Risk Assessment-Oriented Design of a Needle Insertion Robotic System for Non-Resectable Liver Tumors.

Medical robotics is a highly challenging and rewarding field of research, especially in the development of minimally invasive solutions for the treatment of the worldwide leading cause of death, cancer. The aim of the paper is to provide a design methodology for the development of a safe and efficient medical robotic system for the minimally invasive, percutaneous, targeted treatment of hepatocellular carcinoma, which can be extended with minimal modification for other types of abdominal cancers. Using as input a set of general medical requirements to comply with currently applicable standards, and a set of identified hazards and failure modes, specific methods, such as the Analytical Hierarchy Prioritization, Risk Analysis and fuzzy logic Failure Modes and Effect Analysis have been used within a stepwise approach to help in the development of a medical device targeting the insertion of multiple needles in brachytherapy procedures. The developed medical device, which is visually guided using CT scanning, has been tested for validation in a medical environment using a human-size ballistic gel liver, with promising results. These prove that the robotic system can be used for the proposed medical task, while the modular approach increases the chances of acceptance.