caya® contoured diaphragm
The Caya® was designed for use in health systems in many countries, wherever clinic time and resources are limited. Caya is a single-sized, 'one size fits most' diaphragm. The device is hormone-free and does not require a pelvic exam to provide to the user. Because it is single-sized, the Caya is more easily distributed than typical diaphragms which require professional fittings. Caya is made of silicone rather than older style latex diaphragms and holds up to extreme temperatures and poor storage conditions common in developing countries.
3rd Stone Design lead initial efforts to standardize the liquid silicone injection molding process in such a manner that the production platform could be moved to the location of most effectiveness.This involved multiple iterations of the assembly method for the multi-stage injection method. The project then lead to a broad sourcing exercise working with multiple potential molders that required detailed analysis of technical capability, supply chain management, and regulatory standing. An ultimate decision was made regarding production partners and 3rd Stone Design worked with PATH and the production partner to transfer the know-how and technical requirements for the device to the production floor. As a final vote of confidence, the USFDA granted market clearance to the Caya contoured diaphragm in late 2014 and in June 2015, Kessel Medintim GmbH of Germany launched the Caya diaphragm in the United States.