A ground-breaking diagnostic test under development at the Bionics Institute in Melbourne could pave the way to new treatments for Australians suffering the auditory torment of tinnitus.
It takes unexpected skills to turn medical device research into reality. The highly specialised electro-fabrication team are based at our new prototype manufacturing facility, Neo-Bionica. It houses purpose-built cleanrooms for custom, high-quality medical device development.
What are electrodes for?
Engineer, Ross Thomas says that electrodes are a key element of medical devices developed at the Bionics Institute. He said: “In many medical devices, electrodes are essential for gathering data and providing treatments. Electrical impulses generated by implanted electrodes mimic impulses of the nervous system. This allows a device to bypass damage (as is the case in cochlear implants) or stimulate nerve activity (as is the case in our vagus nerve device).”
It’s a team effort
The electro-fabrication team make electrodes for a wide range of medical device research projects.
Working alongside Bionics Institute engineers and researchers they provide expert advice in the design and manufacture of devices to ensure that they will be safe to implant in a human body.
“We turn the design concepts into the initial prototype implants that meet the requirements of specific research problems, so that researchers can execute their projects,” Ross concluded.
How are they made?
Making electrodes is an incredibly intricate and manual process completed using a high precision microscope. The electro-fabrication team are often handling wires that are just a quarter the diameter of a human hair!
An electrode shown under a microscope. Each ring is 0.3mm wide
Electro-fabrication technician, Jenny Zhou says the team assemble the electrodes manually using platinum wires, rings and foils.
She said: “For this reason patience is critical for us to sit down and work for a few hours under microscope.”
A varied team
Our electro-fabrication team have come from a diverse range of backgrounds. From microbiology and jewellery to a master cake baker! Ross says: “What they all have in common is an incredibly steady hand, lots of patience and a desire to contribute to new treatments that can help people.”
Every implant is different
ach research project is different and being able to make custom implants designed specifically for each purpose is essential to getting the best possible results. This means the electro-fabrication team are continually refining and perfecting all the elements of an electrode implant to improve its efficiency and the quality of data it collects. This includes size, shape, materials, and the number of electrodes included, which can range from 4 in the vagus nerve device to 44 in the bionic eye!
Neo-Bionica creates new opportunity
Neo-Bionica is an end-to-end medical device prototype development facility. The first and only facility in Australia with the bioengineering expertise and cleanroom technology required to create first-in-human prototypes for clinical trials, Neo-Bionica is a joint initiative of the Bionics Institute and The University of Melbourne. Located in St Vincent’s Hospital in Melbourne, Neo-Bionica provides access to the full range of medical device prototype manufacturing from initial concept through to clinical testing
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Meet Our Research Director
Associate Professor James Fallon first joined Bionics Institute to work as a Research Fellow in the Auditory Neuroscience research program and was the Lions International Hearing Research Fellow from 2008 to 2010.
In 2016 he became a Principal Research Fellow and was appointed Research Director of the Bionics Institute in 2017 and head of the Medical Bionics Department, University of Melbourne in 2019. He leads our electric medicine research. A/Prof Fallon says he didn’t set out to be in the field of medical research.
“The way I ended up here was following interesting things and working with interesting people, and that’s really been my motivator – to work with interesting people on challenging topics,” he said.
A key example of this, and a personal career highlight for James, is the ground-breaking pelvic nerve research and development of a new vagus nerve device, explained by Dr Payne in our next article.
He said: “For the first time we’re getting clever about listening to what’s happening in the nerves. Our aim is to harness the body’s own signaling system with our medical devices.
The vagus device began as the seed of an idea for the treatment of inflammatory bowel disease and has now, within only 4 years, got to clinical trial stage….To see an idea we’ve come up with and worked on potentially be used to help a patient is pretty exciting
Not only that, but the team have also been able to translate the device into a potential treatment option for other conditions as well, including diabetes and arthritis.
“For me that’s the key. To translate a good idea; to inspire other researchers to drive their own research; and more importantly to translate a good idea into a commercial product so that it makes it into the clinic and ultimately improves patients’ lives.“
“At the Bionics Institute that’s what we want to do and what we focus on.”
