The Rise Of Catheter Tip Surveillance

Central catheter placements in critically-ill children is a relatively common surgical procedure. However, once the catheter enters the patients blood vessel, it is an unknown where the catheter tip ends up during the procedure. For clinicians, this lack of easily accessible, real-time feedback is one the challenging aspects of performing these procedures. Currently, the most common method of confirming the catheter tip location is the use of x-ray, but only after the procedure has taken place. The result - around 40% of catheters are misplaced during the insertion procedure, often requiring clinicians to repeat the procedure that ultimately delays treatment to critically-ill newborn and pediatric patients.

Pictured: Premature newborn in a NICU with an Umbilical Venous Catheter inserted

The problem doesn’t stop there. After the initial placement location has been confirmed, the dwell time (the time the catheter remains inside the patient) can be up to 30 days in some central catheters such as Peripherally Inserted Central Catheters (PICC’s). During this time, the catheter can move or “migrate” from a safe location to other areas in the body, which can have a significant on impact treatment, or cause serious harm to the patient. What’s most concerning is the frequency these migration events can occur, with recent studies showing up to 50% of correctly placed catheters migrate within 7 days.

For example, a correctly placed catheter in the Inferior Vena Cava (a high blood flow vessel area located just below the heart) could migrate away from the safe position over several days and end up in the heart. This can cause a number of complications such as cardiac tamponade, where fluid builds up in the space around the heart that can ultimately extend patient hospital stay, or worse, could be fatal.

Animation example of catheter migrations and related complications

While ECG Tip Location Technologies have been developed in recent years to help with the catheter placement problem, current technologies primarily focus on the adult population, and only focus on the initial placement of the catheter while mostly ignoring the migration issue.

“90% of catheters had migrated from their position on the preceding scan”

— Hoellering A et. al.

Shing Yue Sheung, Navi COO and Biomedical Engineer, knows all too well the current limitations of existing ECG Tip Location Systems,

“Most ECG Tip Location Systems on the market today have limited capabilities when dealing with the pediatric cohort, especially premature newborns. Speaking with neonatologists and clinical staff from around the world, it had become clear to the Navi team that catheter migration was a big problem, possibly bigger than misplacement on insertion, and that it needed a solution.”

There is growing evidence that supports the need for a technology that can provide clinicians with surveillance capabilities of the catheter during its dwell time. Migration, and the subsequent complications that follow, lead to poor patient outcomes as well as increased costs to hospitals.

A 2018 study by Hoellering A et. al.¹ identified that migration prevalence in a neonatal cohort of patients was staggaringly high, showing “90% of catheters had migrated from their position on the preceding scan” after correct initial insertion.

Another recent paper in 2021 by Acun, C et al.² highlighted that “catheter migration is the most common complication in neonates”, recommending periodic imaging during the first 3 days after PICC insertion (as most migration occurred within this period).

Explainer Video On How The Neonav ECG Tip Location System will help with catheter misplacement and surveillance

Navi’s Neonav® ECG Tip Location System, which is currently in development, will address this gap in catheter surveillance, by developing a device that not only is specifically designed for critically-ill newborn and pediatric patients, but also will provide clinical staff with a comprehensive means of catheter tip surveillance - from initial insertion right through its dwell time. This will enable faster treatment, reduced complications, improved hospital efficiencies and reduced costs, ultimately leading to better patient outcomes, and enabling children everywhere to live brighter, healthier futures.

1. Hoellering, Adam et al. “Study of movement of umbilical venous catheters over time.” Journal of paediatrics and child health vol. 54,12 (2018): 1329-1335. doi:10.1111/jpc.14073

2. Acun, C., Baker, A., Brown, L. S., Iglesia, K. A., & Sisman, J. (2021). Peripherally inserted central catheter migration in neonates: Incidence, timing and risk factors. Journal of Neonatal-Perinatal Medicine, (Preprint), 1-7.

2021 - A Year In Review

From restrictions, to lockdowns, to the general fog of uncertainty, this past year has presented a number of challenges that required all businesses to embrace change.

Despite these pandemic challenges, the team at Navi made significant progress towards our vision of giving children brighter, healthier futures through medical innovations. Below are some of the 2021 highlights:  

Expanded Our Clinical Activities

Lockdowns and restrictions brought on by the COVID-19 pandemic had a significant impact on clinical activities, with hospitals taking precautionary measures that included halting clinical research for a period of time.

Pictured: The Neonav® clinical prototype used during the Navi feasibility study and the Royal Women’s Hospital in Melbourne, Australia.

Pictured: Mubin Yousuf and A/Prof Christiane Theda at the Royal Women’s Hospital in Melbourne, Australia.

Despite this setback, our research team, headed by Navi Chief Medical Officer A/Prof Christiane Theda and CTO Mubin Yousuf, made some significant progress on our clinical research activities.

