Figure 1
The vertical axis on the left is labeled “Risk Management Challenges” and lists the category. The horizontal axis at the bottom reads “Frequency cited by Interview Participants” and ranges from 0 to 5 with an interval of 1. Each challenge appears as a horizontal bar that extends from left to right according to its reported frequency. At the top, the bar for “Production and Post-Production activities” extends rightward to approximately 5, showing the highest reported frequency. Just below it, the bar for “Benefit-Risk Analysis” also extends rightward to approximately 5, showing a similarly high frequency. The next group of challenges shows medium-length bars. The bar for “Risk Acceptability Criteria” extends rightward to around 2. The bar for “Disclosure of Residual Risks” extends rightward to about 2. The bar for “Reasonably foreseeable misuse” also extends rightward to roughly 2. The bar for “Risk Reduction as far as possible” extends rightward to about 2. The bar for “Risk Analysis” extends rightward to around 2, and the bar for “Risk Management Policy” also extends rightward to about 2. The remaining challenges show shorter bars. The bar for “Requirements of the standard for cybersecurity risks” extends rightward to approximately 1. The bar for “Broader definition of Harm” extends rightward to about 1. The bar for “Demonstrating Competence” extends rightward to around 1. The bar for “Verification of Risk Control Measures” extends rightward to about 1. The final bar for “Integration of Usability Engineering” extends rightward to 1. Note: All numerical data values are approximated.Main areas of challenges with respect to ISO 14971:2019 implementation. Source: Authors’ own work