BEMPU TempWatch to prevent Neonatal Hypothermia

Neonatal hypothermia (low body temperature in newborns), often termed as a silent killer, has a global prevalence up to 32-85%. Preterm & low birth weight (LBW) babies are particularly at higher risk of hypothermia due to their inability to regulate the body temperature. Regular temperature monitoring and immediate action in the form of Kangaroo Mother Care (i.e skin to skin contact) prevents further hypothermia and its consequences like hypoxia, hypoglycemia, poor weight gain, or death. However, in low-resource settings, adhering to standard of care practices in clinics and compliance of KMC by mothers at home is often low. 

BEMPU Health has developed the TempWatch: a novel hypothermia monitoring bracelet, a cost-effective solution to prevent hypothermia. It is a wearable temperature monitoring wristband that provides continuous temperature monitoring. The hypothermia alerts, in the form of an intuitive audio-visual alarm, and prompts the caretaker to warm the baby with Kangaroo Mother Care.

Every year approximately 20 million babies are born low weight (under 5.5 lbs) globally. Among these, 8 million are born in India, including 3.8 million girl newborns. All these small newborns are at highest risk of injury and death from hypothermia and infection, which can be prevented by BEMPU’s TempWatch. A Lancet study reports that timely detection of hypothermia can prevent 18-42% neonatal deaths.

The TempWatch targets these low weight and preterm newborns in low-resources countries, where hypothermia management is challenging due to lack of awareness, poor infrastructure, and overburdened staff in government hospitals. The innovation aims to empower communities to manage hypothermia and strengthen the “Home Based Newborn Care” by the Government. 

In five years, BEMPU Health has touched the lives of 31,778 newborns in eight low and middle income countries. We estimate that TempWatch has saved approximately 1000 newborn lives and improved lives of 9,674 newborns. However, if scaled globally, the TempWatch has the potential to save 600,000 newborn lives every year. 

Recognized by TIME magazine among the top inventions in 2017, the TempWatch has been vetted and awarded funding from major social organizations including the Gates Foundation, Grand Challenges Canada, USAID, KOICA (Korea), Echoing Green, etc.

In low-resource settings, nursing officers often skip temperature readings among competing priorities in the SNCU and parents cannot operate thermometers due to lack of awareness and education at home. Alternate solutions for hypothermia management do not offer continuous monitoring and may require an electricity source. Kangaroo care (skin to skin care for premature babies) is an effective means of preventing hypothermia, but compliance at home is known to be very low for multiple reasons.

The BEMPU TempWatch is appropriately designed for such contexts and continuously monitors the newborns temperature 24/7 for one month. The intuitive hypothermia alert is an audio-visual alarm (blue light to orange with a beep) prompting the parent to warm their newborn before injury occurs. It is understandable by all education levels making it suitable for adoption across cultures and countries. The built-in battery lasts 30 days (till newborn is large enough to survive) requiring no electricity. The small device is manufactured, shipped across the world and can be delivered by health-care workers. The holistic approach of hypothermia management focuses on the increase in KMC episodes and better weight gain leading to newborn survival and overall development especially in remote areas.

Globally, out of 138 million newborns born every year, approximately 20 million are below the weight limit (under 5.5 lbs).

These are at highest risk of injury and death from hypothermia and/or infection. Our intervention targets these low weight/preterm new-borns in communities and health care facilities where hypothermia management is challenging due to lack of awareness, poor infrastructure, lack of resources and other compelling priorities. The vast majority of our beneficiaries are below the poverty line. BEMPU TempWatch is a simple device enabling hospital personnel and/or parents to continuously monitor a baby’s temperature, and provide quick action for every hypothermia alert.

By integrating with various government programs, BEMPU TempWatch aims to address the gaps in the current Home & Facility Based Newborn Care with respect to hypothermia detection and KMC compliance using a simple & intuitive intervention. It manages hypothermia and promotes KMC for LBW babies in low resource hospitals and homes. We also conduct training and education for families on hypothermia management to seek behavioural change in caregivers. These training programs help in capacity building of the front-line health workers in the communities.

In India, almost 55% of low resource hospitals have inadequate nursing staff that often skip temperature readings due to competing priorities. In low-resource homes, these discharged LBW babies are still at risk of hypothermia; parents do not operate thermometers due to lack of awareness and education. Due to the described constraints for continuous temperature monitoring, hypothermia remains undetected without any effective and feasible solutions. BEMPU TempWatch is appropriately designed for such contexts and has an edge on the existing products/solutions for hypothermia management in newborns due to the following features;

1. It provides continuous temperature monitoring with a visual and audio alarm, alerting caregivers even during the night or at a distance.

2. It is a cost effective solution with less than 7 USD for continuous monitoring per baby per month. 

3. Being worn on the wrist, it is very comfortable and safe for the baby and easy to check by the caregivers.

4. The device’s user interface is extremely simple & intuitive to be understood by people of all levels of literacy and languages, making it suitable for adoption across cultures and countries.

5. Most products available depend on a smartphone to operate, require internet and electricity, all of which are highly constrained in low-resource homes.

