Day-Zero Architecture: Building Your NIST/FDA Compliance Roadmap with

Statutory Readiness: Navigating FDA 524B & NIST 800-53 for Scale

As of late 2024, cybersecurity is no longer "guidance"—it is the law. A "Refuse to Accept" (RTA) ruling from the FDA can end your launch before it begins. In this session, we define your "Day-Zero" operational roadmap. We will discuss strategic vendor selection (QMS, CRM, ERP), the statutory requirements of FDA Section 524B (SBOMs and vulnerability plans), and the hands-on configuration of your Microsoft 365 environment to ensure you are "Enterprise-Ready" from the first hire. Stop wasting $100K on future migrations by architecting your security moat today.

Hi, I'm Chris — a serial founder and product executive with 20 years in Silicon Valley. Over that stretch, the platforms and products I've led have generated more than $1.1 billion in cumulative commercial value, and I've managed cross-functional teams of up to 160 people across the US, Europe, India, and China.
I work best with founders who've raised their seed or Series A and are now facing the hardest stretch: turning early traction into a repeatable, scalable business. You've shipped something people want. Now you need to land enterprise customers, hire your first real GTM team, and write a Series A or B narrative that holds up to partner-level scrutiny — without losing the magic that got you here.
I've been in the rooms where those decisions got made, and I've made plenty of the mistakes you're about to face. At Elevance Health, I unified 30+ scattered AI projects into a single platform that delivered $500M in strategic savings. At SAP, I sketched an IoT platform on a whiteboard, secured $30M in internal funding for it, and grew it into a ~$250M/year business landing deals with Coca-Cola, Unilever, P&G, and Genentech. At Cognizant, I turned a struggling innovation practice from $300K to $60M ARR in under two years by reinventing its business model.
I mentor and advise at Stanford GSB, Alchemist, Techstars, and Plug and Play because I genuinely love this stage of the journey — the chaos, the doubt, the breakthroughs.
I can help you with:

Moving from early traction to repeatable, scalable revenue
Landing and expanding enterprise customers (procurement, security reviews, multi-stakeholder sales)
Sharpening pricing and packaging for real adoption, not just signups
Building the right GTM motion and hiring your first VP Sales or Head of Product
Crafting a Series A or B narrative that actually closes the round
Navigating the technical, compliance, and operational decisions that become deal-blockers at enterprise scale

Book an intro call and let's clear your blockers out of the way.