China and India could steal a march on homegrown Aussie technology for 3D printing bespoke skull and bone implants, says Paul d’Urso, surgeon and founder of Anatomics.
Pioneering 3D printed skull and bone implant maker Paul d’Urso says China and India could steal a march on his home-grown technology if the Therapeutic Goods Administration doesn’t move quickly enough to approve the process.
The TGA currently only regulates manufactured devices. It has issued a consultation paper on the process of 3D printing bespoke bone implants, but Mr d’Urso is worried the Australian regulator will wait for the powerful US Food and Drug Administration to move first.
Anatomics, the company founded by Mr d’Urso 20 years ago, most recently had a bespoke ribcage and sternum 3D printed from titanium and polymer for American bone cancer sufferer Penelope Heller, who had had pain and trouble breathing with her off-the-shelf rib cage and sternum.
Ms Heller found Anatomics online and crowd-funded the operation. Mr d’Urso says Anatomics is 3D printing between 20 and 40 skull and bone implants each week, but needs regulatory approvals to get funding and deals with hospital groups to scale up.
Hospitals can make the implants on their own premises without the need for transport, storage and sterilisation, saving as much as 80 per cent on the cost of traditionally manufactured implants and providing a better match for patients, he said.
But Mr d’Urso fears the FDA is being lobbied by large US medical device manufacturers that want to slow the regulatory approvals process for 3D printed implants. By contrast, he says China and India – large potential markets for Anatomics – want to progress the technology.
‘‘If we don’t do it they’ll leapfrog us. They are doing it already,’’ Mr d’Urso said. ‘‘It’s where Australia has an opportunity to write the rules of the game.’’
Mr d’Urso, who has funded the business from private resources to date, is talking to private healthcare groups and government agencies about funding and deals to scale up the business.
Innovation and Science Australia chairman Bill Ferris cites the company as an example of the type of innovative company Australia needs more of to grow jobs through the commodity cycle.
Mr Ferris says in a speech on Friday that Anatomics’ plan to expand via ‘‘a distributed business model through a network of 3D printers owned and operated in accredited hospitals here and abroad’’. ‘‘Paul’s software and designs will be downloaded through this network, enabling surgeons to directly 3D print their patients’ prostheses using titanium powders sourced from processed Australian rutile,’’ Mr Ferris says.
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