Now for part 2 . . .
If you evaluate the regulatory trends and hot topics, Design Controls usually makes it into the top five. However, the current culture of the medical device industry rarely push Design Controls to the top. Rather, topics like Complaint Handling, Corrective & Preventive Action (CAPA), and Risk Management often dominate medical device industry blogs, conferences, and hot topics. This is somewhat justified due to the focus and attention regulatory bodies across the world have paid to these other important elements. Let me take a few moments to talk a little about each of these other topics with respect to Design Controls.
Complaint Handling pertains to medical device product issues and failures. This topic has received a great deal of attention because so many companies struggle with how they handle complaints. Complaint handling processes are poor at best with supporting documentation being equally as poor. I don’t discount the importance of a sound Complaint Handling process. However, if we spent as much time on the front end during the medical device product development process to ensure the products we design are safe and effective, would complaints go away? Of course not likely. But could the occurrence rate be reduced? Perhaps. Wait, don’t we have mechanisms in place to do just that? Yes, we do. Design Controls.
Corrective Action pertains to fixing product (or process) issues. Preventive Action pertains to having some foresight to fix an issue before it happens or becomes a big deal. Okay, if we spent time up front during Design Controls, could we reduce the need for so many CAPAs? I postulate maybe.
Risk Management pertains to documenting the hazards, harms, risks of medical devices. In a nutshell (please don’t shoot me for oversimplifying), Risk Management is documenting what can go wrong when a medical device is used. Again, if we evaluate the origins of Design Control, safety and effectiveness were intended to be embedded within Design Controls all along. If fact the FDA Design Control regulation for Design Validation includes the term “risk analysis”. In recent years, though, Risk Management has been likely driven more because of our litigious society.
No, I’m not so naïve that I think Design Controls fixes all issues and makes Complaint Handling, CAPA, and Risk Management less important. Clearly, Design Controls is largely part of medical device product development. And once a product is launched into the market and manufacturing, other processes need to take over. Very valid point.
One of the necessary product lifecycle processes is Change Control. Change Control pertains to monitoring, documenting, and maintaining a medical device product throughout its lifecycle. In my way of looking at this, Change Control is a natural progression, maybe even an extension of Design Controls. Change Control is a way to ensure the medical device evolves based on clinical needs. In my opinion, the bond between Design Control and Change Control should be strong. As you likely know, the culmination of all Design Controls results in the creation of a Design History File (DHF). Many ascribe to the belief that a DHF is a snapshot in time of a medical device during the product development process. Okay, I understand that, to a point. I’ve often wondered, though, if a DHF should continually be up to date based on the current medical device design. Those in the DHF is a snapshot in time camp will point to Change Control as the continuation of the medical device design; Change Control is the “living” documentation and records. Maybe a matter of semantics.
But whenever we make changes to a medical device in production, we must assess the impact on verification and validation. Aren’t these Design Control elements? What if we had a way to maintain Design Controls as living throughout the entire product lifecycle?
I’m sharing these thoughts for a purpose. Primarily, I hope to provoke a new way for the medical device industry to think and behave. I truly believe Design Controls are the foundation of all medical devices and think it is time that we treat them as such. To do so, we need better tools and processes for documenting medical device Design Controls.