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    Level Up Your FDA-Required IFUs for Mobile Medical Apps

    For makers of innovative medical devices, mobile apps present a major opportunity for creating products that involve patients more directly in their own healthcare. However, it’s important to understand how the U.S. Food and Drug Administration (FDA) guidelines address these software programs.

    Why User Needs Matter During Medical Device Development

    To market any type of product successfully, it’s important to identify how people will use it and what difference it will make in their lives. Put simply: You must understand your end users’ needs. If you don’t consider user needs during product development, your product is unlikely to appeal to the very audience you created it for. 

    How To Design Home Health Products That Inspire Patient Compliance

    The success of home health products can be measured in much the same way as any other medical device: How well does the product work? To what extent does it improve health outcomes? How are sales? But, unlike medical devices for clinical settings, home health products must also succeed in another category. These devices must facilitate patient compliance. 

    Marrying Software and Hardware: The Pressures and Pain Points of Building a Software-Driven Medical Device

    Medical devices are increasingly built around software. Of course, almost any medical device with a battery or power cord has a software component of some kind. But as more and more tech companies enter the medical space, the role of software in medical devices is changing. Today, it’s more common than ever for software to comprise a medical device’s core offering. In fact, the FDA now recognizes some software as a medical device all on its own, without any physical components involved.

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