Device description
The Ivenix Infusion System is a large volume infusion pump supported by a management system specifically designed to simplify every step of infusion delivery, help to eliminate unnecessary work, and enable the system to inform decisions.
Challenge
Apply human factors engineering comprehensively over the full course of developing a large volume infusion pump to help ensure the device's safe, effective, and satisfying use.
Solution
We worked collaboratively with Ivenix's in-house HFE specialists to ensure that the Ivenix Infusion System reflected good human factors engineering principles. Our initial project responsibility was to design the pump's novel software user interface. Later in the development process, we helped to plan, conduct, and report the results of multiple formative usability tests and two HF validation tests – one for the infusion pump and one for the Infusate library. We provided input to and reviewed Ivenix's HFE report, which was included in the 510(k) submission to FDA.
Impact
The FDA's human factors engineering team had no substantive comments on the HFE Report; a tacit confirmation that HFE had been applied properly and successfully in the development of the highly interactive device for administering medication therapy. Perhaps as significant, it was for a device category that the FDA had identified for having the potential for serious harm resulting from use error. The U.S. Food and Drug Administration (FDA) issued 510(k) clearance for the Ivenix Infusion System in June 2019.
Trust built on industry knowledge and first-hand experience
“Support from Emergo by UL's Human Factors Research & Design group has been instrumental in positioning the Ivenix Infusion System for success. We reached out to them early in the development process to establish the infusion pump's user interface look and feel. The design effort sought to ensure that user interactions would be intuitive for new users as well as efficient to use for experienced users. The result was an aesthetically appealing user interface design that was usable during both formative and HF validation testing with the intended users. Today, simplicity-of-use is of one of the main features used to publicize and differentiate the Ivenix Infusion System from other infusion pumps in the U.S. market.”
Ivenix, Inc.
Request more information from our specialists
Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.