Our Development Process
Our development process begins with your idea. The idea can be a rough sketch or a physical prototype. During Concept Development we define the specific requirements for the end product and work with you to refine the design into a functional prototype.
The Working Prototype Phase is where we coordinate the production of a working prototype that may or may not have the final form of the finished device. The goal during this phase is proving functionality.
During the Final Design Phase, depending on the functionality of the working prototypes, the design will be refined into something that more closely resembles the final device. This may require additional refined prototypes and preliminary mechanical testing. During this Phase we also work with manufacturing to implement changes for manufacturability and production.
The Regulatory Phase is when all of the documentation required for a regulatory clearance is compiled and submitted to the regulating body (FDA, CE, etc.). Some of this documentation such as meeting minutes and design changes will be created throughout the earlier development phases. This Phase also includes any final mechanical testing or sterilization validations required for clearance of the device.
The final Commercialization Phase could be releasing a single surgical set or launching multiple systems across the world.