The Neonav® feasibility study, which involves the use of the Neonav® clinical prototype device to record real-world patient data, is in its final stages. To date, over 120 patients have been recruited across multiple studies that cover both Umbilical Venous Catheterisation (UVC) and Peripherally Inserted Central Catheter (PICC) procedures, with hundreds of data points being logged and incorporated into our proprietary location detection algorithm technology.

Local & Global Recognition

Navi’s work on the Neonav® Tip Location System had received attention both domestically and abroad this year, which included significant media exposure, as well as participation in a number of high profile events:

Parliamentary Recognition

A highlight was the Navi team receiving recognition from Federal Minister Karen Andrews, who made a notable mention of Navi as a leading example of next generation of innovative healthcare businesses as part of her address to parliament.

National News Coverage

The work Navi has been doing was also featured on Channel 7 News, where Navi CEO Alex Newton was interviewed as part of a prime time news segment that shared some patient stories and successes from our clinical research at The Royal Women's Hospital.

Additionally, the Herald Sun included a feature article that focused on the real-life impact the Neonav® has had during its clinical study at the Royal Women’s Hospital.

Presented At The Association For Vascular Accesses (AVA) In The USA

Across the pacific in the United States, Navi Chief Medical Officer A/Prof Christiane Theda and CEO Alex Newton presented (virtually) at this year’s Association For Vascular Access (AVA) conference.

AVA is a leading multidisciplinary community that seeks to advance research to bring about evidence-based innovations in vascular access. At the conference, both Alex and Christiane shared the results of the recent Neonav® clinical studies surrounding the Electrocardiogram (ECG) Waveforms Associated with Central Venous and Arterial Catheterisations in Neonates.

Participated on a global stage

Navi also participated in some of the worlds largest pitch competitions and accelerators in 2021:

• Awarded finalists in the Extreme Tech Challenge (XTC), which is the worlds largest start up competition for purpose-driven companies.

• Navi took part in the MedTech Innovators APAC Accelerator Program, which only accepted the top 20 medtech startups in the Asia/Pacific region to take part.

Both the XTC and the MedTech Innovator programs provided a global platform to introduce our technology to a broader audience, and receive valuable feedback and validation to help drive further progress. 

Grants and funding

Navi was successful in a number of grants during 2021, with notable wins including the Victorian Government’s Victorian Technology Adoption & Innovation Program (TAIP) grant. This grant provided important financial support towards core product development activities, but also provided significant media exposure that launched Navi into the national spotlight.

Additionally, Navi was also awarded the Federal Government’s Entrepreneurs program – growth grant, which helped support key business development activities.

Navi also finished up the Accelerating Commercialisation Grant project, which was awarded by the Federal Government, and provided matched funding to support important product development and clinical milestones during the 2021 period.

Significant Product Development Milestones

This year brought further advancement in the Neonav® development, with significant progress made on both the Neonav® capital hardware, as well as the consumable componentry that form a core part of the Neonav’s ecosystem. Both aspects of product development have been progressed to advanced stages of the design process.

This video explains how the Neonav® ECG Tip Location System works, as well as its benefits compared to the current standard of care:.

Increased Accuracy

Preliminary testing of the Neonav® algorithm with real-world procedural data collected from our ongoing clinical studies achieved an accuracy of over 93% for catheter tip location detection for UVC procedures. This result is extremely encouraging, and is a strong indictor that greater accuracy is to be expected as more data is collected and the technology matures over the coming 12 months.

“[The Neonav®] achieved an accuracy of over 93% for catheter tip location detection for UVC procedures.”

Moved into our new home

This year also saw the Navi team move to our new home at Melbourne Connect, which is a purpose-built innovation precinct right in the heart of the city’s Biomedical precinct, and is a powerhouse innovation and collaboration in Melbourne.

We are grateful to be a part of such an amazing, inspiring community of emerging thinkers and leaders in Melbourne.

Growing the Navi family

The latest member of the Navi family was welcomed in October 2021, with the birth of Oliver “Ollie” Newton, Navi CEO Alex Newton’s second child.

Q&A with Navi CFO, Wei Sue

Wei Sue is a co-founder and CFO at Navi Medical Technologies, where she has taken a leading role in managing the financial modelling, reporting and governance within the company.

Wei has also taken a leading role in lifting the Navi brand by representing the company in high profile pitches and presenter events, where she has received a number of awards.

Wei also is passionate about tackling climate change with a long history of consulting work helping large organisations transition.

Q: Tell us about your journey to become a co-founder of Navi?

I was completing my MBA at Melbourne Business School when the BioDesign Innovation course was offered for the first time. I had completed a science degree majoring in biotechnology and environmental management but had spent most of my professional career in sustainability and climate change. So when this opportunity came up, I was instantly attracted to the opportunity to tap into my interest in biological sciences and combine that with my passion for technology innovations.

I was very fortunate to have met the co-founding team at Navi through BioDesign. What could’ve been a simple MBA elective subject turned into reality in the business world due to the passion and tenacity that the team shared. Above all else, it was a 9-month elective working as a team and we worked so well together that it gave us the confidence that we would be ready to take on challenges in the business world!

