From experience, a business can make a difference in how the FDA polices a segment of the industry. You need scientists, who really know the domain (and, perhaps, have some contacts at the FDA), who can try to set the bar with FDA.
Of course, that's out of the realm of most start-ups, unless you are starting from a research facility where someone might already know the ropes. That said, my employer (which was once a tiny start-up that grew from a research lab) has directly worked with the FDA to define the regulations around our particular domain.
Of course, that's out of the realm of most start-ups, unless you are starting from a research facility where someone might already know the ropes. That said, my employer (which was once a tiny start-up that grew from a research lab) has directly worked with the FDA to define the regulations around our particular domain.