Improved feedback mechanisms in DHTs could serve to improve patient safety by making warnings about potential safety issues clear at an earlier point in time. Credit: SOMKID THONGDEE / Shutterstock

Recent years have seen a broad range of artificial intelligence (AI)-assisted Digital Health Technology (DHTs) come to market. However, there is no system in place for real-time data reporting for these devices, which could highlight incidents where there are safety issues.

In a paper published in February in Nature Medicine, a research team including authors from the Else Kröner Fresenius Center (EKFZ) for Digital Health at TUD Dresden University and the UK’s Nuffield Department of Surgical Sciences at the University of Oxford, have proposed the integration of transparent and mandatory feedback collection mechanisms directly into the user interfaces of DHTs, with feedback linked to a national platform.

According to the paper, such measures could significantly improve user experience, increase patient safety by the early identification of any problems, reduce the administrative burden in monitoring tools, and heighten public confidence in devices of this nature.

A core idea of the paper is that implementing real time feedback into DHTs device around potential issues could enable them to be addressed sooner, before significant adverse events (AEs) resulting in severe injury or even death could occur.

Medical Device Network sat down with Rebecca Mathias, lead author of the paper and a researcher in the team of Professor Stephen Gilbert at Else Kröner Fresenius Center (EKFZ) for Digital Health at TUD Dresden University of Technology to learn more about the paper’s rationale.

Mathias discussed the drawbacks of current AE reporting, the barriers towards implementing real-time feedback, and the advantages such a plan could realise in enhancing the safety of AI-enabled DHTs.

Rebecca Mathias: ​​​​​​​The regulations we have that govern DHTs were primarily made for more traditional medical devices like hip implants or pacemakers.

But with DHTs, there is a world of difference. It is not that the European Union’s Medical Device Regulation (EU MDR) does not take this into account to some extent, but there are aspects of digital devices that still behave quite differently, and regulation doesn’t keep pace with the nature of digital devices, including in how quickly they can change, be modified, and the general pace at which they are being developed.

One of the biggest problems areas identified in our paper relates to device problems. Within the EU, manufacturers of devices classified as low risk do not have to do an in-human trial as part of their market approval process. Most digital medical devices will likely fall into this category, meaning a lot of the problems identified are only identified post-market. This puts a lot of pressure on post-market surveillance and feedback and ensuring that manufacturers observe and follow the safety of their devices once they have launched on the market.

If there is an AE, most countries have a requirement where they can be reported in a national system or on a governing platform. However, the scope of what constitutes an AE event may be unclear to users and clinicians.

The point we try to make in the paper is that if we start to gather data around potential issues with a DHT early on, there’s strength in numbers. If you have one or two users reporting a problem, maybe you don’t take it as seriously, but if there is a large number of people reporting a problem, then that’s probably something wrong with the device, and something worth paying attention to.

We consider feedback from direct users, like patients or healthcare providers, to be very powerful, and we don’t believe that their voices are being heard enough in the healthcare system that we have as it is. Regarding DHTs, rather than calling this a gap, the provision of real time feedback is really more of an advantage that digital devices could offer due to their digital nature. What’s to stop a bidirectional flow of information where users can also provide their feedback?

With this feedback, hopefully the manufacturer takes it seriously and does something about it, but there have been cases where that has not been done. If feedback was linked to a national platform, this would create some kind of accountability in the system, just by making this information public. And it’s not an improbable solution. It’s actually quite feasible in terms of technical capacity. We have an idea that we think can work; and we just need the right people, such as the regulators or those who run the national platforms, to implement it.

​​​​​​​Rebecca Mathias: Feedback is integrated in some digital health applications, but what’s being done with that feedback really matters. It’s not enough to get feedback if it falls on deaf ears. In cases where it is present, it has not always been given the attention it deserves.

Another factor is the likelihood of pushback. In talking about radical transparency, there are going to be players in the system who would not be in favour of making data public regarding problems with their devices.

