Project Background
The startup needed titanium instrument components for pre-submission testing. Each iteration required medical-grade documentation plus flexible response to design tweaks.
Constraints
- ISO 10993 biocompatibility and GMP traceability.
- Surface quality Ra0.4 or better with zero burrs.
- 25% scrap rate with prior vendors due to tool wear and deformation.
- Multiple regulatory stakeholders reviewing every change.
Geppetto Execution
- Titanium-specific AI library predicted cutting forces, heat, and tool wear to set optimal feeds and speeds.
- Inline monitoring captured spindle load, vibration, and temperature to prevent deformation.
- QA stack delivered CMM reports, material certs, and process logs in FDA-ready format.
Results
- Precision: Coaxiality and perpendicularity held within 0.02 mm, surface finish improved to Ra0.3.
- Speed: Quote approved in 8h, machining launched within 72h, supporting weekly design iterations.
- Compliance: Complete documentation package reused for 510(k) and CE submissions.
Strategic Value
The company avoided a three-month regulatory slip, freed budget for additional verification builds, and secured investor confidence with data-backed manufacturing readiness.***