A Cascading Delphi Method-Based FMEA Risk Assessment Framework for Surgical Instrument Design: A Case Study of a Fetoscope

Failure Mode and Effect Analysis (FMEA) is crucial for identifying risk reduction opportunities in design. This study aims to aid in the design of sophisticated medical devices by setting guidelines and addressing weaknesses in data collection and risk priority numbers (RPNs). This is achieved by developing an FMEA framework with potential efficiency and efficacy benefits for design engineers, surgeons and patients. The FMEA framework covered risk analysis and risk evaluation by integrating a cascading Delphi method to address data collection and Multi-Criteria Decision-Making (MCDM) technique to address RPN calculations. This study involved the design of a flexible fetoscope for minimally invasive fetal intervention, analyzing and evaluating risks. The cascading FMEA framework had two stages for data collection, namely risk identification by individual interview and risk evaluation by individual email. The cascading Delphi FMEA framework with MCDM identified the potential risks for the mother at the tip (risk score = 0.927) and subsequent risks such as debris loss (risk score = 0.896), material degradation (risk score = 0.896), and glue dislodging (risk score = 0.896) as critical issues. By identifying failure modes early, medical device designers can better mitigate risks during the initial design stages.