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The first step in building a medical device is to identify the full range of user needs your product will meet. Only then can you begin actually designing a product by translating those needs [...]

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 [...]

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 [...]

Most medical devices involve some degree of complexity. Of course, that’s inherently true of high-risk and technologically sophisticated devices. But even the most straightforward medical device [...]

As medical product developers, we observe design every day in what we see and interact with, learning from the problems of the past and using those insights to fuel our ideas for new products. So [...]

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 [...]