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Developing a medical device first requires defining precisely what that product is supposed to do. Discussion among stakeholders often elicits vastly divergent ideas. The challenge here is for [...]

In your quest to design a user-friendly, software-driven medical device, you likely plan to spend the lion’s share of your time and attention on, well, the software. Make no mistake, the quality [...]

If you’re planning to bring a new medical device to market, your first order of business is to determine how your product will be classified by the Food and Drug Administration. As you likely [...]

If you want to defend and grow your medical device brand’s position in the market over the long haul, you need to compete on more than just your technology. You need a top-notch user [...]

If you’re thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDA’s Design Controls. If [...]

Consider a time when you opened up a new product. Maybe you just bought an IKEA desk, and you are super excited to get to using your new “FOLUBAN.” You open the box, pull out the [...]