The shift is coming. The FDA recognizes that “compliance only” has not had the intended consequences. Recalls are on the rise, and quality risk is accelerating as product complexity and change accelerate.
Some leading medical device manufacturers are ahead of the curve. They have already anticipated that shift, and implemented an infrastructure that focuses on proactive quality, with compliance being a natural byproduct of those efforts. They have invested in their product design and manufacturing processes, implementing systems that are connected and intelligent. We call such systems “closed loop,” meaning that the desired output of a process depends on the inputs, and feedback loops inform other parts of the process about the characteristics and results of that step. These systems start with R&D/ideation, support manufacturing operations and include post-market surveillance/obsolescence.