Life-Science Panorama

A Journal for Industry Executives

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April 14th, 2014

Is Compliance an Obstacle to Quality?

By: Daniel R Matlis

Can you distribute poor quality products while complying with regulatory requirements?  Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.
obstacle

Regulatory Compliance and Quality are NOT the same.  In fact, the industry’s hyper-focus on compliance is often an obstacle to quality.

This distinction seems to be the renewed focus at the FDA, from the Commissioner on down…

As Commissioner Margaret Hamburg, M.D. states:

“In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world…”

“…we at the FDA will also continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product.”

“All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.”

FDA is changing its stance on manufacturing. It’s shifting from a primary focus on regulatory compliance to driving the industry beyond compliance by focusing on product quality.

Howard Sklamberg, J.D., Director, Office of Compliance at the FDA’s Center for Drug Evaluation and Research, was instrumental in establishing the FDA’s new Office of Pharmaceutical Quality.

In recent remarks, Mr. Sklamberg stated:

“We don’t have the capacity to all the time to be in every firm.  But we want to encourage those firms to prioritize quality and encourage their boardrooms and their pocketbooks because quality cost money,”

“We want to target our limited inspection resources to the firms that we think are ones that pose the greatest quality risk.”

The Agency’s push toward improved manufacturing quality is evident in the FDA’s “Case for Quality Initiative”. Through this initiative, the Agency is working to implement policies which drive industry to go beyond compliance with regulations and provide an enhanced focus on manufacturing quality.

According to Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health:

“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”

The Case for Quality Initiative is based on an analysis of data that clearly shows firms that managed risks by driving quality across the organization tend to be more productive, with fewer complaints and investigations per batch.  In addition, these firms often have smaller quality units with lower quality-related costs than their competitors.

In today’s complex manufacturing processes, Life Science executives must balance a multitude of divergent interests and concerns.  At the end of the day, the safety, quality, efficacy and/or effectiveness of each product must take overriding precedent.

The question Life Science Executives should ponder is:  How can we improve manufacturing and product quality to ensure that our company does NOT have to execute regulatory compliant field actions?

It is my firm conviction that regulatory compliance must be the by-product of well-designed and executed processes aimed at producing the highest quality product, not their drivers!!!

Ellyn McMullin contributed to this article

March 19th, 2014

Show FDA Your Commitment to Quality

By Daniel R. Matlis

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.
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In this, the final article of this series, Mr. Silverman discusses how firms can demonstrate to the Agency their commitment to quality. We also discuss FDA’s shift from “lagging” to “leading indicators,” and outline next steps for Case for Quality Initiative.

Click play to listen to the interview

Read the interview below:

Matlis: FDA seems to be shifting its focus from the “lagging indicators”, like recalls and other adverse events, to “leading indicators” related to quality and manufacturing to improve product quality and safety. Is that the case, and if so, can you elaborate on this transition?

silverman-photo-200pxSilverman: I think that is definitively the case. We will never get away from lagging indicators. And lagging indicators have value; they serve an important role. Being aware of the causes of recalls, trends with respect to recalls, and the results of inspections, are critical mechanisms to understand and react to problems that may have developed in the marketplace. But that is not the only approach that we can or should apply. It is equally important to understand what are the predictors of quality outcomes - what are the practices that manufacturers undertake when they are implementing quality correctly, which create a high likelihood of a quality product that serves its intended use.

Our understanding of what those practices are is evolving. As I mentioned before, part of the purpose of our pilot program around implantable devices that contain batteries is to allow us to engage in dialogue with manufacturers about what are those leading indicators of quality and to apply the learnings from those conversations, both to our internal operations and, we hope, to operation that manufacturers undertake. But this is a process that is still in its relatively early days and I think that our ability to identify and incorporate leading indicators is very much a work in progress.

Matlis: How can firms demonstrate to the Agency their commitment to quality?

Silverman: We have heard very positive reaction from industry about the Case for Quality Initiative. Both the larger idea that the Agency and industry member should be able to work together collaboratively to identify Quality Practices and more specific reactions to some of the proposals that we have developed, like differentiating manufacturers based on their overall quality capability and interacting with them on the basis of that differentiated assessment.

To be successful, there has to be strong, ongoing collaboration between the Agency and stakeholders. And so what are we are looking for, and what we need in the near-term, is manufacturers finding ways to come together to interact with the Agency around quality-related topics. And those interactions may take the form of the venue that I described earlier with dialogue around quality-related topics or those interactions that can occur entirely independent from FDA with the output of those interactions being brought to the Agency for its consideration. There is nothing that prevents individual manufacturers or groups of manufacturers from undertaking on their own analyses of quality-related practices or mechanisms for advancing quality and bringing to the Agency the results of those reviews for our information and for incorporation into this larger quality-based effort.

