P1.1: Consider and diagnose

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 [...]

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 [...]

In medical product development, the term “research” can mean many different things depending on who you ask. It’s easy to get lost in the phases, requirements and ownership of [...]

The medical device industry is highly regulated. For good reason. These regulations exist to protect patients and consumers by ensuring the safety and efficacy of medical devices. Of course, [...]

Medical device companies must be future-oriented and innovative in order to remain competitive. They must constantly consider how to bring new devices to market that add value and meet users’ [...]

The most successful medical devices are those designed specifically with users’ needs in mind. That’s a pretty basic tenet of product design, right? But what happens when a device has more than [...]