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The process of developing a new medical device is overwhelming. The sheer volume of logistics and requirements makes it extremely challenging to anticipate and plan for each of the many steps [...]

Competition in the medical device industry is already cutthroat. But an influx of investor-backed startups means the pressure is only ratcheting up. The investors who back these startups often [...]

The FDA recommends that all medical products with some level of complexity include appropriate instructions for use (IFU). Doing so ensures the user will be able to fully understand how to [...]

You want the healthcare products that you design to improve people’s lives. But that extends beyond the patients you aim to heal. Other than clinical efficacy, a medical device’s ability to [...]

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 [...]

Other than clinical efficacy, a medical device’s ability to meet its users’ needs is the most important predictor of success. For that reason, medical device development should begin with an [...]