You have a functional prototype. It works perfectly. Now you need 10,000 units.
For general industry, you just cut a mold and go. But for Medical Devices, the bridge from Prototype to Production is a minefield of regulations, validations, and process capability studies.
1. The "Un-Stampable" Prototype
Prototypes are often machined or 3D printed. These processes allow for geometry that stamping cannot replicate.
Common Traps:
- XZero Radius Corners: Easy for CNC, impossible for stamping.
- XThick-Thin Walls: Stamping uses sheet metal of uniform thickness. You can't have a 2mm wall next to a 1mm wall.
- XTall, Narrow Features: Deep drawing has limits (Draw Ratio).
2. The Validation Trinity (IQ, OQ, PQ)
Under ISO 13485, you must prove your process is stable.
IQ
Installation Qualification
"Is the equipment installed correctly?"
We verify the press is leveled, calibrated, and safety guards are active.
OQ
Operational Qualification
"What are the process windows?"
We test the limits. What happens if we run the press 10% faster? What if the oil pressure drops?
PQ
Performance Qualification
"Can we do it consistently?"
We run 3 full production lots (e.g., 5,000 parts each) to prove Cpk > 1.33.
3. Soft Tooling vs. Hard Tooling
Don't commit to a $20,000 Progressive Die on day one.
| Stage | Method | Cost | Lead Time |
|---|---|---|---|
| Alpha Prototype | Laser Cut + Brake Press | $ (No Tooling) | 3 Days |
| Beta / Clinical | Soft Tooling (Stage Die) | $$ | 2-3 Weeks |
| Mass Production | Hard Tooling (Progressive) | $$$$ | 6-8 Weeks |
Launching a Medical Device?
We have successfully validated over 50 medical components. Let us help you build your Validation Master Plan.
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