Bringing a new medical device to the market is a Herculean task. It requires all of the standard start up work such as determining product market fit, product design, manufacturing and production, marketing message, and much more. In addition to these, since it is a medical device it requires layers and layers of FDA approval, which is akin to hiking up a mountain carrying an 800-pound backpack.
Once a startup medical device company gets beyond its FDA approval, it must determine how to best sell and deploy its medical device into the field. This requires much more than just hiring sales reps. Such companies have to figure out how to get their device installed, have customer staff members trained on how to use it, and service it once it is in place. All of this equates to complicated logistics and scaling difficulties.