Finding Value in Post Market Clinical Data Collection

Description: Working towards EU MDR compliance has resulted in a focus on collecting ‘sufficient’ clinical data for your devices, at least sufficient to get your initial MDR certificate. However, with the time constraints of MDR submissions, this has not always resulted in the most valuable way to collect clinical data for your device.

The most valuable way to collect clinical data does not only take regulatory requirements on sufficient clinical data into account, but also covers requests from your marketing department, user requests, requirements for reimbursement, and of course time and costs are important factors. This creates opportunities in terms of expanding indications, expanding claims, and launching devices in new markets. Exploiting these opportunities by partnering cross-functionally across the company helps to extract additional value from the investment in ongoing clinical evidence generation. Designing PMCF studies with a global perspective can create multiple synergies and opportunities.

This session focuses on how you can define a valuable post-market clinical data collection strategy based on collected inputs. During the session, clinical data collection methods will also be discussed. Using examples, the advantages and disadvantages of these methods will be considered. The session will also focus on extracting additional value from the PMCF collection activities by partnering cross-functionally and thinking globally. Specific attention will be paid to registries and the collection of clinical data that are readily available, such as data already collected in hospitals.