To reduce the risk of application error, the federal legislator has demanded a development process which is oriented towards usability (DIN EN 62366). Therefore, the research question concerns the application of this standard by medical device manufacturers. Questionnaires were filled out by five trained interviewers in fully standardized face-to-face interviews at MEDICA Düsseldorf 2010. The results are based on 65 interviews. Almost all companies evaluated usability as relevant for product development; however, the understanding of usability through companies can still be improved as well as increasing the amount of trained usability experts in the process.
Introduction: A team has been working on a high-fidelity surgical training model for a lumbar disc herniation made of synthetic materials. Since other types of surgical training (as VR Simulators and cadavers) lack optical and haptic realism, the goal was to develop a training model that transfers knowledge about the feeling when operated on and enables training with a realistic workflow. Furthermore, after a training operation, feedback should be provided to the trainee about the applied stress to risk structures during an operation. Methods: The model was designed iteratively with intense validation from surgeons. First, human tissues were developed separately, validated, redesigned and repeated. Then the model was developed in the same process. An intra operating bleeding system and a sensor system were developed and integrated. Results: The surgeons were enthusiastic about the realism of the developed training model. It does not matter which instruments and techniques are preferred, surgeons have realistic haptic response and the surgical workflow follows a real operation when training on the model. This is a huge benefit when compared to VR simulators and cadavers. Discussion: In future steps, stress data to the risk structures will be analyzed, in order to a better understanding of what the critical moments during this operation are and what the stress thresholds of the nerve roots are.
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