Translating User Needs Into Actionable Design Inputs
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 [...]
Failsafe Your Medical Device Development Process with a Comprehensive Project Plan
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 [...]
Don’t Just Listen to Your Users — Watch Them, Too
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 [...]
After the Designs are Done: Why Your Medical Device Needs an Agency’s Support Phase
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 [...]
5 Top Tips to Create Effective Quick Guides for Complex Medical Products
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 [...]
