Technology Challenges and Opportunities Across the Cascade of RDS Care
There are proven interventions to reduce neonatal deaths caused by RDS. CPAP therapy is predicted to play an increasingly outsized role. Additional contributions are predicted from tools and treatments including lung surfactant, antenatal corticosteroids, and AI-supported point-of-care ultrasound. Innovation is needed to make these interventions suitable for effective, sustained use in LMIC settings.
Treatment
The first-line treatment for infants with RDS is neonatal CPAP administered in NICUs. For infants needing more support, additional treatments include mechanical ventilation and lung surfactant administered by intubation.
Device-based
There is a critical need for innovative designs for CPAP devices to increase their effective use in LMICs. Most LMIC NICUs have either a few neonatal CPAP devices, a mix of improvised systems that carry significant risk of harm to the baby, or a combination of these. The available devices are often inappropriately administered, or they have been put aside in a store of broken products. There are several reasons for these challenges, and there are different market factors driving product innovation.
There are CPAP devices on the market with regulatory approval from national regulatory agencies in India (CDSCO), the European Union (CE marking), and the United States (FDA). In addition, NEST360, an international alliance of 17 institutions with 13 in Africa, have listed only two CPAP devices, Pumani and Diamedica as appropriate for low-resource settings, based on a set of qualifying criteria.
The technologies listed in the table are a representative sample of available products in market and development. The purpose is to provide an overview of the state of innovation. This target product profile (TPP) is established by Nest 360 with input from UNICEF and other stakeholders.
Name | Innovator | Description | Image | Development Status + Regulatory Approval | Landed Price of Device | Technology Type | Automatic monitoring and maintenance of therapy setpoints | O2 and Air source flexibility | Durable Design | Learn More |
---|---|---|---|---|---|---|---|---|---|---|
Vayu Innovations | Low-cost bubble CPAP kit built around a low-cost blender and requiring no power | On Market in select countriesLocal country registrations only | $400 | Blender and Bubble CPAP Kit | No | Requires >8psi O2. Does not require air | Maintenance requirements unknown; internal testing showed breakage risk | |||
3rd Stone | Medium-cost bubble CPAP with integrated compressor and no humidification | On MarketCE (2022) | $2,000 | Bubble CPAP | No | Any or no O2 source; generates own air flow | Frequent service required | |||
GH Labs | All-in-one CPAP with integrated compressor, humidifier, blender, alarms, and automatic therapy control algorithms | Under DevelopmentCDSCO and CE planned for 2026 | $2,800 | Flow-driven CPAP | Yes | Any or no O2 source; generates own air flow | Tested/designed to last 5-years | |||
Innaccel | High-quality, high-cost CPAP offering bubble CPAP, flow CPAP, high-flow nasal canula (HFNC), and various alarms | On Market in IndiaCDSCO | $3,200 (without humidification) | Flow CPAP, Bubble CPAP, HFNC | Yes | High pressure or no O2 source; generates own air flow | Requires oxygen sensor replacement every 2-2.5 years | |||
Diamedica | CPAP with integrated oxygen concentrator and voltage protector to protect machine from unstable power surges | On MarketCE | $4,000 | Bubble CPAP, Oxygen concentrator | No | Yes | Requires oxygen concentrator maintenance (Sieve beds should be serviced at least every 5,000-10,000; ~1-1.5 years) | |||
MTTS | High-cost all-in-one CPAP with integrated compressor, humidifier, blender, and alarms | On MarketCE | $4,060 – 6,000 | Bubble CPAP | Maintains FiO2 / temp; Monitors pressure | Any or no O2 source | Robust; Only requires oxygen sensor replacement every 18 months | |||
Phoenix | High-cost CPAP with adjustable pressure and flow and alarms | On MarketCDSCOCE | $7,800 – 9,000 | Bubble CPAP, Flow CPAP | Maintains FiO2; Monitors pressure | Requires high pressure O2 and air | Requires oxygen sensor replacement | |||
Fisher & Paykel | High-cost, gold-standard humidifier that can be bundled with a blender and bubble CPAP kit | On MarketFDA (2023)CE(probably) CDSCO | $9,000+ | Bubble CPAP (heated humidifier) | Maintains temp only | No | Yes |
Pharmaceutical
Liquid surfactant can be delivered by intubation directly into an infant’s trachea.
Technology solutions for this treatment category are not highlighted in this knowledge repository because it is not a technical focus area of Global Health Labs. Please explore examples highlighted for other steps in the care pathway.