Community Research and Development Information Service - CORDIS

H2020

Baby Beat Report Summary

Project ID: 673011

Periodic Reporting for period 1 - Baby Beat (Providing Clarity of Fetus Heartbeat Through Baby Beat Bracelet Measuring Fetal Arterial Pulse Wave)

Reporting period: 2015-05-01 to 2016-04-30

Summary of the context and overall objectives of the project

Baby Beat is an innovative project in a scenario of decreasing birth rate, increasing number of risk pregnancies and other risks associated with the age of pregnants. Baby Beat device consists of a wearable device integrating non-invasive technology based on laser interferometry, which measures the fetal heart rate continuously during the last months of the pregnancy. This device is able to communicate with Smartphones by Bluetooth and to generate automatic alarms when the heart rate exceeds certain thresholds (below 100 or above 180 beats per minute).
Thus, it will generate great social and health benefits:
• Better control of high-risk pregnancies, by monitoring the fetal heart beat continuously.
• Transfer of responsibility of the physician to the mother, who has a direct view of the data concerning the condition of the fetus.
• Increasing the tranquility of pregnant by having a continuous, timed and immediate medical attention.
• Decrease in utero perinatal mortality.
• Prevention of hypoxia, which can trigger brain edema, hemorrhage and neuronal damage.
• Reduction of hospital costs thanks to rapid emergency transfer of the patient.
• Improved safety and reduced risk of infection by using noninvasive system.

Baby Beat is being developed with focus on the market. The ultimate objective is for any pregnant woman – of any age, background and nationality – to be wearing Baby Beat, be it for medical reasons or simply to establish a closer emotional connection with their offspring. For risk patients, Baby Beat would allow close monitoring of the fetal heartbeat and allow customized medical attention instead of systematic hospitalization. For no-risk patients, Baby Beat would help parents to be certain about their baby’s health and give them the feeling that their fetus is communicating with them in an additional way. The outcome in terms of product would be the wearable, the Smartphone application (Android or iOS) and the web platform in the cloud to centralize data storage and analysis.

This system offers an alarm service to receive and keep track of mobile data in real-time, generating relevant alarms and informing the corresponding medical institution or professional. Baby Beat target market includes all pregnant women, who will be reached directly through pharmacies and indirectly through healthcare institutions (including private clinics, hospitals and insurances). This means that, theoretically, 208 million pregnant women may use Baby Beat worldwide per year. It is more likely to be adopted first in the developed world, accounting for 23 million pregnancies.

The main innovation of the method is that it is non-invasive and targeted to be available at an attainable price of a few hundred Euros. The overall objective of the project development is to adapt, integrate and strengthen the prior design of the optics, electronics and software so that it can cope with the hard conditions of continuous daily use. Also, the aim is to test and demonstrate its usefulness on a larger group of pregnant women in clinical trials.

The project objectives are summarized in the following points:
Objective 1: Redesigning the Baby Beat components. Revisiting the heart rate monitor design in all its aspects: optical, electronic and software, in order to develop a wearable device for continuous monitoring.
Objective 2 : Integrating and demonstrating the Baby Beat bracelet. Integrate the redesigned optical, electronic and software components into a smaller and visually appealing wearable and to proceed with laboratory demonstrations.
Objective 3 : Validating and certifying the Baby Beat bracelet. Validate Baby Beat in clinical trials and get the necessary certifications so as to be accepted as a medical device.
Objective 4 : Developing a Business Innovation Plan. Develop a business innovation plan incorporating a detailed commercialization strategy and a financing plan in view of market launch.
Objective 5 : Developing a Communication Plan. Promote the project and its findings during the execution period.

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

During the execution period the effort has been focused in all the active WPs. Technical work packages from one to three are dedicated to the design of the heart rate monitor in all its faces: optical (WP1), electronic (WP2) and software (WP3). During WP1, the measurement system has been improved by developing a VCSEL laser based SMI sensor for detecting the heart rate. The optical design has been centered in using a focusing lens setup. Some issues have been detected, and the effort is to improve the optical system in order to reach an optimal focusing distance. The electronic system was redesigned in WP2, with off-the–shelf electronics and software to measure the fetal heart rate. Moreover, wireless connection with a Smartphone was implemented. In WP3, the Smartphone application and the cloud platform was designed and it will be concluded when the optical design is finalized. The Smartphone application has been tested to communicate remotely with the cloud platform.
The dissemination strategy was implemented in parallel with the technical work packages described above, while work in WP8 management activities has coordinated all tasks in the project.

