MTAA Women’s Health MedTech Summit

May 2026

At the Medical Technology Association of Australia (MTAA) Women’s Health MedTech Summit Jasjit Baveja, Ph.D. challenged Falko Thiele and me to be bold in considering what if women’s health qualified for a global regulatory priority pathway. Below is a summary of our discussion.

Can we justify prioritising women’s health conditions?

Women’s health innovation has been held back by a structural data deficit and decades of underinvestment in devices specific to the female biology. A regulatory priority pathway is about equity - it's a targeted correction to address that imbalance.

How do we ensure fairness and still address the problem?

By making the regulatory priority pathway only available to devices if they meet clear eligibility criteria including:
-  Addressing a female specific unmet clinical need OR: a condition with disproportionate burden of disease for women and where sex specific performance differences affect outcomes
-  Demonstrating clinical superiority in women with representative clinical trial populations

Mandating sex specific validation as a requirement will prompt sex specific research to be prioritised in line with National Health and Medical Research Council (NHMRC) Statement on Sex & Gender and speed up closing the data gap. This shift would move us from “protecting women from research” to “protecting women through research” and would also apply to pregnant and lactating populations. There would be explicit incentives for use of real-world evidence.

Will it incentive investors?

Faster, more predictable pathways to market reduce risk and attract capital, particularly when paired with aligned reimbursement and HTA processes. Without parallel reviews by MSAC and MDHTAC, patient access will remain limited, so this needs to be factored into workflows.

Innovative incentives like a Priority Review Voucher could further unlock investment, creating transferable value (similar to carbon credits) that de-risks early-stage women’s health innovation and benefits the broader MedTech ecosystem, beyond FemTech.

Could this be a global pathway?

Every country has its own laws/systems to comply with but there are ways to collaborate to minimise duplication and accelerate approvals. Enabling global scalability and impact through regulatory reliance models and shared evaluation pathways within existing partnerships like the IMDRF would mean Australia could position itself as a regional hub for women’s health MedTech, accelerating both innovation and access across Asia Pacific and beyond.

In summary, we agreed - a regulatory priority pathway intersecting globally is about scaling access, not just local reform. It is about better data, reduced risk, faster access, and increasing investment in women’s health to improve patient outcomes.

Looking forward to continuing to explore how we can work together to make this a reality.

Click HERE to read more.