Diagnostics


compliance with the NHS Evidence Standards Framework for Digital Health Technologies. This regulatory journey is particularly complex for AI- enabled technologies, which must also address additional requirements around data protection, algorithmic bias, and ongoing performance monitoring. Finally, new technologies must seamlessly


integrate with existing hospital systems, from electronic health records to laboratory information management systems, while minimising disruption to established clinical practices. This integration requires careful consideration of staff training needs, development of standardised operating procedures, and thorough assessment of impacts on current clinical pathways. These challenges are even more difficult to


overcome for early-stage medical innovations, and the pathway from initial concept to clinical adoption can span several years. This extended development timeline means that medical technologies are not seen as appealing investments against the competition. Combined with stringent healthcare regulations, this creates significant barriers to bringing potentially life- saving technologies into clinical practice. On top of this, each stage of the process


requires substantial financial investment – a major barrier for startups looking to commercialise new technologies. Without adequate support through investment, these startups are not given the opportunity to flourish and rarely make it out of the ‘valley of death’ – a period between the initial launch of the startup and the commercialisation phase characterised by financial challenges and mounting expenses. Recent initiatives are emerging to bridge the gap between military medical innovation and clinical implementation. Government- backed funding mechanisms and accelerator programmes, including the Ploughshare Accelerator Fund2


to clinical implementation is complex, these funding initiatives provide startups with pre- seed and seed funding that will guide them through the financial challenges associated with ‘the valley of death’ and avoid being stalled at the crucial validation phase. In addition to financial support, these programmes provide expertise in navigating clinical trials, regulatory requirements, and NHS procurement processes. They also support founders in developing compelling business cases to attract investment. To liberate innovation in healthcare, there is a need for more varied sources of funding, more tailored support for early-stage innovators, and a better understanding of the unmined benefits of dual-use technologies. This comprehensive approach has already demonstrated success in bringing military-origin technologies to clinical practice. Such technologies, originally designed for battlefield medicine, are being successfully adapted to address pressing clinical challenges while maintaining their core advantages of speed, accuracy, and ease of use in resource- constrained settings.


and the MedTech Accelerator,3


now support the critical phase of validation and regulatory approval. These programmes combine financial support with clinical expertise to help promising technologies navigate the complex requirements of the healthcare system adoption and reach clinical settings. While the pathway from military application


Breakthroughs in early infection detection One example of successful military-to-civilian technology transfer is Presymptom Health’s AI- powered diagnostic solution for early infection detection. Originally developed at the UK’s Defence Science and Technology Laboratory (DSTL) to protect military personnel from biological threats, this technology has been adapted through support from Ploughshare, the UK Ministry of Defence (MOD) and the US Department of Defence (DOD), for civilian acute care settings. The diagnostic tool is capable of accurately identifying infection and sepsis up to three days before current standard of care methods. The


56 www.clinicalservicesjournal.com I June 2025


technology’s development leveraged 15 years of blood sample data, encompassing thousands of cases including patients who developed infections and sepsis, enabling it to effectively detect early infection markers. This early detection capability could significantly reduce unnecessary antibiotic prescriptions, supporting antimicrobial stewardship efforts at a time when antibiotic resistance is projected to cause more deaths than cancer by 2050.4 The core of the technology lies in RNA-based


host response analytics, which examines the body’s response to an infection rather than attempting to detect the pathogen directly. This approach provides an early, highly sensitive signal for infection or sepsis and avoids the delays and inaccuracies often seen with traditional tests, which can lead to unnecessary or incorrect treatments. The technology is likely to be made available


to the NHS in 2025 following positive results from the PRECISiON clinical trial, which was designed to assess the tool’s performance in the management of infection and sepsis in patients presenting to Emergency Departments with respiratory infection. The trial showed that the product may have >95% accuracy at ruling out lower respiratory tract infection,4


a significant


improvement over the standard of care. With NHS overcrowding being one of the most pressing issues facing the UK healthcare system, this diagnostic tool holds the potential to alleviate pressure surrounding NHS overcrowding as up to 38% of all UK emergency department admissions are patients with presumed infection who are potentially at risk of developing sepsis.5 Beyond its clinical impact, this new


technology also stands to benefit the NHS through cost reduction. The ability to accurately rule out sepsis cases for those with non-specific symptoms will lead to a reduction in the length of unnecessary hospital stays for patients,


Zerbor - stock.adobe.com


Олександр Луценко - stock.adobe.com


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