## 4 Video Otoscope with an Integrated Scanner Prototype Validation  
The development and adoption of new medical devices, such as the new video otoscope, requires systematic evaluation to ensure their effectiveness, efficiency, and acceptance by healthcare professionals, which is essential to ensure that they meet the needs of healthcare professionals and provide a satisfactory and efficient user experience [41]. According to the International Organization for Standardization (ISO), usability is defined as \"the extent to which a system, product or service can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use\" [42]. To validate the new system, it is essential to measure not only its technical efficiency but also the user's experience of using the equipment in real clinical environments. Clinical performance is related to the equipment's ability to provide accurate, reliable, and safe results when used in real situations. In the case of the video otoscope, clear and detailed visualization of the structures of the EEC and tympanic membrane is crucial. Indicators such as complete visualization and the ergonomics of the equipment are fundamental to validating the device as a valuable tool in clinical practice. An efficient device reduces examination time, improves patient comfort, and increases diagnostic accuracy, which are essential characteristics in the clinical context of performing otoscopy. This includes diagnostic or therapeutic efficacy, safety for the patient and the healthcare professional, compliance with current international standards for the use of medical devices, and minimizing the risks and adverse effects associated with the use of the equipment. On the  
Figure 5: Workflow of the methodology used. other hand, the device must also be able to adapt to the different anatomies of the EEC and head without compromising the performance of the function for which it was designed, maintaining its performance over time under normal conditions of use (i.e., reliability) [43]. The construction of the video ootoscope prototype followed a set of stages illustrated in Figure 6 and is now at the prototype evaluation stage. The analysis of ergonomics and patient safety is essential to ensure that the use of the device does not compromise the comfort or physical integrity of the patient, so the device's design has been thought out to address these aspects as well. The construction of this device took into account its physical and functional adaptation following the safety and efficiency standards required in the medical device industry [44]. A clinical trial was carried out to validate and verify this prototype of the video otoscope in which feedback was obtained from health professionals in the area, as well as from users of the device, to collect qualitative and quantitative data on usability, ergonomics, and satisfaction with the equipment [42]. The feedback was collected by self-administering two questionnaires, one for health professionals and one for device users. The questionnaire is a crucial tool to ensure that the new video otoscope meets the needs of healthcare professionals, namely audiologists and patients while contributing to advances in clinical practice and medical technology. Analysis of the results will make it possible to identify areas for improvement and validate the device as a practical and efficient solution in otoscopy. Figure 6: Usability-oriented model for the design of medical devices [41]. The application of this questionnaire aims to provide valuable feedback that will contribute to the optimization of the otoscope, both in terms of performance and acceptance in the clinical context. This evaluation aims to ensure that the new device is effective and safe for diagnosis and to identify ways of improving the healthcare professional's experience, positively impacting the quality of patient care.