A large multi-national medical technology company has recently developed a new, innovative medical device to be used in operating rooms by anesthesia providers. The system, which includes hardware, software, and disposables, is designed to help fulfill an unmet need in the market and aid in improving patient safety. This multi-year new product development initiative is considered to be a high strategic priority for the Company.
 
The Company originally engaged LHF to assist in conducting a mid-stage formative usability study. One of the study outcomes was our suggestion for the Company to reconsider a significant update to the prototype’s graphical user interface (GUI), which would streamline the workflow and optimize the information architecture, real estate, color/iconography, and navigation scheme. The Company saw the user experience as a top priority, and further engaged us to serve as their primary human factors subject matter experts and lead the GUI redesign effort.
 
Our team, in partnership with designers from another firm, brainstormed and developed new GUI wireframes and icons, then performed iterative testing and implemented design refinement based on users’ feedback.
 
From there, our relationship with the Company continued to expand as they delegated additional human factors work, asking us to take the lead on developing the product’s Instructions for Use (IFU) and Quick Reference Guide (QRG), while also planning additional usability evaluations of the system. Throughout the robust product development process, we served as the HF lead, which included unifying multiple disciplines within the Company (including marketing, software engineering, systems engineering, quality, regulatory, medical affairs and training/education) to advance all aspects of the system design.
 
Over the course of the 3-year collaboration, we have coordinated the inputs required for the pre-submission to FDA, conducted over 10 usability studies and research sessions with hundreds of target end users, performed an expert review of a back-end software component, and conducted an online survey to obtain missing inputs to the training curriculum. The program culminated in a multi-arm summative study which was conducted in 2024 with three user groups across multiple U.S. cities.
 
We are confident that their investment in a rigorous human factors engineering process will result in a ground-breaking system with an intuitive user experience.