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
Technical due diligence for a private equity investment in an AI-powered healthcare technology company, assessing engineering capability, product strategy, and how much of the AI story held up under examination.
Assess whether an AI-powered healthcare technology company's technical capability, product roadmap, and organization justified a significant investment, and whether its AI claims reflected genuine capability or repackaged third-party tooling.
Independent technical assessment covering AI and ML capability, platform architecture and scalability, security posture, acquisition integration, data maturity, and the strength of the product and engineering organization.
Engagement
Focus
AI strategy advisory for a private equity firm's portfolio companies, working across industries to identify where AI would pay off and what it would take to implement.
Help portfolio companies across engineering, healthcare technology, food processing, and fitness identify where AI could address real operational problems, and separate those opportunities from the ones not worth pursuing.
A workshop-based advisory process moving each company from problem identification through solution design to an implementation roadmap with architecture, data requirements, and cost estimates.
Engagement
Industries
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
