Medical Device Commercialization Overview

Clearly define the product opportunity Understand your users Understand your market Develop a plan to get regulatory approval Explore concept alternatives Evaluate and choose a design direction Prove the concept is technically feasible Protect your idea by filing provisional patents Design and develop the product in detail Source materials, standard components and vendors Build an (alpha) prototype Test, evaluate and make any changes needed Build and test a (beta) prototype of the revised design File non-provisional patents Transfer the design to manufacture Validate the design Develop product labeling and other required documentation File for approval with regulatory agencies