The neoGuard vital signs monitoring solution

The World Health Organization estimates that nearly 2.5-3.0 million newborn deaths occur globally each year. Majority of these deaths occur in low-and-middle income countries (LMICs) and are largely a result of avoidable causes. Approximately 75% of newborn deaths could be prevented if these patients were able to access timely medical care from trained health workers. However, even as the rate of facility-based deliveries and admission of newborns to special care units steadily rises in LMICs, the critical shortage in health staff and the limited availability of functional medical equipment contribute to a high propensity for errors and delays in identifying early warning scores of patients in distress before their conditions worsen. 

Small and sick newborns require timely, high-quality clinical care to subvert a number of risks, including Apnea of Prematurity (AoP), which they are particularly vulnerable to during the first 28 days of life. Continuous vital signs monitoring often contributes to providing early warning scores to help detect patients who are at an increased risk of apnea events, allowing medical workers to observe them more closely, intervene more quickly and administer effective treatments which can ultimately saves lives, prevent further complications and help improve recovery time.

At least a third of neonatal deaths are due to prematurity. Prematurity affects 15 million (11%) babies a year. Moderate preterm infants comprise ~25% of Neonatal Intensive Care Unit (NICU) admissions at the University Teaching Hospital (UTH) in Lusaka, Zambia. AoP occurs in up to 90% of infants who are born at less than 34 weeks of gestation age (GA) and may lead to brain injury, SIDS (sudden infant death syndrome), or BRUE (brief, resolved, unexplained event).

While methylxanthine therapy reduces both AoP signs and morbidities, breakthrough apnea commonly occur, can be detected by accompanying bradycardia and hypoxemia, and allow timely intervention by bedside providers. The absence of continuous monitoring may limit real time identification of AoP events, preclude interventions by bedside care providers, and could even result in brain injury or death. However, the practical implications of increasing the sensitivity of AoP detection may also include the development of systematic provider intervention strategies, alarm fatigue, and increasing the length of hospital stay. Therefore, integration of continuous monitoring into clinical care must carefully balance the risks and benefits of this valuable resource.

The common practice is to discontinue treatment for AoP once the infant is apneic-free for 5 to 7 days and discharge the infant from the hospital. However, there is fear of discharging preterm infants too early in low- and middle-income countries (LMICs) due to lack of continuous monitoring identifying AoP resolution, thereby increasing infants’ risk for recurring apneic episodes at home, which may result in death. A study found that 15.8% (222/1403) of infants at 34 weeks’ post-menstrual age (PMA) had recurrent apneic episodes after hospital discharge. Furthermore, continuing treatment beyond the usual short apnea-free period may decrease late episodes of apnea in the hospital, which can shorten hospitalization and may prevent hospital readmissions from complications of AoP.

NeoGuard is a wireless, wearable vital signs monitor that continuously measures pulse rate, oxygen saturation, respiratory rate and temperature to enable more responsive and effective management of hospitalized newborns in resource-constrained health facilities. The affordable technology is designed to improve operational efficiency by enabling health care staff to monitor up to 15 patients in parallel from just one tablet. With an automated system that provides real-time audio and visual alerts whenever a vital sign measurement exceeds the preset upper or lower normal limits, neoGuard can improve the speed of action in life-threatening situations and trigger timely interventions to ensure that newborn’s have the best chance to survive and thrive.

NeoGuard's is also equipped with a reporting function to allow tracking of vital sign trends for each patient and synthesis of valuable data insights to inform patient care and predict institutional-level resource needs.

The aim of this project is to develop a comprehensive care strategy for AoP at the NICU and KMC wards at UTH in Lusaka, Zambia through the (1) introduction of continuous vital signs monitoring with the neoGuard technology, (2) development of iterative AoP management strategies and (3) measuring the impact on institutional neonatal mortality among infants with AoP.

The neoGuard technology has been designed to fulfill the unmet need of vital sign monitoring in critically ill newborns aged 0-28 days in LMICs. The 0-28-day age group is the primary focus of this technology owing to their vulnerability and high risk for severe morbidity and mortality. 

Nurses and clinicians caring for newborns will also benefit from receiving access to adequate and sustainable equipment that enhance their efficiency and enable them to deliver the most appropriate care to their patients. We anticipate that this will have indirect positive effects on health worker satisfaction and morale, as lack of appropriate tools and equipment has been frequently cited as a key grievance among health staff in LMICs.

