Background to Post-Market Clinical Follow-up: End-User Surveys

In general terms, Post Market Clinical Follow-up within the Post-Market Surveillance Plan provides documentation relating to how the device manufacturer will collate and analyze the clinical data that has been collected from the device. This area is a key differentiator between the MDD and MDR, and its process and plan must be solidified for continued compliance moving forward.

According the MDCG, the goals of the PMCF are as follows:

• Substantiate the performance and safety of the device, and if applicable, will also contain the clinical benefits for the duration of the product’s lifetime.
• Highlight unknown side-effects when necessary, and be able to monitor them, along with any contraindications moving forward.
• Utilizing relevant and proven evidence, be able to identify and evaluate emergent risks.
• Confirm that the device’s benefit-risk ratio is maintained at an acceptable level.
• Be able to assess any potential misuses, or uses of the device not outlined on label, and ensure the intended purpose is accurate.

There are a variety of approaches that can be considered as you are collating evidence for your PMCF. Some of the most common are literature reviews, registry studies, randomized clinical trials and end-user surveys.

When deciding your company’s strategy, you must determine a solution considering the volume and substance of the evidence, along with the effort involved in collecting this evidence. End-user surveys do not allow for the highest level of evidence compared to some of the other approaches, like randomized clinical trials. Surveys offer companies a solution that is relatively inexpensive while still providing substantial levels of evidence.

This comes down to what your device’s clinical evidence portrays. With that said, you must keep in mind that your clinical data collection doesn’t always have to be to the extent of a randomized clinical trial. With justification, there can be various levels of clinical evidence that can be considered acceptable. It is also recommended that you utilize any existing datasets and be able to identify any gaps in your current safety objectives. Again, you must analyze the data that you have available. The device classification, the clinical data relevant to the indications, and a variety of device specifics are all aspects your team should consider when deciding whether to go the survey route or not. These additional device details can include: the standard of care and/or alternate methods (state of the art), the novelty, target patient population, and emerging hazards, among others.

What is the existing Clinical Data that you have available? This could vary depending on legacy status, as legacy devices will have a lower level of attention to individual indications. In contrast, novel devices will have restricted pre-market clinical data in their CERs. This is another area of the discussion that pertains to your team’s ability to interpret the requisite changes from MDD to MDR. This transition may identify gaps in data that your team previously did not need to consider.

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.