Wek:AI powered fetal monitoring device

We are creating affordable and sustainable healthcare solutions to combat maternal and infant mortality in the developing countries, where there is strain on resources and challenges in accessing quality healthcare services. Our first product is a low cost hand held device that allows pregnant mothers to continuously monitor the conditions of unborn babies and provide better information to doctors. Access to quality care during prenatal period can save 60% of deaths. Fetal health assessment is very important and lack of facilities leads to complications lead to more than half a million still births. Wekebere a portable IoT based fetal heart monitoring solution enable fetal heart assessment anytime and anywhere. Portable and affordable nature of solution will increase accessibility of test by 10X and improve health seeking behaviour with positive experience of test at home

In low-resource settings, most hospitals are overcrowded, understaffed, and ill-equipped. Vulnerable expectant mothers suffer most from this strain, and often die from preventable causes. Our solution aims at tackling the problem of high maternal and infant mortality that are related to pregnancy complications at or around birth. Although these conditions can be prevented with known interventions, many expectant mothers do not receive the attention they need because facilities are understaffed and under-equipped. Midwives in these facilities rarely have necessary tools needed to provide high quality maternity care. As a result, vulnerable expectant mothers are suffering- avoidably. Many initiatives have focused on preventing or treating the primary conditions, but there is an unmet need for tools to help overburdened healthcare workers better manage high volumes of patients. Without proper equipment or staff to routinely monitor vital signs, high risky mothers in distress often go unnoticed, their health deteriorating and likelihood of effective intervention declining.

We have developed a wearable device that allows midwives to remotely monitor and manage high-risk pregnancies and intervene, as needed, upon detection of labor or other potential pregnancy complications. Our solution is a 3-in-1 wearable device integrating continuous monitoring of fetal heart rate, fetal movement, and uterine contraction. By enhancing early detection of fetal well-being and increasing access to care, our solution allow for improved healthcare delivery, thus increasing mother and infant safety, preventing maternal and neonatal morbidities, and lowering healthcare costs. By applying machine learning to what could become the largest and most comprehensive dataset on maternal and fetal health, the proposed platform could become a valuable resource to researchers to identify underlying causes and biomarkers of preterm birth. Primary end users are women with high-risk pregnancies, and elevated risk of preterm birth. Target customers are hospitals, health care providers and insurance companies.

Our solution empowers expectant mother to participate in her prenatal care by extending care outside hospitals. The solution is also powered by data analytics that monitors real-time uterine activity for contraction frequency, duration, patterns and trends, enabling doctors to earlier predict and manage pregnancy complications.

Our solution delivers the Ugandan standard of care in an affordable, locally-appropriate product focused on maximizing the impact of existing healthcare workers. By enhancing early detection of fetal well-being and increasing access to care, our solution allows for improved healthcare delivery, thus increasing mother and infant safety, preventing maternal and neonatal morbidities, and lowering healthcare costs. By applying machine learning to what could become the largest and most comprehensive dataset on maternal and fetal health, the proposed platform could become a valuable resource to researchers to identify underlying causes and biomarkers of preterm birth.

Hospitals are profit by reducing the number of hospital beds, hospital staff as nurses and midwives and as such allowing more time and resources to focus on treatment of other pregnancy-related complications. This results in improved healthcare and annual household revenues. Increased revenues for the expectant mothers  results in better living standards, better feeding and education for school going children and in addition, it acts to reduce the inequality levels (UN’s Sustainable Development Goal #5).

We are creating affordable and sustainable healthcare solutions to combat maternal and infant mortality in the developing countries, where there is strain on resources and challenges in accessing quality healthcare services by allowing  mothers to continuously monitor the conditions of unborn babies and provide better information to doctors. Access to quality care during prenatal period can save 60% of deaths. Fetal health assessment is very important and lack of facilities leads to complications lead to more than half a million still births. our solution  increases accessibility of care by 10X and improve health seeking behaviour with positive experience  at home

The feedback systems of our solution is designed to be easily understood by different care providers with different levels of experiences. To address the needs of the users with hearing problems, decreased vision and color blindness, our solution provides the heart rhythm in three different feedback channels; as a number on the display, a LED over the display flashing in sync with the heartbeat and a speaker that plays the fetal heart sounds. To better guide the user on which number and beat is good or bad, the visual feedbacks change color in relation to the child's heart rhythm and appear in green (normal heart rhythm), yellow (abnormal heart rhythm) and red (abnormal heart rhythm over time). These color contrasts were adjusted to be distinguishable even by colorblind users. our solution is suitable for all health workers related to maternity care, from highly trained doctors to midwives with more limited education

The wekebere system is composed of our award-winning wearable sensor, an adapted electrode belt, a consumer app and a web-based dashboard for the care-giver, integrated with a secure Cloud platform that can be accessed at healthcare institutions. Wekebere focuses on the early detection of preterm labor based on maternal and fetal physiological indicators. It uses our latest technological and clinical breakthroughs in signal processing, data analytics and machine learning to build a comprehensive risk score for the probability of labor based on overnight recordings. This score provides a direct measure for the risk of preterm labor.

Our solution 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%.

