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Medical device development is full of regulatory hoops and documentation. Unfortunately, it’s all too easy to view some of the requirements as little more than “paperwork.” The use specification [...]

It doesn’t matter if your medical device company is a hungry new startup or a seasoned industry leader: There are times when you need to augment your in-house team’s capabilities. Whether [...]

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 [...]

Original equipment manufacturers (OEMs) and contract manufacturers play an important role in the medical device industry. Whether they produce their own proprietary components or build entire [...]

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 [...]

The business of introducing new medical devices requires us to address enormous technical challenges that require plenty of hard work. As we strive to meet these challenges, the FDA reminds us [...]