Our Story
At S-Squared MedTech, we believe the current pace of MedTech innovation is outpacing the systems meant to support it. Brilliant technologies stall, not because they didn’t work, but because regulatory missteps, vague strategies, and clinical delays turned potential into paperwork. That’s not just frustrating. It’s unacceptable.
S-Squared MedTech exists to change that.
We are here for the innovators who won’t wait.
The founders who refuse to play it safe.
The teams bold enough to challenge legacy thinking with products that can truly change lives.
We bring 30 years of regulatory and clinical insight as a strategic force. We don’t do copy-paste. We don’t bury you in jargon. We bring clarity, urgency, and precision to every challenge.
We partner early.
We plan wisely.
We execute fiercely.
Regulatory strategy is not a box to check...
- It’s a competitive advantage.
- It’s a patient access strategy.
- It’s a promise to move faster, smarter, and stronger than the system expects.
At S-Squared MedTech, we challenge inertia. We accelerate impact. And we do it with integrity, insight, and relentless drive.
Because behind every submission is a patient waiting.
And we will not let bureaucracy be the bottleneck.
Our Founder
Flora Sandra Siami, MPH
Founder & CEO, S-Squared MedTech LLC
Flora Sandra Siami didn’t build her career by playing it safe. She built it by challenging how things have always been done, thinking out of the proverbial box. With three decades of experience leading global clinical trials, regulatory strategy, and real-world evidence initiatives across 30+ countries, Sandra has built a reputation for outsmarting bureaucratic bottlenecks and designing bold, business-aligned regulatory strategies that actually accelerate access to innovation.
She’s led clinical and regulatory functions for CROs, Fortune 50 health companies, and public-private partnerships, including the Head of the FDA-established NESTcc, building the RWE platform and transforming the go-to-market strategies.
Sandra has negotiated directly with FDA/CDRH, CMS, and global regulators. She’s built teams and departments from scratch, led up to $250M funding programs, executed trials on 5 continents, and mentored rising talent across the MedTech industry.
At S-Squared MedTech, she brings that same no-BS, high-integrity mindset to early-stage startups and established companies alike, because great technologies deserve more than generic advice and cautious consultants... They deserve a partner who knows the rules, and when to rewrite them.