[koji]

There is also a very high overhead required for simply getting products to market. When the easiest way to proceed is by hiring high-priced consultants who hold all the keys, it makes it very difficult for new ideas to become available. Only established players really have the pockets deep enough to navigate the regulatory process.

There are numerous costs that you can't avoid, such as lab testing, clinical trials, and fees for acquiring certifications, but being able to do more on your own as far as documentation is a big first step.