Development of final prototype for RespiHeart
|Funding from Vinnova||SEK 900 000|
|Project duration||June 2018 - January 2019|
Purpose and goal
RespiHeart is a new method for registration of respiratory rate, heart rate and oxygen saturation, by optical measurement of the blood flow in the sternum bone. The project has aimed at developing a final prototype for the RespiHeart system, for clinical studies and required tests for CE certification as a medical device. A final sensor and software has been developed. The result will meet the demands of forthcoming: clinical evaluation, user tests, physical and functional tests, and adaptations for the final 0-serie version for CE marking.
Expected results and effects
The project results encompass: (1) Final prototype of RespiHeart sensor with functional performance according to technical requirements specification, in 20 units, (2) Software for sensor unit and for parameter calculations, analysis and presentation in an external app, (3) Quality documentation, finalized risk management, preparations for clinical trials, and plan for CE certification. Linköping University Hospital and IBM have followed the project and are now interested in collaboration with RespiHeart in upcoming tests, implementation and market launch.
Planned approach and implementation
The project has been conducted in three work streams: (1) Technical utveckling and production of sensor unit, (2) Development of software for the sensor unit and external app for signal processing and presentation, (3) Regulatory governance, documentation and planning for evaluation and tests. Collaboration with external expertise within electronics and software development, as well as clinical processes and regulatory compliance, has contributed with a strong concept and platform for coming finalization of the product development phase.