Insights from the TT Lifesciences Clinical Evidence Conference
Last week, experts from Purdie Pascoe’s Post Market Clinical Follow-Up (PMCF) Survey team attended the 6th Annual European Medical Device and Diagnostic Clinical Evidence Strategy Conference in Berlin. This event brought together leading clinical experts and industry professionals to discuss key issues in advancing clinical evidence. The conference focused on critical areas such as strategy, innovation, and regulatory excellence for medical devices, providing a platform for sharing insights and best practices.
PMCF Managers Chris Webb and Alice Robertson represented Purdie Pascoe at the event. They engaged with numerous clinical experts at our exhibition stand, and on the first day of the conference, presented "Mastering PMCF Data Collection: How to Overcome Challenges with PMCF Surveys" to a packed room of delegates. Their presentation addressed common challenges in PMCF data collection and offered practical solutions, highlighting Purdie Pascoe's expertise in this area. The session was well-received, sparking lively discussions and further emphasising the importance of effective PMCF surveys for medical device manufacturers.
Key Takeaways
Struggles for Manufacturers
A recurring theme at the conference was the struggle manufacturers face in collecting sufficient quality data for their submissions. Discussions highlighted several challenges, including the difficulty in engaging healthcare professionals (HCPs) effectively and obtaining the necessary data without overburdening them. This issue is particularly pronounced for Class III legacy devices, which require extensive and high-quality data to meet regulatory standards but is often difficult or unfeasible to conduct clinical investigations for these devices.
Participants raised questions about how to gather 'sufficient data', emphasising the need to address both major and minor gaps in clinical evidence using various sources of data collection. The complexity of this task often leads to significant hurdles for manufacturers. One solution is the use of PMCF surveys. These surveys provide a cost-effective method for collecting real-world evidence, especially for Class III legacy devices. By leveraging PMCF surveys, manufacturers can obtain the necessary data to support their submissions while minimising the burden on HCPs.
Planning is Key
Another critical issue discussed was the necessity of proper planning. Device manufacturers must prioritise planning their regulatory and clinical data collection processes early. Early planning is essential as it helps streamline data collection, ensuring that all necessary information is gathered efficiently and effectively. Representatives from Notified Bodies also emphasised the need for planning to avoid a backlog for reviewers due to manufacturers leaving their MDR transition to the last minute, risking availability of devices on the market.
Moreover, involving all relevant departments in the planning phase is crucial. This collaborative approach ensures that the strategy is comprehensive and addresses all aspects of the device's lifecycle. It is particularly important to include departments responsible for publicising clinical claims, as these claims will be advertised and must be supported by robust clinical evidence; Notified Bodies will cross check against information online or in brochures. By integrating input from various departments, manufacturers can design a well-rounded strategy that not only meets regulatory requirements but also enhances the device's marketability and credibility.
Proper planning also facilitates smoother execution of data collection activities, reducing the likelihood of delays and complications, as well as ensuring only relevant and usable data is collected. It allows manufacturers to anticipate potential challenges and develop contingency plans, thereby improving the overall efficiency and effectiveness of the clinical evidence collection process.
Purdie Pascoe’s Dedicated PMCF Survey Team
Purdie Pascoe has developed a best-practice approach, approved by EU regulators and compliant with ISO requirements and GDPR regulations, having conducted over 400 PMCF surveys, collecting both Level 8 and Level 4 data. 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.