R&D

Developing a medical device starts with identifying every user need your final product will meet. Then, those needs are translated into actionable product specifications. These are called design [...]

From a medical device development perspective, the goal of human factors engineering, usability, and user experience activities is the same: To release a product that meets users’ needs in a [...]

Today’s development standards are different, even for medical devices. Products evolve faster because of improved technology as well as new, more readily available use and safety information. [...]

Risk management is a crucial aspect of medical device development. You need to account for and mitigate the risks associated with your product early on, so it’s safe for users and passes [...]

Medical device regulation gets more stringent all the time. It’s harder to get FDA approval now than it was just five years ago. For good reason.

Geometric dimensioning and tolerancing (GD&T) is intimidating even for trained engineers to pick up. GD&T has a set of vocabulary that is initially impenetrable and throws out a lot of [...]