Challenge icon

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:

  • Highly complex device, including Nitric Oxide delivery, software in a medical device, and warning system components
  • Intended use environment with specific environmental conditions (NICU)
  • Compact timeline required for approval
Doctor with a stethoscope listening to a newborn infant's heartbeat
Solution icon

What We Did

  • Combined Human Factors, Device Development and Regulatory Subject Matter Experts (SMEs) to tailor project plan to unique project needs
  • Designed a Human Factors Program based upon the client’s risk management documentation (i.e., task analysis, risk assessment, etc.)
  • Executed and Reported on Summative Validation testing with 47 participants (Registered Nurses & Respiratory Therapists)
  • Provided recommended updates to Task Analysis and Labeling
  • Conducted Residual Risk Analysis and Risk Benefit Analysis
  • Provided SME support during FDA interactions pertaining to review of the protocol and study results
Results icon

Results Delivered

  • Gained alignment with FDA on Human Factors Validation protocol
  • Confirmed effectiveness of training for intended users to safely and effectively use the device through implementation of the Human Factors Program
  • Produced Human Factors Engineering (HFE) Summary Report and Use Related Risk Assessment (URRA)
Key outcomes icon

Key Outcomes

  • Client received successful 510(k) clearance for the system
  • Reduced the need to use large NO cylinders and increase efficiency in set up for treatment