How we helped our client expand the indication of their device through a survey collecting real world data
The Challenge
Our client’s device is used for a specific indication, however, users identified a potential benefit of the device’s design to perform successfully in another indication.
This study has different project objectives to other PMCF studies as the client aims to add information in the labelling (IFUs) for the device to guide users on the safety and feasibility of use in the expanded indication.
Our client, therefore, required help to collect data from retrospective real world cases to support the indication expansion.
The Approach
There are currently ~20 procedures that have been performed by known physicians across the US for the off-label indication. With this in mind, a quantitative online survey was designed to collect data on a case specific level to address the performance, safety and feasibility of the off-label procedures.
The client was responsible for identifying the sites and physicians to be surveyed, while Purdie Pascoe was responsible for the design, programming, data management and analysis.
Considerations needed to be made for the following:
Patient confidentiality
Institutional ethics committee and/or IRB requirements
Data Integrity
The Impact
Data was collected on 30 cases for which the device had been used for the off-label indication
Across the 30 cases, the procedure was successful, with 100% success
Results related to safety were favorable from a device user perspective as no device or procedure related complications were encountered across the cases reported on in the survey
This data collection allowed the client to evaluate the safety and effectiveness of the off-label indication, and to add this information in the labelling (IFUs)
Our expertise
Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with ISO requirements and GDPR regulations, for PMCF surveys.
We can support you with the design, implementation, data collection and reporting of your PMCF surveys to ensure you collect appropriate PMCF data to be used within your MDR submissions.