We’ve all seen it on television: a careful, methodical turtle taking one cautious step at a time. Very. Slowly. Meanwhile, a rabbit nearby is rushing, then maybe napping, but always losing the race. We might cheer for the turtle or…
Being different makes a difference. That’s why I began MAE Group, to use my own outside-the-box thinking to help others bring life-saving devices into the world. In other words, bring purpose into my business. In the climate of innovation in…
First, being a key decision maker and leader in any company becomes a challenge when you don’t have the bandwidth. Whether it’s an expansion of tasks due to company growth or new demands on your own time, you need to…
Truth be told, medical device startups make preventable mistakes. Learn first how to avoid the common mistakes mitigating disaster, saving time, and preventing costly delays. This article breaks down why medical device startups make these mistakes. Then, we’ll outline how…
Why Do You Need a Design History File? In short, the FDA requires a Design History File (DHF) as part of the application and marketing process for medical device manufacturers. First required by the United States FDA in 1990 as…
A Success Story Unfolds When the Co-founders of Neopenda, Sona Shah, CEO and Teresa Cauvel, CTO approached MAE Group they needed regulatory approval and quality system. Because their life saving product, NeoGuard, was ready for market, they came to MAE…
Discover the purpose of a quality management system in the medical device industry.
At first turning a concept into a marketable medical device feels daunting. Your great idea solves a critical concern in the health care field, however, the concept itself comprises the first step among many to getting your innovative product safely…
So you want to release your medical device or pharmaceutical product into the US or global market for your company expansion goals. Perhaps you are already behind on the timeline and over your budget. In order to get your product…
Product Development & Manufacturing
Congratulations! You’ve developed an idea for an innovative product. A great idea is your first step, getting it to market is the next. That’s where MAE Group comes in. We can take your prototype idea, determine how to make it…