A fundamental principle of BioDesign was about creating multidisciplinary teams, which in the case of Navi included three MBA candidates, 2 biomedical engineers and a clinician. This has been critical to the successes we’ve had, particularly for a medtech startup in a complex and challenging environment.

We graduated from the classroom environment and our confidence was boosted through winning a number of pitch competitions. What really sealed the deal was winning our first $10k cheque – that was the impetus to incorporate the business – so we could cash in the cheque.

Q: Not being someone who has a medical background, tell us how you took a leading role in representing Navi (very successfully) in high profile events such as the MAP Gala?

Pictured: Wei receiving an award at a pitch event in Melbourne, Australia

I have never been one to put my hand up for public speaking – it’s always been one of the things that require effort on my part. Representing Navi, however, was easy. While I don’t have a medical background, the team has always been forthcoming and generous with their time and support. Both in helping me prepare for pitches and presentations, but also in patiently explaining the details behind the clinical and engineering aspects of the Neonav.

Another reason I love representing Navi is the belief and passion I share with my co-founding team – in the mission to improve the lives of children and babies through much needed medical innovations. I’ve always been passionate about technological developments and in particular putting technology to good use, to improve the lives of others.

Q: What are the things that keep you up at night?

Pictured: Wei (centre) taking part in a panel discussion at the Melbourne Business School

Raising our next round as we’re kicking off our Series A capital raise and my role as co-CFO. I have absolute confidence that our technology works so it’s just a matter of securing the capital needed to get the product through to regulatory approval.

Based in Australia, venture capital can be less comfortable with medtech investments. It is my hope that as part of the growing medtech startup scene in Melbourne and Australia, Navi will be able to find the right investors and bring them along this journey to become a globally competitive medical device company. 

Q:  What are you most excited for about the future of Navi

I am most excited by the pipeline of future products Navi could work on once we got the Neonav approved and in the market! Between Christiane, Mubin and Shing, the clinical and engineering dream team has a wealth of ideas for things that can be improved for newborns and children, particularly in the intensive care setting. One of my highlights in Navi are the brainstorming sessions we had together as a team and I would love to be doing that for our next product and the next!

Pictured: Wei receiving first prize at a StartUp Vic pitch competition

Q&A with Navi COO, Shing Yue Sheung

Medical device innovation requires a broad range of skillsets; entrepreneurship, an expert knowledge in engineering and biology, a deep understanding of clinical regulations, the ability to grasp complex financial and funding requirements, and strong leadership traits to name a few.

At the cross section of all of these skills sits Navi co-founder and COO Shing Yue Sheung, who applies his steady mind and broad knowledge to help guide Navi operations across multi-disciplined areas.

When Shing is not busy with QMS and ISO regulations, you will find him pitching to investors, diving into product design, or mentoring the next generation of Biomedical engineers. He was recognised for his achievements at Navi by being listed in “Forbes 30 under 30” in 2018, and is constantly driving team Navi to achieve its collective vision of creating brighter, healthier futures for children everywhere.

Q: Tell us about your journey to become a co-founder of Navi?

I have been very fascinated with medical devices and their development since starting my studies at University; I enjoyed the ability to problem solve and to find a link between medicine and technology to improve the lives of patients. In my second year of my Master’s of Engineering degree, I enrolled in the BioDesign Innovation subject, where the goal was to educate students on the medical device commercialisation pathway. By chance, I formed a team with an amazing group of individuals (who are now my Navi co-founders) to develop a solution to an unmet clinical need of positioning central lines in the neonatal intensive care unit - I guess you can say that’s where my life changed. We worked quickly to understand the clinical problem, develop several prototypes, validate our business model, and came up with a team name ‘Navi’ based on our first solution to assist with navigating a central line to its optimal position.

Pictured (left to right): Navi CTO Mubin and Shing

After our final assignments were submitted, we continued to work on our medical device concept. In the meantime, I was working in a large consulting firm in their R&D Tax Incentive Team, where I realised that while I was assisting clients utilise their R&D activities through the Federal Government’s R&D Tax Incentive Scheme, I wanted to have my own R&D project which reinforced my motivation (any additional hours I had) to work on Navi.

A few months later, we entered Navi in a pitch competition in Suzhou, China. This was my first ‘formal’ pitch and we felt blessed to finish in second place. This was also one of the first times we had presented our concept to a panel of experts for their assessment, and we really felt that other people believed in our idea and that we were onto something worth pursuing. A week later on 8th July 2017, we incorporated our company ‘Navi Medical Technologies Pty Ltd’ and I have been a full-time co-founder ever since.  

Q: In 2017 you spent some time in Houston, Texas at the TMCx Medical Device accelerator program at the Texas Medical Centre. Tell us about your time there, and how it helped Navi in its development journey?

