Managing the variability of biomechanical characteristics before the preliminary design stage of a medical device

Abstract

The very high level of requirements for certification procedures often limit research and development departments to innovate using increments and iterations during the design process for medical devices (MD). Instead of this semi-empirical approach, a structured procedure, a breakthrough innovation should be used when designing an articular MD (prosthesis, implant). The search for concepts can be based on functional analysis and producing behavioural models of the joint in its natural state and/or equipped with the prosthesis. This paper shows how anatomical variables can be managed and integrated using a modular design approach.