If a medical device cannot undergo clinical trials due to ethical reasons, and there is no medical device equivalent to the product, how can it be clinically evaluated?

Use a prospective observational study method: This method evaluates the effectiveness and safety of medical devices by collecting patient data, such as clinical cases, medical history, examination and treatment records, etc. This method requires the consent of the patient and can evaluate the effectiveness of the medical device by following the patient and recording information such as treatment effects and adverse reactions.

Using a retrospective study method: This method evaluates the effectiveness and safety of medical devices by analyzing past patient data, such as case records, diagnosis, treatment and follow-up records. This method needs to ensure data quality and avoid bias to ensure the reliability of the evaluation results.

Use simulation test method: This method uses computer simulation, simulation and other technologies to evaluate the performance and effect of medical devices. This method needs to ensure that the simulation conditions are as consistent as possible with the actual usage conditions to ensure the reliability of the evaluation results.