TMCx was one of our first big breaks into the medtech startup ecosystem and helped establish a foundation of understanding of the steps required for device commercialisation. I was sent to Houston for the TMCx program as we felt this would be the best way to take Navi to the next level and ‘accelerate’ the work we were doing. And I felt that’s what it did – Navi was given great exposure to the TMC ecosystem and we established connections with other medtech startups. And we received some early funding from the FDA-funded pediatric device consortium while I was in the US which really helped our initial product development and commercial activities. Towards the end of TMCx, a few of my co-founders joined me in Houston where we presented Navi on ‘demo day’, established new clinical and commercial contacts, and ate lots of BBQ.

Pictured: Shing pitching at the TMCx Demo Day in Houston, Texas

Q: What is the most challenging part about your role as a COO of a medtech startup?

I have a background in commerce as well as engineering, while Alex (our CEO) mainly focuses on the commercial side of things and Mubin (our CTO) mainly focuses on all things technical. So naturally I fit somewhere in between with shared responsibilities in product development and commercial activities. Having responsibility on different ends of the company means that I need to ‘context switch’ frequently which can sometimes be a challenge especially when juggling many projects at once. It keeps things interesting, but nowadays I try and stay focussed on one task at a time to avoid getting too side-tracked.

Navi team pictured from left to right: Shing Yue Sheung (COO), Mubin Yousuf (CTO), A/Prof Christiane Theda (CMO - Medical), Wei Sue (CFO), Alex Newton (CEO)

Q: What is your current highlight in your Navi journey?

Pictured left to right: Shing with Navi CTO Mubin Yousuf

The journey of medical device development has been a long one, so inherently there are many highlights for me to choose from. One of the earliest highlights in my Navi journey was related to kicking off our observational clinical study in the NICU (Neonatal Intensive Care Unit) – where we had set up our equipment and prepared for our first recording. We established all necessary connections to the patient and we held our breath to see the results on our display. No signal. We stayed calm as we were confident that our set-up was correct. While Mubin and I inspected our equipment, we heard Christiane’s voice from the bedside: “Ah, the line is clamped” and with a quick motion she removed the line clamp and voila, a beautiful ECG signal was displayed on our set-up. Success! Christiane, Mubin and I were delighted with the results and we shared a moment that I will never forget.

Navi commences PICC lines study at the Royal Women’s Hospital

Navi has taken another big step in the development of the Neonav ECG Tip Location Device, expanding the existing research study at the Royal Women’s Hospital’s Newborn Intensive Care Unit (NICU) to investigate Neonav’s application in the placement of PICCs in newborns.

Pictured left to right: Navi CTO Mubin Yousuf and Navi CMO (Medical) Dr. Christiane Theda at the commencement of the PICC study at the Royal Women’s Hospital in Melbourne, Australia.

Navi’s Chief Medical Officer, Christiane Theda, is leading the expanded study and is excited about what can be learnt through this research.

“The expansion of our study at the Women’s means we will be able to work towards our goal to significantly improve the procedures newborn babies have to undergo to provide them potentially lifesaving vascular access to give fluids, medications and intravascular nutrition,” said Christiane.

“This new phase of our study is an important further step towards safer care for critically ill children.”

Globally, it is estimated that there are over 2 million PICC insertion procedures performed in newborn and pediatric patients, with up to 50% experiencing instances of misplacement or migration due to lack of real-time confirmation technologies available.

According to Mubin Yousuf, Navi’s CTO and the person managing the development of the software that powers the Neonav, this study will help broaden Neonav’s ability to identify catheter tip locations during PICC procedures, and ultimately reduce instances of misplacement.

“We have been able to significantly improve Neonav’s software using the learnings and the data collected from our previous studies,” said Mubin.

The Neonav clinical prototype being used during a PICC line insertion procedure as part of the Neonav observational study in the Royal Women’s Hospital - Melbourne, Australia

“The focus now is to apply these learnings to collect new data and expand the software’s capability to allow for accurate placement and migration detection of PICCs.”

The expanded research study into PICC procedures has been funded in part by the Victorian Governments Medical Research Accelerating Fund (VMRAF), and is conducted in partnership with, and incredible support from, the Women’s.

Doctor's Day 2021

The 30th of March is National Doctors’ Day; a day that celebrates the impact physicians around the world have on people lives. 

As a medical device company that is driven by a vision of giving children brighter, healthier futures, we have a deep awareness and appreciation for the incredible work doctors do. We are also privileged to work alongside some passionate physicians who have helped us on our journey, and who we would like to show some appreciation and recognition on this day.

We have chosen three doctors that we’d like to highlight for this special day.

One such doctor is our very own Chief Medical Officer, A/Prof Christiane Theda, who has dedicated over 30 years of her life caring for critically-ill newborns.

Christiane is currently a senior Neonatal Consultant at the Royal Women’s Hospital, as well as co-founder of Navi. She leads our clinical studies which support the development of the Neonav ECG Tip Location System, a device that will provide clinicians with real-time feedback on the location of the catheter tip across a number of procedures.

