How to Implement a High-Fidelity Prototyping Approach in a Cardiac Surgery Device?

Increasingly often, the surgeon operates remotely. More and more, he/she does neither see nor touch the patient directly but acts with miniaturized systems, such as catheters and robotic instruments. This reduces intervention time and accelerates the patient’s recovery. This paper reports the ergonomic contribution to the design of a device for the resection of stenosed aortic valves and the implantation of a new aortic bioprosthesis. In high-risk contexts as in cardiac surgery, high fidelity prototypes are necessary to allow clinical trials. An association between engineers and ergonomists becomes essential, because the prototype becomes a key stage of the design process. We suggest a triangulation of methods (heuristic inspection, task analysis and usability testing) to produce a high-fidelity prototype reliable for clinical trials. The clinical trials themselves then constitute a preliminary step for further improving the device.