Real-world examples of how we've helped organizations achieve their AI goals while navigating complex regulatory requirements.
Serving as embedded Entrepreneur-in-Residence to a grant-funded university research program developing textile-based biosensors, covering FDA regulatory pathway, business model, and capital formation across a 24-month engagement.
A university team had a genuinely novel sensing technology and a 24-month grant, but no regulatory pathway, no business model, and no clear route from a research prototype to a product anyone could buy or a company anyone would fund.
An embedded Entrepreneur-in-Residence role covering FDA regulatory strategy from wellness-device clearance through a software-as-a-medical-device transition, alongside customer discovery, business model development, and funding roadmap.
Our Role
Engagement
Commercialization, regulatory, and fundraising strategy for an academic research group taking a validated clinical diagnostic technology from published research toward market entry.
An academic group with substantial publications and clinical validation needed to turn its diagnostic technology into a company: a market entry path, a regulatory route, the right industry partners, and materials credible enough to raise on.
A strategic engagement covering market and competitive analysis, go-to-market design, FDA pathway planning, partner identification, and preparation of investor materials and financial models.
Engagement
Regulatory
