From the beginning of the project, we achieved the following results:
1) We have successfully developed a new miniaturized wearable electronics and a new patch tailored to labor detection;
2) We have collected our physiome dataset composed of longitudinal physiological recordings collected during the last 10 weeks of pregnancy on 125 women;
3) Using the physiome dataset, we have developed and validated the algorithms and machine learning model to automatically detect labor based on physiological recordings, and we have embedded the algorithms in our sensor;
4) We have developed a mobile app that women can use to visualize the data they collect with the WISH sensor and patch, and to get feedback on their progress towards labor;
5) We have developed a cloud-based back-end to securely store user data and information;
6) We have integrated all components of the WISH solution in a first release of the product ready to be tested by our end-users.
7) We completed testing of the WISH solution with end-users in the context of a beta testing study.
8) We achieved ISO 13485 certification, a fundamental step towards CE marking.
9) We obtained CE marking for Bloomlife Hopper, the class I medical device that includes the hardware, firmware, and software infrastructure of the WISH solution
10) We validated that the WISH solution is equivalent to the standard hospital monitor
11) We showed that using the WISH solution would result in significant cost savings for both patients and healthcare providers.
We have taken multiple actions to provide visibility to the project. We have created and regularly updated the WISH website with news and updates on the project. We have published early project results in technical publication (International EMBS conference) and presented our results at the World Congress on Maternal, Fetal and Neonatal Medicine in London. Finally, we have participated in high profile events, both at the European (Supernova, Ideas from Europe, VivaTech, FemTechnology Summit) and National (MedTech Meetup, ITF Conference) level, creating high exposure for the WISH project. In 2021, we shared our vision on the future of prenatal health at the European HealthTech Investment Forum (March).
At the end of the project, successful results were achieved on all project objectives (clinical validation, healthcare economics validation and CE marking).
