The more frequent manufacturers launch products, the better they become at being able to anticipate FDA approval requirements. Over time they increase their “regulatory intelligence” around design controls regulation which allows them to more efficiently launch products relative to competitors which will become a competitive advantage. Manufacturers will begin to better understand the level and type of development activities and documentation the FDA will expect during regulatory submissions. As a natural consequence, the significance and number of delays that may occur during these submission activities will be reduced.
Initially new medical device manufacturers may struggle “getting off the starting blocks”, but over time regulatory intelligence will increase and the process of implementing design controls will become a “well-oiled machine”.
Medical device startup companies often hire consultants to get through the initial regulatory learning curve quickly and to provide a quick download of regulatory advice which provides these companies with the necessary regulatory intelligence for initial regulatory submissions and quality system inspections.