Neonav® ECG Tip Location System

Navi Medical Technologies engaged a multidisciplinary team of industry experts, biomedical engineers, industry partners, and a senior neonatologist in the development of the Neonav® System. The process began with extensive research in neonatal and paediatric intensive care units across Australia and the USA, gathering first-hand insights from clinical staff about the challenges of reliable and repeatable catheter tip location.

Phase one involved identifying problems and defining user and operational environment needs, highlighting the necessity for real-time feedback during catheter insertion and ongoing surveillance to prevent migration. Navi developed several prototype iterations, incorporating feedback from healthcare professionals. These prototypes were tested in controlled clinical environments on over 100 babies, ensuring they met safety and efficacy standards.

A significant milestone was achieved with FDA Breakthrough Device Designation, validating the system’s approach, where only medical devices that demonstrate a significant improvement over existing solutions for patient healthcare outcomes are granted such a designation from the FDA. The design incorporated Navi’s proprietary software and hardware solutions for accurate ECG signal interpretation and real-time catheter tip location feedback. The team focused on a non-invasive, user-friendly device that integrates easily into existing clinical workflows.

Collaboration with partners like the University of Melbourne, the Royal Women’s Hospital, and Design + Industry (D+I) ensured rigorous testing and refinement. D+I’s design and development processes were compliant with ISO 13485:2016, ensuring the highest safety, reliability, and usability standards in line with regulations for medical devices.

The system underwent extensive clinical trials, including the ”ECHO” study, which confirmed the device’s precision and reliability compared to ultrasound technology. Navi progressed the technology through research trials and test builds, gaining a solid understanding of system use cases, workflows, and users. The clinical evaluation with over 100 newborn participants demonstrated the technology’s accuracy. The final design exceeded the brief by providing real-time feedback during catheter insertion and continuous post-procedure surveillance, reducing the need for confirmatory X-rays and multiple insertion attempts.

The system addresses critical challenges in paediatric and neonatal care, enhancing patient safety, improves clinical efficiency, and reduces healthcare costs.

The Neonav® ECG Tip Location System satisfies and exceeds the criteria for good design through its focus on functionality, accessibility, safety, quality, and sustainability. The device addresses a critical need for accurate catheter placement in neonatal and paediatric care, providing real-time feedback during insertion and continuous monitoring to prevent migration. This functionality reduces the need for post-confirmatory X-rays, decreasing the overall radiation dose to patients, saving procedure time and costs, and contributing to a safer healthcare environment.

Accessibility is a core feature, with the device designed to be user-friendly and non-invasive, integrating seamlessly into existing clinical workflows. The system’s real-time feedback and easy-to-read interface ensure that clinicians can use it effectively without extensive training.

Patient Safety at the Centre - ISO 13485:2016 compliant development: Neonav® has been designed to minimise the risks associated with catheter misplacement and migration. By providing accurate, real-time location feedback, the system reduces the need for repeated insertion attempts, decreasing the potential for complications.

Quality and reliability are ensured through rigorous testing and refinement in collaboration with leading institutions such as the University of Melbourne and the Royal Women’s Hospital. The device’s accuracy was confirmed through extensive clinical trials, including the “ECHO” study, which validated its precision compared to ultrasound technology.

The user experience was central to the design process. Feedback from healthcare professionals was incorporated to ensure the device met practical needs. The final design offers a high-quality experience, improving clinical workflows and enhancing patient outcomes.

Headquartered at Melbourne Connect, the support from Victorian programs and grants like the VMRAF, MMGP, TAIP and MMCP was instrumental in achieving design excellence. Furthermore, Navi received support and investment from Breakthrough Victoria in 2023 to accelerate the development of the Neonav system. This support enabled Navi to create a product that sets a new benchmark for design excellence in Victoria, Australia, and internationally, showcasing the benefits of integrating advanced technology with user-centred design principles for superior patient care.

The Neonav® ECG Tip Location System solves the critical problem of accurately placing and monitoring central venous catheters in neonatal and paediatric patients through an innovative approach. Traditional methods, such as post-procedure X-rays, lack real-time feedback, leading to high rates of catheter misplacement and migration, which pose significant risks. The system addresses this by providing real-time, accurate feedback on catheter tip location during insertion & continuous monitoring afterward, achieving a 94.6% agreement rate with ultrasound.

The system’s use of advanced ECG signal interpretation technology enables precise, real-time location detection. This non-invasive method replaces the need for multiple X-rays, reducing radiation exposure and risks for patients. The incorporation of Navi’s proprietary software and hardware solutions offers a significant improvement over existing technologies that are primarily designed for adults and lack continuous monitoring capabilities.

The user-centred design ensures that the system is intuitive & easy to use, integrating seamlessly into existing clinical workflows. Clinicians can operate the system without extensive training, making it accessible in various healthcare settings. The system’s real-time feedback allows for fast & accurate placement, reducing the need for repeated procedures - enhancing patient safety.

The system’s continuous monitoring feature sets it apart from other ECG-based technologies. This capability allows ongoing surveillance of catheter tip position, alerting clinicians to any migration or dislocation, which helps prevent complications and ensures the catheter remains in a safe position throughout use.

The project’s success was supported by extensive research and clinical trials, including the “ECHO” study, which validated the device’s accuracy compared to ultrasound technology. This rigorous testing ensured the system met high standards of safety and reliability, achieving a 94.6% agreement rate with ultrasound.

Neonav® sets a new benchmark for innovation in medical device design, addressing a significant unmet need in paediatric & neonatal care. Its combination of real-time feedback, continuous monitoring, and user-centred design offers a solution that enhances patient outcomes, improves clinical workflows, and reduces healthcare costs.

The Neonav® ECG Tip Location System has the potential to save countless lives of critically ill newborns and paediatric patients by providing accurate, real-time feedback during catheter insertion and continuous monitoring afterward. This innovative approach addresses the critical problem of catheter misplacement and migration, leading to severe complications and increased mortality rates.

The ”ECHO” study and clinical evaluations involving over 100 newborn patients validated the system’s accuracy, confirming its transformative potential. Supported by the FDA Breakthrough Device Designation, and Victorian Government medical research and commercialisation grant programs the system’s path to market is accelerated, ensuring expedited access to this life-saving technology.

The Neonav® system significantly improves the standard of care for one of the most vulnerable patient groups. Accurate catheter placement and continuous monitoring minimise the risk of potentially life-threatening complications such as cardiac tamponade and thrombosis, leading to better patient outcomes and shorter hospital stays. This advancement in medical technology ensures that critically ill newborns and children receive the best possible care, ultimately improving their chances of survival and long-term health. The Neonav® system offers significant cost savings by minimising complications and the need for corrective procedures and additional X-rays. Environmentally, it reduces reliance on multiple X-rays, decreasing radiation exposure and supporting sustainable healthcare practices.

The support from Victorian organisations, programs and grants like Breakthrough Victoria, VMRAF, TAIP, MMGP and MMCP has been instrumental in the system’s development and commercialisation. This investment in professional design underscores the importance of high-quality design processes in creating life-saving medical devices.

From research and development to trials and commercialisation, Neonav® sets a new benchmark for medical device design, showcasing Victoria’s capability to develop world-class healthcare solutions. A dedicated team has devoted thousands of hours to a singular task: building and commercialising a medical device that enables doctors and nurses to deliver better care for newborn and paediatric patients.