SmartPAN an intraoperative pancreatic juice leakage indicator

Purpose and goal:

Magle Chemoswed has developed SmartPAN, a medical device product that can detect, localize and quantify leakage of pancreatic fluid during surgery. SmartPAN can thereby guide the surgeon if and where further measures must be taken. The goal of the project was to bring in clinical expertise that could help us design our market surveillance programme, set up study plans for clinical follow-up studies, and identify what clinical data is needed for optimal market introduction.

Expected results and effects:

In this project, together with clinical experts, we have further developed our programme for market surveillance so that we now have a clear plan for ongoing and future activities. We have planned two clinical follow-up studies, one of which has already started and the majority of patients are included. In parallel with this, we have collected information and identified which additional clinical data is needed for optimal market introduction.

Approach and implementation:

The work has been carried out in collaboration with external experts in clinical testing of medical devices and experts in price and market access. We have had frequent online meetings where we discussed ideas, as well as sending documents back and forth for review. It has been of great value to be able to test our thoughts and ideas with the consultants and thus educate ourselves further in the field.