I think that an additional topic to add to this discussion is while large corporations experience this issue with class II and class III devices, sometimes going the less creative or risky route with their devices to get it approved by the FDA, this most certainly is even harder in smaller companies. When a really good idea is brainstormed, even if it will cost a lot to get approved by the FDA, a large corporation has the option to determine whether they see a return on investment and visualize this making a big impact in the healthcare community because of its larger budget. On the other hand, this seems like it would be harder on a smaller company with less funding. However, it seems like smaller companies, such as start ups, are often the ones driving innovation. Does anyone have any opinion on this or experience with this? In addition, does anyone know of any bias that may occur with a large well known company to a small unknown company when it comes to the FDA? Are these large well known companies given priority or is everything looked at on an even playing field and the order it comes in?