WISH – Wearable Integrated System for Early Detection of Preterm Labour

Project Information

WISH

Grant agreement ID: 778503

DOI 10.3030/778503

Closed project

EC signature date 31 October 2017

Start date 1 November 2017

End date 31 October 2021

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Total cost € 1 798 562,50

EU contribution € 1 258 993,75

Coordinated by

BLOOM TECHNOLOGIES
Belgium

Periodic Reporting for period 4 - WISH (WISH – Wearable Integrated System for Early Detection of Preterm Labour)

Reporting period: 2020-08-01 to 2021-10-31

Summary of the context and overall objectives of the project

Over 15 million babies are born preterm each year, and over 1 million children die each year due to complications of preterm birth (PTB), thus constituting the leading cause of neonatal mortality. Preterm birth is a global health problem with significant social and economic impact and within one of the priority areas in the health policies of the EU, as is women and children health. The WISH project aims at reducing the economical and psychological burden of PTB by offering a complete, technology-enabled and clinically validated solution to predict and detect labor.

At the end of the project, we have developed a new wearable device for antepartum pregnancy and fetal monitoring. We have clinically validated that the WISH solution is equivalent to standard-of-care. We also showed that using the WISH solution would result in significant cost savings for both patients and healthcare providers.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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).

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

With the WISH project, we’re breaking new grounds in prenatal health. At the end of the project, the goal is to have, for the first time ever, a way for pregnant women to detect labor from home. This has the potential to radically change how prenatal care is provided today and we will work closely with healthcare providers and payers in European countries to continue validating our approach and evaluating its impact on improving maternal and neonatal outcomes. There are 15 million babies born preterm every year throughout the world, with dramatic emotional and financial consequences. Through the WISH project, we aim to reduce the emotional and financial burden associated with preterm birth, and to improve neonatal outcomes.

Expecting mom wearing the WISH sensor and using the mobile app

WISH patch and sensor

WISH complete solution

Expecting mom wearing the WISH sensor and patch, allowing comfortable monitoring at home