All Case StudiesMedical Devices
Medical Device Mechanism
Power
Class II
Result
Production CAD package
Industry
Medical Devices
OF
The Challenge
A health-tech startup needed production CAD for a handheld diagnostic device mechanism — latch, cartridge insertion, and sealed button actuation — under a tight pilot build date. Previous freelancer models were unparametric, failed tolerance stack on the latch, and could not support ISO 13485 design history expectations.
Our Approach
- Rebuilt mechanism in SolidWorks with fully parametric sketches and datum scheme
- Ran tolerance stack on latch engagement and cartridge retention (worst-case + RSS)
- Designed cleanable external geometry — radiused seams, no fluid-trapping pockets
- Specified materials and UDI label recess zones on housing drawings
- Delivered assembly instructions, BOM, and revision-controlled drawing set
- Supported first-article inspection criteria for critical latch forces
Results
PASS
Tolerance stack
Latch retention within spec at WC limits
Production
CAD package
Parametric models + drawings for CM
On schedule
Pilot build
Parts released for CNC + molding