Animal models and in-vitro assays have become indispensable tools for researchers in nearly every scientific discipline. Although definitive studies, which are conducted on human subjects, are the final testimonial of product efficacy, such studies can present several practical, ethical, and moral concerns. In-vitro assays are extremely useful when examining the effect of agents on particular cell types or specific environmental factors that could be influential during repair or infection. Some of the attractive benefits of these studies include: 1) relatively inexpensive, 2) fast, 3) convenient, and 4) provide important information on their potential cell to cell function. However, in-vitro assays are incapable of completely reproducing biological conditions such as immune response, healing, and disease. Animal models are the next step when assessing product efficacy. Animal models are beneficial to wound research because of their compliance, and are ethical, easily manipulated, and flexible. Both small and animal large animal studies have their benefits and limitations. Pre-clinical testing should address toxicology, safety, and efficacy effects, preferable in a dose-response fashion. Ultimately well-controlled, randomized clinical trials are needed to finally demonstrate the true potential of any formulation. Overall, product development of wound healing/infection therapies is a progression of steps within each stage (in-vitro to in-vivo) and need to be carefully conducted to obtain an optimal product for the patient.