For this project, we are targeting newborns admitted to University Teaching Hospital (UTH) in Lusaka, Zambia. Mortality records show that a total of 2,894 infant deaths were reported in Lusaka between August 2017 - August 2020 (Gill et al, 2022). Majority of these deaths were captured at University Teaching Hospital (UTH), which serves a catchment area of about 2 million people.

A recent report by Banda et al (Born to Soon, 2022), estimates that prematurity and accompanying complications contribute to about
27.2% (0.2722894/3=262) of infant deaths in Zambia annually. While the incidence of Apnea of Prematurity (AoP) among neonates in Zambia is not well documented; globally, AoP is estimated to occur in up to 90% of newborns delivered at less than 34 weeks gestational age. Therefore, assuming that AoP events would likely occur in at least 90% of preterm deliveries that resulted in death, about 236 (0.9262) newborns directly admitted or referred to UTH annually are at risk of life-threatening AoP. This is a conservative estimate of the scale of the problem, our project will be the first to directly quantify the prevalence of apnea at UTH through the use of the neoGuard vital signs monitoring solution.

In a Cochrane systematic review, methylxanthines reduced the number of apnea events by 44% and the risk of mechanical ventilation in premature infants by 34%. Methylxanthines were also associated with better long-term outcomes in infants (Henderson-Smart et al., 2010). By developing a comprehensive management strategy for AoP, along with integrating a robust vital signs monitoring solution to increase timely detection of AoP, we conservatively estimate that we can also reduce the risk of AoP by 44%. This could help save 104 newborns in our first year of implementing the new vital sign monitors and AoP management strategy, and many more over time.

As a medical device company, Neopenda's key area of expertise is creating needs-based health technology for high-growth emerging markets. The organization is led by co-founders Sona Shah (CEO) and Teresa Cauvel (CTO) - two mission-driven, globally oriented engineers who met in graduate school at Columbia University, where they developed the initial idea of Neopenda in a biomedical design course in 2015. Sona and Tess have participated in accelerators including PULSE@MassChallenge, GE-GSBI Healthymagination, and Techstars Chicago, were recognized on Inc. 2017 “30 Under 30 Entrepreneurs” list, Business Insider’s 2018 “30 Under 40 Healthtech Leaders” list, and Conscious Company Media’s “31 Social Entrepreneurs To Watch in 2018” list, and are supported by a strong advisory board, mentors, and key partners with expertise in technology, social entrepreneurship, and global health. 

Neopenda's larger global team consists of 10 full-time staff based in the United States, Kenya, Colombia, Uganda and Nigeria. Collectively, we have relevant expertise in a number of areas including, product design and development, biomedical engineering, project management, regulatory and quality systems, supply chain, business strategy, customer support, biostatistics, clinical research, and monitoring and evaluation. Over the last 7 years we have firmly established our proof of concept and business feasibility in our target markets. 

Some of our biggest accomplishments include: (1) acquiring ISO 13485 certification and CE mark approval, (2) piloting the neoGuard product in over 30 facilities in Kenya, Uganda, Ethiopia, Nigeria and Tanzania, (3) signing distributor contractors with two leading distributors in Uganda and Kenya, (4) generating over $200,000 in revenue from product sales.

As we continue to grow, we are constantly reviewing and assessing our implementation strategy to ensure meaningful impact, user satisfaction and long-term sustainability. In addition to hiring local talent for our internal team, we also continue to engage and work with a number of external stakeholders, including government partners, non-profit and multilateral institutions, local distributors and academic researchers to better understand the nuances of the health systems we seek to serve and measure the impact our technology is having. In Zambia specifically, we are working with the University Teaching Hospital (UTH) and the Center for Infectious Disease Research in Zambia (CIDRZ) to implement our solution.

We are applying to this challenge to obtain financial support to expand the neoGuard solution to Zambia. We have built a strong presence in East Africa and are confident in our ability to replicate our success in neighboring regions. 

Neopenda's interest in Zambia began earlier this year when the director of newborn health programing at the Center for Infectious Disease Research in Zambia (CIDRZ) reached out to us to express interest in implementing the neoGuard solution to aid in the development of a comprehensive management solution for apnea of prematurity. We were very intrigued by his proposal as neoGuard has been used in a more general capacity for observation of vital signs in hospitalized newborns; and while we have conducted many previous studies, no study to date has specifically looked at the impact of the technology on the management of apnea. 

This project will also further look at the use of apnea interventions for at-risk neonates both in primary care facilities and at home settings where the risk is still present upon discharge.

