On one hand, it is easy to see how the burdensome costs of regulatory controls may deter businesses from pursuing medical device development. But there are reasons to believe that this is not as large a downside as it initially seems. First, it must be noted that these regulations are essential for patient safety and product success. Further, developing appropriate standards and controls is not a cost-free process. Recouping these costs through charging companies helps the associations and departments involved remain free of political disturbances in the government by preventing their funding from ever being made hostage.

While small companies are at a definite disadvantage since these are fixed costs that larger companies can easily pay, it is better to have loan or grant programs available for them than rather than simply make these controls free and lose out on an important source of revenue.