Our paper points to the prospect of app store style ratings for DHTs that exist in other marketplaces; and if companies have a good device, this degree of transparency should not be much of a concern and could even give them a competitive edge.

Rebecca Mathias: ​​​​​​​I would say that it comes down to the plain regulatory will to make it happen. And it would not necessarily even have to be a change in legislation. If you follow the MDR, for example, within the EU, you could have an implemented act and guidance to clarify.

Feedback and post-market reports, like prompts and outcome measures are already required. We just don’t have a structured way of doing this, so I wouldn’t even say we would have to change the fundamental purpose of legislation like the EU MDR, but rather the way it is currently implemented.

This could be done in the form of guidance, but it could also be done in other ways, to incentivise manufacturers to use this approach. If we make other options seem less feasible, and we incentivise the option where manufacturers integrate this feedback into their systems, this could be a way of making it work. For example, the provision of implementing a feedback system could be made a requirement for reimbursement.

We envision this as a two-part system, in which feedback is gathered and also linked to a national platform where some amount of this data is made public and transparent.

Rebecca Mathias: ​​​​​​​With the implementation of a system like this, patients would have a voice, which has not always been given due consideration before, and this would help in identifying safety issues early on. Considering the processing power we have now, it can be just from simple thresholds and maybe even towards predictive analysis. If you bring AI in, that’s a whole different stream of how you can analyse data.

Such a system could also potentially be integrated, on a much later scale, with a patient’s health record. When we talk about unifying the patient’s data in one place, the system could also be more tailored towards extracting data from hospital systems.

A big difference between current AE platforms is that a system like this could also be used for positive feedback, where manufacturers can use it to improve the usability of their device, see what features work better and generally learn from their direct user requirements.

But the strongest factor, I would say, is that a system like this could result in improved safety for patients, which of course ends up being the most critical point in terms of life and death or injury or harm.

GlobalData’s business fundamentals senior analyst Ophelia Chan says: “Oncology continued to dominate as the leading therapeutic area for IPOs this year, highlighted by CG Oncology’s $437m upsized IPO—the largest and first of the year. The company’s robust clinical data and ability to secure substantial capital have contributed to its strong performance in 2024.”

After a quiet summer, the IPO market reached full swing in autumn when Bicara Therapeutics, Zenas BioPharma, and MBX Biosciences all opened on the NASDAQ on the same Friday in September. The ‘triple-header event’ saw the three companies pull in over $700m combined. It was no surprise that the surge in activity came after the Federal Reserve’s decision to lower interest rates for the first time in years, ushering in a more inviting funding environment. This fruitful month was a stark contrast to August, which saw a significant global stock market dip amid fears of a US recession.

In June, Telix Pharmaceuticals – an emerging player in the fast-growing radiopharmaceutical space – pulled a last-minute plug on its IPO. The Australian company had been planning to list on NASDAQ and was on course to raise $232m – a value that would have placed it high on the list of biotech IPO sizes this year. Telix cited that its board did not move forward with the plans due to market conditions at the time.

Numb feet, bleeding legs and dehydrated bodies mark their journeys – not to mention infectious diseases and psychological trauma. Studies have identified outbreaks of measles, diphtheria and malaria across Venezuela, while tuberculosis, typhoid and HIV, are also resurgent.

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.

J&J’s potential exit from the neurovascular market follows a trend among medtech leaders such as Medtronic and Stryker. Credit: Michael Vi / Shutterstock

The Financial Times recently reported that Johnson & Johnson (J&J) is considering the sale of Cerenovus, its neurovascular division. This aligns with a broader industry trend where companies are shifting toward high-growth, high-margin markets, and focusing resources on areas with higher perceived growth potential.

