Clinical Verification of Innovative Product that Facilitates Intravenous Access
Reference number | |
Coordinator | Ortrud Medical AB |
Funding from Vinnova | SEK 142 424 |
Project duration | December 2016 - December 2017 |
Status | Completed |
Purpose and goal
The project goal was to examine and develop the prototype alongside the end user to ensure its readiness for production and use in the clinic. It was successfully verified with the end user at the clinic and in the lab. We have performed several rounds of optimisation for production in order to reach readiness for production at the level required for the CE mark, which allows clinical trials and sales.
Expected results and effects
The project has verified that the product meets the demand of the end user in terms of user friendliness as well as functionality in the clinic. Following this project, functionality has increased and product versions for patient sub types were identified. The product is now CE marked and first production is initiated.
Planned approach and implementation
WP2 and 3 were in part performed in parallel as both related to the end user. Both ran within the planned time interval. Since CE-mark work took longer than anticipated, this incurred WP1 delay, causing costs for the clinic to be delayed.