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[vc_row][vc_column][vc_column_text]Historically, much has been made of Australia’s record of innovation in medical devices and pharmaceuticals. Inventions such as the Cochlear Implant, the vaccine to protect against cervical cancer, spray-on skin and penicillin have long attracted the attention of medical professionals and the public.

Parallel to this, Australia has developed a world-class regulatory regime that facilitates patients’ access to these inventions both here and overseas, while maintaining high standards of public health and safety.

Not long ago, the 3D printing of medical devices – the personalisation of a device to suit an individual’s unique physical characteristics and medical needs – seemed like science fiction. Now it’s a reality, and Australia is leading the way, quietly maybe, but in a manner that is delivering to patients, Australian businesses and the economy.

As ever, this is thanks not only to cutting edge Australian scientific and manufacturing ingenuity, but also regulatory innovation, creating frameworks that help facilitate access to safe high quality products.

Since 2017, the Therapeutic Goods Administration (TGA) has been working towards a modernisation of the regulatory regime to achieve this.  With that process now rapidly heading towards implementation, new classifications of medical devices will provide novel regulatory pathways onto the Australian Register of Therapeutic Goods (ARTG) for mass “personalised” medical devices, which were previously categorised within the much broader “custom medical device” category.

This ground-breaking regulation will support a business environment that encourages innovation and investment, whilst facilitating Australian businesses to export their devices to the markets that need them. The TGA has clearly recognised technological changes in 3D printing and the impact this has had on the market for 3D-printed medical devices.

This is particularly reflected in the harmonisation of definitions relating to personalised medical devices, with the International Medical Device Regulators Forum (IMDRF), agreed in November 2019. This development is extremely important for Australian businesses.  The global leadership demonstrated by the Australian TGA, led in this role by Dr Elizabeth McGrath, cannot be overstated.  In short, it is Australian regulators who have set the gold standard now being implemented by their peers across the world.

For pioneering Australian companies, international harmonisation facilitates access to new markets and broadens existing ones. It supports further innovation by giving greater confidence that new devices will reach sufficient markets to support the investment needed to develop them, as well as local manufacturing facilities to produce them.

This harmonisation of the regulatory approach to 3D printed and personalised medical devices is an achievement of which the Australian Government, the Minister for Health Greg Hunt, and the TGA should all be justly proud. If, as expected, the Australian regime is the first of the IMDRF-harmonised regimes to accept applications for Personalised Medical Devices to enter the ARTG, there is a very real prospect that some of the most sophisticated medical device companies from around the globe will now consider an Australia-first lodgement strategy to facilitate the fastest possible pathway to certifying safety, efficacy and conformity prior to global export.

3DMEDiTech is one Australian company poised to take advantage of the new regulatory pathway onto the ARTG and international equivalents. This Melbourne-based company aims to deliver customised 3D printed devices and manufacturing services to the health sector across the Asia Pacific region and beyond.

Each medical device the 3DMEDiTech develops requires significant research and development to allow it to be rapidly mass personalised according to the prescription of the patients health care provider.  This includes mapping and interpreting the full spectrum of the clinical problems the device aims to address, the development and application of novel algorithms, and finding solutions to significant design, material and engineering problems.

Once all those challenges are addressed, the multidisciplinary collaboration of clinicians, engineers, mathematicians, programmers and technicians needs to ensure that the devices can be produced at scale for thousands of people.  The workflow is entirely digital. This means that they can deliver the fastest and most accurate design and delivery of customised devices to healthcare providers and their patients.

3DMEDiTech has also partnered with world-leading clinical and research partners including Melbourne University, St Vincent’s Health Australia, Orthokids and Ivoclar Vivodent. The company also recently joined as foundation industry partners of the Australian Research Council Training Centre for Medical Implant Technologies “CMIT”, headed by the University of Melbourne’s Professor Peter Lee.

Printed devices developed and manufactured in Australia by 3DMEDiTech include prescription clear aligners for by dental clinicians, orthoses for prescription by orthotists and prosthetists, plagiocephaly helmets (used to help infants’ heads form properly), leg braces and ankle foot orthotics.

While much of 3DMEDiTech’s work is still pre-clinical and not in the public domain, several of their lower risk-class devices are already in market and have been spun out into stand-alone commercial entities.

SmileStyler® www.smilestyler.com.au makes prescription-only clear aligners which has uniquely solved the primary clinical problem that had faced both dental professionals and patients.

Serkel® https://serkel.org/ makes personalised orthoses for prescription by orthotists and prosthetists which include plagiocephaly helmets (used to help infants’ heads form properly), bracing and ankle foot orthotics.

There is enormous demand for these products across Asia Pacific. Australian excellence in the research, development and manufacture of these first-rate devices is evident, and recognised.  So too is the role of the TGA in enhancing the reputation for safety and efficacy of the companies and devices they regulate.

The TGA has recognised the opportunities that exist not just for patients, but for Australian businesses in 3D printing, and has taken a global leadership role in advancing personalised medical devices. However, to fully realise the capabilities and ingenuity of Australian companies like 3DMEDiTech, an effective regulatory system is essential.

3DMEDiTech’s founder, Paul Docherty, said: “Our company operates at the forefront of this rapidly growing sector. But we couldn’t do that if the regulations weren’t being put in place to ensure market access and help achieve a return on the substantial investment necessary. In helping deliver international harmonisation in how to define and regulate these emerging devices, the TGA has helped support Australian businesses and jobs. It’s made it possible for companies like ours to continue leading the way in the research, design and production of outstanding printed, personalised medical devices for patients across Asia Pacific.”

Like all industries, there are rogue operators in 3D printing, but the TGA’s work ensures that unscrupulous companies do not undermine patients’ wellbeing and that companies like 3DMEDiTech thrive, delivering innovation, value and better clinical outcomes both to the Australian economy and health system.

Few people recognise what has been achieved in this field in the last three years.  That is a mistake – it’s an Australian success story in the making, and another triumph in the distinguished history of Australian medical innovation. It deserves to be celebrated.[/vc_column_text][/vc_column][/vc_row]

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