In 1999, a young engineer named John was working at a large medical device company. He was frustrated with the slow pace of innovation and the bureaucracy of Big Ortho. He decided to start his own company to develop a new type of orthopedic device.
John knew that he would need to find a way to get his product to market quickly and cheaply. He also knew that he would need to find a way to differentiate his product from the competition.
John decided to focus on the sports medicine market. He knew the space and knew that these customers were willing to pay a premium for a new solution than saves them time and gave them more control in surgery. He also knew that they were more likely to be satisfied with a product that was developed by a small company and that he could be more responsive.
In the stealth mode, John started by developing a prototype of his product, a proof-of-concept. He then used his network of contacts to get the product in front of some trusted surgeon evaluators..
After many re-designs and market-fit iterations, John's efforts paid off. He froze the design and flew through the 510(k) path. By working fast and smart, he was able to get his product to market in just a ...
