The FDA Updates You Need to Consider for Your Next-Generation Medical Device
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.
Whitepaper: The Ultimate Playbook for Launching a Medical Device Startup and Bringing Your Product to Market
If you’re reading this, you probably have a viable idea for a new medical device — and that’s exciting. You’re ready to launch a startup and get your product into the hands of the users who need [...]
When (and How) to Integrate Usability into Your Medical Product Development
Human factors and usability activities play a vital role in medical product development. Not only do they help provide insight for development, they are also closely tied to risk management and [...]
Determine Your Medical Device’s FDA Classification Before It’s Too Late
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.
What Can You Learn From COVID-19 About Good Design?
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 [...]
The Fundamentals of Product Design Research
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 research [...]
