Engineering Services · Client-facing
PISMO-Generated CAD Drawing Tool
Produces parametric first-pass CAD geometry for surgical fixture families, with engineer review before any drawing reaches the client's design history file.
Business owner
Arun Patel
Executive sponsor
Helen Okafor, Partner — Medtech
Start date
Mar 9, 2026
Target rollout
Jan 20, 2027
Completion
ROI
Finance-reviewed, annualized where noted
Hours saved / mo
145
Hours saved / yr
1,740
Cost avoided
$26K
Margin impact
$88K
Health & Risk
Critical — pilot paused pending client QMS review.
Blockers
- Dimensional accuracy below the 95% acceptance threshold
- Client QMS sign-off for PISMO-assisted design artifacts outstanding
Risk flags
- Regulated deliverable exposure (FDA 21 CFR 820.30)
- Third-party CAD kernel license scope
Mitigation notes
Outputs restricted to non-regulated concept studies. Joint working session with client quality team scheduled Sept 2; go/no-go gate Oct 1.
Activity feed
Synced from connected delivery systems
- S
#medtech-cad: thread flagged a data quality issue in fixture set B
1h ago
- J
CAD-77 raised — tolerance stack-up failures
Yesterday
- G
PR open: geometry validator harness
2 days ago
PISMO Output QA
Last validation run Aug 16, 2026 · 21:30 UTC · 96 samples
Reviewer notes · Grace Yoon
Tolerance stack-ups fail on 1 in 5 fixture variants. Not fit for any regulated deliverable until dimensional accuracy clears 95%.
Governance posture
NIST AI RMF-aligned control checks
- Risk AssessmentFlagged
Regulated-use exposure not yet accepted by client.
- Bias MitigationPassed
Not applicable to geometric output; documented.
- Data PrivacyNeeds Review
Client IP retention policy under legal review.
- TransparencyNeeds Review
Drawing provenance metadata incomplete.
- SecurityPassed
Isolated client enclave, no shared tenancy.
- Human OversightPassed
Licensed engineer signs every drawing.