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Neo-Bionica, a joint venture between Bionics Institute and The University of Melbourne is pleased to announce the appointment of two extremely well credentialled individuals to lead our journey. Dr Ludovic Labat has been appointed as CEO and Lusia Guthrie has been appointed Chair of the Board.
A world leading centre for medical development and manufacture, Neo-Bionica is the first and only facility in Australia with the bioengineering expertise and technology required to create first-in-human prototypes for clinical trials.
Dr Ludovic Labat has been appointed as CEO. After completing his PhD at Le Havre University in France, he has gained over 20 years of medical device and technology industry experience with increasing levels of responsibility.
This includes 13 years working at the Fortive group of companies (NYSE: FTV), most recently serving as APAC Integration Leader at Advanced Sterilization Products (ASP).
He initially joined Fortive as part of Invetech, a med tech innovation firm in Melbourne where he held a broad range of roles including VP Engineering and Manufacturing.
Ludovic spent several years in the USA for Fortive as Global VP of Sales for Invetech and as a General Manager at Tektronix. His skills, qualifications and experience will be an enormous asset to Neo-Bionica.
Dr Labat says: “I am very humbled and excited to join Neo-Bionica. Our team encompasses electro-mechanical and biomedical engineering expertise, highly skilled device fabrication technicians and broad experience in regulated devices development.
“Uniquely located in St Vincent’s Hospital, Melbourne Campus with connections to leading clinicians, our world class facilities and two ISO7 cleanrooms are equipped with the latest technology. This means we can enable our client’s success through providing excellence in medical device prototyping services from early ideation to clinical testing”.
Neo-Bionica is also proud to announce that it has appointed Mrs Lusia Guthrie as its initial Chair.
With over 35 years in the pharmaceutical and bioscience industries, Lusia is a highly experienced and respected executive and med tech entrepreneur.
Lusia started her career as a medical laboratory scientist before joining the manufacturing division of pharmaceutical company FH Faulding & Co.
She then went on to co-found medical technology innovation company LBT Innovations Limited (ASX: LBT) where she served as Chief Executive Officer and Managing Director until 2016 and Chair, Clever Culture Systems, Zurich (LBT’s European joint venture company) until 2018.
Lusia’s passion and proven track record in bringing innovative products to global markets, embracing the entire process from company formation, capital raising and concept development to product launch and sales is an enormous asset for Neo-Bionica.
Her current Board roles include Chair, BioMelbourne Network; Non-Executive Director, 4Dx Limited; and Chair, Australian Lung Health Initiative (ALHI). Lusia is also a Member of industry advisory committees at the Australian Institute for Machine Learning and the Australian Regenerative Medicine Institute.
Lusia says “I am extremely excited to be asked to oversee the development of Neo-Bionica.
“I am a major believer in the excellence of Australian innovation and the possibilities it provides for the development of Australia, both economically and for the training of our future generations.
“I very much look forward to working with Ludovic, his team and the scientists at Bionics Institute and University of Melbourne to create something very special.”
Bionics Institute CEO Robert Klupacs says that the combination of Dr Labat’s background in engineering research early in his career combined with broad experience in the industry and Mrs Guthrie’s experience in transforming innovation to products will take Neo-Bionica to the next level.
He said: “We are delighted to welcome Ludovic and Lusia to Neo-Bionica and look forward to transforming Australia’s medical device prototype manufacturing capabilities in the future.”
University of Melbourne Executive Director of Research, Innovation and Commercialisation Ken Jefferd said research translation is a critical priority for both the University and the Victorian Government, which generously funded fit out of the new facility through the Victorian Higher Education State Investment Fund.
“We would like to extend a warm welcome to Ludovic and Lusia.
Through their leadership Neo-Bionica will strengthen Victoria’s reputation as a global biomedical powerhouse and boost the economy”.
For more information about Neo-Bionica, go to: www.neo-bionica.com
About the Victorian Higher Education State Investment Fund (VHESIF)
The Victorian Government is supporting the establishment of Neo-Bionica with a $4 million contribution from the Victorian Higher Education State Investment Fund. The fund is a $350 million investment in the Victorian tertiary education sector and supports universities with capital works, applied research and research infrastructure to support jobs and the state’s economic recovery from the coronavirus crisis.
