Among our expert team, there is a consensus that there are four major considerations when conducting an end-user survey. The first consideration is the Clinical performance assessment. This would include the CER, any literature reviews, or any prior clinical investigations. The second would be the Safety and PMS Assessment, entailing the complaints, adverse events, recalls, or new risks. Third, is to ensure the study’s objectives are in line. This means that the safety and performance feedback is aligned with the regulatory labeling, and that you are not making any new claims about the device. Finally, you must gain an understanding of the limitations of your study. This last piece aims to minimize biases, identify budget constraints, and evaluate the user base of the survey. All of these aspects must be considered when designing and conducting an end-user survey.
There are many factors that can inhibit the success of a survey. Luckily, our team has worked on numerous end-user surveys and are able outline some of the most prevalent obstacles. First, a survey might not even be the right route for your device in the first place, that is why it is vital that you properly determine the best path. Another difficulty we see among our clientele stems from their research questions. If your research questions are poor, it will be difficult to identify the objectives of your survey. Further, if your field observations are not taken into consideration, that could also discredit the survey. In general, the target of your survey needs to be highly focused and maintain the clarity of the aims and intentions of the study.