Development of a novel neonatal resuscitation monitor to ensure safe and effective provision of breathing support to newborn infants

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UK medical device SME, Europlaz is ISO13485 and has a core project team of Frede Jensen (Neonatal Medical Device Specialist), Ian Goodacre (Engineering Manager), Katharine O'Keeffe (Business Sponsor and Project Manager).Delivery room resuscitation is needed for 10% of newborns. Resuscitation of neonates is stressful and highly pressured, but clinicians do not have the equipment to enable them to accurately evaluate the baby's cardio-respiratory system and act accordingly. Three-quarters of newborn resuscitations are considered unsafe or below the accepted standard (Vaidya,2021 ). Total cost of maternity care claims are £4.2bn and brain damage during birth accounts for 39%, or £1.6bn. The lack of reliable, objective data hinders the evaluation of errors and limits opportunities for learning/improvement.Europlaz's solution is an intuitive, multiple-parameter, respiratory monitor to display tidal volume, C02 elimination, Sp02, dual (R/L) oxygenation and mask leak for even the smallest patients. The device enhances NICU capability and transfers skills to the under-served, low-tech delivery room.Real-time data is displayed as a straightforward bar graph, and export enables recording the resuscitation event for accountability and learning/improvement. Europlaz is bringing ICU technology (tidal volume/CO2) into the maternity ward.The Europlaz device will improve resuscitation efficiency and prevent volume induced lung and CO2 induced brain injuries. It will reduce the escalations of 2.2% of babies into high-intensive care and could save the NHS £15M in neonatal intensive care. The innovation compensates for staffing shortages and skills deficits.The project will increase R&D activity by 50% and will create 20+ jobs for a medical device manufacturing company producing life saving products here in the UK.