Medical Device Commercialization Overview
Building and Testing a Beta Prototype
Is the design ready to be manufactured?
Testing and evaluation of alpha prototypes will almost certainly uncover opportunities for improvement and changes to the design that will need to be made. You will need to incorporate the learnings from the alpha prototype build into an additional iteration of the design. The embodiment of the product that results from this iteration should be very close to the final product that will be manufactured. However, you will still need to test the design by constructing a “beta” prototype to make certain the product performs as expected and that no additional changes are required.
Forma can help you obtain parts for and build beta prototypes, which will be used to “validate” your medical product design. Design validation testing is intended to “ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions”. Generally, parts for beta prototypes will be manufactured using “pilot tooling” – usually tools that will be used to produce parts in volume for production, but which might yet need to be fine-tuned.