Abstract
BACKGROUND/OBJECTIVE: Surgical technology has advanced rapidly with the introduction of robot technology. Apart from mechanical and electronic elements, housing design is an essential component that must be thoughtfully considered, bearing in mind the general requirements for medical devices used in operating theatres. The aim of this study was to design a modern and safe housing for a surgical robotic system for orthopaedic applications in Hong Kong that would meet the general requirements for obtaining local regulatory body approval. METHODS: Based on the general requirements for Class II Medical Devices, industrial product designers worked in close collaboration with a robot research team formed by engineers and orthopaedic surgeons to design a modern and safe housing for the HybriDot (®) Surgical Robotic System that performs computer-assisted surgery. RESULTS: The design received local regulatory body approval for its application in operating theatres and was approved for orthopaedic surgery in Hong Kong after fulfilling the general requirements for safety, accuracy, movability and operability. CONCLUSION: This project demonstrated a good model of multidisciplinary R&D of surgical robotics led by orthopaedic surgeons, in collaboration with mechanical and electronic engineers and industrial designers.