Few innovations are currently available to help overburdened nurses better manage the high quantity of newborns for whom they are responsible. In the neoGuard solution, Neopenda is taking a known and proven science of clinical vital signs monitoring, and re-imagining it for the users and the constraints of low-resource environments. The current practice at most intensive care units in low-and-middle-income countries is intermittent, manual measurement of vital signs. Nurses must manually count heart beats or breaths—at best every few hours—or share the few available, functioning devices, such as pulse oximeters, which only intermittently measure oxygen saturation and pulse. This practice is insufficient for early detection of distress and optimal management of common neonatal conditions.

Gold standard monitors used in the U.S. and other high-resource areas, such as from Covidien or Philips, are prohibitively expensive, inappropriately designed, and challenging to maintain or repair. They fail to meet unique sets of environmental constraints such as unstable power supply, lack of internet access, and heat & humidity. If donated to a low-resource environment, they often end up in the equipment graveyard within a year. Existing products in the global health space do not meet the need for continuous monitoring in the clinical setting (e.g. Lifebox pulse oximeter), only measure 1 or 2 parameters (e.g. Bempu TempWatch and NeMoCare) and/or are geared toward diagnosing specific conditions (e.g. pneumonia diagnostics like the Philips CHARM).

Neopenda’s solution greatly improves the quality of newborn care over the standard-of-care and addresses the unmet need for a feasible way to continuously monitor multiple key vital signs. The neoGuard product is designed to operate in dynamic clinical environments with space constraints, unreliable power supply and limited numbers of health staff. At less than a 1/10th of the average cost of conventional patient monitors, the neoGuard technology is highly sustainable; requiring minimal maintenance or servicing. The wearable band is bio-compatible, reusable and easy to sanitize, ensuring that there are no additional costs spent on single-use accessories. In addition, neoGuard has been developed and tested with feedback from more than 400 health workers with varying degrees of expertise to ensure that it is intuitive to a wide range of users including lower skilled personnel like nursing assistants and community health workers in remote settings.

Further, the neoGuard technology uses analytical algorithms and big data tools to generate valuable data insights from archived information. This serves as a useful feature for both patient-level care and facility-level decision-making. Clinicians can use immediately available trend data to evaluate if an individual's condition is improving and make a timely decision on whether to switch to a more effective intervention or discontinue care once a patient is responding adequately and no longer requires it. Hospital administrators and district officials can also use aggregated statistics to identify critical gaps that might be impacting patient outcomes and forecast essential supplies in a way that allows them to plan more efficiently and reduce pressure on limited resources.

Over the next year, we hope to achieve impact at 3 levels:

1. Health facility level
(a) Increase access to an affordable vital signs monitoring solution and digitalized data archive in at least 50 health facilities across 5 countries. 

This will be achieved by registering the product in 2 additional countries (Zambia and Nigeria/Ghana) and widening our current distribution efforts through local partnerships and hiring more marketing support staff.

(b) Utilize data from neoGuard to develop and implement an effective management strategy for apnea of prematurity at University Teaching Hospital in Zambia.

This will be achieved by implementing a pre-post study to analyze newborn outcome trends before and after introduction of neoGuard; so as to identify important clinical predictors for apnea such as patient profiles, treatments given and vital sign trends.

2. User level
(a) Complete training over 200 health staff to use the neoGuard technology and increase health staff satisfaction with regard to availability of effective tools to perform their tasks and aid in clinical decision making.

This will be achieved through broadening our customer outreach efforts and performing bi-annual feedback surveys for new and existing users of the neoGuard technology. Responding promptly to customer feedback or complaints will be key, and we have already put in place a robust customer complaint handling process.

3. Patient level
(a) Support provision of clinical care to over 1500 patients observed with the neoGuard vital signs monitor. 

This will be achieved through ensuring that technology users are well-trained and comfortable with using neoGuard to monitor their patients and make clinical decisions. Training will therefore be assessed using a comprehension check tool and customer support will be provided as needed if there are any technical or user-related issues with implementing neoGuard. Data from the neoGuard application will be extracted at regular intervals (monthly or quarterly) to measure the number of patients observed, hours of usage and treatment success rates.

• Nurse’s response time to patients in distress: The amount of time elapsed (in minutes) between when a monitor alarm is triggered and a nurse responding to a newborn in distress (This will be captured through the digital app logs).

