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 not solely aligned with the goal of public health.
A critical insight that companies often miss is that the FDA is primarily incentivized to avoid negative publicity and political fallout. The agency is deeply influenced by its historical experience, particularly the thalidomide tragedy, which has instilled a culture of extreme caution. This means that the FDA's top priority is to avoid approving a device that could later be found harmful, which would lead to public scandal and congressional scrutiny. The result is a conservative approach that prioritizes minimizing risks over maximizing benefi...
