Next steps:

• Submission of IRB for prospective data collection of neonates’ vital signs at Johns Hopkins Hospital (Early Summer)

• Begin collection of neonatal data at Johns Hopkins Hospital (late summer or when IRB approved)

• Iteration of ML methods, algorithm development

• Pilot testing of device efficacy with project partners in Bangladesh

Adoption pathway:

• Preliminary small scale dissemination in Bangladesh, feedback collection and improve on device

• Larger scale deployment in Bangladesh, possibly followed by India.

Regulatory classification:

• FDA approval for a Class II device with predicate

IP protection plan:

• Design patent for SepSock, utility patent for the SepScore system, copyright for the manual and a trademark