Designed by Queensland University of Technology (QUT) Associate Professor Devakar Epari and Dr Markus Windolf from the AO Research Institute Davos in Switzerland, the biphasic plate aims to achieve the fast, robust, healing of long bone fractures — specifically those occurring in the distal femur — through an innovative design allowing patients to confidently weight bear while maintaining the integrity of the fractured site using a novel semi-flexible plate.
The project was originally onboarded in 2019 by 41medical under the Head of R&D Silas Zurschmiede and Head of Quality and Regulatory Affairs Andreas Lanz, achieving milestones in design input and output, and undergoing development of the first two zero series and an initial clinical trial.
The device’s novel transverse slot differentiates the biphasic plate from traditional alternatives, giving the fracture fixation device conflicting properties of flexibility and strength to provide adequate stimulation for healing whilst enabling full post-operative weight bearing without risk of implant failure.
QUT Associate Professor Devakar Epari said while the majority of product development took place in Australia, the cooperation with the AO Research Institute, the funding and guidance by the AO Development Incubator and the partnership with 41medical in Switzerland was integral in the development of the project in terms of accessing industrial quality management processes and unique manufacturing capabilities which, until now, have been unavailable onshore
“Our partnership with leading medical manufacturing organisation 41medical in Switzerland has been vital in transforming what was an initial design concept into a viable and fully commercial MedTech device, capable of revolutionising the treatment of long-bone fractures across the globe,” he said.
“Now with the establishment of subsidiary company 61medical in Australia, this type of advanced manufacturing capability and rich pool of knowledge on product development is available in Australia, eliminating the challenges and lead times associated with distanced collaboration and manufacturing.”
Now in the validation and verification phase with a final design and fixed supply chain in place, the biphasic plate project is set to undertake manufacturing of its third zero series later this year with the implants to be used in a robust clinical trial.
Following third zero series production taking place later this year, the biphasic plate may be available to surgeons as early as 2021.
61medical Board Chair Ian Walker said it is timely that 41medical and the State Government are joining forces to establish MedTech manufacturing in Queensland to help accelerate the development and commercialisation of Australian-born medical devices such as the biphasic plate for the global market.
“At 61medical, our focus is on manufacturing high-value medical technology to provide intelligent, connected health care options, to help improve quality of life for patients across the globe,” he said.
“By producing medical devices on our own soil, our Australian researchers can be confident in the process and quality, and can maintain a close eye on the manufacturing process, which can be difficult if the manufacturing is taking place overseas.”
61medical is currently investigating several opportunities to ensure a pipeline of investment ready opportunities when it commences operations in January 2021.
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