Saans:A neonatal breathing support for low resource settings

Saans is a resource independent and low cost breathing support system for premature neonates in the resource constrained settings.

1.14 million babies die of respiratory distress yearly, yet the majority of these deaths are easily preventable by the application of Continuous Positive Airway Pressure (CPAP). Even in a low-income country, a well-designed bubble CPAP improves survival by 24 to 65% (8). Unfortunately, a significant number of newborns and infants do not have access to this technology during transport nor is electricity and skilled manpower widely available at these care centers. In India alone, nearly 32% of affected babies die during transport (7). 

Saans is an unpowered, purely mechanical, low-skill, neonatal CPAP device, which maintains respiration and oxygenation in premature neonates with RDS (Respiratory Distress Syndrome) by providing constant airflow and pressure to keep the lungs open during transport to a tertiary care / NICU setting.

Neonatal CPAPs have been in existence for decades in NICUs and have served the developed world well. However, India (and other emerging countries) has a specific context where a majority of neonates with RDS are born in non-tertiary care settings, and require transportation to a center with neonatal intensive care facilities. Our research shows that less than 40% of such neonates have access to an ambulance, or to skilled paramedics/nurses during transport—necessitating a CPAP that could work with private and public transportation systems, and used by low-skill attendants. This specific need (of a transport CPAP) in low-resource settings has not been adequately addressed by existing products—a gap Saans aims to fill.

In India alone we lose around 162,000 babies due to RDS annually, of which around 32% die while they are being transported (7,11,12).  Studies show that various vehicles are typically used to transport newborns such as - ambulances (in 26.8% of cases), public transport (22.1%), own vehicles (23.4%) and auto-rickshaws (27.5%). Some newborns are attended to during transport by skilled attendants (11.4%), but the majority of babies are either accompanied by an unskilled attendant (23%) or by relatives (73.2%) (7,11,12). Saans is designed to work in all of these ‘typical’ scenarios as described above. Our partner and co-inventor of the Saans, Dr. Data Santorino, a paediatrician and lecturer at MUST (Mbarara University of Science and Technology), Uganda and the Uganda Country Manager for CAMTech (Consortium for Affordable Medical Technologies), first described the need for such a device to provide respiratory support when electricity is unavailable. The use of CPAP in rural Africa has been demonstrated to be lifesaving with a potential to save close to 178,000 neonatal deaths on the African continent annually (8).  

Neonatal CPAPs have been in existence for decades in NICUs and have served the developed world well. However, emerging countries has a specific context where a majority of neonates with RDS are born in non-tertiary care settings, and require transportation to a center with neonatal intensive care facilities. Our research shows that less than 40% of such neonates have access to an ambulance, or to skilled paramedics/nurses during transport—necessitating a CPAP that could work with private and public transportation systems, and used by low-skill attendants. 

Saans uses a proprietary, arrangement of pressure and flow control systems to convert inflow pressure to a user-defined air-flow (between 5-8 lpm) at a constant positive output pressure (0-15 cm of water). CPAP is a proven technology, and our system has already achieved equivalence to electrical CPAPs on flow and pressure characteristics. The output measures (pressure and flow) of Saans have been tested according to ISO 17510-1:2007 (CPAP mode). Saans is able to provide output pressures in the range of 0-15 cm of water (with 93% accuracy) and gas flow in the range of 5-8 lpm (with 96% accuracy). 

We are targeting for 50 installation this year and by this planing to impact around 500 neonatal lives this year in the India.

We already have a tie up with a manufacturer having ISO 13485 Certified manufacturing facility and we have stabilized the manufacturing for the scale. We have national and international distribution partners to help us to reach neonates in need faster. We are also planning to do large scale clinical and economical benefit data collection to convince public healthcare providers. 

We have a goal of impacting around 180,000 lives (12,000 deployments with an average of 10 uses annually) in the span of 5 years. 

We have been working with Key Opinion Leaders (KOLs) in the field of pediatrics and neonatology since the conception of the idea. We will be promoting the product by engaging with more KOLs, neonatologists, pediatricians, and public health officials by publishing clinical results in peer reviewed scientific journals and national/ international conferences to drive uptake. We will use existing regional medical device distributors to sell the product to private healthcare centers (nursing homes, maternity centers, and private hospitals).

Currently we are doing a pilot with the 2 large hospitals in the Bangalore Karnataka with 10 devices. This Has impacted 30 neonates till now. 

We are launching this product officially in the July 2018 and planning to sell around 50 devices this year. 

We have proven clinical efficacy of the Saans.

The Coeo Labs development team has interviewed 53 caregivers including Almost 90% of the care-givers interviewed identified this need at their care center, and approximately 93% had a positive opinion about the Saans solution and device design. 

Within next 3 years we would be able to serve 40500 babies with 3000 installation and average use of a devices 10 times a year. 

Our core engineering and development team consists of Nachiket Deval (B.E. Mech, M.Des. NID Ahmedabad, experience at Godrej, Seashell and Honeywell); Nitesh Kumar Jangir (B.E., Stanford India Biodesign Alum, with 7 filed patents, and experience at Electrosystems); Basava Kumar (B.E., M.Des. IIT Kanpur, Project Lead Designer and Engineer, experience at Essar); Sujay Shetty (MS, Product Design and Mgmt); Ankit Bhatia (M.Tech Clinical Engineering, IIT Madras, regulatory specialist, worked at HCL); Srushti Chakki (B.E., clinical research and testing).  

Saans has a market potential in India of 84,000 healthcare centres across 22 states through PHCs, Government Hospitals, private charitable institutions, nursing homes, PSU hospitals (Public Sector Utility) and small private hospitals in rural areas in the next five years. We are targeting the cost to the end user to be around USD 250 with a manufacturing cost of USD 70 (half of the cheapest bubble CPAP today). The total requirement of Saans will be over 200,000 devices assuming only 10% market penetration, Saans can generate revenues of USD 3.7 million, which will be sufficient to sustain the product. 

We are applying to solve to accelerate our product's growth by getting access to right resources (financial, technical and operational) and right connections (finance, technical, government, impact analysis and measurement, process of scale etc.) at right time. We think that we are at a position where technology has been proven,we have a great product ready to serve people but now we need help from solve to take this solution to the people in need ASAP without degrading the quality this is where experienced advisors and network of solve can help us as they have done it multiple times. 

• Being a new product awareness would be a key challenge.
• Clinical data: Being an innovation clinical data for the specific product would be limited.
• Capital for the product to sustain till volume comes.
• Access to the marketing channels in the emerging countries.
• Access to the decision makers for the procurement.
• Access to the public health specialist to measure and present impact of the solution.