INOmax® EVOLVE™ DS Delivery System Receives the Stanley Caplan User-Centered Product Design Award

The INOmax EVOLVE® DS Delivery System, a device for the delivery of INOmax® (nitric oxide) gas for inhalation, has received the 2023 Stanley Caplan User-Centered Product Design Award from the Human Factors and Ergonomic Society.

Created by Mallinckrodt in partnership with Delve, the EVOLVE DS includes many user interfaces: the delivery system itself, nitric oxide cylinders, an Operation Manual, various disposable accessories, and training materials.

The EVOLVE DS is validated and compatible with numerous gas delivery systems in a Neonatal Intensive Care Unit (NICU). It is typically used by a respiratory therapist (RT), with nurses interacting with the device in certain circumstances. Please see Applications and Device Warnings for the EVOLVE DS below.

The award selection committee highlighted five factors in their decision:

• Research Depth: The extensive research initiative underpinning the EVOLVE DS demonstrated a commitment to understanding and meeting user needs.
  
  
• Clarity of Purpose: The EVOLVE DS stood out with its clear identification and explanation of user requirements, design processes, and implementation strategies. The submission showed clarity of purpose and design that aligned with the judging criteria.
  
  
• Innovative Solutions: The introduction of ergonomic design features and automated functions exemplifies user-centered thinking, simplifying the user interaction and enhancing the user experience.
  
  
• Impactful Results: The product was well-researched with the potential to be transformative in delivering therapy. The documented studies, findings, and subsequent modifications highlight a design program that is responsive, adaptable, and effective.
  
  
• Presentation Quality: The EVOLVE DS provided a clear and comprehensive presentation, ensuring that the essence and value of the design program were easily understandable.
  

The Stanley Caplan User-Centered Product Design Award is presented each year to individuals and teams that have demonstrated outstanding innovation and design for products, software, and systems. Evaluation criteria include ease of operation, creativity and innovation, functional obviousness, concept development, design, and evaluation.

^APPLICATIONS

^{The INOmax EVOLVE DS delivers INOmax (nitric oxide) gas, for inhalation. The delivery system must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and are indicated for use in term and near term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. These delivery systems are indicated for a maximum of 14 days of use.}

^{DEVICE WARNINGS}

^{Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the EVOLVE DS eINOblender or the DSIR Plus INOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert.}

^{Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate.}

^{Do not use equipment that is not specified as part of the systems or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the systems to malfunction.}

^{If an alarm occurs, safeguard the patient first before performing troubleshooting procedures.}

^{Use only INOmax, pharmaceutical grade NO.}

^{Rx Only}

^{For information on the INOmax EVOLVE DS delivery system or for technical assistance for any of the INOmax delivery systems, call (877) 566-9466.}