By Daniel R. Matlis

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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 the FDA, I spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health (CDRH).

We are publishing the interview in a series of “Executive Perspective” articles covering our discussion on the Case for Quality Initiative.

In this article, Part I of the series, Mr. Silverman provides an overview of the Case for Quality Initiative and discusses the Agency’s drive for sustained conversations with industry to improve device quality.

Click play to listen to Part I of the interview

Read the interview below:

Matlis: Can you start by providing an overview of the Case for Quality Initiative?

Silverman: Absolutely. We began the Case for Quality initiative about two years ago. We launched it as a fact-based effort that drew from a close review of Agency data and feedback from both the Agency and Industry thought-leaders. Our analysis flagged manufacturing quality risks and showed that firms that managed those risks by driving quality organization-wide tend to be more productive, with fewer complaints and investigations per batch, and often have smaller quality units with lower quality-related costs than their competitors. In developing the Case for Quality, we made a number of findings about the overall state of medical device quality, as well as possible catalysts for improvement. For example, with respect to some of the barriers to quality, we learned that while the sophistication and complexity of medical devices has grown rapidly in recent years, the sophistication of device manufacturers’ quality systems has not necessarily kept pace. So if you look, for example, at issues like device software, software that powers devices and supports capabilities like interoperability among devices, those are very sophisticated technologies and the need to apply equally well-developed quality oversight practices is very present, but we have not necessarily seen that quality capability deployed among manufacturers that are using increasingly complex software in their devices.

From the Agency’s perspective, we heard from Industry, and we think that there is validity to this concern, that the emphasis on the Agency’s part is about compliance as an end-point rather than device quality as an end-point. While compliance as a baseline is an absolute expectation that we impose on device makers, in terms of meeting our mission to protect public health, we are much more interested in promoting device quality. To add a quick point, with that objective of quality in mind, the case for quality developed over time to be a mechanism to allow FDA to come together with stakeholders — which include Industry but also include payers for devices, users of devices, and healthcare providers - to talk about what quality practices are present in the device design and production space; what practices device manufacturers can undertake to both understand and communicate those practices; and how the Agency can operate with respect to device manufacturers in a way that supports quality design and manufacturing practices.

Matlis: As part of this initiative, FDA is driving sustained conversations with industry to improve device quality. Can you give us an update on these activities?

Silverman: Yes. For the Case for Quality Initiative to be successful, we need to have sustained, collaborative discussions with stakeholders, and that certainly includes industry, about what are the quality-connected practices that relate to the design and development of medical devices so that we can benefit from industry members understanding what quality looks like. And we can take actions as regulators that reinforce those quality practices. To date, our interactions with industry have primarily occurred in connection with the presentation and discussion of our Case for Quality Initiative at various meetings around the country, one example of which was the Advamed National Meeting in September. We have been very pleased with the feedback and level of engagement that we have received from industry and other stakeholders in relation to those kinds of presentations, but we are ready to move to the next level. And the next level is a venue in which we can come together on a regular, predictable basis with a known, consistent group of stakeholders to explore and identify topics and maintain the analysis of those topics until we feel that we are ready to move on to new topics. So, we are looking for a venue in which we can communicate with stakeholders, we know who the stakeholders are, we are coming to the table on a regular bases, and we know what we are going to be addressing when we get to the table. We do not have that venue, yet. But we are very focused on finding the right environment for those discussions.

Stay tuned to Part II of this “Executive Perspective” series, where Mr. Silverman discusses the expected benefits of Case for Quality Initiative for FDA and industry as well as the role metrics and analytics will play in support of the Case for Quality Initiative.