The next lines describe the work performed within each WP:
WP1: Optic design
• Confirmation of selected laser diodes as a suitable choice for low current and low power consumption SMI measurements.
• Design of the electronics with a laser + photodiode scheme suitable for the use in a wearable.
• Confirmation of the selected lens as an option for providing stable sensor signal and at the same time not surpassing the maximum power exposure threshold limits expressed in the lasers norms.
• SMI sensor signal quality can be managed by improving the robustness and accuracy of the signal processing algorithms.

WP2: Electronic Design
• Develop a sensor board for the laser technology used in demonstrator.
• Develop a sensor board for the laser in voltage scheme.
• Develop a sensor board for the laser with photodiode in bipolar power.
• Develop a sensor board for the laser with photodiode in unipolar power.
• Develop a processing board to validate the integration of the microcontroller.
• Develop an updated version of the processing board correcting flaws.
• Validate that the laser configuration is the optimal option for good performance and low power consumption.
• Develop the communication protocol.
• Perform algorithm tests to check the needs for improving robustness.

WP3: Software Design
• Software specifications have been described and documented in deliverable D3.1.
• Use cases and use scenarios have been described and presented to doctors so that medical feedback could be obtained.
• Communication protocol between wearable and Smartphone has been implemented.
• Smartphone application has been implemented.
• Wavelets analysis has been implemented in the Smartphone as a first version starting from the Matlab implementation of the algorithm.
• This wavelet analysis version has been optimized.
• Alarm notification system has been defined and implemented.
• Communication protocol between Smartphone and cloud server has been implemented.
• Data storage in data base has been implemented.
• Web interface for the cloud server has been designed.

WP4: Integtaion and Test
The WP has not been started in this RP1 and will be started in RP2.

WP5: Validation and Certification
Delay in WP1 forces WP5 to be delayed as it has a full dependence on the outcomes of the optical (WP1) and electronic design (WP2). Management actions have been started by means of meetings with doctors and innovation personnel at hospitals for understanding the requirements to apply for a clinical validation of the device.

WP6: Commercialization Activities
In this RP we have performed an analysis of the current market, focusing on wearable devices in the market that try to cover any need from pregnant women. We also included gold standard devices that are commonly used by doctors.

WP7: Communication Activities
• Participation in relevant health and innovation events: 9
• Meetings with doctors: 6
• Meetings with hospital personnel and innovation units: 7

WP8: Management
Project management, intellectual property and knowledge management and control and coordination in the use of resources. Communications with the European Commission.

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)

The collaboration with doctors and hospitals allowed Baby Beat to check all the concepts and the potential in order to increase the knowledge in the field. The communication channel is established by means of face to face meetings to present the project aims, presentations of the use cases and scenarios, weekly telephone calls, updated versions of the functional analysis document (internal document used for the design) and questionnaires. Moreover the BABY BEAT Project has been presented in relevant health events as well as we have participated in congresses to know the state of the art in wearables and mobile applications for the health sector. Some progress actions are listed below:

• Participating in relevant health and innovation events: attending events where the project could be presented or contact network could be expanded.
• Meetings with doctors and close collaboration: which are very important actions to ensure that Baby Beat design fulfils final user expectations. Also to receive clinical feedback and validate the use cases.
• Meetings with hospital personnel and innovation units: which are the tentative implementers of the clinical validation.
• News in web media: using BCB website, LinkedIn profile, and third parties websites.
• Presentations and leaflets used in events or web media.
• Publications in congresses or conferences, and when possible, in combination of a presentation.
• External coach guidance: in terms of having meetings with a coacher, and with companies in the fields of plastic fabrication, design of enclosures and certification of devices.

Related information

Record Number: 195014 / Last updated on: 2017-02-16
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