Accelerate approval and de-risk development
Every device has a different pathway but a shared goal - make healthcare better for all involved. Here are some ways we've helped design and execute world-first studies, secure FDA approvals, and transformed healthcare for the better.
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Guiding you through what you don’t know yet
We answer the questions you may not even know to ask, from readiness to cost, timelines to regulatory differences, so you can move forward with clarity.
If you’ve completed your prototype, generated pre-clinical data based on a robust risk analysis plan, and defined your intended use, you’re likely ready to explore a first-in-human or feasibility study. We can assess your device, documentation, and regulatory pathway to confirm readiness and define the next steps.
Australia offers globally recognised ICH-GCP/ISO 14155-compliant standards, rapid ethics and regulatory approvals, and generous R&D tax incentives—up to 43% cashback on eligible spend. Data collected here are widely accepted by international regulatory authorities, making it the ideal place to start.
Budgets vary by study size, endpoints, and number of sites. Early feasibility studies with full-service typically range from AUD $250K–$1M; pivotal studies are higher. We tailor budgets to your design and help identify tax and funding offsets.
Running early feasibility or safety studies in Australia allows you to collect high-quality data quickly, which can be used in your FDA IDE or 510(k) submission. This “ANZ-to-US bridge” is one of the most time-efficient routes to market.
Medical device trials focus on performance and safety, not drug pharmacokinetics. They’re usually smaller, faster, and more iterative—requiring deep technical and engineering understanding as well as clinical rigour. Focus is on safety and feasibility of the application or procedure, technical training and user experience whereas in drug trials, controlled exposure for safety and efficacy are paramount.