After defining user needs, understanding how to develop and document design inputs and outputs is the critical quality task in medical device design and development. Properly identifying what the design inputs should be, and specifying them in such a way that they can be objectively verified will make all the difference in whether your project will run smoothly or will devolve into a cluster*&%#.
Here is the link to a great article by Jon Speer of Greenlight.guru that I found at medcitynews.com on the importance of defining medical device design inputs and outputs. Jon explains, in very clear language, how to go about drafting design inputs and outputs so they capture the critical factors that will ensure your medical device design will meet quality standards.
I bet that most medical device designers view quality control regulations as a bureaucratic burden that slows down the development process. I view them as a tool that, when used properly, reduces overall project cost and development time by ensuring that the process is efficient and complete.
Importantly, Jon states that “establishing design inputs can easily take up to 30% of the project timeline.” Many companies are in a rush to market and think that moving into the design phase as quickly as possible is the way to get them there. But without spending the time upfront to properly identify user needs and then determine the design inputs that will meet those needs, I guarantee they will be doomed to having to regroup and redesign late in the cycle. The quickest way to market is to plan the product development effort efficiently. Embracing and following the FDA’s Design Control Regulations will help you do that.