A Cascading Delphi Method-Based FMEA Risk Assessment Framework for Surgical Instrument Design: A Case Study of a Fetoscope  
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1 Department of Biomedical Sciences and Biomedical Engineering, Faculty of Medicine, Prince of Songkla University, Hat Yai 90110, Songkha, Thailand; [EMAIL_ADDRESS]  
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2 Department of Occupational Safety and Environmental Health, Faculty of Public Health, Khon Kaen University, Khon Kaen 40002, Khon Kaen, Thailand; [EMAIL_ADDRESS]  
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3 Department of Mathematics, Faculty of Science, Khon Kaen University, Khon Kaen 40002, Khon Kaen, Thailand; [EMAIL_ADDRESS]  
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4 Department of Computer Science and Information Technology, Faculty of Science, Naresuan University, Phitsanulok 65000, Phitsanulok, Thailand  
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5 Center of Excellence in Nonlinear Analysis and Optimization, Naresuan University, 99 Village No. 9, Tha Pho, Maung District, Phitsanulok 65000, Phitsanulok, Thailand  
5 Department of Public Health and Primary Care, KU Leuven, 3000 Leuven, Belgium; [EMAIL_ADDRESS]  
[PERSON]  
1 Department of Biomedical Sciences and Biomedical Engineering, Faculty of Medicine, Prince of Songkla University, Hat Yai 90110, Songkha, Thailand; [EMAIL_ADDRESS]  
[PERSON]  
2 Department of Occupational Safety and Environmental Health, Faculty of Public Health, Khon Kaen University, Khon Kaen 40002, Khon Kaen, Thailand; [EMAIL_ADDRESS]  
[PERSON]  
3 Department of Mathematics, Faculty of Science, Khon Kaen University, Khon Kaen 40002, Khon Kaen, Thailand; [EMAIL_ADDRESS]  
[PERSON]  
4 Department of Computer Science and Information Technology, Faculty of Science, Naresuan University, Phitsanulok 65000  
process of advanced medical devices to improve patient safety and reduce adverse medical events [1; 2; 3]. Implementing risk analysis during the initial design stage can reduce the cost and operational complexities associated with subsequent device redesign [4]. Risk assessment should be applied during the initial conceptual and design stages [6]. Failure Mode and Effect Analysis (FMEA) has been used for the medical device industry to analyze risk [7], but its use within the medical device design paradigm is still intrinsically complicated and challenging. ISO 14971 recommends FMEA as a risk assessment tool [4]. FMEA is in origin an engineering industry technique now also used to identify and analyze risks in healthcare products or equipment [8]. It has been adopted as a prospective method to reduce adverse medical events involving sophisticated equipment [9; 10]. This method has been widely used both in initial design [6] and then later in the application, of medical devices and procedures [7]. This technique helps designers and engineers to understand risks by identifying and understanding the potential failure modes of the instrument or procedure [7]. The FMEA procedure is a highly effective technique relying on feedback provided by experts in a subjective approach. A multidisciplinary expert team is required to identify potential failure modes (FMs) [6]. FMEA expert team members' dedication and agreement are crucial to an effective conclusion [11]. Attempts can be made to minimize undue subjective influences by changing from the experts' subjective approach to a more objective one. FMEA has become increasingly popular and it is generally considered to be an appropriate and effective method for risk assessment in healthcare systems [9]. However, it has been noted to have several potential issues [12; 13], two of which we consider critical: data collection and the calculation of the risk priority number (RPN). The hazards in data collection are primarily potential group bias and time constraints. To collect data, several approaches were considered, including focus-group discussion [14], brainstorming sessions [15], interviews [16], observations, surveys [17], and related approaches [18]. Alternatively, the Delphi method has been used increasingly for collecting data [17].