Award-winning regulatory strategist. Clinical scientist. International keynote speaker. Founder & CEO of RCI Global Partners – speaking at the intersection of MedTech, Biotech, and business, where science meets strategy and startups scale.
Every talk is customized to the room – founders, investors, clinicians, or corporate leadership – and can be delivered as a keynote, workshop, panel, or fireside.
Powered by The ACCESS™ Code and the ADOPT™ Pathway
Bringing an innovative healthcare product to market requires more than regulatory clearance — it requires a strategy for commercial success. In this signature keynote, Shaherah introduces her proprietary Commercialization Intelligence System™, a practical approach that helps innovators bridge the gap between product development and market adoption.
Built on two proprietary frameworks — The ACCESS™ Code, which positions products to earn market attention, and The ADOPT™ Pathway, which transforms attention into sustained adoption and revenue — this keynote provides leaders with a roadmap for building products that regulators clear, clinicians embrace, payers support, and markets reward.
Best for:
MedTech and Biotech founders, commercialization leaders, investors, accelerators, innovation programs, healthcare executives, and research institutions.
Audience walks away with:
Regulatory strategy isn’t a compliance cost — it’s the highest-leverage business decision an innovation company makes. This talk reframes the FDA pathway as architecture: how classification and sequencing decisions determine valuation, clinical burden, and time to market.
Best for:
Founder audiences, accelerators, investor forums
Audience walks away with:
A decision framework for pathway selection, the most expensive sequencing mistakes and how to avoid them, and what FDA engagement looks like when you control the narrative.
Brilliant science fails for non-science reasons. Drawing on 200+ product launches, this talk maps why innovations stall between approval and adoption — and how to build commercialization into the strategy from day one instead of bolting it on after clearance.
Best for:
Innovation summits, university tech-transfer programs, corporate innovation teams
Audience walks away with:
The commercialization decisions that must be made pre-submission, and how evidence planning serves regulators, payers, and customers simultaneously.
A clinical study is the most expensive sentence a startup ever writes. This talk covers designing studies that satisfy FDA, support claims, and convince investors — the first time — rather than generating data that answers the wrong question.
Best for:
Clinical and scientific audiences, biotech programs, research institutions
Audience walks away with:
How to scope evidence to the actual regulatory question, where trials over-build and under-build, and design choices that compress timelines without compressing rigor.
Don’t see the exact fit? Talks are regularly customized or built fresh for specific audiences and themes.
Shaherah’s perspective bridges worlds most speakers only know one side of: corporate leadership at global MedTech giants and in-the-trenches guidance for first-time founders; the science and the system; the boardroom and the FDA meeting room. She’s a trusted voice in rooms where clarity is currency.
Proof points
“When I first met Shaherah Yancy I was truly blown away. Yes, she has an incredible background. Yes, she is beyond qualified to guide you through regulatory hurdles. She is also so warm, genuine, kind, generous, and is an all-around inspiration. It’s not easy find someone so incredibly accomplished who was so down-to-earth and helpful!”
“Shaherah Yancy’s clinical and regulatory strategy sessions have been invaluable, efficient and on point.”
Whether it’s a summit keynote, an accelerator workshop, or an internal session for your regulatory and innovation teams – Shaherah equips audiences to turn complex ideas into decisive action.
