The Challenge
Our client had developed a novel life-saving technology that would treat neonates with hypoxic respiratory failure by delivering inhaled Nitric Oxide (iNO) to neonates in the Neonatal Intensive Care Unit (NICU).
The system was complex and included several components, all of which needed to be best in class to support safety and usability, to gain regulatory approval, and to prompt market adoption. This device, while improving the operations of iNO in hospital settings, required a Human Factors Program.
Improvita was selected to design and execute the Human Factors Program due to our highly skilled cross-functional Human Factors team. Improvita also provided support for the regulatory interactions with the FDA.
Unique Challenges Included: