ABSTRACT
BACKGROUND: The aim of this study was to present the validation and optimization process for a new innovative medical device to create a standardized episiotomy. DESIGN: We performed a preclinical validation study. SETTING: This study was performed at the University hospital. SAMPLE: Animal, cadaver. METHODS: Together with technical engineers, we designed a new medical device that involves a knife and cuts back from buttock toward introitus, in contrast to the conventional episiotomy. We optimized the design and its performance in consecutive animal and cadaver studies. MAIN OUTCOME MEASURES: Ability to perform a standardized incision, ease of use. RESULTS: After multiple adjustments, based on the results of multiple animal and cadaver studies, a medical device was developed to perform a standardized clean-cut episiotomy of 4-6 cm length. CONCLUSION: We have shown that optimizing the technical performance and safety of an innovative device in animals, prior to opposing patients to its potential hazards, is feasible. Our design optimizing study can be used as a model for the pre-clinical validation of future innovative medical devices.
