Periodic Reporting for period 1 - WISH (Wearable Integrated System for Early Detection of Preterm Labour)
Reporting period: 2016-11-01 to 2017-02-28
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 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.
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.