P2.2 Detailed Dev. of Solution

Developing a medical device first requires defining precisely what that product is supposed to do. Discussion among stakeholders often elicits vastly divergent ideas. The challenge here is for [...]

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 [...]

It goes without saying that medical devices should be both safe and effective. But those qualities are really just the baseline. If a product is safe and effective but doesn’t actually solve [...]

If you’re considering partnering with an agency to help you realize your vision for a new medical device, you already know you need outside expertise for the design phase of your project. But [...]

The FDA recommends that all medical products with some level of complexity include appropriate instructions for use (IFU). Doing so ensures the user will be able to fully understand how to [...]

Well-crafted interface design transcends being just a pretty face for software applications. Companies often put less importance on the user interface design of a software application than the [...]