Live! #87 – Built for Her: Funding, fixing, and fueling the next era of MedTech

Device Advice by RQM+

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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