Neopenda newborn vital signs monitor

Neopenda is innovating medical technologies for high-growth emerging markets, starting with a wearable neonatal vital signs monitor.

Neopenda is a medical device startup creating needs-based healthcare solutions for high-growth emerging markets. We believe that all communities deserve access to cutting edge health technology. There exists a massive opportunity to create appropriately designed medical devices for a largely untapped market, and to do so in a way that can improve quality of care for millions of people.

In low-resource settings, most hospitals are overcrowded, understaffed, and ill-equipped. Vulnerable patients suffer most from this strain, and often die from preventable causes. With our first product, currently in development, we are targeting the problem of high newborn mortality. Nearly three million newborns do not survive their first month in low-resource settings. 80% of newborn deaths are preventable; the primary causes are complications of preterm birth, birth asphyxia, and infections. Although these conditions can be treated with known interventions, many newborns do not receive the attention they need because facilities are understaffed and under-equipped. Nurses in these facilities rarely have necessary tools needed to provide high quality neonatal care. As a result, vulnerable newborns 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. Neonatal nurses’ current standard of care for monitoring is to periodically count heartbeats or breaths manually, and share a thermometer or pulse oximeter if one is available. Without proper equipment or staff to routinely monitor vital signs, ill newborns in distress often go unnoticed, their health deteriorating and likelihood of effective intervention declining. Gold standard monitors used in high-resource hospitals are prohibitively expensive and inappropriately designed--if donated to a low-resource environment, they often end up in the “equipment graveyard” within a year.

Our solution is a 4-in-1 wearable device integrating continuous monitoring of pulse rate, respiratory rate, blood oxygen saturation, and temperature. It uses clinically validated technologies and is designed specifically for use in resource-constrained environments, where continuous power and wireless connectivity may not be available. The small rechargeable monitoring devices are worn on reusable bands, collecting continuous sensor data at the point of care. The devices wirelessly send vital signs data from multiple infants to a single tablet. On the tablet, Neopenda’s custom software enables a nurse to view the health status of all the patients in real time, and access health statistics and historical data. If a patient’s vital signs go outside the healthy range, healthcare workers are immediately alerted with visual and auditory indicators. Neopenda’s system delivers the U.S. standard of care in an affordable, locally-appropriate product focused on maximizing the impact of existing healthcare workers. Ultimately, our solution has the potential to improve the quality of care for the 45 million newborns in need in developing countries each year, and to improve neonatal mortality rates.

The current practice in our target market is manual, intermittent measurement of vital signs, which is insufficient for early detection of distress. Unlike other monitoring tools available in emerging markets (e.g. LifeBox), Neopenda’s solution continuously measures four crucial vitals. Multiparameter clinical monitors (e.g. by Covidien or Philips) are the gold standard in high income countries, but are prohibitively expensive and challenging to maintain and repair elsewhere. Our solution is unique in providing comparable sophisticated functionality at an affordable price point and in a system developed iteratively with our users in Uganda to ensure appropriate design. 

Our system leverages simple, cost-effective sensor technology to measure crucial health parameters. The wearables use reflectance pulse oximetry to obtain the pulse rate and blood oxygen saturation. To keep our solution as simple as possible, we are also deriving respiratory rate from the pulse oximeter plethysmograph with customized algorithms. The system also utilizes Bluetooth Smart for a local centralized monitoring system. Furthermore, our solution collects valuable frontline health data in areas where data is a major challenge; the backend data are invaluable to stakeholders, such as NGOs and ministries of health, as we work towards large scale newborn health initiatives.

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 and Boston. 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 hospital in Cote D’Ivoire (through an NGO partner), and 1 hospital in Tanzania. By the end of Q1 2019, we will design freeze and submit to CE Mark. We will also begin production with our large-scale manufacturing partner.

We have currently involved over 150 users from 43 hospitals throughout Uganda in the iterative design of our solution. Over the next three to five years, we will scale our solution beyond Uganda and into other emerging markets through our strong relationships with NGO partners (estimated 12 countries by 2023). Additionally, we will adapt our technology to many other patient populations in need of continuous monitoring (e.g. pediatric, surgical CHWs).

Starting in East Africa, Neopenda will achieve rapid market penetration by leveraging dual customer channels: hospitals in emerging markets via in-country wholesale equipment distributors (e.g. the JMS in Uganda), and to NGOs with international reach. Initial traction is demonstrated by LoIs from renowned NGOs. Our first customers will be private facilities in Uganda because of their greater resources and agility in purchasing compared to public facilities. By creating a solution to a problem sourced directly from our users, we have engaged various stakeholders (clinicians, MoH, NGOs) to create a sustainable market-based product. 

Our device is currently patent-pending and in the prototype stage. To date we have tested on 15 adults and 14 infants, 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 2019.

In 12 months we expect to reach 1,200 newborn patients with our solution (within clinical trials). In 3 years, 2021, we will be serving 1.4 million patients. 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.

Founded in 2015, Neopenda is social enterprise developing sustainable and impactful medical solutions. Co-founders Sona and Teresa began Neopenda as graduate students in Biomedical Engineering at Columbia University, after witnessing firsthand the massive opportunity to sustainably improve health outcomes for vulnerable patients in low-resource settings. We have raised over $750,000 and have been recognized  in Global Citizen and Forbes, selection as a Fast Company World Changing Ideas finalist (2017), and names in Inc’s 30 Under 30 Entrepreneurs list (2017). We have also participated in accelerators  including PULSE@ MassChallenge and the GE/GSBI Healthymagination Program, and are currently members of Techstars Chicago.

Neopenda is a for-profit social enterprise with a double bottom line of improved health outcomes and financial returns. Our product will be sold in packages of 15 wearable devices, 1 tablet, and all associated software, power supplies, etc, for US$2,500, yielding high profit margins. This package covering an entire average-sized newborn unit for less than half the price of a single bedside multiparameter patient monitor currently on the market.System installation, training, and product support is included. Data collected from the system are aggregated and monetized for recurring revenue. We can readily adapt our newborn monitoring technology to other patient populations and use cases, including pediatric patients, surgical and other adult patients, and as a tool for midwives and community health workers to reach rural environments. Additionally, Neopenda is building a pipeline of complementary product. In 2016 we filed a provisional patent on another medical device that will improve care in resource-constrained neonatal wards, related to supplemental oxygen therapy delivery.

We are excited for the community and network that Solve provides. Building and implementing a scalable, successful solution requires input from a variety of stakeholders, and we believe that Solve will be able to help us receive feedback from organizations and stakeholders beyond our current network.With additional input, we will be able to iterate on our solution to ensure appropriate design, and be able to scale our solution efficiently. We endeavor to connect with additional leaders in philanthropy, tech, and business to help bring our solution to commercialization, and then rapidly scale to maximize our impact and sustainability.

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