About the organisations involved in Neo-Bionica
The Bionics Institute, The University of Melbourne and St Vincent’s Hospital are partners in the ACMD – Australia’s first hospital-based biomedical engineering research centre located at St Vincent’s Hospital Melbourne. The Bionics Institute is a world leader in the research and development of innovative medical devices to treat and diagnose a wide range of conditions, including hearing impairment, epilepsy, Parkinson’s disease, Crohn’s disease and diabetes.
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Electrical medical devices can be used to alter the activity of nerves to treat a wide range of diseases that aren’t responding to drug treatments.
At the core of this ‘electric medicine’ research lies the vagus nerve which runs from the brain to the gut and controls many processes in the body.
What is EarGenie™?
EarGenie is a hearing test that uses near-infrared light to measure the brain’s response to sounds. A comfy band wrapped around the baby’s head contains small light sources and light detectors.
When a sound is played, specialised software recognises the brain’s response through changes in the reflected light, indicating whether the baby heard the sound or not. It also shows whether the baby can tell the difference between two different sounds, known as discrimination between sounds.
Information about the discrimination of speech sounds is critical. It tells us whether the baby’s hearing aid will help them to learn to talk, or whether they will need to have a cochlear implant.
Why is EarGenie needed?
Babies born with hearing impairment can miss out on the vital sounds that they need to hear at a young age in order to learn to talk.
If the right treatment is not found in the first months of life, they never fully catch up with their peers, and have a permanent communication deficit delay throughout their whole life.
The earlier the hearing loss is identified, and the baby provided with either a hearing aid or a cochlear implant, the sooner the baby can start learning to speak, and the better their language development will be.
There is a hidden hearing loss in babies
For many babies, the current newborn hearing test can tell us how bad the hearing loss is but does not give key information about discrimination between sounds. These babies have to wait until they are around 9 months old for us to tell whether or not their hearing aid is helping them to develop language.
And 10% of hearing-impaired children, with a condition called auditory neuropathy, have to wait till they are 2 years old before we know if they need a cochlear implant. Their language development and communication skills are then permanently delayed.
What impact will EarGenie have?
EarGenie will ensure that babies born with hearing impairment:
– are diagnosed correctly, so that the right treatment can be given as early as possible
– can hear and distinguish between the sounds that teach them to speak.
-get the best chance to keep up and excel at school and succeed in life.
How does funding help EarGenie get into the clinics faster?
Until now the research team has been using a system designed to undertake research only. This system is too large and difficult to use in clinics.
Now that the concept has been proved using this multi-purpose device, our researchers have been able to custom design a prototype system specifically for hearing assessment in clinics
The new system is smaller, lighter, more automated and more portable.
In addition, we have assembled a highly trained team of engineers and clinicians to create a software system that is easy for clinicians to use.
Future support will allow the team to purchase more custom-designed devices for use in clinical trials across Victoria. We also need to support the recruitment and salary of team members for this important work.
Want to get involved?
To continue with our research and development, we need to test EarGenie on infants younger than 24 months old, both with and without hearing loss. If you are a parent or guardian and would like to be involved, or to find out more, please contact the team in East Melbourne on 03 9667 7569 or [email protected].
You might be interested in…
Electrical medical devices can be used to alter the activity of nerves to treat a wide range of diseases that aren’t responding to drug treatments.
At the core of this ‘electric medicine’ research lies the vagus nerve which runs from the brain to the gut and controls many processes in the body.
The cochlear challenge
Cochlear implants are amazing, but they’re not perfect. The sound heard through a cochlear implant is very different to natural hearing. That’s because there are 3,500 hair cells in the average human inner ear. Each cell can detect sound at a very specific frequency (pitch) and passes that information to a single auditory nerve cell.
Replacing 3,500 inner ear hair cells with 24 electrodes
In contrast, cochlear implant arrays have between 12 and 24 electrodes, which do the work of those 3,500 hair cells – a bit like trying to play Chopin’s piano concerto on a child’s electronic keyboard. Needless to say, it doesn’t sound the same to the brain!
Music can be distorted and background noise is an issue
Despite this, most people using a cochlear implant are able to understand speech and make sense of other sounds with relative ease. However, people can struggle to hear well if there’s a lot of background noise and music can sound distorted and often unpleasant.
