GENIT - Handle with Care. Helping Handle for safer childbirth
| Reference number | |
| Coordinator | Karolinska Institutet - Institutionen för klinisk vetenskap, intervention och teknik |
| Funding from Vinnova | SEK 1 930 048 |
| Project duration | November 2014 - October 2017 |
| Status | Completed |
Purpose and goal
The aim of the project was to show the value of objective, quantitative and continuous information gathering during assisted delivery. With the help of the Genit, you can increase the safety and quality assurance of vacuum extraction. We also wanted to make the product available to the market so that mothers and children would benefit from safer deliveries. We have managed to show that Genit adds value for patients and caregivers. However, we have not managed to introduce the product to the market. Additional work remains before we reach market introduction.
Expected results and effects
Several prototypes of the instrument have been developed and are now being tested with good results in clinical trials at 2 different delivery clinics. We believe that with Genit you can avoid the most difficult vacuum extraction procedures and thus avoid negative outcomes for the children. Genit can also warn early on during the procedure, with the help of algorithms, which vacuum extractions that are unlikely to succeed. Unfortunately, we have not been able to take the project all the way to the market; the project will seek more funding for the product to be available for delivery care
Planned approach and implementation
The project has been implemented with 4 main workflows: - Technical development R & D - Clinical studies - Regulatory documentation and certification - Businessdevelopment / planning All areas have been pushed forward and most planned milestones identified during project start have been achieved. However, the project should have had a further focus, namely production. There remains work to take all the learnings from current prototypes and create a product for series production.