Robot-Assisted Fracture Surgery: Surgical Requirements and System Design

Area of Science:

• Medical device design
• Surgical robotics
• Patient safety engineering

Background:

• Medical device design is critical for patient safety, as poor design leads to errors and costs.
• Early stakeholder involvement in development provides crucial insights into clinical practice and identifies issues with existing equipment.

Purpose of the Study:

• To demonstrate how user study findings informed the development of the Robot Assisted Fracture Surgery (RAFS) system.
• To outline the process of translating user needs into actionable requirements for a novel surgical robotic system.

Main Methods:

• Qualitative methods were used to capture user needs during the early stages of the RAFS project.
• User needs were converted into operational, functional, and non-functional requirements.
• System components were developed to meet identified requirements, with intermediate verification tests.

Main Results:

• User-centered requirements guided the design of a new workflow for intra-articular joint fracture reduction using robotics.
• System development explicitly addressed identified user needs.
• A cadaveric trial validated the robotic system's effectiveness and its ability to meet user requirements.

Conclusions:

• Early integration of user feedback is essential for successful medical device development.
• The developed Robot Assisted Fracture Surgery system effectively addresses user needs and research objectives.
• User-centered design principles contribute to the safety and efficacy of advanced surgical technologies.