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Roadmap/deliverables towards FIM (Device for FIM (Prototype (tech specs,…
Roadmap/deliverables towards FIM
Clinical Strategy to gain the ENT endorsement
FIM - MOA
define first population: adults vs kids
MOA readouts
study protocol/CRF
ethics approval
FDA registration/notification?
define population and endpoints of children with OME (>3 yrs?)
Trial/registry in target children population 1-3 yrs
Device for FIM
Manufacturing
costs
where and who
Prototype
tech specs
feels like testing
bench model - works like
mouth compoinent
Nostril component
treatment regimen for FIM
frequency
synched with sips or programmable
single insufflation specs
tracking
app based component
Validation interview
user (children/parents testing & interviews
ENT specialist
pediatrician
Lunar sprint October 2018
Objectives & deliverables
Antropometry Pictures
Review business plan/model
value proposition to ENT and pediatrician
Review regulatory strategy
Budget FIM