A/Professor Christiane Theda pictured beside a clinical prototype of the Neonav

Whilst dedicating a huge part of her life to Neonatal medicine, she did not really know what area of medicine she wanted to focus on when she commenced her medical studies;

“I had not “planned” to become a neonatologist. During my studies, my thoughts were to become a specialist in sport medicine, radiology or neurology.” 

However, a chance encounter with a young 8-year-old patient during her rotations in paediatrics as a student caused her to consider helping children as an area of focus.

“When I had my first workday in the NICU (neonatal intensive care unit), I went home thinking: Neonatology is it, the NICU is the place I am going to spend the rest of my professional life”.

Having worked as a clinician around the world in Germany, the USA as well as Australia, Christiane is focused and driven by one simple yet powerful guiding principle,

“[It’s] very simple – and maybe it sounds a bit cliché: help the babies and their families!”

And it is this guiding principle that drives Dr. Theda not only as a doctor, but also as an entrepreneur and inventor.

“New technologies offer so many opportunities to innovate; if it is software and data processing or other amazing new engineering developments, I feel that there is “a lot out there” in regard to advances and technology that will contribute to improved care for critically ill newborns and children”.

Another doctor that Navi has worked with closely in development of the Neonav is A/Professor Andreas Pflaumer.

Originally from Munich, Germany, Dr. Pflaumer is a Paediatric Cardiologist with a sub-specialty interest in electrophysiology. He holds an honorary appointment at the MCRI Murdoch Children’s Research Institute), and sits on Navi’s Advisory Panel as a key clinical advisor. 

A/Prof Andreas Pflaumer.

Source: rch.org.au

His journey to becoming a doctor was one driven by impact;

“I did my internship 30 years ago in Germany. At that time Electrophysiology was not an established field of practice. During my internship, I was impressed how children deal with disease and how much potential for change there was with the right treatment.”

This observation led him to focus on helping children as a paediatrician, which ultimately led him towards his speciality in cardiology;

“During my time as paediatrician, I learned that cardiac disease and neural disease have the most severe impact on a child’s early life”.

Whilst there are significant challenges and stresses that Dr. Pflaumer faces as a paediatric cardiologist, it is the outcomes that really drive him,

“Working in a very technical field, it is important to keep the balance between the technical possibilities, the potential risks of a treatment and the benefits for the child while still providing the best care. While this can be very difficult, the reward of a seeing a previously sick child thriving is always worth it.”

Looking forward, Dr. Pflaumer is most excited for the digital transformation of the health industry and the introduction of new technologies to help ease administrative burden that comes with it;

“The digital transformation of the health industry is the most exciting, though also the most challenging development. In the past 20 years, technology dramatically changed the way we understand and treat heart disease.”

“This first step of digitalisation though burdens all health care workers with administrative tasks and reduces the time we spend with the patients and their families. I hope that the further development of machine-learning and artificial intelligence will reverse this development and allow not only a more effective, but also a more personal and patient centred medicine.”

Another inspiring doctor and good friend of the Navi team is Dr Mardi Steere, who is currently Executive General Manager for Medical & Retrieval Services at the Royal Flying Doctors Service (Central Operations). Dr. Steere also has a strong driving passion for the development of universal health coverage for the underserved, especially for countries and communities with limited access to health care, and has provided some valuable insight to the Navi team on the challenges of delivering effective care to sick children in regional and Low-Middle Income Countries.

Pictured: Dr. Mardi Steere . Source: Royal Flying Doctors Service

“After completing my postgrad Paeds Emergency training in the US, I and my husband (a civil engineering projects manager) really felt convicted that we have been given so much that we needed to give back. We moved to Kenya with our kids in 2011 to serve in a Christian mission hospital - we planned to go for 2 years initially and ended up staying for 8.”

Living and working with her dedicated and professional Kenyan colleagues gave Dr. Steere life changing perspective of healthcare.

“We are incredibly fortunate to live in a wealthy country in Australia that views healthcare as a right & prioritises funding it.”

In her current role at the Royal Flying Doctors Service, Dr. Steere is facilitating equitable healthcare access for rural, regional and remote Australians.

“It is simply unacceptable that urban Australians have some of the best health outcomes in the world; while our most remote communities have outcomes on par with LMIC’s (Low-and-Middle Income Countries).”

“Comprehensive healthcare access should be available in this day and age to all Australians, no matter where you live.”

What most excites Dr. Steere about the future of medicine are the possibilities brought on by innovation, 

“There has never been a greater time to innovate - in telehealth; in new approaches to chronic disease management; in nanotechnology to miniaturise diagnostic equipment & therapeutics; in creative approaches to healthcare delivery. If we can improve how to better care for isolated communities in Australia, the broader applications for other countries could also be astronomical”

“Wouldn’t it be amazing to make a real difference for our own population that also happens to have a global impact?”

