Melbourne-based Professor Nicholas Opie has been a superstar exemplar among Australia’s deep tech entrepreneur researchers for more than a decade.
Professor Opie is a co-founder of the brain-computer interface (BCI) pioneer startup Synchron with New York-based Australian Dr Thomas Oxley, and co-inventor of the Stentrode device – a neuro-prosthetic computer interface that can be implanted in patients via blood vessels to the brain rather than invasive surgery.
He is also the founding director and head of the Vascular Bionics Laboratory at Melbourne University, and remains on Synchron’s board of directors.
Through Synchron and the Stentrode, Professor Opie has been a poster child for deep tech entrepreneurship, and something of a hero among the MedTech startup community. Synchron has created a path for other ambitious Australian MedTech entrepreneurs to follow.
Synchron started life in Melbourne in 2012 with early funding from the Australian government and a substantial grant from DARPA (the US government’s Defence Advanced Research Projects Agency). It has since attracted venture funding from foundations led by Bill Gates and Jeff Bezos, as well as Khosla Ventures, ARCH Ventures and Sigma Partners.
Synchron has been at the forefront of BCI technology since its earliest days. It has reached key milestones in front of its principal international rivals – including Elon Musk’s BCI outfit Neuralink.
There are lessons to be learned from Synchron’s journey so far, especially in relation to the collaborative efforts that combine the resources of public research institutions, industry and private investors.
In this interview, Professor Opie outlines the specific funding challenges that deep tech startups face, and the peculiar nature of challenges faced by MedTech companies in particular that must navigate the long-term commitment to the time horizons needed for in-human trials on new-to-the-world technology.
The funding challenges in Australia faced by companies like Synchron in its early days have started to turn around, Professor Opie says, with more adventurous venture companies willing to take longer term risks associated with MedTech.
There is sobering advice to the research entrepreneurs who are planning to follow Synchron pathway to commercial translation of their research: That there is no such thing as low-hanging fruit, and that things will take longer and cost more than the entrepreneur would like.
Professor Opie has published more than 55 peer-reviewed articles and has filed more than 90 patents. He was awarded the 2021 National Foundation for Medical Research and Innovation (NFMRI) John Raftos Award for Advancing Innovation – as well as the Paul Shetler Disrupter of the Year Award at the InnovationAus Awards for Excellence in 2023.
In this interview with The Health Liftout, Professor Opie discusses his new venture Ultra Bionics which aims to help Australia maintain a competitive advantage and leadership in medical device innovation.
Australia excels in health research, but translating that research commercially is a significant challenge. What are the key factors that allowed Synchron to bridge this gap? What were some pivotal moments in translating your research?
One of the key factors to our success was the team, which included those employed and our large network of collaborators and key opinion leaders spanning a diverse range of fields.
We were also fortunate to have been successful in receiving funding through local and international grants, although perhaps the key factor was our imagination and ingenuity and our ability to see problems and solve them in ways that hadn’t been thought of.
The pivotal moment for me was seeing our first participant use the device for the first time. He was with his family, and the joy and excitement seeing him control a computer with his mind was really magical.
How did you navigate the complexities of securing both public and private funding?
For sophisticated neural technology such as that developed by Synchron and my new company Ultra Bionics, funding needs to come from both public and private sources.
The initial fundamental research can be completed with government grants, but the capital required to complete a clinical trial and progress to commercial trials and manufacture is orders of magnitude greater than what conventional grants can supply.
There is often a misconception that these two sources are significantly different, as the key items that are required for a successful grant (indication, milestones, budget, timeline, team, etc) are similar to the information investors are looking for.
The main difference is that instead of needing to have an academic track record, you need to have a vision on how the technology will make an impact to individuals and the community, and how you can achieve this better and faster than competitors.
What have you learned about the pathway from lab to market in deep tech in Australia’s health sector? What regulatory hurdles did you have to overcome to build and execute a strong commercial strategy?
Lots, and learning more all the time. Australia continues to be one of the best places on the planet to develop new life-changing technology and conduct invaluable first-in-human trials.
We are privileged with leading hospitals, research institutes and personnel accessible and supportive of next-generation medical devices, with private investors becoming more aware and accepting of the time it takes to get from concept to clinic (and then commercial sale).
There are extensive, and justified, regulatory hurdles that must be overcome to demonstrate a new technology is safe for a clinical trial, with the Florey Institute for Neuroscience and Mental Health well equipped to conduct the required GLP testing.
I think that Australia is (or will be in the future) in need of more clinical-grade manufacturing facilities and approved biocompatibility test houses to complete the checklist of infrastructure needs across the medical device life cycle from idea to human trial.
How important has collaboration between public institutions, investors and industry been in Synchron’s success? And what has it taught you about how Australia’s innovation ecosystem can be better aligned to support more ventures like yours?
Collaboration between different parties is very important, as each provides a unique and critical piece of the technology transfer puzzle. Disappointingly, Synchron was unable to raise private capital in Australia as the time required to see a return on investment was too long.
The reality is that MedTech takes a long time to design, test and implant in a first-in-human trial, and even longer to conduct a large clinical trial to receive approval for device sale.
However, recent discussions with investment groups have given me hope that this old-fashioned thinking is changing, and there are fantastic teams out there, and groups (Possible Ventures, Blackbird, etc) that genuinely want to help inventors make a monumental differences to the lives of people burdened by damage or disease.
It is exciting to see groups like these support early-stage companies with exciting and life-changing ideas, as this is a critical starting point for a successful ecosystem.
The more startups that have an opportunity to succeed, the greater the number of successful companies that will returning capital back to their investors, and the more capital the investors will have to support the journey of the next start-up.
Given the growing interest in deep tech and MedTech, what elements are necessary to create a sustainable pipeline of innovation that can be commercially successful in Australia?
There are four main elements required for successful device translation, which include:
1. Research institutes, universities, and accelerator programs for the conceptualisation of ideas and provision of initial funding to rapidly conduct of proof-of-concept research to validate ideas that are worth progressing.
2. Certified manufacturing design houses that can work with teams to upgrade hand-made prototypes or concepts into products that would be suitable for human implantation
3. Preclinical facilities and test houses that are equipped and qualified to conduct all the necessary TGA/FDA required biocompatibility testing
4. Hospitals that have the desire and capability to identify suitable patients and enable the validation of technological performance in a clinical setting.
These obviously cannot be achieved without funding, and government grants and private capital are critical to successful translation. Also critical are the non-research activities, including regulatory and reimbursement, intellectual property, market evaluation and penetration, among others.
As a pioneer in commercialising deep tech, what advice would you give to other local researchers and entrepreneurs looking to turn their research into impactful companies?
Find a team with goals aligned to yours and don’t compromise on the commercial goal you want to set.
There is no such thing as low hanging fruit. These are often a distraction, take just as long (or longer) to achieve, cost just as much (or more) and end you in a position that you may not care about.
This doesn’t mean that you shouldn’t be strategic about your pathway to market, and sometimes the best way to translate a technology is to prove it works on an alternate indication.
However, be honest with yourself and your team of where you want to go and how you want to get there and be prepared that it will always take longer, and cost more than you’d like.
Looking beyond Australia, how do you envisage Synchron’s role evolving within the global health sector? What steps are you taking to maintain its competitive edge?
I am taking steps to help ensure that Australia can maintain its competitive edge and reputation as a global leader in medical device innovation and translation through my new company Ultra Bionics.
In addition to designing and developing a novel, life-changing technology to assist those with a myriad of neurological disorders, this endeavour will fine-tune the concept-to clinic process that I have walked before and provide a framework for future MedTech developers to follow.
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