Welcome to the wonderful world of design controls! Implementing design controls into medical device product development can be a very exciting experience. Design control requirements should be seen as more than just another regulation that needs to be followed; they should become an integral part of an organization’s product development process. In other words, design control regulation should not be seen as just another regulatory hoop to jump through, but rather a robust method of developing safe and effective medical devices.
Inherent to any new product development environment there are always technical, business and commercial challenges which introduce unknowns which will often require creative solutions for solving monumental problems. In addition to these traditional challenges, design control requirements add an additional hurdle which must be championed during product development.
Due to the “umbrella” approach the FDA uses to define the regulation, there is significant allowance for interpretation of how the regulation should be implemented. This is where the exciting part comes in to play! Not only do development teams get to figure out how they can overcome their technical problems, they also have to anticipate what development methods will be acceptable to the FDA. As organizations become expert in their devices and work closely with the FDA during device submissions, they will soon be able to effectively anticipate and understand the FDA’s expectations.