The neurovascular market, estimated at $4.2bn in 2024 by GlobalData, is becoming increasingly specialised and competitive. Major players such as Stryker, Medtronic, and Terumo control about 68% of the global neurovascular market, making it challenging for mid-sized companies such as Cerenovus to scale effectively. J&J’s acquisitions of Abiomed for $16.6bn, Shockwave Medical for $13.1bn, and V-Wave for $1.7bn highlight a commitment to the cardiovascular interventions sector, which is expected to outpace the neurovascular market.

The success of neurovascular interventions relies on rapid device application, as effective treatment must occur within minutes to hours of symptom onset. This time constraint limits market growth despite the rising demand for stroke treatment. To succeed in this market, companies must go beyond technological innovation. As stroke care evolves, improving treatment protocols, accelerating the adoption of new devices, and expanding access to life-saving interventions are critical. A multi-pronged approach is key to growing the neurovascular market, shifting toward faster, more efficient solutions to meet increasing demand. While larger, more established players with significant market share are likely to lead these innovations, this dynamic also creates opportunities for disruptive competitors to tap into underdeveloped market segments.

J&J’s potential exit from the neurovascular market follows a trend among medtech leaders such as Medtronic and Stryker, which have refocused on high-growth markets. Medtronic divested its patient monitoring and respiratory businesses to concentrate on core markets, while Stryker expanded through acquisitions in digital surgery and neurovascular care. J&J’s potential move reflects a similar strategy to strengthen its position in cardiovascular care.

While this shift could provide short-term financial benefits, it risks limiting J&J’s ability to capitalise on the growing demand for advanced stroke care. Medtronic, Stryker, and Terumo have successfully invested in both the cardiovascular and neurovascular markets. Terumo strengthened its neurovascular portfolio with the 2016 acquisition of Sequent Medical and its innovative WEB aneurysm treatment device. While the cardiovascular market remains Terumo’s primary revenue driver, its ongoing investment in the neurovascular market has enabled it to capture new growth opportunities and monopolise the emerging intrasaccular flow device sector.

With the ageing population and rising stroke rates, health systems are increasingly prioritizing stroke interventions and expanding access to thrombectomy procedures. Additionally, AI is transforming stroke care, improving detection and triage. These developments make neurovascular care an attractive long-term opportunity for companies investing in these advancements.

Ultimately, J&J’s potential exit could provide short-term financial gains, but it may forfeit long-term growth in the evolving neurovascular sector. As J&J shifts resources to cardiovascular care, competitors such as Medtronic, Stryker, and Terumo may strengthen their foothold in neurovascular care, shaping the future of stroke care.

GlobalData’s business fundamentals senior analyst Ophelia Chan says: “Oncology continued to dominate as the leading therapeutic area for IPOs this year, highlighted by CG Oncology’s $437m upsized IPO—the largest and first of the year. The company’s robust clinical data and ability to secure substantial capital have contributed to its strong performance in 2024.”

After a quiet summer, the IPO market reached full swing in autumn when Bicara Therapeutics, Zenas BioPharma, and MBX Biosciences all opened on the NASDAQ on the same Friday in September. The ‘triple-header event’ saw the three companies pull in over $700m combined. It was no surprise that the surge in activity came after the Federal Reserve’s decision to lower interest rates for the first time in years, ushering in a more inviting funding environment. This fruitful month was a stark contrast to August, which saw a significant global stock market dip amid fears of a US recession.

In June, Telix Pharmaceuticals – an emerging player in the fast-growing radiopharmaceutical space – pulled a last-minute plug on its IPO. The Australian company had been planning to list on NASDAQ and was on course to raise $232m – a value that would have placed it high on the list of biotech IPO sizes this year. Telix cited that its board did not move forward with the plans due to market conditions at the time.

Numb feet, bleeding legs and dehydrated bodies mark their journeys – not to mention infectious diseases and psychological trauma. Studies have identified outbreaks of measles, diphtheria and malaria across Venezuela, while tuberculosis, typhoid and HIV, are also resurgent.

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.