There’s an inspirational thread that links Dr. Theda, Dr. Pflaumer, and Dr. Steere; despite the challenges they face in their respective fields, they are all focused on their patients first and foremost, and optimistic about the role technology can play in improving standards of care.

The team at Navi would like to thank Dr. Theda, Dr. Pflaumer and Sr. Steere, as well as doctors globally who dedicate their lives to helping others.

Federal Minister Commends Navi For Medtech Innovation In Parliament

Navi was honoured to be mentioned in the House Of Representatives at Parliament House today by the Federal Minister for Industry, Science and Technology, Hon. Karen Andrews, who gave a speech outlining some of the recent significant achievements made by Australian medical companies.

In her speech, Navi was highlighted and commended for its recent successes in the development and commercialisation of the Neonav Catheter Tip Location System; a medical device that aims to helps improve catheter placement in critically-ill newborns and pediatric patients.

Navi CFO Wei Sue noted that the Navi team were pleased to be included in the Minister’s speech among incredibly successfully medtech companies like ResMed and Cochlear;

“Like many, COVID-19 has been a challenging year for our company. But, our team has shown incredible resilience continues to make significant strides in the commercialisation of the Neonav device, including as the Minister mentioned, expanding our clinical research activities as well as setting up a US subsidiary in preparation for US market entry in the future.”

“It is an honour to be mentioned among some of Australia’s most successful medtech organisations. The incredible support of the Federal Government through the Accelerating Commercialisation Grant has provided us with critical resources in this commercialisation journey, and ultimately will help us achieve our goal of providing children everywhere with brighter, healthier futures.”

Below is a partial transcript from the Minister’s speech, spoken in the House Of Representatives on 22 February 2021:

“Many of us here would be very familiar with the Cochlear story and the work they have been doing with their hearing technology solutions. I've already mentioned ResMed and what they did with ventilators. But there are so many fledgling companies that are producing medical products right across Australia. We as Australians should be so proud of them and the work they are doing. They are great examples. One business, a Melbourne based business, is Navi Medical Technologies. Last year this government backed them with a grant of $400,000 to help them commercialise their new catheter technology for seriously ill babies. Even during COVID, faced with enormous challenges, they expanded their business. They employed an extra six people. They set up an Aussie-owned office in the United States, and they significantly progressed their clinical research.”

Q&A with our CEO, Alex Newton

The medical device industry is a challenging environment for any new start up company: high start up costs, long development timelines, and highly regulated. Throwing in a global pandemic and subsequent recession adds a new dimension of challenges to overcome. 

Alex Newton, the co-founder and CEO of Navi Medical Technologies, discusses some of the challenges Navi Medical Technologies has faced, and how his team has navigated these challenges to be in a strong position for the work ahead. 

Being a CEO of a medtech start-up can be described as like trying to navigate a rollercoaster ride – tell us a bit about how your past experience has helped you lead Navi through the start-up journey?

In my previous career I worked in aerospace industry on some really interesting and complicated projects as an engineer, team lead and project manager. After studying my MBA I transitioned to the medical device industry, and there are some important parallels between aerospace & medical devices; both are highly regulated industries where the safety of the end users is the paramount consideration, and both industries require multi-disciplinary teams that need to balance technical and commercial factors to develop a successful product. I had the good fortune to work with some of the best engineers and companies in the aerospace industry both in Australia and the United States, and learned a lot about what ingredients make an effective and high performing team.

Alex Newton (right), receiving medical supplies as part of his non-for-profit work that provides health education programs to low-resourced settings

More recently, I’ve been involved with a non-for-profit that aims to improve health outcomes in low-resource settings by providing education to local medical & nursing staff to improve local healthcare capacity. This has been incredibly rewarding, from seeing the impact that can be made with our partners, being inspired by some incredible clinical educators, and learning about how healthcare is delivered in very different environments.

The most important lesson I learned from these experiences is that a successful project always starts with a great team that’s truly motivated to solve problems and change the world somehow. You really need to get the right mix of people in the founding team.

Even in a complex environment where it’s impossible to predict all the challenges a high performing team will be able to adapt, experiment and learn to overcome obstacles, and I see that on a daily basis at Navi.

According to the US FDA, the pediatric market is often under-represented in terms of new medical devices - why do you think there is a shortage and why has Navi decided to focus on this area?

On the surface this seems strange to me because society implicitly places a higher value on children’s lives than those of adults, but we just don’t see that translate to equivalent amounts of investment in medical device innovations which is probably the key reason we see such a disparity in terms of products that are approved for adults vs children. Data from the US FDA shows that less than 5% of innovations that are approved by the FDA seek an indication for use in newborns, and there are a few reasons for this:

The first and most obvious reason is a perception that the pediatric market is too small for some investors, which I think is a bit misguided and overly simplistic. Of course, the pediatric medical device market is smaller than the adult market, but it’s still a relatively large space to play. For example in the Vascular Access market the pediatric segment is around 12-15% of the total market size, so it’s a fairly significant chunk of a large market, with a lot of room to grow.

