Human Factors and Ergonomics Society Announces 2023 Stanley Caplan User-Centered Product Design Award
November 1, 2023 –Human Factors and Ergonomics Society (HFES) today announced the winner of its 22nd Annual Stanley Caplan User-Centered Product Design Award to Mallinckrodt plc (in examinership) in partnership with Delve for its INOmax EVOLVETM Delivery System (DS).
The INOmax EVOLVETM DS, created by Mallinckrodt and in partnership with Delve, is an investigative system for the delivery of INOmax® (nitric oxide) gas for inhalation. The EVOLVE DS is currently with the FDA and not cleared; The EVOLVE DS and the features described here are subject to a pending 510(k) application. At this time, the EVOLVE DS is not available for sale, distribution or use.
INOmax® (nitric oxide) gas, for inhalation, is an FDA-approved treatment that is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.[i] Please see Important Safety Information for INOmax below.
The EVOLVE DS includes many user interfaces: the delivery system itself, nitric oxide cylinders, an Operation Manual, various disposable accessories, and training materials. If cleared by FDA, the EVOLVE DS would typically be used in series with a ventilator in a Neonatal Intensive Care Unit (NICU). Primary users are respiratory therapists with nurses interacting with the device in certain circumstances.
More details on the date and time of the award ceremony are to be announced soon. This special session will include a presentation from this year’s winner on the design and development of the award-winning product. The ceremony is open to all members of HFES and interested members of the general public.
Factors Contributing to Decision
Upon selecting the EVOLVE DS as this year’s winner, the award selection committee stated that the following several factors contributed to this decision:
- Research Depth: The extensive research initiative underpinning EVOLVE DS demonstrated a commitment to understanding and meeting user needs.
- Clarity of Purpose: 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 not only well-researched but also potentially transformative in delivering therapy. The documented studies, findings, and subsequent modifications highlight a design program that is responsive, adaptable, and effective.
- Presentation Quality: EVOLVE DS provided a clear and comprehensive presentation, ensuring that the essence and value of the design program were easily understandable.
In summary, the EVOLVE DS epitomized the balance of thorough research, user-centered design, innovative solutions, and transformative outcomes. We commend the team behind the EVOLVE DS for their exemplary work and contribution to the field.
Curt Irwin, Senior Director of Human Factors Engineering on the project said, “We are honored to receive the prestigious Stanley Caplan Award. It is gratifying to see the collaborative effort of our global cross-functional team recognized. What is even more gratifying is that this award acknowledges the accomplished primary goal of creating a simple-to-use and innovative product that promises to, contingent upon receipt of appropriate marketing authorizations, deliver advanced therapy for patients around the globe.”
Mallinckrodt and Delve generously requested that the $1000 award money be donated back to the PDTG.
About the Stanley Caplan User-Centered Product Design Award
The award is named after Stanley Caplan, an HFES fellow, for all his efforts and accomplishments over the years at promoting the importance of user-centered design and research within industry while mentoring others to do the same. 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 in multiple categories. Nominations of consumer, commercial and medical products are eligible, and candidates/teams don’t have to be a member of HFES or PDTG to participate. Evaluation criteria include ease of operation, creativity and innovation, functional obviousness, concept development, design, and evaluation.
The award selection committee this year was made up of a panel of five judges drawn from the PDTG members. Each one is an experienced practitioner in their respective fields from collective backgrounds aligned with the type of products from the submissions received. The panel included:
- David Aurelio, Faculty Lecturer, Tufts University
- Eric Bergman, Director Human Center Innovation, Fresenius Medical Care
- Lindsay Slater, Senior Human Factors Engineer, Galvion Inc
- Michael (Mick) Rakauskas, Principal Research Engineer, Human Factors, Abbvie
- Paul Ritchey, Senior Test Project Leader, Consumer Reports
This award is chaired by Adam Shames.
Nominations for the 2024 award are due by April 30, 2024, and can be submitted at www.UCDaward.com.
IMPORTANT SAFETY INFORMATION FOR INOMAX
- INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood
- Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation
- Methemoglobinemia and NO2 levels are dose dependent
- Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia
- Nitrogen dioxide may cause airway inflammation and damage to lung tissues
- In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema
- Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration
- INOmax must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System
Please see Full Prescribing Information
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