance of planning for commercialization early in the development process, ensuring that innovative technologies can be effectively integrated into healthcare systems and reach the patients who need them. Hear from Prof Smith why licensing was the preferred option and what were the main advantages leading to this decision in the clip below.

Dr John McDermot reiterates the importance of focusing on patient benefit and addressing unmet clinical needs

Driving innovation in health technologies is fundamentally about addressing clinical needs and improving patient outcomes. Patient benefit is at the heart of translational research, ensuring that new technologies provide tangible improvements in healthcare. Identifying and focusing on clinical needs helps prioritize research efforts towards the most pressing health issues, making the innovations more relevant and impactful. Moreover, considering the bigger picture involves understanding the broader implications of these technologies on healthcare systems and public health. This holistic approach ensures that innovations are not only effective and economically viable but also socially responsible, ultimately contributing to the advancement of medical science and the betterment of society. Hear from John about the importance of remembering "why" we are developing a particular health technology in the clip below.

As academics and clinicians, we don't think about money a lot of the time, but if you're making something, and collaborating with industry, I think it is important to ask "Who is going to buy it?"

Dr John McDermott

Final advice: Persistence and Long-Term Strategy

We asked Jacky and John what is the nugget of information they wished they knew and would like to pass on to people embarking into health technology innovation.

Jackie emphasizes the importance of persistence, advising researchers to stay committed and find alternative routes when faced with obstacles. This tenacity is crucial for overcoming the inevitable setbacks in the development process. John highlights the need for a long term strategy, encouraging researchers to think beyond immediate goals and consider the entire pathway from innovation to clinical application. By planning for the long term, researchers can ensure that their projects are not only scientifically robust but also practically viable and impactful in the healthcare landscape.

Conclusion

These case studies demonstrate the transformative potential of translational research in health technologies. By bridging the gap between scientific discovery and clinical application, these projects have made significant strides in improving patient care. The success of these initiatives underscores the importance of interdisciplinary collaboration, industry partnerships, and strategic planning in advancing medical research and innovation.

Explore these case studies in full to learn more about the innovative work being done at the University of Manchester and its impact on healthcare by listening to the Health Care Matters Podcast Series from the Christabel Pankhurst Institute.