We will use the following impact indicators to measure success and to compare data from a comparison group, such as an adjacent Doppler’s intervention area receiving standard maternal care at labor and in the last two months of pregnancy. We expect a difference (effect size) between the two groups of at least 15– 20 percent in the achievement of these indicators, as follows:

• Reduction in neonatal mortality rates at study sites (assessed within 28 days of life)
• Reduction in the incidence of neonatal asphyxia because of early detection of fetal distress by wekebere solution and the resulting improved antenatal and  intrapartum management (assessed within 28 days of life)
• Improvement in feeding behaviors and breastfeeding rate and quality (assessed during the first six months of life)
• Improved infant cognitive and behavioral indicators at one year using standardized assessments.

3.   Reduction in the incidence of infant developmental delay (assessed periodically within the first year of life)

Indicators 3, 4, and 5 are based on the premise that prematurity leads to long- term morbidities. Early identification and prediction of premature labor through wekebere, and effective labor monitoring through wekebere system, will lead the clinician to attempt to prolong the pregnancy (for example, by administration of tocolytic drugs) or provide appropriate obstetric intervention (for example, providing steroids for fetal lung maturation) to reduce newborn morbidity (commonly from asphyxia) and improve short-term and long- term infant health and developmental outcomes.

Our device is currently patent-pending and in the prototype stage. To date we have tested on 140 pregnant mothers and are preparing to launch two clinical pilot studies assessing device performance and accuracy. This will be followed by a product iteration phase, and additional studies evaluating the feasibility and impact of the solution, prior to commercialization in late 2020.

In 12 months we expect to reach 1,200 expectant mothers with our solution (within clinical trials). In 5 years, 2025, we will be serving 1.4 million mothers. Our monitoring solution will improve the quality of care for patients in low-resource health facilities by providing healthcare workers with more detailed information about patients’ status and real-time alerts to patients in distress.

Over the next year, we will conduct several clinical trials and produce the market-ready version of our solution. First, we will complete our accuracy pilot studies in Uganda. The data collected in these studies will be used in the development of the second, optimized version of the device. We will then conduct efficacy studies at 3 hospitals in Uganda, 1 Vietnam, (through an NGO partner), and 1 hospital in Kenya. By the end of Q4 2020, we will design freeze and submit to CE Mark. We will also begin production with our large-scale manufacturing partner.

We are creating solutions for a highly regulated sector, and as such have encountered hurdles in piloting our solution in countries where the regulatory strategy for medical devices is still actively being developed. Additionally, we hope to see more investors focus efforts on emerging markets, where there is a largely untapped opportunity to sustainably improve quality of care for millions of patients.  We also anticipate challenges around securing letters of intent/ pre-orders as this is not customary practice in Uganda.

We hope to connect with others who have been through this process before.

we are 5 fulltime staff,10 part time staff and 2 contractors

We are a diverse (50% women), tight-knit team of experienced professionals who have worked in healthcare, technology, and consumer across multiple functions. We think big and bold, and relentlessly execute.

We have the scientist, data experts, developers and they all work together to build a robust technology to tackle mined a data and build algorithm is quiet big and is committed and driven by passion to reduce high rates of maternal and infant mortality.

Vilgro kenya for business support and incubation services

Makerere university  for clinjical studies
 

Uganda industrial research institute for hardware design and development

Business- to- consumer (B2C): Direct engagement with pregnant women.  Because wekebere is portable, wireless smartphone– connected devices, we might make them available through an appropriate market channel to engage pregnant women directly and offer them consultation by allowing them to select a doctor.

  Business- to- business (B2B): Government and developmental organizations. We target government and developmental organizations for large sales with the initial pilot. The B2B model will involve direct sales of devices and an annual contract for software maintenance and updating. We also plan to experiment with a service model, in which our solution is paid for every test performed and there is no capital investment. This model can be implemented through nongovernmental organization champions who work or wish to work with the government. It can increase the scalability of the solution. 

  B2B/ Business- to- business- to- consumer (B2B2C) in private hospitals: Wekebere will be offered to private hospitals on a subscription basis. There will be fees for enrolling in the system and recurring costs on a monthly basis, which will also include maintenance and software. The results obtained our solution can be auto- interpreted and a prediction algorithm developed to correlate them with neonatal outcomes. This solution can link midwives, doctors, and gynecologists in low- resource settings with doctors and gynecologists in the urban segment or with medical experts for additional online (and remote) consultation.

We want to present and market the solution differently in the private versus public and urban versus rural health segments. In the private sector, we want to enable monitoring of high- risk mothers, both in clinics and remotely supervised by health workers. First, we will collaborate with the most influential urban midwives, gynecologists and obstetricians and promote the solution through local midwives and nurses union and conferences. Meanwhile, we are establishing a collaboration with the Association of Obstetricians and Gynecologist of Uganda (AOGU), which includes 1500 gynecologists. Auto- interpretation of data will provide more objective and frequent results for remote monitoring. In the rural segment, where there is an acute scarcity of health professionals, we will enable physicians to conduct nonstress testing and monitoring of uterine contractions. The system’s auto- interpretation of data and the grade of severity flagged by the prediction algorithm will reduce dependence on the doctor. We can also extend fetal monitoring services through ground- level health workers, to enable nonstress testing at home or at nearby sub centers, during  home visits, allowing patients with any anomalies to be promptly referred to secondary or tertiary facilities.

Our solution also aligns with the objectives of the government of Uganda and ministry of health to reduce maternal and infant mortality. When used at a facility, it can increase the rate of institutional deliveries, a key objective of the government’s National Health Mission to reduce maternal and neonatal mortality.