There are many more unmet clinical needs and much less competition in the pediatric space which I think creates an interesting environment for companies willing to focus on this segment and configure their business in the right way.

My belief is that a dedicated and focussed company can be very successful in this area – at Navi we’re being as efficient as possible with our resources to minimise the amount of capital required to get to market, and to progress as quickly as we can to make sure we deliver the best possible return to the people and investors who back us.

“The most important lesson I learned was that a successful project always starts with a great team that’s truly motivated to solve problems and change the world”

I think the other big reason for the shortage of pediatric device approvals is the belief that making devices for newborns & children is harder, because they are more diverse in terms of size & behaviour, and therefore the regulatory pathway and clinical trials will be more expensive.

In the pediatric segments we’re dealing with everyone from extremely pre-term newborns through to young adults. While this can be a challenge, there’s also an opportunity for companies to improve their product designs by including pediatric indications for use from the very beginning of the process. It’s often more difficult to retrofit an adult medical device into a pediatric use than it is to include kids from the start. Including children from the start can often lead to better product designs overall as the design constraints force engineers to solve problems in more creative ways.

A lot of the technology and innovations we’re seeing developed for the pediatric domain have applications in larger patients, but rarely does it work the other way around. We’re also starting to see a lot of support for pediatric devices from regulatory groups such as the FDA who are funding the development of Pediatric Device Consortias around the US and putting into place mechanisms to ‘reduce the burden without lowering the bar’ which is a huge help. I’d love to see similar kinds of initiatives locally. 

2020 was a challenging year for many companies; what was the biggest challenge that Navi faced and what actions have you taken to navigate it?

We faced a few major challenges last year including delays in commencing some of our key clinical studies as our hospital partners refocussed their priorities on the effects of the COVID pandemic. The shift in timelines was a challenge to manage, but we were able to reconfigure our work to minimise the impact.

We realised early on that it would probably be a good idea to raise a small capital round to ensure sure we had enough runway to see us through what we thought could be a difficult time. It was really pleasing to see how quickly that round came together with the support of existing shareholders as well as new investors, and in retrospect this was a great decision as it gave us confidence to focus on the most important work without the worry of running out of funding. In the end though, I think the biggest challenge we faced was probably how we adapted to the new working from home environment.

Pictured: Navi Medical Technologies CEO Alex Newton with the Neonav clinical prototype in a NICU setting

One of the best things about working with our team is how well we all get along and work together, and trying to maintain that momentum and culture while being physically separated was tricky. We started short daily video meetings in the morning to share a coffee and chat about our work in a very informal way which I think helped us feel a bit more connected, and of course we all got very familiar with Zoom and Teams calls. We held a couple of virtual team dinners to celebrate a few important milestones which I think were a great idea, it was something fun to look forward to in the calendar during the long lockdown here in Melbourne.

Team Navi working virtually during the 2020 pandemic

In the end we still managed to make excellent progress last year while largely working remotely, but I think we’re all looking forward to getting back to the office when it’s safe to do so.

What would you say is the most important part of any high performing and successful start up company?

It’s the people. The most important aspect of an early stage company is building the right team and surrounding yourselves with advisors and mentors who can give honest feedback based on relevant experience.

I think it’s easy to get swept up in the buzz and excitement around some of the technology that start-ups are generating, but the core value of the early stage company is always in the people. Without the right team it’s hard to properly de-risk the technology and validate the market & commercial strategies that are required to realise the potential, and we see time and again some promising ideas that fail to reach the market because the company didn’t get the basics right.  

A Year In Review: Major Milestones Of 2020

2020 has been a truly remarkable year that has brought with it both challenges and opportunities. The team at Navi is proud of the significant progress and milestones achieved over this period, putting the company in a strong position for an even more successful 2021.

Below are some of the highlights of key achievements and milestone events that have taken place over the last year:

Grants & Funding

In collaboration with our partners, Navi has been successful in obtaining funding from a number of high-profile grants both from Australian State and Federal initiatives, and even the US FDA.

A list of notable grants awarded to Navi in 2020 are:

• Accelerating Commercialisation Grant (Department of Industry, Innovation and Science) ~$396,000

  • Funding important commercialisation activities

  • https://www.minister.industry.gov.au/ministers/karenandrews/media-releases/help-critically-ill-newborns-among-47-million-grants

• VMRAF Grant (Victorian State Government) ~$100,000

  • In collaboration with the Royal Women’s Hospital, this grant funding will assist the completion of clinical research activities that will broaden the Neonav’s indication for use across multiple procedures in the neonatal patient group

  • https://www2.health.vic.gov.au/about/clinical-trials-and-research/victorian-medical-research-acceleration-fund/round-4-vic-med-research-fund-recipients#lp-h-0

