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Wearable Integrated System for Early Detection of Preterm Labour

Periodic Reporting for period 1 - WISH (Wearable Integrated System for Early Detection of Preterm Labour)

Reporting period: 2016-11-01 to 2017-02-28

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. In Europe, about 75% of all neonatal deaths and 60% of all infant deaths occur to infants born preterm. Premature babies are also prone to serious long-term illnesses, lifelong disabilities and poor quality of life. PTB causes a great suffering, concern and psychological stress to parents. Preterm birth is therefore 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. PTB occurs across all countries and income levels and has a significant global economic impact, with an average preterm birth rate in the EU between 6% and 12%. Recent studies suggest that PTB could cost the EU healthcare system up to €30 billion per year.
Bloomlife will reduce this burden by offering a disruptive solution: WISH, a complete, technology-enabled and clinically validated solution to predict and detect labor. WISH is user-friendly and intuitive and integrates seamlessly into any expectant woman’s routine. WISH is composed of Bloomlife’s award-winning patch and wearable sensor, a consumer facing app and a web-based dashboard for the care-giver integrated with software available at healthcare institutions. WISH focuses heavily on the early detection of preterm labor based on physiological indicators and behavioral patterns. WISH uses our advanced signal processing of the sensor’s data, combined with data analytics triggers and cross-checks, to build a real-time comprehensive index score on the probability of labor. This score provides a straightforward measure of the risk of PTB and the most appropriate responses.
As a result of an early and accurate detection of preterm labor, WISH will facilitate preventive actions and timely interventions in pregnancies to reduce the economical and psychological burden of PTB. WISH will be useful for both consumers and healthcare providers and will allow a more efficient prenatal care in EU, provide an essential tool for high-risk pregnancies and reassure and guide all pregnant women.
On the technical front, we studied different methods to investigate key data behavior differences between pregnancy and labor. We first analyzed manually selected contraction data and explored feature differences during contractions between the two conditions. Then, we investigated the possibility to use automatic contraction detection methods through data analytics to isolate contractions and single out feature differences. Finally, we analyzed our previous pilot data over longer periods of time to extract features statistically representative of labor without requiring manual data segmentation or contraction detection. As a result of this process, we isolated several data processing and analysis methods particularly adapted for this purpose and achieved an already outstanding labor prediction accuracy of 87%, while also envisaging further adaptations into our existing sensor prototype to improve the quality and value of the measurements.
On the commercial front, we performed a complete market analysis, including comprehensive market, segment and competitor research, we investigated the current and future trends in the field of consumer health, we perfected our strategy regarding both direct and indirect dissemination and commercialization channels, we prepared for the necessary requirements for commercialization (CE marking, operational agreements with hospitals), we performed a detailed price sensitivity analysis, and perfected our Business Plan, including the identification of potential risks and barriers.
On the regulatory and IPR front, we identified the key aspects regarding current standards and regulations for medical devices and carried out an exhaustive Freedom-to-Operate analysis that concluded with a favorable IP landscape for the future development and commercialization of WISH.
Finally, on the operational front, we carefully planned the necessary Work Plan for the ensuing Phase II project that will allow us to finish the development, testing and certification process to achieve a TRL9 and prepare for large scale commercialization.
Currently, we have already developed a wearable contraction monitoring system, including an advanced version of the sensor and patch, as well as early versions of a WISH mobile app and a WISH cloud-based platform to be used by both expectant women and healthcare professionals. Our prototype is able to measure uterine electrical activity longitudinally, either in a clinical environment or at home, and has already been tested in several clinical pilot studies in hospitals, where it was validated against reference data from Cardiotocography (CTG), which is the reference method for labor monitoring, and against actual delivery dates. As a result of our early pilot studies, our initial labor detection algorithms were already able to predict labor with an accuracy of almost 90%.
According to our estimates, the expected social, economic and clinical impact of WISH term will already be significant on the medium term and allow further clinical research on the long term:
- WISH is designed to reduce global healthcare risks and costs associated to preterm birth. The adoption of WISH by expectant women and the use of its data by healthcare professionals will result in an important shift in gestational age at delivery, thus facilitating reductions of PTB. According to studies by Frost & Sullivan, regular self-monitoring systems during pregnancy could avoid 74% of mother and infant mortalities.
- Through the advanced monitoring app and insightful and entertaining features, we will be able to improve behavior compliance from expectant women, which will also result in a general reduction of pregnancy risks.
- By integrating it as an option for their clients, WISH will provide a competitive advantage to insurance and healthcare companies willing to offer differentiated and innovative technological solutions.
- WISH will also contribute to the well-being of expectant women through the reduction of stress linked to PTB risks. Our pilot studies with WISH prototypes already demonstrate a 15% reduction in labor-related anxiety.
- WISH will position our company as a global reference in the field of prenatal monitoring solutions. WISH will combine the user-friendliness of our current products with outstanding and proven clinical accuracy, thus allowing us to become market first comers and boosting our growth in Europe and abroad.