Concept generation and concept selection are two fundamental tasks of the biomedical device development process. After the definition of the consumer needs and the establishment of the product specifications, concept design will enable the development team to generate many solutions for the problem at hand. But without a structured methodology, the quality of the result can be inadequate. Structured methodologies provide procedures, rules, and approaches to the design and selection process. With them, the development team will be able to make explicit decisions, secure the correct translation of the product specifications into product features, and generate development reports automatically. This chapter provides an insight into some of the most important structured methodologies for concept design of biomedical devices. As part of the biomedical device development process, the activities of concept generation and concept selection will be explored, using the development of an electrocardiograph signal acquisition and transmission device encapsulation device. An important emphasis will be given to the use of modern computer-assisted design tools, with online environments for collaboration and sharing of ideas. The use of 3D printing to produce prototypes of the generated concepts will also be analyzed as a fundamental tool for the selection process. With the provided tools, the development team will be able to obtain a strong final concept with better performance in the product development process.