This panel was recorded 20 March 2025. Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com.
Women’s health is finally getting the attention it deserves, yet progress is still slowed by gaps in clinical trial diversity, complex regulatory pathways, and funding challenges.
In this RQM+ Live! panel discussion, industry leaders and regulatory experts will share real-world strategies MedTech companies can use to navigate these barriers and bring life-changing innovations to market.
Why listen:
- Unlock Market Opportunities – Women’s health is one of the fastest-growing MedTech sectors, with rising investor interest and funding.
- Gain Regulatory Insights – Understand how evolving regulations impact clinical trials, approvals, and commercialization.
- Learn from Real-World Success – Hear how industry leaders are overcoming challenges and making an impact.
- Ask Your Toughest Questions – Engage directly with panelists during the live Q&A.
- Bring Innovations to Market – Get expert insights on bridging clinical research, regulatory approval, and commercialization.
Discussion topics:
- The Business Case for Women’s Health Innovation – Why investors, manufacturers, and regulators are prioritizing this space and what it means for MedTech companies.
- Clinical Trials and Data Gaps – The urgent need for inclusive research, historical data biases, and evolving regulatory expectations.
- Regulatory and Market Access Hurdles – Key challenges in securing approval and reimbursement—and how to overcome them.
- Scaling Women’s Health Solutions – Lessons from industry leaders on funding, partnerships, and commercialization strategies.
Who should listen:
- MedTech professionals driving innovation in women’s health
- Regulatory and quality leaders navigating complex approval pathways
- Clinical trial specialists improving diversity and data accuracy
- Investors and strategists seeking insights into funding and market growth
- R&D and product development teams designing women’s health solutions
- Healthcare policymakers and advocates shaping the future of women’s health innovation
Panelists and moderator:
- Marissa Fayer – CEO, Her Health Equity & DeepLook Medical
- Megan Callanan – US & Global Regulatory Lead, Natural Cycles
- Stephanie Kladakis – Executive Vice President, Chief Technology and Regulatory Officer, AgNovos Bioscience
- Alexia Haralambous – Senior Principal, RQM+
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Global Regulatory Affairs, RQM+ (moderator)
Chapters:
00:00 Introduction to Women's Health in MedTech
10:09 The Surge in Women's Health Innovation
20:08 Regulatory Challenges in Women's Health
29:52 The Business Case for Women's Health Innovation
33:54 Bridging the Gender Gap in Clinical Trials
37:02 Enhancing Diversity in Clinical Trial Recruitment
40:08 Understanding Regulatory Misconceptions in Women's Health
44:09 Strategic Partnerships for Market Access
56:03 Future Directions for Women's Health Innovation
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