Intuitive HF-Generator HMI through Usability Engineering
How we conducted state of the art Usability Engineering in Electrosurgery.
In recent years, USE-Ing. has undertaken various formative and summative user interface evaluations on behalf of BOWA MEDICAL as part of the usability engineering process. These activities go along with the documentation in compliance with IEC 62366-1, as a vital part of the medical technology approval process. One outcome of this collaboration is the user-centered design of the ARC Energy System, an innovative electrosurgical system driven by an intuitive, safe, and efficient Human-Machine Interface (HMI). The ARC generator offers a wide array of instrument and foot pedal configurations, supplying high-frequency power. The adaptive menu and flexible touchscreen interface facilitate swift adjustments and provide a clear status display for the current instrument setup. The usability of such platform systems is reinforced by their ability to accommodate future functions and instrument configurations. Let’s answer the question how to validate the safe operation of such a versatile electrosurgical medical device adaptable to numerous applications?
Early Emphasis on Usability Engineering
Recognizing the value of early, development-accompanying evaluations, the BOWA project team embraced the concept from the project’s inception. A comprehensive usability evaluation plan was meticulously drafted, outlining the phases to be followed. In the initial formative usability test featuring an early prototype of the user interface, USE-Ing. usability engineers identified use-related problems and pinpointed areas for optimization in terms of intuitive navigation and dialog interaction. Building upon these insights, BOWA engineers fine-tuned the operating concept of the ARC Energy System.
In the concluding user interface evaluation, USE-Ing. validated the product-specific requirements of the ARC Energy System, thereby enabling the finalization of user requirements engineering. The summative usability test, involving representative users in simulated use scenarios, centered on the safe and efficient operation of the HF generator via the Human-Machine Interface (HMI). Our usability engineers devised the test plan based on pre-identified use-related risks and requirements. Hazardous use scenarios and critical tasks within these test cases primarily focused on instrument and foot pedal assignments, as well as the timely recognition of system statuses and warnings, which can be easily overlooked during surgery.
Ensuring Usability Quality in Medical Technology
Our medical technology usability laboratory simulates the representative use environment of an electrosurgical medical device. This includes a specialized operating table with a laparoscopic instrument training torso, an HF generator trolley, and an instrument table housing prepared instruments, connections, and consumables. Facilitated by experienced moderators and meticulously documented by dedicated transcript writers, the representative users recruited by USE-Ing., including surgeons and scrub nurses specializing in HF surgery, successfully completed the summative test cases.
Important outcomes from each test session were comprehensively documented through our multimedia approach, encompassing digital logging tools, photos, and video recordings. In the final stage of development, this material forms the foundation for evaluating the described test series in terms of potential use-related risks. It is discussed with the project team as part of a root cause analysis. The ultimate documentation, in the form of the summative evaluation report, completes the regulatory usability engineering file for the ARC Energy System. This attests to the fact that the jointly developed ARC Energy System complies with quality requirements for safety and effectiveness for specialized user groups in real-world surgical settings.
Discover More About Our Proven Usability Engineering Process
Do you have questions about how we can enhance and evaluate your medical product using a user-centered approach, aligning with existing human factors and usability regulations? Our team of usability engineering experts will help and guide you through the entire process to ensure that your device is safe and effective when it comes to market readiness. When your process is already bulletproof but you need help with test participants and access to a high-quality usability lab, we are there for you as well. Contact USE-Ing. GmbH
