neoGuard: A wireless vital sign monitor

Sona Shah is CEO and Co-founder of Neopenda. Her path to global health entrepreneurship began when she earned a BS in Chemical Engineering from Georgia Tech (2011), and subsequently worked as an engineer in Bioprocess Research and Development at Eli Lilly and Company. She followed her passion for service to Kenya, spending time as a teacher and a Engineering Without Borders volunteer. Sona’s interest in aiding under-resourced communities continued during her research involvement with mChip, a point-of-care diagnostic device for HIV and syphilis developed at Columbia University. She also worked at the TB Alliance, both in community engagement and drug discovery for medications that treat tuberculosis. Sona completed a Masters in Biomedical Engineering at Columbia University (2016) before launching Neopenda, where she develops works to develop impactful health care solutions, and sustainably deliver them to the world’s most vulnerable populations.

LinkedIn: https://www.linkedin.com/in/sonarshah

Continuous vital sign monitoring is a basic tenet of specialized care in the developed world, but is vastly underutilized in the intensive care units of most low-and-middle income countries. Despite the positive outcomes associated with vital sign monitoring (i.e. increased survival-to-discharge rates, lower complication rates and shorter length-of-stay in hospital), the prohibitive costs of conventional patient monitors and the difficulty in maintaining complex medical equipment limit adherence to recommended vital sign monitoring practices.

neoGuard is a wireless vital sign monitor that continuously measures temperature, pulse rate, oxygen saturation and respiration rate, providing real-time alerts when measurements exceed pre-set upper or lower limits. The technology is designed to trigger more timely and effective interventions that can help prevent a patient’s status from declining irreparably. From the central monitoring application, nurses are able to observe up to 20 patients at a time - enhancing limited workforce in facilities with low nurse-to-patient ratios.

The mortality among paediatric patients in LMICs is unacceptably high, with many deaths occurring within the first days of admission. Kenya has some of the highest rates of neonatal mortality in the world at 19.6/1,000 live births. Translated into numbers – this equates to over 20,000 neonatal deaths per year in Kenya.

Advancing newborn health and ending preventable newborn deaths, as emphasized in U.N. Sustainable Development Goal (SDG) 3, is an urgent global challenge. SDG3 strives to end preventable deaths of newborns and children under 5 years of age by 2030, with all countries aiming to reduce neonatal mortality to as low as 12 deaths per 1000 births, an ambitious target that will require ambitious and fast-tracked innovations.

Measurement of vital signs is an important component of many best practice neonatal care procedures, such as those outlined in the WHO Recommendations on Newborn Health, and in the Kenya Ministry of Health, Clinical management and Referral Guidelines. Improving optimal supportive care such as monitoring vital signs in a hospital Special Care Baby Units (SCBU) could avert 70% of neonatal deaths due to preterm birth complications, and 90% with availability in hospital Neonatal Intensive Care Units (NICUs).

The neoGuardTM device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate, respiratory rate and blood oxygen saturation (SpO2) in newborns. It was developed by Neopenda, PBC (Chicago, IL, USA | Kampala, Uganda) in compliance with international medical device standards and for feasibility in low-resource settings, including: low-power design, safe re-usability, ruggedness, portability, and ease of use. The devices are wireless and designed to be worn on the forehead through an adjustable silicone rubber band. The Neopenda monitoring system runs on a tablet which is placed nearby (within 20 meters). The data are transmitted from the devices to the tablet by encrypted, isolated wireless communication via low-emission short-range Bluetooth® Low Energy.  

NeoGuard has been tested on a limited scale in a series of IRB-approved clinical trials designed to assess preliminary performance and safety. Presently, final accuracy validation for neoGuard is on-going at performance testing labs Laboratories in Boulder, Colorado and San Francisco, California and multiple feasibility studies are set to begin in August in Kenya, Tanzania, Uganda and Mali. 

With additional funding from The Elevate Prize, we hope to scale the use of the neoGuard technology to at least 10 additional health facilities.

The neoGuard product is addressing the unmet need for multi-parameter and continuous vital signs monitoring in critically ill newborns in low resource settings. Approximately 8-10 million newborns globally are in need of critical care each year from causes including low birth weight, birth asphyxiation, sepsis and pneumonia. In our pilot countries, Uganda, Kenya and Tanzania, which have some of the highest newborn mortality rates in the world, our technology has the potential to impact at least a million newborns each year.

To date, the technology has only been implemented in clinical studies. We are on track to obtaining CE mark certification by December 2020. Between January 2021 - December 2021, we intend to distribute the technology to ~20 facilities in sub-Saharan Africa, at cost or subsidized rates through funding raised from grants and/or non-profit partners. These early adopters will be followed up for 12-24 months each and multiple qualitative and quantitative indicators including: number of clinicians trained, number of patients monitored, actionable vital sign alarms, improved detection of clinical deterioration, enhanced work flow and clinical decision-making, feasibility and acceptability scores, changes in newborn morbidity and mortality metrics and technology-retention rates will be tracked to ascertain clinical impact and cost-effectiveness.

In the neoGuard technology, Neopenda is taking the known and proven science of vital signs monitoring and re-imagining it for users in low-resource settings. The product aims to improve quality of care in low-infrastructure ICUs. By automating time consuming tasks like intermittent vital signs checking (the current standard of care), health staff can focus their attention and time on more complex and impactful life-saving procedures. 

