Medical Device Commercialization Overview

Building and Testing an Alpha Prototype

Does the design require changes?

Rapid prototyping processes are likely to be used throughout the design and development phase to evaluate interim designs. Once your design has been initially finalized (design changes could still be required, based on testing and evaluation), you will need to build an “alpha” prototype.

Forma can help you build parts for and assemble alpha prototypes, which represent the first iteration of what the market-ready product will be. We will use these prototypes to test and evaluate all facets of the product for design verification purposes (federal regulations of medical devices require that “design outputs” be verified to correspond to the specifications defined as “design inputs”). We will also use the alpha prototypes to check for anything that should be changed or improved, which will almost certainly be the case – it is extremely rare that a product is perfected with only one prototype iteration.

Let Forma help you build and test an alpha prototype of your medical device design so that opportunities for improvements can be identified and incorporated into a final product design that is of the highest quality.