Plain talk about the FDA’s real incentives.

Most people cannot say this out loud, but I will.
When submitting a new device for approval, many ortho companies focus on meeting the FDA's stringent safety and efficacy requirements. However, what they often overlook is the underlying incentive structure that drives the FDA's decision-making process.
The FDA, much like other regulatory bodies such as the SEC or FAA, operates within a framework designed for a 20th-century environment. This structure primarily aims to protect the public from potential harm, which sounds noble in theory. However, the FDA's incentives are more complex and are ...