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Over the past few years the FDA has increased their emphasis on the importance of applying sound human factors procedures during medical device development. That means they’ve increased their [...]

When medical device companies set out to produce a new product, they are often driven primarily by one of two things: business goals or technological innovation. These are necessary elements of [...]

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 [...]

Let’s say one of your competitors introduces a successful new medical device to the market that would make sense as part of your suite of products. If you’re like most medical device companies, [...]