Australia’s MedTech advantage: Speed, predictability, and high-quality clinical data 

Moderated by Joseph Panetta, Chief Marketing Officer at Ascend CRO, the panel “Australasia: A Clinical Research Destination” brought together Vanessa Gallois, Senior Director of Clinical Affairs at HighLife SAS; Pedro Eerdmans, Clinical Strategist; and Youssef Biadillah, CEO of BariaTek Medical. Held during MedTech Malta 2025, the session explored why Australia has become a preferred destination for early-stage and pivotal MedTech clinical trials, especially for startups seeking speed, quality data, and regulatory alignment with global authorities. 

Sponsored by Ascend CRO, Panetta opened by noting that “quality data is the fuel that propels your next milestone,” highlighting the need for startups to understand site selection, enrollment, and CRO partnerships. He invited panelists to share their firsthand experience navigating Australia’s trial environment.

Building the right foundations for clinical trials 

Pedro Eerdmans began by stressing the importance of clarity at the earliest stage. “I always start with the basics,” he said, pointing to the need to define indication for use and select the appropriate patient population. He added that “every data point is important,” even in a first study, as it will be needed later during submissions. 

Youssef Biadillah shared similar priorities from a startup perspective. “Time is the most expensive commodity for a small company,” he said, explaining that the main question becomes how to generate data “recognised in Europe and most importantly, recognised in the US in the fastest and most economical way,” noting that “in most cases… it was Australia.” 

Vanessa Gallois highlighted regulatory planning as a critical early step. “I also take into account the regulatory pathway at the very early stage,” she said, adding that shaping clinical strategy early prevents misalignment with CE-Mark or FDA evidence requirements. 

Regulation, timelines, and the value of predictability 

Throughout the discussion, the panel underlined how Australia reduces uncertainty. Eerdmans explained that regulatory strategy influences trial design and even pricing later. “A fast 5-10K route can be extremely bad for you if you want to have another pricing,” he noted. 

Gallois described Australia as a destination that “hits a lot of bullet points,” offering reliable data, predictable timelines, and consistent site contracting and budgeting. She added that “capacity is also very predictable” based on her experience. 

Biadillah reinforced the importance of a streamlined system. “You’re only dealing with one contact point and everything is streamlined,” he said, pointing out that this differs from other regions where companies must work through ethics committees, hospitals, and several regulatory bodies. 

Speed-to-trial and site performance 

Speed remained a dominant theme. Gallois noted that “time is money and money is tight,” making site initiation and first patient enrollment essential milestones.  

“Preparation, preparation and preparation,” she emphasised, crediting strong local CRO support for enabling early starts. 

Biadillah pointed out that Australia allows companies to move quickly from first contact with authorities to first-in-human. “Those same sites in Australia can be your first recruiting sites in your pivotal study as well,” he said. 

Eerdmans added that hospital agreements and competition slow down many regions, whereas in Australia, predictability stands out. “If you go to Australia, you know how long it will take,” he said. 

Engaged investigators and a strong trial ecosystem 

Gallois said she had “never really encountered” competition issues in Australia and described clinical teams as “very dedicated and motivated.” Biadillah highlighted the strength of Australian key opinion leaders, saying they are “eloquent, understand the business sides and also understand… new technologies.” 

Panetta also pointed to Australia’s 43.5% rebate, noting that a USD 300,000 study effectively costs US$178,000. Gallois added that “it’s rebates, not tax credit,” which helps companies reinvest and extend their runway. 

The panel concluded that Australia’s advantages regulatory alignment, speed, predictability, financial incentives, and engaged clinical leaders make it a strong choice for first-in-human and pivotal MedTech trials. As Panetta summarised, “clinical is not the time to cut corners,” and Australia offers the environment needed for high-quality, globally acceptable data. 

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