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.

Bridging the Gap Between Scientific Innovation and Enterprise Scale
I am a strategic product executive and "intrapreneurial" operator with a 20-year track record of converting complex technical breakthroughs into $1.1 billion in cumulative commercial value.
Most accelerator mentors focus on "the what." I focus on "the how." I differentiate myself by being a "Full-Stack" operator: I can sharpen your Series A pitch deck in the morning and personally architect a zero-trust cybersecurity network in the afternoon. For startups in regulated industries, I am the "Shield" that ensures technical debt and compliance gaps do not become terminal events during due diligence.
The Full-Stack Value Proposition
1. The Fundraising Catalyst (Pitch & PMF) I help founders navigate "The Hook"—securing stakeholder confidence by transforming abstract technology into compelling business cases with clear ROI. I have a proven history of securing high-stakes investment, including obtaining $30M in funding for an internal IoT startup at SAP that began as a solo concept. I use Design Thinking and ethnographic research to validate Product-Market Fit (PMF) before you burn precious capital.
2. Market Velocity (GTM & Sales Enablement) I specialize in "clarity out of chaos." I build sales enablement systems that equip teams to pass the most rigorous scrutiny from enterprise procurement and C-suite stakeholders. At Cognizant, I scaled a failing innovation practice from $300K to $60M ARR in under two years by shifting the business model to outcome-based "Product Engineering."
3. Day-Zero Architecture (The "Compliance Trap") For MedTech and DeepTech startups, the product is only half the battle. I solve the "Sales Blocker" that occurs when an enterprise CISO audits a startup’s informal IT.
• FDA Section 524B: I navigate the new statutory requirements (SBOMs, SPDF, and vulnerability management) to prevent "Refuse to Accept" (RTA) rulings.
• Hands-on Infrastructure: I don't just provide a roadmap; I execute. I personally build and configure the technology stacks—including Microsoft 365 (MFA, SAML, SCIM, Intune), Salesforce, and QMS (ComplianceQuest)—that allow you to pass audits on the first attempt and avoid $100K in future migration taxes.
Quantified Operating Impact
• Elevance Health: Unified 30+ fragmented AI projects into an enterprise platform; delivered a Real-Time Prior Auth engine that realized $500M in strategic savings.
• MedTech Scaling: Serving as Fractional CIO for a 50-FTE medical device startup; personally built the entire cybersecurity architecture and NIST 800-53 roadmap to clear the path for enterprise sales.
• SAP: Conceived SAP IoT platform, now generating ~$250M in annual revenue; landed deals with Coca-Cola, Unilever, P&G, Genentech and Tennant.

Please reach out to me for a an intro call.