How alumni are helping make Navi Medical Technologies a global success
How do you turn a classroom idea into a medical device for newborn babies in just three years?
With a lot of hard work and support from early investors including several Melbourne Business School alumni, says Navi Medical Technologies CEO Alex Newton.
Alex and his co-founders will be at this year's Alumni Reunion in February to talk about how five students and a doctor managed to raise almost $2 million dollars since forming Navi in 2017, and their experience starting clinical studies to seek US Government approval for the device.
"It's a great story about closing the loop," Alex says. "We've come out of the University of Melbourne and Melbourne Business School, and alumni are investing in us.
"Through individuals, venture capitalists and grants, we've raised something in the order of $1.7 million now, enough to get us to the end of the current phase of work, including the next round of clinical studies."
The most recent of those grants was awarded just this month, in the form of $400,000 from the Department of Industry, Innovation and Science as part of its Accelerating Commercialisation program.
Navi's invention – called the Neonav – is a medical device that helps doctors and nurses find the right position when placing central venous catheters in newborn babies in need of nutrients and medicines, reducing the risk of complications and minimising the number of X-rays they receive.
It's an innovation that particularly excites Navi co-founder and paediatrician Dr Christiane Theda.
"It's like a dream come true, because the idea has been in my mind for quite a while, but I've never been able to do anything with it," she says.
The chance to do something began with Melbourne Business School's Biodesign Innovation subject, which brings together clinicians, Part-time MBA students and engineering students from the University of Melbourne to identify and commercialise solutions to medical problems.
"We partnered with Christiane through Biodesign, and her clinical experience over the last 30 years helped us identify a clear, unmet, clinical need in vascular-access procedures," Alex says.
For Dr Theda, who often cares for premature babies weighing just 500 grams – seven times less than the average full-term baby – the difference the new device will make for clinicians like her is enormous.
"Before this device, we had nothing. We use measurements, and then insert the catheter blindly, advance it, hope we're in the right spot and take an X-ray to see if we need to make adjustments," she says.
"If we're in the wrong spot, we have to start all over again, clean up, put on our masks and adjust the line or take it out and start once again."
Alex says the Navi device also reduces the risks associated with catheters moving from the right place to the wrong place, which they do often.
"Some of these children are in the hospital for 90 days and longer, and over the course of their treatment, the catheter tip can move to a non-central location, which might not be safe. Data coming out in journals suggests that up to 50 per cent of catheters might migrate in this way."
With clinical studies now underway at Melbourne's Royal Women's Hospital, where Dr Theda works, and more testing in Australian and US hospitals set to start, the next step is to collect the study data which will be used to develop intelligent software and eventually submit the Neonav for US Food and Drug Administration approval.
"We'll use the results of the study to raise the next round of funding because that is when we can stand up in front of investors for the first time and say without a doubt, hand on heart, 'It works.'"
While the final hurdle of FDA approval is in sight for the Navi team, Alex says they still have a long way to go.
“The average medical device takes seven years, roughly, to get to market from the ideas stage to FDA approval, and we're a little ahead of that. But it's a bit of a trap to say, 'Oh, yeah, we'll have approval in 18 months or two years because something always comes along to make it longer.
"So I don't necessarily want to draw a line in the sand, but we're making pretty good progress."
Alex is keen to share his experience at the Alumni Reunion of taking an idea from an MBA subject through the highs and lows of forming a company, to raising money to commercialise it.
"Hopefully there's some lessons that people can take away if they're interested in creating a startup," he says – but he can tell you one of the most important ingredients for success right now.
"Find the right people. Nothing else matters at the start. The problem, solution or market will change over time, but if you can't find the right mix of skills, personality and dedication then it makes it really tough."
The right mix of people for Navi included MBS MBA graduates Wei Xin Sue and Brad Bergmann and University of Melbourne School of Engineering alumni Shing Yue Sheung and Mubin Yousuf, all of whom will be at the event on 21-22 February.