Starting the EU-CAD project proved to be more challenging than anticipated. The first big milestone to hit is the recoding of the aQuant software, and the demand specification took four month longer than planned. Subsequently we discovered that we needed to recruit two new internal resources alone to manage this work package.
However, the solid work done on demand specification helped accelerating work package delivery once it was kicked-off. Today, we are approx. 2 months behind plan.
The overall project delivery is however not delayed as we have been able to tap into an already ongoing clinical study for our own validation testing. Besides, we have fortunately secured one of the limited seats for CE-marking at the Dutch notified body BSI, other projects have experienced wait times of 2-3 years for this.
The EU-CAD project is more relevant than ever. Demographic development increases coronary artery disease (CAD) and the cost pressure on hospitals post-Covid-19 is higher than ever before. A solution to improve diagnostics in CAD while improving efficiency and reduce costs is mitigating this pressure significantly.
There are no changes to the end products of the project deliverables, but we have had to realign the budget composition to reflect the much higher amount of internal work necessary to secure progress of the EU-CAD project in line with the overall project objectives.
WP 1 - Project Management and Dissemination
-Financial reporting, IPR management and risk register now up and running
-Thor Brønsvig has been added to the MedTrace team as Head of Controlling and Business Support applying continuous dedication to controlling the EU-CAD project
-There is a solid structure around the project now
WP 2 - Code and Infrastructure Development
-Dedicated project manger and project coordinator (2*100%)
-Code development closely monitored
-Have had first big adjustment
-Most likely challenges ahead
-Little behind schedule but more the 50% done
-First test validations of code - good results
-Clinicians eager to participate in technical validation
WP 3 - Clinical study EU
-A more relevant study (Dan-NICAD3) emerged after projects start. It was decided to collaborate with Aarhus University Hospital instead of acquiring the PACIFIC trail data from Amsterdam UMC
-All hardware systems produced at A/S Kurt Hansen
-1st installation of hardware system went really well (Uppsala, SE, see images)
-Installations delayed due to Covid-19 travel bans
-Kits has been more challenging then expected due to redesign and technical errors. Final delivery have been made.
-Notified body engaged; BSI (major achievement)
WP 4 - Market Access EU
-Most of the seven sub-work packages in WP4 have been delayed due to Covid-19’s travel bans
-Scope is not going to change, but a lighter approach necessary
-Virtual dialogue have been more positive than expected
-Mock-up produced as planned, just not used at conferences yet due to Covid-19
