Human review is visible
Every candidate routes through surgeon and engineer decisions before any downstream package step.
AI-assisted design-control workflow
CranioSwift
Reviewable implant candidates and traceable case packages for retrospective partner pilots.
CranioSwift helps licensed implant and clinical partners evaluate AI-assisted cranial implant design without moving release authority away from surgeons, engineers, or QMS.
20-30
retrospective cases
0
critical misses tolerated
QMS
evidence package first
Platform position
Evidence before output.
CranioSwift is not a standalone STL generator. The product is a workflow: case intake, defect boundary confirmation, candidate generation, automated checks, human review, and case-package export.
Traceability stays attached
Geometry, warnings, comments, versions, and role ownership stay attached to each retrospective case.
Partner metrics drive the pilot
Speed, cleanup time, reviewable rate, package completeness, and critical misses become the scorecard.
Operating model
The product keeps ownership visible.
CranioSwift should help a partner move faster without blurring who owns clinical judgment, design revision, QMS review, or manufacturing release.
Accept, revise, or reject.
Reviews fit, contour, defect coverage, and surgical intent. Their decision becomes the first gate in the case package.
Owns revision quality.
Converts clinical feedback into candidate versions, reruns checks, and keeps design rationale attached to the case.
Checks the evidence package.
Reviews provenance, decision records, warnings, and completeness before a partner-facing package is treated as ready.
Controls release authority.
Reviews mesh readiness, material route, process constraints, and final release inside the partner's own registered workflow.
Commercial wedge
Low-switching-cost paid pilot.
Partners keep their current CAD, manufacturing, and QMS workflows. CranioSwift adds a reviewable candidate, automated checks, decision capture, and a case package that can be compared against the current process.
Select retrospective cases
Confirm boundary and intent
Review candidate and checks
Export partner case package
Case package
The deliverable is a review packet, not a black-box mesh.
The paid-pilot artifact is a repeatable case package that lets a partner compare CranioSwift against their current engineer-led workflow on the same retrospective cases.
CS-RETRO-094
60% complete
- Input anatomy and defect data Ready
- AI candidate implant geometry Ready
- Boundary, mesh, and overlap checks Ready
- Clinician review decision Pending
- Manufacturing release evidence Blocked
Downstream states
What happens after review
Clinical concern is attached to a versioned engineering branch.
Quality reviewer checks evidence completeness before export readiness.
Partner sees DfM warnings while release actions stay unavailable.
Demo workbench
A case-control cockpit for retrospective review.
The workbench uses the current six-case research demo set, but presents it as a partner pilot review workflow rather than a one-click model output screen.
01 Intake
02 Defect
03 Candidate
04 Human review
05 Package
Evidence package
What the partner evaluates.
Faster first candidate generation is the measured workflow signal.
Enough cases must be reviewable before a starter license conversation.
Inputs, outputs, warnings, comments, and approvals must be traceable.
Critical manufacturability misses are not tolerated in pilot scoring.
Quality roadmap
The path is staged on purpose.
The website should make the maturity boundary obvious: research demo now, non-clinical pilot next, productization after evidence, regulated use only after formal validation and partner controls.
Research demo
Provenance, known limitations, and review-only case packages.
Non-clinical pilot
20-30 retrospective partner cases, review forms, and failure taxonomy.
Productization
Design controls, risk file, software lifecycle, cybersecurity plan.
Regulated use
Formal validation and controlled releases with the licensed partner.
Partner conversation
Bring CranioSwift into a retrospective pilot review.
The right next conversation is with implant partners, clinical reviewers, and QMS owners who can compare CranioSwift against their current case workflow.