A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach

This paper focuses on the importance of the regulations, in particular the Food and Drug Administration (FDA), in the development of medical devices. The FDA regulates medical devices to assure that these products are safe and effective before their release into the Unites States market. We introduce the concept of Design for FDA (DfFDA) and describe DfFDA guidelines for medical device development. While many researchers describe the regulations in the form of reviews and models, the literature to date has not reported a DfFDA method. Here, DfFDA is proposed as a method to be used in parallel with other DfX methods when applicable. The DfX methods identified include: Design for Validation (DfV), Design for Reliability (DfR), Design for Quality (DfQ), Design for Manufacturing (DfM), Design for Assembly (DfA) and Design for Usability (DfU). This paper also reviews the literature addressing the FDA regulations and DfX methods, and an overview of the FDA regulations is presented. DfFDA is developed to increase awareness about regulatory compliance and promote designers to consider the regulations throughout the development process of medical devices.