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Moving towards rapid regulation of AI for the medical device market
One of the primary challenges in regulating AI in medical devices is the volume of fragmented standards.
The US FDA currently has over 200 individual standards related to AI in healthcare. Credit: earth phakphum / Shutterstock
As AI continues to revolutionise the medical device industry, regulations are struggling to keep pace. While AI holds immense promise for improving patient outcomes, ensuring safety, and enhancing clinical efficiency, the evolving landscape of AI technologies including predictive and generative AI presents new challenges for regulators, industry stakeholders, and clinicians alike.
One of the primary challenges in regulating AI in medical devices is the volume of fragmented standards. The US Food and Drug Administration (FDA) currently has over 200 individual standards related to AI in healthcare, yet does not have a universally accepted framework or set of best practices. This lack of cohesion complicates the regulatory process, leading to potential confusion for companies trying to navigate the regulatory landscape. Efforts are underway to develop more unified, international guidelines for AI in healthcare, but achieving a consensus across diverse global stakeholders remains a significant hurdle. A collective shift toward standardised, evidence-based practices is critical in ensuring both the safety and efficacy of AI technologies across borders.
In the regulatory landscape, predictive AI and generative AI must be treated differently due to their distinct functionalities. Predictive AI has been used in medical devices since 1995 and involves locked algorithms that are designed to provide forecasts or diagnoses based on historical data. These systems are often considered ‘trusted’ and undergo rigorous premarket testing to ensure their performance. In contrast, generative AI creates new content or solutions (such as images, text, or data models) and is still relatively new in healthcare applications. Its use in medical devices raises additional regulatory concerns due to its more dynamic, evolving nature. As generative AI technologies continue to develop, regulators are tasked with crafting new guidelines that strike a balance between innovation and patient protection.
A key area of focus for AI regulations is the post-market life cycle. Unlike traditional medical devices, which can be static once approved, AI-based devices may evolve over time through software updates and refinements. This means regulators must account for continuous post-market review and oversight. Predetermined change control plans have become a crucial part of the regulatory framework, especially as AI algorithms can be updated or tuned after deployment. The question of how to balance innovation with patient safety remains central. Regulators and companies must work collaboratively to ensure that modifications to AI systems – whether they involve local adjustments for specific patient groups or broader updates – do not compromise performance or safety.
DPIs offer drastically reduced emissions
On October 14, ENCHE announced its initiative to train 10,000 medical students in what it calls ‘green prescribing.’ ENCHE, a consortium of institutions led by the University of Glasgow, stated that over the next three years, it aims to help students manage healthcare in the context of climate change.
Students will be taught to treat conditions exacerbated by climate change and to push environmentally friendly therapies, including DPIs. Supported by the World Health Organization, AstraZeneca, GSK, and Novo Nordisk among others, the network seeks to offer education in constituent medical schools and to influence national curricula to follow suit.
Another supporter of this initiative is Dr. Christer Janson, professor of respiratory medicine and allergology at Uppsala University, Sweden, who has researched the potential environmental impact of switching to DPIs.
In a 2019 paper, Janson calculated that pMDIs produce a carbon footprint 20–30 times larger than that of DPIs. Although the volume of an inhaler’s propellant may be small, the hydrofluorocarbons (HFCs) that are often used in these inhalers can have greenhouse effects 1,400 times greater than carbon dioxide.
Janson likens dropping pMDIs for DPIs to a person becoming vegetarian or switching to an electric car.
In the same paper, he stated that 70% of inhalers sold in the UK in 2017 were pMDIs compared to 13% in his native Sweden; applying Swedish DPI use to the UK would result in an annual emissions reduction equivalent to 550,000 tonnes of CO2. “It would reduce the carbon footprint of the NHS by about 3–4%,” he says, driving home the importance of such a change.
Reduced emissions on this scale are particularly relevant to the pharmaceutical industry. Not only is it a major contributor to climate change, being more emissions intensive than the automotive industry, but it is also notably vulnerable to its consequences. A volatile climate poses a serious threat to international supply chains, while vast water supplies are needed to support research and manufacturing.
“We do this all virtually on the computer, so we can make the osteotomy in multiple different places to decide where the most appropriate place to do the correction is.”
From here, relevant standard orthopaedic plates are selected for use in the surgery.
Following these preliminaries, surgical guides, jigs, and plastic models of the patient’s anatomy, in this first case the radius, are 3D printed and then sterilised for use in surgery.
“We make sure that the guide fits the bone in the patient exactly the way we planned for it to fit on the plastic bone. Once we have made sure that’s the case, we secure the guide to the bone with wires, and then we do whatever the plan has been,” says Lattanza.
In osteotomy, such plans generally involve drilling holes and then making the necessary bone cuts.
The great thing about this approach, Lattanza states, is that all that needs to be done to ensure the correction has been completed as planned during the surgery is to line up those holes.
She explains: “If the bone is rotated off 90° and when we drill those holes, they’re off 90° on the bone, we make the cut then we rotate and line up those holes to put the plate on because the plate holes are straight, and that’s how we know that we’ve got the correction.”
Beyond making relatively common osteotomies more accurate, a 3D provision also allows for more complex cases to be worked upon. Lattanza relays a recent case in which a child had broken the radius and ulna bones in their forearm.
“During the time that she was growing, this deformity got ‘very 3D’, meaning it was off in the sagittal, coronal, and axial plane,” says Lattanza.
“You can’t see the axial plane on an X-ray, and if you can’t see it, you can’t correct it.”
In this case, the procedure required two cuts in the radius to restore it to normal anatomy, and one in the ulna.
“In my career prior to having the 3D technology, that’s something that is difficult or impossible to plan and to execute in the operating room, because you wouldn’t even be able to see that you needed two cuts to make it normal again,” explains Lattanza.
Lattanza is keen to add that the influence of 3D printing on preoperative planning and during surgery should not be a cause for complacency, particularly given that there remain limitations to 3D visualisations of CT scans, chiefly in that the current technology cannot show soft tissue.
“Some people think that this is kind of a phone it in now, but that’s not how it works,” she says.
“This is a collaboration between an engineer and a surgeon, and it has to be that way to get a good result.”
Once we see where those changes are, we can plan where we’re going to cut the bone.
Dr Lattanza
Astrocytes are a type of neural cell that builds the BBB, and Excellio plans to derive exosomes from them to make them even better at targeting the brain. Credit: ART-ur / Shutterstock
Caption. Credit:
Phillip Day. Credit: Scotgold Resources
Total annual production
Australia could be one of the main beneficiaries of this dramatic increase in demand, where private companies and local governments alike are eager to expand the country’s nascent rare earths production. In 2021, Australia produced the fourth-most rare earths in the world. It’s total annual production of 19,958 tonnes remains significantly less than the mammoth 152,407 tonnes produced by China, but a dramatic improvement over the 1,995 tonnes produced domestically in 2011.
The dominance of China in the rare earths space has also encouraged other countries, notably the US, to look further afield for rare earth deposits to diversify their supply of the increasingly vital minerals. With the US eager to ringfence rare earth production within its allies as part of the Inflation Reduction Act, including potentially allowing the Department of Defense to invest in Australian rare earths, there could be an unexpected windfall for Australian rare earths producers.
