FLUISENSE
Client: Fluisense
Fluisense’s innovative fully portable and automated blood sampling system, Fluispotter®, is a unique new technology to be used for collection and storage of blood samples over the course 24 hours or less with minimal blood loss.
The Fluispotter is programmable and will collect the samples according to individually designed sampling schedules decided by the user. Drops of blood are dispensed onto a roll of special paper at a requested rate, and can subsequently be analyzed one by one.
THE CHALLENGE
Strategic focus on entering the market for human use, made a CE approval according to the Medical Device Directive (MDD) imperative. Glaze’s experience with the development of medical devices has been valuable in achieving this goal. Together with colleagues from Prevas, Qmed Consulting and Techpeople we have helped Fluisense in a speed version of a traditional medical device development project.
Naturally, the areas of approvals, safety and software within medical devices, was a challenge to Fluisense as there was limited experience within these areas. But also the transformation of the company from sandbox development to controlled and documented development has been interesting and it has been beneficial for Fluisense to bring in consultants in this change.
QUOTE
Ulf S. Skimmeland, the CEO at Fluisense says: “Having a person with managing capabilities and a vast experience in medical device development joining the project has been essential to the project. The ability to communicate at all levels and the tools used to structure the work at Fluisense proves the experience from similar situations and works very well with us.“
