Risk analysis and safety assessment in surgical robotics: a case study on a biopsy robot

Area of Science:

• Medical Robotics
• Surgical Technology
• Clinical Workflow Integration

Background:

• Physician adoption of medical robots hinges on safety and ease of use.
• Limited research exists on risk management for robotic prototypes in clinical trials.
• Complex interfaces and handling hinder the integration of robotic systems.

Purpose of the Study:

• To discuss risk management strategies for medical robotic systems.
• To demonstrate safety considerations in developing a prototype biopsy robot.
• To address barriers to clinical adoption of robotic surgery equipment.

Main Methods:

• Review of risk management principles in medical device development.
• Exemplary case study: development of a prototype biopsy robot.
• Analysis of safety features and user interface design.

Main Results:

• Risk management is essential for safe and effective robotic prototype development.
• A well-designed user interface and handling are critical for clinical workflow integration.
• Addressing safety concerns directly impacts physician acceptance and trial participation.

Conclusions:

• Prioritizing safety and user experience is paramount for successful medical robot implementation.
• Proactive risk management throughout the development process is key.
• Further research on clinical integration and risk mitigation is warranted.