The “Case for Quality Initiative” is a strategic priority for the US Food and Drug Administration. To support this initiative, the agency is working to implement policies that go beyond compliance with regulations and provide an enhanced focus on the manufacturing quality.
To learn more about this strategic shift at FDA, I spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health.
We are publishing the interview in a series of articles covering our discussion on the Case for Quality Initiative.
In this article, Part II of the series, we discuss the expected benefits of Case for Quality Initiative for FDA and industry as well as the role metrics and analytics play in support of the Case for Quality Initiative.
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Read the interview below:
Matlis: What are the expected benefits of Case for Quality Initiative for FDA?
Silverman: First and most broadly, we are tasked with promoting and protecting public health. Creating an environment in which manufacturers are able to design and produce high-quality devices that best serve patient needs, that are reliable, and that perform in the manner in which they are intended to perform is an undertaking that is in service of 
patient health. And so we believe that this initiative is an effective mechanism to help meet our mission. Somewhat on a lower level, from a regulatory perspective, the nature of device manufacturing is changing. I talked earlier about the complexity of devices; we are increasingly seeing devices produced around the world with components sourced from around the world. And we are an Agency that has a set pool of resources and we want to apply those resources as efficiently as possible. If we are able to work with manufacturers to create a shared understanding of what quality design and production practices look like, manufacturers who want to lead the industry in terms of the quality of their products are able to do so. That means that we are able to direct resources away from those manufacturers in whom we have confidence to other manufacturers for whom we may have less confidence or more limited information. We are able to use our resources more strategically to accomplish broader, but also more effective surveillance.
Matlis: What are the expected benefits of this initiative for Industry?
Silverman: From industry’s perspective, I think that there are myriad benefits. We hear from industry that they are very interested in meeting the Agency’s expectations and producing high-quality products that serve their customer’s needs. By creating transparency around the Agency’s expectations, and predictability regard what it is that the Agency will look for when we are on-site evaluating a firm’s manufacturing operations, we allow manufacturers to focus on those operations that are tied to quality outcomes and to be less concerned, for example, about variable interpretations and variable review of their operations by FDA personnel when they are on-site conducting inspections.
Matlis: Will metrics and analytics play a role in support of the Case for Quality Initiative?
Silverman: I would say that analytics and metrics play an important role in two respects. First of all, they play an important role in terms of our ability to provide useful information to manufacturers and other stakeholders, and we can provide that information in the aggregate. We receive, for example, information on an ongoing basis from manufacturers about recalls that they are undertaking. And we can compile that information and make it available, likely in a de-identified manner, to shed light on issues associated with particular products or classes of products that manufacturers can evaluate as they attempt to improve their own products over time.
Likewise, leaving products or product categories aside, we conduct quality inspections of thousands of manufacturers inside and outside of the United States each year and we have the ability to aggregate the outcomes of those inspections to talk about particular quality practices that we see where the Agency’s expectations and manufacturer practices may be misaligned. And that also is a useful resource to manufacturers, both as they develop and as they review their own quality operations.
The other side of the equation is evaluating the impact of the Case for Quality Initiative, and that is an area in which metrics are equally important. Recall that we are undertaking this effort because we are trying to enhance the overall quality of medical devices and we have invested quite some time in discussions about how we can develop metrics that over time track the impact of this initiative. And we hope to demonstrate that using this initiative as a tool that compliments other regulatory tools we have available to us is an efficient and effective application of the Agency’s limited resources.
In Part I of the “Executive Perspective” series, Mr. Silverman provides an overview of the Case for Quality Initiative, driving sustained conversations with industry to improve device quality. See Part I of the “Executive Perspective” series here
Stay tuned to Part III of this series, where Mr. Silverman will discusses how firms can demonstrate their commitment to quality to the Agency. We also discuss FDA’s shift from “lagging” to “leading indicators,” and outline next steps for Case for Quality Initiative.