Medical Device Manufacturing · 8,000+ employees · $500M+ revenue · Regulated (FDA, ISO 13485)
45/100
Readiness
5
Phases
15
Projects
84/100
Confidence
18mo
Timeline
Readiness Verdict: NOT READY. Critical gaps in authority & decision rights (25/100) and coordination mechanisms (40/100). Regulatory Affairs not engaged. Governance principles in draft — no legal/compliance review. No production AI until governance infrastructure exists.
What AESOP Received
12 documents, 8 departments, 7 projects
A complex, regulated enterprise — the roadmap was generated from their existing org context, portfolio, and readiness assessment. No consulting engagement.
12
Context Documents
8
Departments
7
Portfolio Projects
5
Readiness Dimensions
Readiness Breakdown
25
Authority & Decisions
40
Coordination
55
Tacit Knowledge
60
Exposure Posture
65
Portfolio Coherence
What the Organization Told Us
"Governance is welcomed, not resisted"
From 6 stakeholder interviews across the C-suite and department heads — the roadmap reflected the actual organizational reality.
Stakeholders Said
"The concern is not 'governance will slow us down' — it is 'we don't have governance yet and that makes us uncomfortable.' Regulatory Affairs and Legal are not yet in the room. This is the most significant gap."
AESOP Responded
Phase 1 is entirely governance foundation. No production AI systems until the AI Steering Committee is operational, gatekeepers are formally engaged, and the Governance Framework v1.0 is ratified by Legal, Compliance, and Product Security. Patient-proximate initiatives blocked until Regulatory Affairs signs off.
The Transformation Journey
Governance first. Patients can't wait for us to get it wrong.
5 phases across 18 months. The first three are shown below — the roadmap includes two additional phases for customer-facing deployment and advanced process intelligence, gated by regulatory readiness.
1
Governance Foundation
Month 1–6
Ratify governance framework. Engage Regulatory Affairs, Legal, Product Security. No production AI.
2
Pilot Deployment
Month 7–12
HR agent first. Field Service agent with validated escalation. Internal confidence before external.
3
Regulatory-Adjacent
Month 13–18
510k Assistant + Regulatory Intelligence. Mandatory human review per QMSR. Validated compliance.
Risk Mitigations
Every phase names what could break and how to catch it
HIGH: Rita Hermann single point of failureHIGH: Regulatory Affairs disengagementHIGH: 510k non-compliant content riskMED: Consensus culture → decision paralysisMED: Exception Inflation in regulatory AI
Want to see the full TBCT roadmap?
The complete roadmap is currently available as a markdown document with all 5 phases, 15 projects, milestones, risk mitigations, and source citations. A PDF version is in progress.