Since this is my first contribution, let me give you the intro - my name is Mike Andreas and I am a Senior Quality Engineer with RQS. My background, aside from 5 years in the medical imaging industry, includes mechanical engineering, configuration management, and a lot of pizza. As much as I would love to base my posts on the latter, I fear it may not be terribly relevant to this community. Bummer...

For this post, I want to discuss what is a burning question in my mind - why so many Cleveland area medical device manufacturers have had compliance challenges with the FDA. Some in the industry say that everyone gets "their turn" with the agency, and that over the last few years, it was simply "Cleveland's time". Now, please understand that I don't believe that this problem is specific to this region for some cryptic reason (although maybe the plights of the sports teams is rubbing off???); however, it IS interesting that the problem seems not to discriminate in the 216, 440, and 330 area codes. Without getting into specifics, most major device manufacturers have had to at least temporarily significantly redistribute their resources to respond to FDA obsersations within the last olympiad. From bringing in consultants to help with remediation to building long term cross-functional compliance program teams, the challenges have been significant and many.

Whether the root lies in the area of Management Responsibility as the FDA would probably say can be debated. My experience has shown me that the aforementioned management faction will contend that the (intended) ambiguity of the 21 CFR 820 regulations and the many possible interpretations lead manufacturers down a compliance road that isn't on FDA's map. To this end, the many guidance documents published by the agency certainly intend to reduce this ambiguity; however, substantial compliance has always been, and will be, a moving target. Factors at play are:

1. Current FDA focus: risk, usability, software validation, to name a few
2. Inspector focus: Seemingly depending on the inspector, "substantial compliance" means different things
3. Manufacturer's product line: Does the device have significant potential impacts to user/patient safety, or are claims of the device's function more relevant?

Many in the industry use the pendulum analogy to describe the nature of compliance. At the extremes, compliance rigor is either tightly or loosely enforced, with the nadir only a fleeting coordinate. Perhaps the Cleveland area medical device companies have simply had the (good or bad - you pick) fortune of seeing the right-most position of the pendulum. While ambiguity in regulation interpretation is debated, these companies would do well to have an internal locus of control on this issue; to have a mindset of commitment to not only substantial compliance but also continuous improvment, driven by sound financial objectives. In future posts, I intend to explore the impact that management has on FDA compliance, how it can integrate continuous improvement initiatives (Six Sigma, Lean) with the quality system, and the fundamental leadership required at all levels to see this commitment through. And I might talk about pizza a little bit too.

-RQS

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