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 benefits.
This incentive structure leads to an environment where the FDA may delay or reject devices that could significantly improve patient outcomes. The agency’s focus on avoiding blame for potential side effects often overshadows the potential benefits of new, innovative technologies. This is why the approval process can seem frustratingly slow and why companies may find themselves jumping through seemingly unnecessary hoops.
Moreover, it’s essential to understand that FDA officials are not just motivated by financial rewards but by power and status within the regulatory framework. These non-monetary incentives drive them to maintain control over the industry, sometimes at the expense of innovation and patient access to potentially life-saving devices.
For ortho device companies, understanding these underlying incentives is crucial. It’s not just about meeting the technical requirements but also about navigating the FDA’s complex bureaucratic culture. Companies need to be prepared for a process that is not just about science but also about the politics of regulation.
In conclusion, while the FDA plays a vital role in ensuring the safety of medical devices, companies must recognize that the agency’s motivations are multifaceted. By understanding the real incentives at play, companies can better strategize their approach to gaining FDA approval, ultimately bringing innovative and beneficial devices to market more efficiently.