Issues Involved in the Process of Developing a Medical Food

Abstract

The creation of a medical food with potential health benefits for a particular patient population is a surprisingly complex process. Fortunately, the developmental process for a specific medical food is not as rigorous or as tightly regulated as that of a pharmaceutical agent. However, numerous factors unique to the enteral formulation of a new product come into play, such as physical/chemical compatibility, pH, stability, bioavailability, decay, and even palatability. Additional considerations such as strength of health benefit claims, packaging or presentation, and marketability determine the ultimate commercialization and whether a product ends up being released to the public. A full understanding of the development, substantiation, and commercialization of a medical food is necessary for important physiologic concepts in nutrition therapy to end up as part of the therapeutic regimen at the bedside of the critically ill obese patient.