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When discussing medical software, user experience (UX) is a broad term used inside and outside the realm of medical devices. It includes all interactions a user has with the device. This experience involves many things on the user’s end. Someone who uses a medical device as part of their daily life, or even for a brief period, attaches thoughts, feelings, emotions, behaviors and responses, and numerous other things to that device. All those various aspects make up the user experience. It’s a catch-all term and understanding all it entails is crucial to developing the most effective and user-friendly design possible. Defining the User Experience Interaction determines user experience. Any type of interaction a user has with a product, app, piece of equipment, and so on, contributes to the user experience. Whatever opinion the user develops of the product is their experience. A product typically needs high levels of usability and accessibility to show a positive UX. Effectivity is not always a good indicator of user experience, which means some developers and manufacturers place little value in working toward good UX. UX does include aspects like the User Interface, design, and layout, but the user experience is the collective interaction and any thoughts, emotions, issues, and responses prompted by that interaction. Is Designing for User Experience Required? Despite its importance, some developers still skirt around the idea of user experience. They shouldn’t. The FDA mandates safe, effective use, and the standards set by IEC 62366-2 outline those terms. The word “effective” does not have a concrete definition, however, so some developers don’t heed it to the degree they should. Effectivity does not only mean a product does exclusively the minimum of what it’s supposed to do. If it isn’t user-friendly or accessible enough for users to operate and easily understand it, it isn’t effective. How to Design for UX Designing UX-friendly software requires research. When a product is being developed, development teams must look at it from the viewpoint of the people who will be using that product. Their thoughts and opinions might not match what a research and development team thinks will work. The development team likely won’t be the people who depend on or operate the device regularly, though. Conducting formative usability testing on a medical device is the most efficient way to test and develop with the user experience in mind. Development should include identifying the problem you’re solving and making the subsequent solution as usable and accessible as possible, which means regularly and consistently examining it from a user perspective. Formative usability testing isn’t one-time use. Ideally, it occurs multiple times throughout the multi-step development process. Development focusing on user experience may look like the following: Research and Discovery - This stage is primarily used to ask what device needs creating, why, and what it will look like. This step occurs at the very beginning before most design work can start, so formative usability testing will not look the same. Use this step to plan for future user observations. Composition - Prototypes develop in this stage and the focus is figuring out the best composition, configuration, or arrangement for the device in question. Bring users in to help assess the available prototypes. This is an excellent time to begin incorporating feedback into the design. Risk and Hazard Assessment - A use-related risk analysis is FDA required. Couple the requirements outlined in IEC 62366-1 with those in ISO-14971 for full risk analysis. Identify any risks in your device and move on toward solving them. At this point in development, it’s time for more formative usability testing. The prototype may be far enough along to conduct usability testing in the field and incorporate any feedback into the final design. Conclusion Designing medical software and medical devices with the user experience in mind results in a product curated for the people operating it. In addition to being an FDA requirement, UX-friendly designs focus on patients and their well-being. Well-being and satisfaction are at the center of the user experience and should reflect in all stages of development.

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Understanding User Experience and Medical Software Device Design

What Are Four Types of Risk Analysis for Medical Device Software Design?