Central venous access devices (CVADs) are thin, flexible tubes inserted into large veins to deliver essential medications and fluids directly into the bloodstream. They are lifelines in care for critically ill children.
However, placing a CVAD in the tiny and fragile veins of a child can be difficult - not just because of their age, size and mobility. Clinicians must estimate how long the catheter should be and insert the CVAD without direct visual guidance. They then use X-rays to check if it is in the right place. Even then, the line can move and cause problems.
Navi Medical Technologies has developed the Neonav® ECG Tip Location System, a non-invasive device that uses electrocardiographic signals to track the location of CVADs. It works in real-time, reduces the need for X-rays and improves patient safety.
Born from a classroom project
Mr Shing Yue Sheung (Shawn) is co-founder and Chief Operating Officer of Navi Medical Technologies. He explains how a classroom project during his Master of Biomedical Engineering at the University of Melbourne turned into a life-changing mission.
"Our founding team interviewed Associate Professor Christiane Theda, a neonatologist in the NICU who has over 30 years-experience caring for critically-ill newborn patients. She has personally experienced the challenges of locating a catheter tip both during and after the catheter placement procedure. This has led to significant clinical challenges and frustration, not just to Associate Professor Theda, but to her colleagues as well."
"Through further research, our team found that there was a significant shortage of purpose-built medical devices for paediatric patients. This is largely due to the fact that most medical device manufacturers around the world tend to focus on addressing needs for adult patients."
They began brainstorming and prototyping a new device. "Our team decided to continue with the concept after university. We continued to work on Navi over weekends while studying and working on the side."
Translation and commercialisation support
Shawn reflects on how the Clinical Translation and Commercialisation MedTech (CTCM) program, a Medical Research Future Fund initiative delivered by MTPConnect, helped Navi.
"At the start of the CTCM program, the Neonav project was in the early stages of technology translation and commercialisation. We had two key objectives. The first was to complete a pilot clinical translation study to validate the technology's effectiveness and refine its design. The second focused on commercialisation activities and recruiting key personnel. The development of a next-stage business plan was critical, as it would outline strategies for market entry and assist with capital raising activities.
The CTCM program allowed us to focus on these objectives, providing the necessary support and resources to advance the Neonav project."
Navi collaborated with the Royal Women's Hospital on a pilot clinical study and worked with Design+Industry on product design and development.
The team conducted over 200 clinical interviews, 250 clinical recordings and 100 product demonstrations, using feedback to refine the device.
Navi also received mentoring and guidance from Cicada Innovations.
"Throughout the CTCM program, we were able to progress Neonav's Technology Readiness Level from level 5 to level 7."
Impact and future plans
Neonav® received clearance from the United States (US) Food and Drug Administration in January 2025 and has launched in US hospitals.
Shawn has now relocated to the US to support Navi's rollout and growth. "We're excited about what's next. My mission is 3-fold: support Navi's first customers in the USA, grow our US-based team, and develop relationships with strategic partners and potential investors."
"As a team we believe that if we could impact a baby's or infant's life in their earliest days of age, they could grow up to live a more fulfilled life and have their own experiences.
We're proud to be helping clinicians and improving outcomes for newborns. If we can make a difference in those early days of life, it means everything."
