Why must Australia expand its global footprint in industry-sponsored medical device trials?

Medical: Australia has a significant opportunity to expand its role in global medical device trials, which have plateaued at around 10% of the country’s total clinical trials over the past five years.

Regulatory shifts like the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the EU, along with proposed changes by the FDA for in vitro diagnostic products (IVDs) in the US, are intensifying the burden of proof and timelines for medical device trials.

The demand for robust clinical evidence to drive adoption of devices by clinicians and patients is also increasing. Recent guidelines from the FDA on using real-world evidence (RWE) in medical device regulatory decisions and updates from the TGA on clinical evidence guidelines to improve the use of RWE in device applications highlight this trend.

Medical device trials in Australia account for 9% of industry-sponsored trial expenditure, with drug trials making up the remaining 91%. From 2015 to 2022, drug trials saw an average annual growth rate of 3.4%, whereas device trials only grew at 1.0% per year.

For over a decade, Medtronic and Edwards Lifesciences have chosen Australia for first in human clinical trials, citing the country’s rigorous ethics review process, expedited study commencement, and skilled healthcare workforce.

Both companies have conducted clinical studies locally for transcatheter aortic valve implantation (TAVI). Heart valve disease affects more than half a million Australians, with many unaware of their condition. Aortic Stenosis (AS) is the most common type, potentially leading to severe complications if untreated, including heart failure and death.

TAVI offers a less invasive alternative to open-heart surgery for AS patients, involving valve replacement via catheter insertion. This breakthrough has benefited many Australian patients, thanks to pioneering clinical studies for those with severe AS at high, intermediate and low risk of surgery.

Australian clinicians involved in the TAVI trials have become global leaders, serving as advisors, experts, and educators worldwide. Their expertise has been crucial in advancing therapy development and supporting broader access to innovative health technologies.

The nation boasts several centres of excellence in medical device research and development, such as SAHMRI and Monash University, which host national medical device registries. These registries facilitate patient recruitment, particularly for post-market studies.

To broaden the scope of clinical trial metrics monitored by the ANZCTR, it is essential to include phase and therapeutic area reporting for medical device trials, mirroring current practices for drug trials.

Australia has the opportunity to capitalise on its competitive advantages to attract more medical device trials. This effort will necessitate better promotion of the nation’s strengths as a clinical trials hub, similar to those that have made it a favoured destination for drug therapy trials.

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