Manufacturing companies in Australia are finding niches in the medical technologies sector as their traditional markets diminish, and South Australia is rapidly emerging as a key hub.

With the exit of mining and automotive component manufacturers from Australia, industry and government support have helped some firms evolve their advanced manufacturing skills and enter the medical technology market. Medical device production in Australia has grown by 1.3% annually since 2012 and is now valued at $3bn a year according to IBISWorld.

South Australia is emerging as a hub for the medical devices industry and is home to the Tonsley Innovation Hub and the Adelaide BioMed City precinct, a $3bn tripartite health hub comprising a major hospital, research centres and educational institutions. The Tonsley hub is located on the site of a former Mitsubishi car manufacturing plant in Adelaide, and major tenants include medical device manufacturer Micro-X, Siemens and ZEN Energy.

From automotive into medical

The downturn in world commodity prices has forced South Australian company Plastico and Hackett Engineering to shift its focus from mineral analysis equipment development to components for orthopaedic implants. The company first dabbled in medical devices in 2014 but has now decided to make it a major focus following collaboration with another Adelaide-based firm, Austofix.

Plastico and Hackett Managing Director David Schiller said 20 years’ experience making mining components had it well placed to succeed in the medical field: “The decline of the mining industry in Australia has forced us to look at other things. China seems to be commanding a large chunk of the mining components manufacturing and we have seen our business move there recently, which is hard. There is a large push for South Australia to transform itself into a medical device hub and there is an opportunity for us to do well here.”

Austofix has developed innovative orthopaedic trauma devices for more than 25 years including a device that allows surgeons to accurately insert an implant inside a bone without the use of x-rays. The Ezy-Aim Electronic Digital Targeting System and associated nails are used to repair fractures of the femur, tibia and humerus bones. Plastico and Hackett received a $47,500 grant from the South Australian Government to help it transition.

South Australia-based SMR Technologies is an independent division of SMR Automotive Australia focused on the design, manufacture and distribution of high-quality products for a broad range of industries. SMR Automotive is a leading car sensor manufacturer and developed the world’s first plastic automotive mirrors, earning it more than $160m in exports. However, the exit of the automotive industry from Australia also has it looking to medical devices.

SMR is working on a number of products including take-home tests for bladder cancer patients. The non-invasive devices use biosensors to test urine and aim to help people avoid uncomfortable follow up tests where tubes are inserted into the urethra to access the bladder.

In an industry-university collaboration in Adelaide, researchers from the University of South Australia and Flinders Medical Centre are preparing the device for a 1000-patient hospital trial. An SMR spokesman said the company was very interested in exploring more opportunities in the area of cancer research.

“Cancer is a global issue and we hope that these sensors will play a key role in the fight against the deadly disease,” he said.

The spokesman said preliminary results suggested it was a superior method to common cancer detections methods such as cytology and endoscopy.

Injectable medicine factory to set up in Tonsley

A groundbreaking ‘fill-and-finish’ injectable medicines factory will soon be opeining in Tonsley Innovation Hub, after securing crucial set-up funds in an investment round.

As reported in InDaily, biopharmaceutical company GEN1 last year revealed its aim to create up to 200 new jobs and inject around $650m into the state economy over a decade with its new operation pending the establishment of a suitable site and international investment. These caveats have now been met, after a funding round raised $8m through Australian private equity investors, local banks and the South Australian Government’s Health Industries Fund.

GEN1 Chief Financial Officer Kishen Vijayadass said the initial investment round “will support the company’s delivery of a factory in Adelaide that will benefit all Australians”.

“Adelaide has a vibrant, fast-growing life sciences community and the South Australian Government, through Health Industries SA, was very responsive to GEN1 and provided invaluable support,” he said.

The company says its planned 15,000sqm factory, which would formulate base compounds into medicines to fill syringes, vials and cartridges as ready-to-use injectables, will be the first of its kind and scale in the country. Australia currently imports injectable medicines for chronic conditions such as cancer, hypertension and diabetes. The national market for injectable medication exceeds $10bn annually and is growing by 15%-20% cent a year, according to IMS Health.

Health Industries SA CEO Marco Baccanti said GEN1 would be a boon for the state’s health system, with “the potential to save SA up to $70m a year in medication spending”.

“GEN1 will be in a great position to provide high-quality cost-effective products, and it will be doing so locally, right here in Adelaide,” he said.

Lightweight X-ray machine gains FDA approval

AN Australian-made lightweight x-ray machine set to revolutionise mobile radiography has been given approval by the Food and Drug Administration (FDA) in the US. Micro-X recently announced to the Australian Stock Exchange (ASX) that the FDA had determined the “substantial equivalence” of its DRX Revolution Nano, meaning it can now market the product in the US.

The 510 (k) approval is the first regulatory approval for a carbon nanotube powered x-ray product following a collaboration between the South Australian company and US-based Carestream Health, a global leader in medical film and digital imaging solutions. To be sold in up to 130 countries, the DRX Revolution Nano uses carbon nanotube technology to dramatically reduce weight and increase portability.

Micro-X established its headquarters at the Tonsley Innovation Hub in Adelaide, in January 2016 in preparation for the production of its lightweight machines. It has since manufactured a small number of pre-production carts, which have been through a detailed validation process.

Micro-X Managing Director Peter Rowland said the product would use Carestream’s DRX digital detector and the company’s global marketing and distribution reach.

“We are pleased and proud to have achieved this highly significant milestone in the Nano’s commercialisation program,” he said. “Our focus now is on supporting Carestream’s upcoming trade trials and preparations for volume production at Tonsley with our supply chain partners.”

About half of Micro-X’s staff previously worked at General Motors’ Holden car assembly plant in Adelaide, allowing Rowland to use their production line expertise to streamline his own manufacturing process.

“So much of it is about the supply chain,” he said. “We can build one of these things in four hours so we can be very flexible to respond to market demand but it comes down to how many parts are on our shelves. Therefore managing the supply chain is a big part of what we’re doing.”

The machine’s sleek and compact design, coupled with the carbon nanotube technology and an advanced lithium iron phosphate battery helps it achieve a weight of about 93kg. Carestream’s previous model weighs in at 567kg. The lighter weight also means the machine does not need a motor to move around, making it easy to transport and position in cramped critical care areas.

Micro-X has capacity to build four machines a day on a single shift but its facility can be extended to meet demand.

The carbon nanotube technology that makes the lightweight machines possible was developed at the University of North Carolina and partially at Duke University in the US. Micro-X has the sole rights to apply the technology in the field of mobile medical. Micro-X has a contract with the Australian Department of Defence to develop and demonstrate the technology of an ultra-lightweight, digital mobile x-ray, which is optimised for use in military deployed medical facilities. It also has a contract to develop a small, lightweight, Mobile Backscatter Imager (MBI) system for stand-off imaging of Improvised Explosive Devices.