Established Medical Device - Prototyping

Depending on the individual needs of the client and the project, RBC Medical Innovations can create prototypes at various stages of development. This includes:

Proof-of-Concept Prototype
Analyzes the technical and business risks of the desired solution and proves, with a predefined, working and tested prototype, that the challenges can be overcome and risks managed.

Form/Concept Prototype
The Form/Concept prototype is an opportunity to view and “feel” how the product will look and function once it’s completed. Before significant engineering detailed design, implementation and test has begun, this prototype cost-effectively facilitates feedback from all stakeholders regarding the shape, color, and design of the final product.

Form, Fit, and Function Prototype
Once the design is finalized, a fully-functional, working prototype is created and tested for manufacturability, electro-magnetic compatibility (EMC), and full functionality. This prototype is usually suitable for early clinical testing as well.

Pre-Production Prototype
This prototype acts as the formal verification and validation product. In addition, it is used for manufacturing bring-up to eliminate issues with the fabrication processes.

First Manufacturing Run (Process Validation)
This process validation step allows the development and manufacturing team to experience full production runs of the new device. It remains a prototype if issues surface that need resolution. If successful, these prototypes become your first units available for sale.

 

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