NeWTS: Advancing Neonatal Care with Wireless Technology: From Prototype to Commercial Product

Aim Transformation of our alpha prototype design into a commercial product that is easily integrated into standard clinical care. Background Neonatal intensive care (NICU) combines monitoring of vital signs with addressing the developmental and psychological needs of babies and their parents. This is challenging for preterm infants who are extremely small and vulnerable, with fragile skin and who may be in hospital for many months. Parents and staff have reported that wired sensors create both physical and psychological barriers to care, and limit physical contact. Increasing physical contact has been shown to increase breastfeeding rates, reduce length of stay, and improve neurodevelopmental outcomes. Therefore, the introduction of wireless monitoring could result in savings for the NHS, with a reduction in the one million annual days of NICU, which cost the NHS approximately £800 million in 2018/19 as well as improving the long-term outcomes for babies and their parents. We have designed the Neonatal Wireless Transmission System, NeWTS, a novel and bespoke wireless bridge between vital sign sensors and the patient monitor. NeWTS includes modules for four vital signs: temperature, electrocardiogram (ECG) measuring heart rate, respiratory rate, and oxygen saturation. Our proof-of-concept has been successfully tested with 34 babies in NICU. Funding to date has led to an alpha prototype in line with NHS sustainability goals, end to end functionality, looks-like prototype, the filing of a patent, and demonstrated viability of the product. Further funding is required to realise this design to fulfil all user and regulatory requirements (CE/UKCA/FDA) for manufacturing. Objectives A–Manufacture miniaturised wireless modules for ECG, temperature, and pulse oximetry with a wireless receiver module that connects to standard patient monitors. B–Deliver clinical studies to collect data for regulatory submission and to inform future clinical trials C–Develop a robust business case and commercial pathway for adoption in the NHS and then the US. Methods A–System Development In light of the design complexities we are working with Wideblue, a specialist medical devices consultancy, who will undertake the system development, involving four design phases: Design Refinement Prototype Development and Testing Design Optimisation Manufacturing and Deployment B–Clinical Studies The beta production prototype will undergo validation testing and regulatory compliance testing in an adult study, as well as use in a neonatal study. The small neonatal study (n=50) will evaluate the reliability, utility, and safety in clinical practice and feasibility of data collection of key clinical outcomes to inform the design of a randomised controlled trial (RCT). C–Commercial Development With support from our wide-ranging network, we will develop a sustainable business strategy and establish the optimal route to market. Anticipated Impact At a patient level, NeWTS improves quality of care, reducing barriers between babies and their parents. This will improve infants' physiological stability, reduce parental anxiety, and has the potential to increase breastfeeding rates and reduce length of stay. Impacts for staff include time saved in providing clinical care. These impacts would be cost saving for the NHS as well as improving quality of care and addressing the drive to improve family-centred care.