Aggregated data from neoGuard's back-end repository can also be harnessed to shed more light on risk factors and clinical trends. Our goal is to provide sick babies with the best opportunity to survive and thrive.

The idea for neoGuard was first conceived in 2015 when co-founders Sona Shah and Teresa Cauvel met in a biomedical engineering design course at Columbia University, and led needs-assessment project of 20 health facilities in Uganda. The study determined that less than 4% of critically-ill newborns were receiving continuous monitoring of their vital signs while admitted, and the nurse-to-patient ratio in these facilities was approximately 1:13. This led to further surveys and interviews of health staff on the ground to determine what would be an ideal and feasible solution to improve the monitoring of newborns and automate the time-consuming task of taking repeat measurements intermittently. 

The final product neoGuard has undergone 3 major iterations following an immersive human-centered design process that has generated in-depth feedback from 400+ health workers, primarily in Uganda. 

Collectively Sona and Tess have spent 170 days in Uganda and completed over 80 hospital visits as they spearhead efforts to optimize, commercialize and scale neoGuard. They have participated in accelerators including PULSE@MassChallenge, GE-GSBI Healthymagination and Techstars Chicago. They were recognized on Inc 2017 "30 Under 30 Enterpreneurs", Business Insider's 2018 "30 Under 40 Healthtech Leaders" and Concious Company Media's "31 Social Enterpreneurs to Watch in 2018" lists.

After completing my undergraduate degree at Georgia Tech, I had the opportunity to volunteer with Engineers Without Borders in Kenya where I gained a deeper understanding and perspective on health disparities between the global north and global south. When I later joined Eli Lilly and Company as a bioprocess engineer, I couldn't help but wonder if the medical products I was helping develop would ever reach the populations in most need in low-and-middle-income countries. I came to the realization that closing the vast health gap would require bold ingenuity. I returned to graduate school to study biomedical engineering with the aim of gaining skills to create innovative, affordable and sustainable health solutions for low-resource settings.

Approximately 2.5 million newborn deaths occur annually, and countries like Kenya, Uganda and Tanzania report some of the highest numbers due to weak and overburdened health systems that are faced with critical health staff shortages, low infrastructure and obsolete, unsuitable and often ineffective diagnostic, therapeutic and patient monitoring equipment. I hope to use my love for engineering to develop solutions that can help ease some of these challenges and increase access to more equitable health services.

Neopenda is led by co-founders Sona Shah (CEO) and Teresa Cauvel (CTO) - two mission-driven, globally oriented engineers with vast expertise in human-centered design and product management. 

Our internal team is further enhanced by: an Embedded Engineer (Matthew Tomback)  with  an advanced skill-set in software and firmware development for medical devices; a Supply Chain and Operations Lead (Crystal Trivedi) with over 10 years of experience as a quality engineer in the automotive industry; a Program Coordinator (Dorothy Aanyu) who oversees partner relations, market research and customer acquisition, and finally a Research Coordinator (Assumpta Nantume) charged with our field investigations and M&E for clinical impact and cost-effectiveness of the neoGuard technology.

In addition to our 6 full-time staff, Neopenda is also supported by a strong advisory board, mentors and key partners who constitute a combined 80+ years of experience in technology, engineering, social entrepreneurship, product development and global health. Over the past 5 years we have built strong collaborations with: Americares (Tanzania), Doctors Without Borders (Mali), Makerere University (Uganda), Center for Public Health and Development (Kenya) and multiple other organizations.

Building a company and launching a novel product in an unfamiliar setting requires a lot of tenacity. My experience working in Uganda has had several highs and lows, and one of the most notable challenges has been navigating unclear and inconsistent regulatory procedures which often left me feeling defeated and wanting to give up. Luckily, because of my strong passion for this project, I have been able to whither the storms and rise every setback my company has experienced. For instance, in 2017, when we first applied for research approval, the research ethics committee rejected our application with the no concrete explanation. After some persistent probing, we realized that the IRB had trouble finding expert reviewers with medical device research experience and was therefore hesitant to grant us approval for a technology they could not fairly assess. We were able to pursue a long process with the IRB and other regulatory bodies in Uganda which saw the creation of an independent medical device review committee to review and approve our research application. After 1.5 years, in 2019, we were able to successfully conduct our first pilot study.

I co-founded Neopenda in 2015 with my partner Teresa Cauvel. Since then, we have built the company from a team of 2, to a team of 6 and expanded our network to include multiple advisors and mentors in the space of biomedical engineering and social entrepreneurship. One of my main roles as Neopenda CEO, is working daily to identify resources for my team and leveraging existing partnerships to help us advance our efforts.

Though we are still only a small team, we have managed to achieve so much already. We have raised considerable funding through private investors and grant opportunities, transitioned our neoGuard device from a prototype to a commercial-ready product and built research collaborations in 5 countries.

In 2020, we were at risk of being derailed by the COVID-19 pandemic, but we realized on opportunity to pivot the use of our technology from use on newborns alone, to use on wider patient groups including older pediatrics and adults. As a result, we have been able to accelerate our goals and attract additional funding to pursue new efforts. I am proud to have steered these efforts with my passionate and dedicated team.