Navi Awarded Victorian Government Manufacturing Grant

The team at Navi are pleased to announce that we have been successful in receiving a $178k grant from the Medtech Manufacturing Capability Program (MMCP).

Funded by the Victorian Governments Department of Jobs, Precincts and Regions, the MMCP grant aims to support local manufacturing of Victorian-based medtech companies.

“Navi was founded in Melbourne, our office is located in Melbourne, and our amazing clinical and commercial partners are also based in Melbourne. We are thrilled and appreciative of the support the Victorian Government has provided us, and the broader Victorian medtech industry,” says Mubin Yousuf, Navi co-founder and CTO.

“The grant will go towards critical product development milestones as we transition from prototype to a market-ready device in the coming years,” says Mubin.

Pictured from left: Mubin Yousuf (CTO), Alex Newton (CEO), Shehan Wisidagama (R&D), Wei Sue (CFO)

The device being developed, called the Neonav® ECG Tip Location System, provides clinical staff with real-time location information on where central catheters are positioned inside patients, taking out a lot of the guess work in these common procedures and allowing for fast and effective treatment of critically-ill newborn and pediatric patients.

To date, a number of Neonav® clinical prototypes have been manufactured locally in Melbourne, Australia, and have been used in clinical studies held at the Royal Women’s Hospital, also located in Melbourne.

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.

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.