Feb 2013

Author: Tiffini Diage, MPH


Congratulations, you’ve received approval to market your device in the United States and possibly international regions as well. Given the time and effort it takes to get approval from a regulatory body such as the US FDA, this is quite an accomplishment. Yet clearance alone does not guarantee a revenue stream. Acceptance within the medical community, strong sales, and market growth are what determine the next stage of product success. Reimbursement and payment are key factors in determining sales growth and market adoption. Even if sales are forthcoming, additional reporting and compliance requirements may threaten to hinder momentum. Proper planning is necessary to ensure you hit the ground running the second you receive that long-awaited clearance so you can begin generating revenue as soon as possible after what can be a long regulatory approval process.