Australian enterprises specialising in innovative medical devices are showing the world what our technology and design have to offer. An exciting new R&D facility for innovative medical technology devices, Neo-Bionica will be officially opened in late August in Melbourne. By Carole Goldsmith.
A joint venture between the Bionics Institute and The University of Melbourne, and located in St Vincent’s Hospital, Neo-Bionica actually already commenced operations in June this year. The purpose-built, highly specialised laboratory is equipped with the latest clean-room technology, cutting-edge robotic equipment, enhanced 3D printing and precision engineering tools that are needed to develop and manufacture prototype medical devices for clinical trials.
The driving force behind the new facility, Bionics Institute’s CEO Robert Klupacs, advises that Neo-Bionica will provide Australia with the capability to build clinical-grade medical devices, increasing the speed from initial concept to clinical application. On a site tour of the facility, there’s a cabinet near the entrance displaying a range of medical devices developed by the Bionics Institute in collaboration with other organisations and now by Neo-Bionica researchers.
Among the items on display, there are: an electrode designed to stimulate the vagus nerve, for use in the treatment of inflammatory bowel disease; a Bionic Eye implanted during clinical trials in 2018; EpiMinder’s Minder device, which monitors seizures related to epilepsy and is now undergoing clinical trials; and a Cochlear ear implant, originally developed by the Bionics Institute team.
Neo-Bionica has two clean rooms: one with a Coherent laser cutter; and the other a fully equipped manufacturing workshop, with a Modela Pro-ll MDX-540 3D milling machine, a Ryobi EDP 252 drill press and a HAFCO Metal Master drill press among the range of machines.
Electronics engineer and Neo-Bionica research fellow Alex Thompson says that he “likes making things” and he is certainly in the right place for it. He points to the 3D printers and the resin printer in the second laboratory workshop. There’s a model of a skull on the wall, which Thompson explains was used to stress test implants in the Bionic Eye.
The University of Melbourne’s Chair of Medicine and Director of Neurology at St Vincent’s Hospital, Professor Mark Cook’s consulting rooms are adjacent to Neo-Bionica’s entrance. He says that the new facility will enable clinicians, scientists, engineers and industry partners to collaborate closely in the quest to find solutions for people with hard-to-treat diseases like epilepsy. Professor Cook is leading the medical research team behind Epiminder.
Klupacs advises that Neo-Bionica is set to fast-track treatments for people with epilepsy, urinary incontinence, Crohn’s disease, Parkinson’s disease, Alzheimer’s disease, hearing loss, stroke, arthritis and diabetes. He’s been the Institute’s CEO for more than four years and has more than 30 years of international corporate experience in technology development, mainly in the fields of medical technologies and biotechnology. Trained in pharmacology and biochemistry, Klupacs is also an Australian registered patent attorney and the founder of 33 companies in Australia and Singapore.
“EpiMinder is one of those companies which has come out of the Bionics Institute,” advises Klupacs. “It’s developing Minder, an ultra-long EEG (electroencephalography ) implant to monitor brain activity to improve the standard of care for epilepsy sufferers. Minder monitors the number of seizures in people with epilepsy. Specialists are able to analyse the device’s readings to assess when and how many seizures their patient has had, to assist in epilepsy seizure management. The device will eventually be able to warn people when they are going to have a seizure.
“We were lucky enough to bring Cochlear into the EpiMinder venture as a partner and a major shareholder. EpiMinder is currently undertaking clinical trials for Minder, and we are hoping for FDA (the US Food and Drug Administration) and TGA (Australia’s Therapeutic Goods Administration) approval in two to three years.”
Klupacs adds that in the past, Australia has relied on overseas companies to build prototypes and manufacture the latest medical devices for use in clinical trials.
“One example of this was when we developed a vagus nerve stimulator device for inflammatory bowel disease,” he explains. “We designed it and built a prototype but we had to have it manufactured in Minnesota at a cost of over a million dollars in 2018-19. The US plant had facilities we could not find in Australia, including cleanrooms, documentation and quality systems. And that’s why we have set up Neo-Bionica, to provide that service.
“If you want to get the next generation of Australian-manufactured medical devices, you need a PhD-trained capability, like we have at Neo-Bionica,” he adds proudly. “Our vision is to create a med-tech manufacturing hub in the future.”
While Neo-Bionica will undoubtedly help to lay the foundations for a strong medical devices sector in this country in the years to come, Australian manufacturers have already been moving forward, and collaborating, on innovative new projects – spurred on in part by the COVID-19 pandemic.
Carole Goldsmith has shares in Cochlear