TABLE OF CONTENTS The goal of all development work in any company is to get a product to market as quickly and as efficiently as possible. For biomedical products to get to market, there is an additional consideration, as the market is defined through very specific language in the approval from the Food and Drug Administration (FDA). The disease for which the product is approved is called the indication (the impact on the market is discussed in greater detail in Section 2.5.5). All data collected in carefully designed experiments (clinical studies with human subjects) and submitted to the FDA have to satisfy rigorous evaluation by the FDA and show that the product will perform as stated for the specific disease condition that it is being indicated for. Each new indication for the same product needs a separate application to the FDA by the product developer (follow-ons to the primary approval are shorter). On approval, the FDA issues a label, which very specifically defines the indication for the product; and the manufacturer cannot market or make any claims outside of treating or diagnosing the disease condition or indication on the label. Therefore, the product development process begins with the selection of the indication or the specific state of the disease for which the product is going to be developed (see Section 2.5.5 for more details on how this selection will affect markets and marketing).