6. Evidence to date shows it detects higher hypothermia incidences than the standard of care, and also improves weight gain in newborns through better KMC compliance.

A key risk during the early development was the ability to accurately detect core hypothermia by monitoring temperature at the wrist of the newborn. The wrist was chosen as a measurement sight as it is simple for parents to access with a bracelet, and it becomes cold earlier than the core does enabling early intervention. To address this, our team began a study measuring the temperature of 400 newborns to correlate peripheral and core temperature (r=0.7).

 A separate 27 baby study was done to continuously monitor, record and correlate abdomen, wrist and ankle temperature. For this study, a specific temperature monitoring wearable clinical prototype device was created. The data sets from these two studies, as well as the available clinical literature, were processed to create an accurate proprietary algorithm for early detection of mild hypothermia (also known as cold stress) on newborns. Incorporating this proprietary technology, we have applied for a patent for the BEMPU TempWatch as well.

To validate the accuracy of the device in its ability to detect hypothermia, a large independent study on 480 newborns, was begun at JIPMER Pondicherrry, one of the top ranked and reputed hospitals in India. This is also a government run facility, demonstrating usefulness of the device in government settings. These results translate into a device sensitivity of 98.7% and a specificity of 95.0%.

In only five years, BEMPU Health has touched the lives of over 31,778 neonates in eight low and middle income countries. We estimate that TempWatch has saved approximately 1,000 newborn lives. However, if scaled globally, the TempWatch has the potential to save 1.2 million newborn lives every year.

BEMPU TempWatch has clinical evidence through studies conducted in government & private centres among rural, tribal and urban populations that support its effectiveness. The device is 98.5% accurate in detecting hypothermia. Use of the device led to parents doing more skin-to-skin care time each day (3 hrs vs 2.4 hrs) and subsequently, higher weight gain (28g vs 23g) in neonates enabling better long-term survival. The device use also prevented excessive postnatal weight loss in healthy newborns. A pilot community study with the Government of Rajasthan reports decreased mortality rate (6% vs. 14%) of low-weight newborns using TempWatch. The intervention earned approvals from India’s Ministry of Health, Indian Council of Medical Research and is part of India’s "Swasthya Kit (newborn health box)" initiative led by several Indian national corporates.

UNICEF has also evaluated the TempWatch in multiple countries. In Papua New Guinea, the US Center For Disease Control (CDC)’s report showed improved clinical outcomes around weight gain in neonates, more skin-to-skin care by caregivers, positive responses from healthcare workers, and increased bonding of babies and mothers. Other evaluations from UNICEF in Benin, Pakistan and Zimbabwe show positive results.

BEMPU Articles: UNICEF (link), TIME Magazine (link), Guardian (link)

According to The Lancet, Hypothermia prevention and management is estimated to save 18-42% newborn lives worldwide. In low-resource hospitals, nurses often skip temperature readings due to other competing priorities. In low-resource homes, parents do not operate thermometers due to lack of awareness and education. Due to the described constraints, hypothermia mostly remains undetected. 

If unresolved quickly, hypothermia leads to low oxygen, low blood sugar, poor weight gain, and eventually death. In high income countries, these LBW newborns stay in the hospital until the risk of hypothermia is minimised and the standard of care for hypothermia management are strictly followed. However, in low-resource settings, adhering to the standard of care practices in clinics and compliance of KMC by mothers at home is often low for multiple reasons. Mothers are not able to perform optimum KMC as it requires long hours of sitting without being able to move. Embedded within the broad social context, barriers to KMC adoption by caregivers included adherence to traditional newborn practices, stigma surrounding having a preterm infant, and gender roles regarding childcare

The Ministry of Health and Family Welfare, Govt.of India, has already implemented programs in facilities for sick newborn care including kangaroo care wards to teach and promote KMC. However, these Facility Based Newborn Care (FBNC) costs are lost when the newborn is discharged and KMC is practiced in the facility but is not continued at home. Home Based Newborn Care (HBNC) intermittent visits are valuable but may miss or catch sepsis and hypothermia too late.  Therefore, there is a need for timely detection of hypothermia and promptly correcting it through practicing KMC.

There is thus a critical need for system change and policy makers to take on the challenge of hypothermia management with special focus on gender disparity in newborn health.

In five years since market introduction, the TempWatch has touched the lives of 31,778 newborns in eight low and middle income countries. We estimate that TempWatch has saved approximately 1000 newborn lives and improved lives of 9,674 newborns.

In the next one year, we estimate to impact approximately 12,000 high risk neonates.

We estimate to reach 2 million babies by 2025.

Over the next year, we hope to provide hypothermia management to ≈12,000 newborns through our intervention. In order to achieve this, we plan to implement the following key steps:

1. Build a strong sales and marketing function to support our outreach within the Indian government, UNICEF and private market in India

2. Execute pilots in selected locations for acceptability of the device

3. Set-up a strong training function within BEMPU to educate clinical staff and healthcare workers 

Our specific initiatives to improve adoption across key sales channels are outlined below:

Government and Public Health Adoption:

1. Create & retain dedicated sales resources to support procurement via India’s National Health Mission, state-level budgets and stand-alone central government hospital systems. 

