Medical Device Design Process: A Medical Engineering Perspective

An approach for the planning phase of a medical device design process is presented. Challenges are discussed and a strategy to identify all required specifications is proposed. Hereby, the interdisciplinary collaboration of engineer, patient and clinician will be examined. As an exemplary case a shortened version of the development of an instrumented tissue expander is illustrated. The proposed procedure gives a profound knowledge of the medical background, existing devices and resulting limitations as well as their correlations. New aspects of other fields are included, giving a new attempt. Besides, the goal of this exemplary process is to be certain that a product can be developed more easily by including a clinician with his knowledge and experience into the engineering process.     «

An approach for the planning phase of a medical device design process is presented. Challenges are discussed and a strategy to identify all required specifications is proposed. Hereby, the interdisciplinary collaboration of engineer, patient and clinician will be examined. As an exemplary case a shortened version of the development of an instrumented tissue expander is illustrated. The proposed procedure gives a profound knowledge of the medical background, existing devices and resulting limita...     »