Product Development of a Bio-Composite Medical Device

Abstract

The paper presents a development methodology for a new bio-composite medical device used in extensive anatomical reconstructions. Current surgical techniques and devices include auto transplant, surgical meshes or even acellular devices. Due to the high degree of reconstruction and large amount of exposed tissue, the surgeries tend to have high re-intervention rates, leading to severe complications and even death. A functional approach is proposed to develop an improved medical device for the treatment of these severe traumatic lesions. A six step methodology is presented, validating the first three with the development of several concepts. The general need is accurately identified using the APTE instrument and a FAST diagram is constructed for one product existence stage. Nine concepts are generated using the proposed methodology and three were preliminarily kept for development. Further research will be undertaken for manufacturing and testing of the final selected concept.