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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 [...]

When we’re ill, a speedier diagnosis will help you get better faster by shortening the time between seeing a doctor and receiving treatment. To meet rising patient expectations for instant test [...]

For many companies, the first step in producing the right medical device is hiring the right design and engineering partner. In fact, hiring the wrong one can be catastrophic. The [...]

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 [...]