• Total hours of usage: The total number of hours that neoGuard devices are in use on patients over a defined period of time (typically one month, but can also be broken down into daily or weekly hours of usage as needed). This will also be captured through digital app logs.

• Complication rate: Proportion of cases that experience a complication resulting from their underlying illness or a complication resulting from their medical care.

• Failure to rescue rate: Proportion of cases that experience a clinically important deterioration, such as increased severity of illness, permanent disability or death, from a complication of an underlying illness or a complication from their medical care.

• Treatment success rate: Proportion of cases whose clinical status improves after receiving an intervention.

• Length of stay in hospital: Time elapsed between admission and discharge of a newborn (measured in days).

• Readmission rate: Proportion of patients who are readmitted to the hospital within 28 days of discharge.

• In-facility neonatal mortality rate: Proportion of deaths that occur during facility stay, broken down in to 7-day and 28-day neonatal mortality.

• Clinical deterioration: A serious physiologic disturbance or a sudden worsening of a patient’s physiological condition.

• User satisfaction: This is captured through qualitative feedback/ testimonials and net promoter scores (the percentage of promoters minus the percentage of detractors).

Our theory of change is as follows:

1. Input: NeoGuard technology is adopted by health facilities and health staff are trained to use it.

2. Direct output: Critically ill newborns are monitored with the neoGuard technology; vital sign data is measured and distress alerts are generated.

3. Short-term outcome: Nurses respond more quickly to patients in need.

Our earlier studies and adoption efforts have indicated that items 1, 2 and 3 are strongly linked. This has been supported through direct observation, interviews with clinical staff and administrators, analysis of usage data extracted from the neoGuard app.

4. Intermediate outcome: Patients receive more timely and therefore more effective interventions. Literature has indicated that this greatly enhances the newborns' chances of survival, as further deterioration and complications are promptly arrested. (Vital Signs Directed Therapy: Improving Care in an Intensive Care Unit in a Low-Income Country: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0144801)

5. Long-term outcome: Neonates are less likely to die from preventable causes; the neonatal mortality rate is decreased.

NeoGuard, is a 4-in-1 biometric monitoring device designed specifically for newborns in resource-constrained health facilities. The affordable system helps over-burdened healthcare workers better manage their patients and improves speed of action for newborns in distress so that they have the best chance to receive the care they need to survive and thrive. Ultimately, it contributes to reducing preventable newborn mortality and morbidity.

The patented neoGuard vital signs monitor uses reflectance pulse oximetry and temperature sensors to continuously measure 4 key vital signs: pulse rate (PR), respiration rate (RR), blood oxygen saturation (SpO2), and temperature. The device is reusable and rechargeable; it fits into a reusable band that can be easily cleaned by wiping down with alcohol. The device is also optimized for low power consumption, lasting 3-5 days before needing to be recharged, so that most neonatal patients can wear the device as long as is needed before it must be recharged. Data from the wearable devices are wirelessly transmitted to a centralized dashboard display on a tablet or smart phone using short range, low power Bluetooth® Low Energy, which does not require internet access to function. 

On the tablet or smart phone, nurses can monitor the status of up to 15babies in real time, and get alerts when one is in distress (i.e., their vital signs stray outside the health ranges). In addition to audio and visual alarm indicators on the central monitoring app, the devices themselves are equipped with a red alarm light that blinks to help staff quickly find the baby in distress. The system also stores comprehensive data: patient vital signs trends can be examined to guide clinical decision making, and the aggregate reporting functionality generates data insights from the neonatal unit for hospital administrators, ministries of health, and NGO partners.

NeoGuard is designed to operate in dynamic clinical environments with space constraints, unreliable power supply, low equipment repair and maintenance capacity and limited numbers of health staff. It is available in packages of 5, 10 and 15 devices, to meet each facility’s patient needs at the most affordable cost. Health staff can be efficiently trained on how to use the technology in less than a day and a dedicated in-country team member or partner is available to offer any additional tech support required.

Design verification and validation:
NeoGuard has been developed with feedback from more than 400 health workers, primarily in Uganda. To date, the product has undergone two major iterations culminating in neoGuard V3.0, the commercial-ready product. The neoGuard product has also been evaluated at an accredited Nationally Recognized Testing Laboratory (NRTL) for certification of product safety. Testing was completed per appropriate ISO/IEC standards, including IEC60601-1. Several clinical validation studies have been conducted on the neoGuard product, in the United States, Uganda, Kenya and Nigeria. 

