2023 Award Winner
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.
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.
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.”
2022 Award Winner
The VersiTMPD Cycler System* is the smallest, lightest, and quietest peritoneal dialysis (PD) cycler available, meant to fit where and how patients live. Designed specifically to enhance the patient experience, VersiPD aims to enable patient independence, shorten training time, increase patient time on therapy, and improve patient outcomes. Integrated with the KinexusTM Therapy Management Platform, clinicians can monitor patient treatment data and make therapy adjustments remotely. This is PD Reimagined!
The Human Factors Engineering lead on the project, Jon Leclerc, told HFES that “Fresenius Medical Care is honored to receive the prestigious Stanley Caplan Award. It is gratifying to see the collaborative effort of our global cross-functional team recognized. However, what is even more gratifying is that this award acknowledges that Fresenius Medical Care accomplished our primary goal of creating a simple-to-use and innovative product that will eventually deliver advanced therapy for our patients around the globe.”
2021 Award Winner
This is the VIPER PRIME™ System, a novel technique for percutaneous pedicle screw placement that eliminates the need for guidewires, Jamshidi needles and pedicle preparation instruments. Featuring a new screw tip design and a stylet that is fully controlled by the screwdriver, only the VIPER PRIME System enables surgeons to target pedicles and insert screws in one single instrument pass.
2021 Honorable Mention
The PX940 family of high-performance industrial printers with integrated label verification technology provides error-free printing. Developed for companies that are subjected to fines levied for non-compliance to regulatory standards, and returned shipments due to unreadable barcodes, the PX940 series prints barcodes that are defect-free and 100% accurate every time. The fully integrated verifier allows for quick setting up even when printing and verifying different labels.
2020 Award Winner
The SPEEDTRAP® Graft Preparation System is a whipstitch suture delivery device created to simplify soft tissue graft preparation. The SPEEDTRAP® System is designed to apply uniform, consistent whipstitches to the graft faster and easier than traditional techniques.
"On behalf of the Industrial Design and Human Factors organization at Johnson & Johnson Medical Devices Companies, we're honored to be recognized with this prestigious award. We feel privileged that we can apply our approach to human-centered design in all business units to help people return to their passions today – whether that's in sports or everyday life. Our process focuses on elevating the quality of human-to-system interactions across the entire peri-operative care continuum. With emphasis on holistic design and usability, we work in close collaboration with our internal stakeholders to transform healthcare experiences. We are proud to share this honor with all of them." - Jacob Marks, Lead Industrial Designer, Sports Platform, DePuy Synthes, Industrial Design & Human Factors, Johnson & Johnson Medical Devices Companies
2020 Honorable Mention
ZENEO® is a single use needle-free injection system intended to revolutionize the administration of well-established treatments. The prefilled, single-use device propels the medicine through the skin in less than a tenth of a second. Crossject currently has eight solutions in advanced stages of development, seven of which are for emergency situations.
"We are extremely happy that our user-centered design approach has been recognized in the United States. Nothing replaces the satisfaction of seeing the user successfully inject with Zeneo in emergency situations to save a life. However, the recognition by our peer experts in the human factors field truly highlights the 20 years of investment and dedication of our entire team. It is a real pride for Crossject and for me personally to earn this achievement!" - Frédéric MABILE, Human Factors Engineering Manager, CROSSJECT
2019 Award Winners
The Ivenix Large Volume Pump, submitted by Ivenix, Inc., is a smart pump that allows hospitals with electronic health records to automatically program the pump with medication orders prescribed through a computerized order entry system. In doing so, it augments infusion therapy safety, improves nurse workflows, and provides data for continuous quality improvement. It features an easy-to use touchscreen on the pump, a strong power-style grip handle, a cassette-based administration set, an integrated air elimination filter, and effortless updating through its infusate library. Invenix incorporates four main innovations to infusion therapy delivery that significantly enhance safety and usability: an independent secondary inlet, a pneumatic closed-loop diaphragm-type pump, integrated system intelligence, and administration set identification.
Rig DogTM Xtreme Impact Gloves, submitted by Honeywell International Inc., offer oil and gas workers a new level of protection, comfort, and dexterity. The physical design reflects a deep ergonomic understanding of the end user needs and environmental conditions while increasing users’ finger range of motion and reducing hand fatigue. The product features high contrast colors and a symbolic, V-shaped design to increase low light safety awareness and aid communication gestures between users working in extreme conditions. Furthermore, its high quality and exquisite design makes it much easier for workers to be willing to wear and use them, ultimately ensuring the safety of such workers who are otherwise often unwilling to wear mandatory protective equipment.
2019 Honorable Mention
This new iteration is the only mop bucket designed to last 5 years or 200,000 wringing cycles. It is also the first of its kind to include a wringer lift handle and rear bucket handle to improve ergonomics of dumping, a sink rest, and a front pocket handle for two-handed bucket lifting. Other noteworthy aspects include existing patented WaveBrake baffles inside the bucket, proven to reduce splashing, among many other ergonomic improvements proving that the safety and well-being of its users are high priority.
VersiPD Cycler System - Fresenius Medical Care
VIPER PRIME™ System - DePuy Synthes
SPEEDTRAP™ Graft Preparation System - Johnson & Johnson Medical Devices Companies
Ivenix Large Volume Infusion Pump - Ivenix, Inc.
Rig DogTM Xtreme Impact Gloves - Honeywell
Elekta Unity - DCA Design
Centrella™ Smart+ bed - Hillrom
TC8000 Rugged Mobile Computer - Zebra
Hitachi Class 800/801 Train - DCA Design
Polisher's Workstation - MauroNewMedia
iXL Learning System - Fisher-Price, Inc.
WT4000 Wearable Computer - Motorola
Backstrap Weaver's Ergonomic Bench - Synergo
Natural Ergonomic Keyboard 4000 - Microsoft
Medtronic Xomed Straightshot M4(TM) Microdebrider
Symbiq(TM) Infusion System - Hospira
EasyShare One - Kodak
EXPO Dry Erase System - Insight PD
Whirlpool Duet Fabric Care System
Microsoft Office Keyboard
Infiniium Oscilloscope - Agilent Technologies
Evenflo Insight™ Stroller - IDEO
Selected Honorable Mentions
PX940 Industrial Printer - Honeywell International Inc.
ZENEO® - CROSSJECT
Rubbermaid Commercial Next Gen WaveBrake Mop Bucket - Newell Brands
ZC100/300 Series Printer - Zebra Technologies
Xerox Digital Alternatives
ED (Emergency Department) LaunchPoint - Cerner
MEDClick—Medical Central Line Catheter Care Kit
Aearo QuickLatch Safety Mask Respirator - Insight PD
INTUITOOL™ - Gyrus Medical, Inc.