Many of these issues stem from ‘current spread’. When electrodes generate an electrical pulse to stimulate the auditory nerve, this pulse doesn’t just stimulate the nerve cells it’s in direct contact with – it spreads to stimulate the cells nearby. This results in a messy, distorted signal being sent to the brain.
Is light the answer?
Light can be focused much more precisely than electrical pulses, and doesn’t spread as much, so using it to stimulate nerve cells could send more accurate signals about sound to the brain. Light LEDs are also much smaller than electrodes so more could be fitted into the cochlear implant.
A potential problem with this approach is that nerve cells in the inner ear don’t respond to light naturally. For this kind of implant array to work, nerve cells have to be programmed (by gene therapy) to produce a protein that can respond to light.
Modifying nerves to respond to light
Rachael’s team is investigating whether gene therapy can be used to modify auditory nerve cells so they respond to light. They’re also investigating whether the best approach might be a combination of light and electrical stimulation – where light finely tunes the signal, while the electrical pulse makes the signals faster, so sounds aren’t delayed in reaching the brain.
Promising results with a combination of light and electricity
The team recently published a paper in Scientific Report showing that a combination of electrical and light stimulation (called ‘hybrid’ stimulation) following gene therapy could improve the signals sent to the brain by cochlear implants. This could result in better pitch perception through an implant, leading to better hearing in background noise and when listening to music.
For more information, you can download the full RNID article or read more about Bionics Institute research into hearing impairment.
You might be interested in…
Electrical medical devices can be used to alter the activity of nerves to treat a wide range of diseases that aren’t responding to drug treatments.
At the core of this ‘electric medicine’ research lies the vagus nerve which runs from the brain to the gut and controls many processes in the body.
The scholarship means that I can buy a wearable wrist monitor for our research, and we can collect several physiological vitals and perform multi-modal analysis to refine our objective measures of stress in tinnitus.
Affecting about 1 in 5 Australians, tinnitus can severely affect a person’s quality of life. Ms Datta is hopeful that work being done by the Bionics Institute will lead to positive outcomes for those suffering from the condition.
“The tinnitus research being done by the Bionics Institute is really clinically significant because right now there isn’t an objective measurement of tinnitus or tinnitus-related stress – it’s more subjective and is based on what a patient tells us they’re experiencing.
“This is a great opportunity to contribute to that research. A lot of people will benefit from the work being done at the Institute and it has gained the interest of the medical community”, she added.
Ms Datta is currently completing her PhD at the University of Melbourne, investigating how wearable sensors can be used to measure and evaluate movement deterioration in stroke patients.
You might be interested in…
Electrical medical devices can be used to alter the activity of nerves to treat a wide range of diseases that aren’t responding to drug treatments.
At the core of this ‘electric medicine’ research lies the vagus nerve which runs from the brain to the gut and controls many processes in the body.
My video explains how people using cochlear implants currently have trouble hearing music, because the device was originally designed for hearing speech. The aim of my PhD research is to find ways to use a combination of light and electricity to improve the quality of sound heard via cochlear implants
Ms Ajay has been a student at the University of Melbourne since 2020 and will be undertaking two more years of research at the Bionics Institute to complete her PhD.
University of Melbourne Vice-Chancellor Duncan Maskell said: “The ability of researchers to explain their research so that it can be easily understood is an underrated skill.
“I am delighted that Elise’s clear explanation on the future of bionic hearing has been recognised by Universities Australia and I congratulate Elise on her award.”
The cochlear implant has helped over 700,000 people with hearing impairment worldwide since it was first invented at the Bionics Institute by University of Melbourne Professor Graeme Clark.
We’re very proud of Elise who is a great example of the high calibre of PhD students and researchers at the Bionics Institute. Robert Klupacs, Bionics Institute CEO
He said that combining excellence in research with the ability to communicate with members of the public is a skill encouraged at the institute.
“We focus on creating and improving medical devices that will change the lives of people living with conditions such as hearing loss, epilepsy, Parkinson’s disease, Crohn’s disease, stroke and diabetes.
“This research depends on people with these conditions being involved in clinical trials. Understanding the work of our researchers is a vital first step to encourage people to participate,” he concluded.