Manufacturing details:
The neoGuard technology is manufactured, packaged and shipped from CPI Penang, a contract manufacturer in Malaysia. CPI is ISO 13485:2016 certified, and has experience in high-volume production for Fortune 500 companies, including components for several medical device companies. CPI fulfilled 3 mass orders for neoGuard to date, totaling over 1000 units. 

Primary health care data will be collected by the users themselves. This includes the nurses and community health workers that will be availed with the neoGuard device and phone/tablet application. The incentive to do so is that the neoGuard solution is also a vital signs measurement tool that makes taking of vital signs easier. The nurses and community health workers that we will be working with either entirely lack vital sign monitoring tools or have inadequate vital sign monitoring tools both in terms of performance and quantity.  

Neopenda has an incredibly diverse global team consisting of 60% female and 40% male staff. The same gender representation applies across our senior management positions. More than 70% of our team are people of color who identify as black, Hispanic or Asian. We strive to foster an equitable environment and regularly encourage employees to report any gaps and offer suggestions as to how we can do better as a company.

We have a hiring policy and employee handbook that emphasizes inclusivity and protection against discrimination on the basis of gender, race, ethnicity, national origin, religion, sexual orientation and identity, or disability.

Our business model is commercial, with a hybrid of funding sources including donors, governments and private sector. Our product and after sales services are a one-time purchase and we target both public and private health facilities. We also offer services to primary care provided at the community health worker level or home-based services. The neoGuard product is available in packages of 5, 10 and 15 units, making it affordable to a wide range of facilities regardless of their patient volume. Our pricing model ranges from $250-400 per unit, inclusive of the central monitoring tablet or phone and after-sales services provided. That range is due to intermediate costs such as shipping, customs clearance and distributor markups.

While initial sales have come from private health facilities, we are already in advanced conversations with government officials and several non-profits, gearing towards wide-scale implementation of neoGuard in public hospitals and donor-aided health centers by the end of 2023.

The initial market for neoGuard is in East Africa, where Neopenda has strategically established its roots and set up a second office. In Uganda alone, there are over 6,937 registered health facilities, 55% of which are privately owned. And Kenya and Tanzania have more than twice that number. 

Presently, we are registered in Kenya, Uganda and Tanzania and deliver our product to end users through local distributors. At the same time, we are expeditiously navigating additional product registration in new countries, as we simultaneously build our customer acquisition pipeline and supply chain and product distribution networks. The anticipated timeline for regulatory approval to import and distribute our product is ~90 days from the time of submission to each country’s regulatory body. We have sold roughly 1000 devices, generating ~$200,000 in revenue, within our first 18 months of commercialization. We project steady growth in the next year, with a target of reaching $400,000 in sales by Q4 2023 and our break-even point of $2,500,000 + by 2025.

In Uganda, Neopenda has entered a partnership with the largest private wholesale distributor, Joint Medical Stores (JMS), which is a leading supplier of medical equipment to both private and public facilities in the country. We have developed a clear marketing strategy which we are currently testing through facility visits and direct sales pitches to potential customers. Using JMS's wide reach and resources, we will be able to get more boots in the field to scale our product faster and offer optimal after-sales support to our clients. JMS also has affiliations with other leading distributors in Tanzania and Rwanda, which will help us gain quick access to these neighboring markets. In Kenya, we have a distributor with another prominent distributor Mediquip Global Supplies Ltd. 

To fund our efforts over the next 2-3 years we will employ a combination of raising investment capital, selling products and services and receiving grants, awards and prizes. WE anticipate that by Q4 2025, we will be in a stronger financial position and able to sustain our efforts entirely or at least majorly through selling products and services. 

1. To date, we have raised over $4 million dollars in funding from dilutive and non-dilutive sources
2. Non dilutive funds include grants from Wellcome Trust ($636,000), UKaid ($66,000), IKEA Foundation ($100,000), Grand Challenges Canada ($115,000) and Grand Challenges Africa ($100,000)
3. We are currently in our pre-Series A investment round, and have already raised half of our $1.5 million target
4. We have generated $200,000 in product sales over the last 2 years and signed distribution contracts with 2 leading distributors in Uganda and Kenya
5. We have registered the neoGuard product in 3 countries (Uganda, Kenya, Tanzania) and are on track to register it in at least 2 more countries (Zambia, Ghana/Nigeria) by next year
6. We have trained more than 300 nurses and clinicians to use the neoGuard product, and we have implemented it in more than 30 health facilities across 5 countries