ARTICLE SUMMARY:
Balancing focus on the tangible now and the possible future.
The daily work of medtech regulatory and market access professionals is to advance products within a defined set of rules. This work does not happen in a vacuum. The rules themselves can be updated, and there is a constant stream of debates and discussions about the prospect of new reforms.
Public policy, of course, must be advanced in the public sphere, but the process can be the cause of confusion for on-the-ground practitioners. Government bodies touting planned policies via politics or PR can muddle what technical requirements need to be followed in the here and now. The current FDA leadership, for instance, has in some instances engaged in policymaking by press release, announcing new plans without direct linkage to guidance, regulations, or other materials that professionals rely on to implement new procedures.
