R&D

In your quest to design a user-friendly, software-driven medical device, you likely plan to spend the lion’s share of your time and attention on, well, the software. Make no mistake, the quality [...]

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 [...]

If you’re thinking of bringing a new medical device to the market, you probably already know that your first step is to determine whether or not you need to follow the FDA’s Design Controls. If [...]

Consider a time when you opened up a new product. Maybe you just bought an IKEA desk, and you are super excited to get to using your new “FOLUBAN.” You open the box, pull out the [...]

Prototypes are the cornerstone of medical device development. They are powerful and important tools that transform ideas, thoughts and theories into something real. Prototypes also become a [...]

The first step in building a medical device is to identify the full range of user needs your product will meet. Only then can you begin actually designing a product by translating those needs [...]