Australian regulators are lagging global rivals on the use of software and artificial intelligence in medical products, leading to commercialisation problems that sends promising companies moving overseas.
According to Queensland-based artificial intelligence and machine learning developer Max Kelsen’s chief executive Nicholas Therkelsen-Terry, Australia’s Therapeutic Goods Administration (TGA) is simply not as advanced as the US Food and Drug Administration (FDA) in terms of software-as-a-medical-device.
This is the use of software-based devices for medical purposes, such as smartphone apps, x-ray image processing software and computer programs that use data on patients to make a diagnosis.
Australian regulations for these products are based on more conventional medical devices, and it has proven slow and difficult to commercialise them locally, Mr Therkelsen-Terry said.
“We’ve seen that the FDA is somewhat more mature in their approach than the TGA is at this stage. The FDA’s most recent discussion paper on AI-as-a-medical-device had clarity and maturity in risk management of these products and provides more guidance,” Mr Therkelsen-Terry told InnovationAus.
“The challenge is there is not a clear path or clear set of requirements. The quality management process leaves many of the best practices down to the individual company to come up with, and there’s sometimes a mismatch.”
This means many promising MedTech companies are forced to look offshore to commercialise their products, Mr Therkelsen-Terry said.
“The current path for people in this sector is to look to the FDA first – to go to the US first. There’s no advantage of going here first. The TGA is every bit as difficult as the FDA, but the FDA doesn’t care if you’ve got the TGA and the TGA cares if you’ve got the FDA. So, you go there first. There’s a gravity shift of early-stage work moving towards the US,” he said.
“It’s a real problem that we have. If we had clearer regulatory paths that would make it much easier to get a product up here and that would help products stay here in Australia. At the moment there’s a very strong gravitational pull to the US because of the current structures.”
Max Kelsen has nearly doubled its workforce in the last six months, up to about 40 people. The company works with clients on machine learning and AI solutions in a number of sectors, with a particular focus on healthcare.
The company has recently hired Dr Navid Saidy as its quality and tech transition leader, whose primary role is to help accelerate the commercialisation of software-as-a-medical-device products.
“The role is focused on getting our research partners and industry partners to be compliant with regulatory pathways in different jurisdictions and establishing quality management across businesses based on the relevant standards that are available. It’s to get them up to scratch with those requirements,” Dr Saidy told InnovationAus.
Dr Saidy will also consult with the TGA and providing submissions in an effort to improve the Australian regulatory framework.
“There’s a need to have a strategy around AI-based software that is adaptive and can learn from use and improve performance as time goes on, [and] for the TGA to have a more forward thinking, pragmatic approach to addressing these issues and to engage with leaders who have been dealing with this issue on a daily basis,” he said.
“The whole point is for a risk-based approach that is pragmatic and delivers the best outcomes for patients, and that’s only facilitated with good consultation with companies.
“The position around software-as-a-medical-device is basically to just follow the current regulations on normal medical devices. This poses a number of challenges for people who are active in the space to translate a product into market.
“What we’re doing in this space can be a very good backbone and foundation for other companies to start engaging with and to build a better understanding of the requirements across industry and universities.
“Widespread adoption can enable better commercialisation outcomes and put Australia on the map for having this core capability here, that is the development of products compliant with regulatory requirements across the markets.”
A number of TGA reforms planned for this year were postponed due to the ongoing COVID-19 pandemic.
In February the TGA released a consultation paper seeking feedback on clarity around software-based medical products, and the potential for some to be exempt or excluded to ensure there is not unnecessary regulatory burden.
The reclassification of certain software products has also been delayed until next year.