• NHMRC Development Grant (Australian Federal Government) ~$879k

  • In collaboration with The University of Melbourne, the Royal Children’s Hospital and the Royal Women’s Hospital, this grant funding will support the development and commercialisation of the Neonav

  • https://www.nhmrc.gov.au/sites/default/files/documents/attachments/grant%20documents/development-grants-commencing-in-2021.pdf

• City of Melbourne - Small Business Development Grant (Melbourne City Council) ~$20,000

  • Funding to support business operations and commercialisation activities

  • https://magazine.melbourne.vic.gov.au/melbournes-medical-innovators-from-baby-steps-to-success/

• NCC-PDI, Pediatric Innovation Grant (US FDA) - USD$50,000

  • Contribute towards US-based clinical and product development activities

  • https://medtechinnovator.org/ncc-pdi-announces-winners-2020/

These grants not only provide our team with funding that will create enormous value through important R&D and commercialisation activities, but will also provide important validation on both the clinical and commercial aspects of the Neonav® ECG Tip Location System (Neonav).

Navi Chief Medical Officer, A/Prof Christiane Theda, operating the first Neonav ECG Tip Location System clinical prototype in Melbourne, Australia.

In addition to a string of successful grants, Navi also closed a funding round in mid-2020 to support ongoing clinical research activities and provide additional runway in light of delays brought on by COVID-19 restrictions.

Strengthened our intellectual property & intangible assets

The patent that protects the Neonav’s ECG Tip Location technology is now in the national phase of patent application process in 6 key markets globally.

Additionally, our team has been busy working on some exciting new product IP that will further enhance the Neonav’s functionality and usability.

Navi has also been working with a leading industry consulting group to identify sources of value in intangible assets and develop a robust IP & intangible strategy as we progress further into the future.

Pictured: Neonav Tip Location System first clinical prototype in NICU crib

Significantly progressed clinical research activities

2020 was a challenging year for clinical activities, with the COVID-19 pandemic causing a temporary suspension of clinical research activities in hospitals across the globe.

That being said, work performed by our engineering team during this period allowed for significant gains in product development and research once restrictions were lifted.

In collaboration with the Royal Women’s Hospital, our team completed the first phase of our observational clinical study which involved collecting crucial real-world patient data that is being used to train and develop the Neonav’s proprietary machine-learning software. In addition, we commenced the next phase of our clinical study which included the use of the Neonav clinical device in the clinical setting. Early results are promising, and we look forward to continuing our research and collaboration with the Royal Women’s Hospital.

It is worth noting that the use of the Neonav clinical prototype in a clinical setting is a major milestone in the medical device development pathway, which is something the Navi team is personally proud of.

Completed Health Economic Project

Navi has engaged a world-leading vascular access research group, AVATAR, who conducted an independent preliminary health economic assessment of the potential of the Neonav ECG Tip Location System in Australian NICU’s. The report confirmed that there could be considerable cost savings for NICU’s who would use the Neonav for placement & monitoring of umbilical venous catheters in newborn patients.

ExpAnded ouR team

Throughout 2020 Navi has welcomed 6 new team members, which included 5 interns and an associate data analyst. Despite the challenges of working remotely, the Navi team have worked closely to maintain a strong positive culture achieve critical clinical and commercial milestones.

Navi team working remotely during the 2020 COVID-19 pandemic

Established A USA entity

Navi has recently created a wholly-owned US-based subsidiary, Navi Medical Technologies Inc., which will be used as a base to further develop our US-based network and interests as we prepare for the roll out of Neonav devices in the future.

Elevated our BRAND PRESENCE

Developing the Navi brand within national and international markets is an important part of our commercialisation strategy.

Navi has therefore taken part in a number of high-profile technology competitions to help further develop our network, and obtain critical feedback and validation from industry experts and advisors.

Below is a list of competitions we were involved with in 2020:

• Australian Technology Competition - Finalist, Healthcare & Pharma category

  • The Australian Technologies Competition is Australia's premier platform to spotlight and mentor technology scaleups with the greatest global potential.

• MedTech Innovator - Finalist

  • The MedTech Innovator is the medtech industry's global competition and accelerator, accelerating the growth of companies that are transforming the healthcare system

• NCC-PDI - Make Your Medical Device Pitch for Kids! - Winner

  • Prestigious national pediatric medical device competition funded by the Food and Drug Administration (FDA) to support the advancement of pediatric medical devices

• Extreme Tech Challenge (XTC) - Global Finalist (ongoing)

  • The Extreme Tech Challenge is the world’s largest startup competition for entrepreneurs addressing the globe’s most serious challenges

Navi Medical Technologies featured in the MedTech Innovator Vascular Solutions Showcase Panel.

Looking forward to 2021

We have big plans for 2021 and are determined to continue the  momentum we have generated from a challenging but successful 2020.

The Navi team would like to thank everyone who have supported us through this past year, and we look forward to working with our partners to help children everywhere live brighter, healthier futures.