The Challenge
The startup had an industrial design but no manufacturing partner: existing quotes required 50k-unit minimums, and no supplier could explain the regulatory path. They needed a soft-touch medical-grade LSR cup (US FDA 21 CFR 177.2600 material compliance for the EU/US launch), two sizes (small/large), custom stem geometry, individual sterile-pouch packaging, and a unit cost that kept their D2C margin above 60%.
Our Solution
We co-engineered the two-size mold set with a sharpened rim and soft stem using shore-tuned medical LSR, ran sterilization-compatibility validation (autoclave and gamma), delivered the full FDA material compliance and EU MDR technical-file inputs, and started with a 5,000-unit pilot before scaling to monthly repeat orders.
Results
- ✅ Two-size mold set delivered; first articles in 21 days
- ✅ FDA material compliance + EU MDR technical documentation complete
- ✅ Autoclave & gamma sterilization compatibility validated
- ✅ Pilot of 5,000 units scaled to monthly repeat production
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