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Cable-driven flexible endoscope utilizing diamond-shaped perforations: FlexDiamond 59
                                               Table 3.5: (Continued)

                                Related methods of
                Testing subjects  testing           Acceptance criteria      Results after testing
                Weak guidance of  Functionality tests  Endoscope did not touch the  Endoscope did not touch
                the tube         (conical flask     walls of the conical flask  the walls of the conical
                                 experiment)        while traveling to the   flask while traveling to the
                                                    nasopharynx region       nasopharynx region

                Tango Vero as a  Substitute for     Polyurethane is able to  Time taken for
                substitute for  polyurethane using  withstand load for a more  polyurethane to break is
                polyurethane    Tango Vero          extended period of time  more than twice that of
                                                    (cyclic stability)       Tango Vero
                Biocompatibility of  ISO-10993, “Biological                  Test not conducted
                materials used  Evaluation of Medical
                (polyurethane)  Prototypes Part 1:
                                Evaluation and Testing”


               3.5 Design specifications, review, and benchmarking


               The user specifications (US) aim to tackle the unmet needs of the current nasopharyngoscopes
               by developing a prototype that meets the clinical needs (Table 3.6). This US part translates the
               consumers’ needs into a list of ideal technical specifications or metrics (Table 3.7).
               FlexDiamond then utilizes these target specifications set to develop the ideal prototype. In
               addition, this need-metrics matrix (Table 3.8) serves as a guideline for prototype developers to
               refer to while reviewing and refining the technical specifications of the prototype.


               3.5.1 Clinical needs



               3.5.2 Metrics

               Table 3.6: Identification of needs tabulated according to their importance with 1 being the most
                                      important and 5 being the least important.
                Need no.             Customer need                    Importance (1 5)
                1                    Wide viewing angle                            1
                2                    High steerability                             1
                4                    User-friendly                                 1
                5                    Safe for prolonged usage                      1
                6                    Home-based                                    2
                7                    Subject self-administered                     2
                8                    Comfortable                                   3
                9                    Affordable                                    4
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