2. Continue advocacy activities including a large multi-centre community level clinical trial.

Private Hospital Adoption:

1. We aim to create more market awareness especially in the largest 300 hospitals in India. We aim to structure our sales and marketing team to focus on key markets within the country. 

2. We will also expand our distributor network to further improve our coverage.

UNICEF:

1. Given our evolved understanding of UNICEF, we are investing in raising awareness about BEMPU within UNICEF and approaching more countries and regional stakeholders.

The BEMPU Health team comprises of 25 full-time employees working in engineering, product design, sales, public health and manufacturing.

We work with 3 contractors on a part-time basis, who support manufacturing.

BEMPU was founded by Ratul Narain, CEO (13 years of healthcare engineering experience from Stanford, Johnson & Johnson, Embrace) and headed by Naveen Bali, COO (23 years of medical device leadership with Depuy, 3M Healthcare, and Dentsply-Sirona). Our board has the former CEO (Quest Diagnostics) and former VP (Direct TV).

BEMPU team has 25 employees based in India with experience in design, manufacturing, clinical research, marketing and sales across private, public and international Markets. We are supported by Villgro (social-enterprise incubator), our Clinical Advisory Board (multiple Indian and international neonatologists), Global Technical Advisory Group (members from USAID & Save the Children).

BEMPU’s business model adopts 3 primary channels to reach parents:

1. To the Government & Public Health Organisations: To reach babies born in public hospitals in India and other LMICs, BEMPU offers hypothermia management program to the Indian Government directly, or partners with public health organisations like UNICEF

2. To Doctors and Hospitals: BEMPU sells products to private hospitals who in turn, provide them to parents of newborns born in their facilities

3. Directly to Parents: BEMPU also sells the products directly to our beneficiaries (parents of low weight babies) through e-commerce websites like Amazon and through our website.

Our long term vision is to contribute in eradicating preventable newborn deaths through innovation. For fulfilling this vision, BEMPU needs to become a trusted partner for the well-being of the world’s children. With BEMPU TempWatch, we envision a world where all babies wear a simple bracelet that can prevent hypothermia related injury during their first month of life. The TempWatch can be a new standard of care, saving 1.2M lives per year. Our aim is integration of BEMPU TempWatch into the local home based newborn care program or Essential Early Newborn Care programs across LMICs, leading to better survival rates and improved growth outcomes of newborns. 

1. In India, we plan to achieve this by working with the government on state and national level programs, incorporating into government schemes or packages that are being implemented for newborn care. 

2. In LMICs we plan on securing necessary certifications such as CE/FDA for scale up. 

Given our traction, capabilities and vision for growth, we have also reinvested profits and raised funds for a recently launched complimentary portfolio of products: ApneBoot is a shoe that detects when babies have stopped breathing and auto-stimulates the foot to restart breathing; KangaSling is a garment making life-saving skin-to-skin care and breastfeeding easy for long periods, Monarch is a pregnancy support service in the US.

We believe that the TempWatch is a fit for the Maternal and Newborn Health Challenge by SOLVE. If our solution is selected, we believe that it would give us access to potential funders and partners for long-term growth.

BEMPU Health aims to be a global partner trusted for the well-being of the world's children. With TempWatch, we envision a world where all babies wear a simple bracelet that can prevent hypothermia related injury during their first month of life. We aim to influence policy level changes to result in a new standard of care where all newborns are effectively protected from hypothermia related injury and death.
1. we plan to achieve this by working with the government on state and
national level programs, incorporating into government schemes or packages that
are being implemented for newborn care.
2. In LMICs we plan on securing necessary certifications such as CE/FDA for scale
up.
This grant will help us reach more high-risk newborns in low and middle-income countries 

BEMPU Health aims to be a global partner trusted for the well-being of the world's children. With TempWatch, we envision a world where all babies wear a simple bracelet that can prevent hypothermia related injury during their first month of life. We aim to influence policy level changes to result in a new standard of care where all newborns are effectively protected from hypothermia related injury and death.
1. we plan to achieve this by working with the government on state and
national level programs, incorporating into government schemes or packages that
are being implemented for newborn care.
2. In LMICs we plan on securing necessary certifications such as CE/FDA for scale
up.
This grant will help us reach more high-risk newborns in low and middle-income countries 

BEMPU Health aims to be a global partner trusted for the well-being of the world's children. With TempWatch, we envision a world where all babies wear a simple bracelet that can prevent hypothermia related injury during their first month of life. We aim to influence policy level changes to result in a new standard of care where all newborns are effectively protected from hypothermia related injury and death.
1. we plan to achieve this by working with the government on state and
national level programs, incorporating into government schemes or packages that
are being implemented for newborn care.
2. In LMICs we plan on securing necessary certifications such as CE/FDA for scale
up.
This grant will help us reach more high-risk newborns in low and middle-income countries