Matlis: What are some of the next steps for Case for Quality Initiative?

Silverman: We are going to continue our work on the pilot program that relates to implantable battery-containing devices. We are going to use the learnings from that pilot program to expand our interactions with industry and other stakeholders around quality. We are going to work diligently to identify and establish a forum in which we can have continuing discussions with a defined set of stakeholders around identified quality-related topics in order to develop our understanding of and actions around quality-related design and manufacturing. We are going to look for mechanisms to organize and present quality-related data in a way that informs the dialogue between FDA and manufacturers around quality and that supports manufacturers’ individual quality-related efforts, whether by making available data for discussion between the Agency and stakeholders, or making that data available for analyses that are undertaken independently by manufacturers or associations on behalf of manufacturers.

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.

In 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.

February 21st, 2014

FDA Official Addresses the Benefits of Manufacturing Quality for FDA and Industry

By Daniel R. Matlis

silverman-photo-200px

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.

Click play to listen to Part I of the interview

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.

February 6th, 2014

What Keeps Terumo Executives Up at Night?

By Daniel R. Matlis

In this exclusive interview with Terumo Cardiovascular Group Executives, Mark Lincoln and Chris Zarecki address key issues and trends impacting the Medical Technology industry in particular as well as the broader Life-Sciences industry.

Find out which industry trends keep Terumo Executives up at night in this three part “Executive Vision” interview series addressing:

  • Managing price and cost pressures
  • Dealing with the Excise tax
  • Adding value beyond quality and compliance
  • Tapping Emerging Markets for growth
  • Managing Med-Tech globalization, outsourcing and offshoring
  • Complying with increasing global regulatory pressures
  • Preparing for FDA’s Risk-Based Approach

Click on the image to see the interviews (requires sponsor registration)

terumo-interview-series-banner

January 28th, 2014

2014 Life-Science Global Trends Forecast

By Axendia Staff

This is the time of the year when we are asked: What are the trends that will impact the industry in 2014?

Based on discussions with Industry Executives, Government Regulators, Technology Providers and our primary research, we are releasing Axendia’s 2014 Life-Science Global Trends Forecast

We identified the following as key areas impacting the industry in 2014:

  • Regulatory Environment → Focus on Quality, not only Compliance
  • Emerging Markets → Continued growth in emerging markets
  • Brand Protection → Protect brand equity
  • Supply Chain → Improve supply chain resilience
  • Smart-Sourcing → Focus on value instead of cost

See the infographic for details.

2014-forecast-infographic

January 14th, 2014

FDA’s Steve Silverman on the Case for Quality Initiative -Part I

By Daniel R. Matlis

silverman-photo-200px

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.

December 18th, 2013

2013 Life-Science Global Trends Forecast Review

By Daniel R. Matlis

“Past Performance is No Guarantee of Future Results, “goes the disclaimer; but it is a good practice to look back and evaluate past performance for accuracy.

At the beginning of the year, we issued our “Life-Science Global Trends Forecast” where we identified the following as key areas impacting the industry in 2013:

  1. Regulatory Environment → Tougher global regulatory environment
  2. Emerging Markets → Growth in emerging markets
  3. Brand & IP Protection → Protecting brand equity and intellectual property
  4. Supply Chain → Need for supply chain resilience
  5. Smart-Sourcing → Focus on value instead of cost

Looking back at 2013, I think few would disagree that our forecast was On-Target.

year-in-review-forecast-infographic-final

December 9th, 2013

FDA Driving Industry “Beyond Compliance” to Promote Manufacturing Quality

By Daniel R. Matlis

ADVAMED 2013 lived up to its reputation as “the leading MedTech conference.” One highlight of the event for me was the panel: “Case for Quality FDA & Industry Progress Update”

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 manufacturing quality.

This panel examined the results of the FDA initiated Case for Quality. Top FDA and Industry leaders discussed the impact of the recent guidances on this initiative and FDA efforts at transparency. FDA representatives discussed how this program is being rolled out in the field offices and what industry should expect going forward.

The panel was moderated by Judith Meritz, Associate General Counsel, Covidien
Panelists included:

  • Donna Godward, Chief Quality Officer, MD&D, Johnson & Johnson Corporation
  • Joseph Sapiente, VP, Global Quality & Regulatory Operations, Covidien
  • Steven Silverman, Director, CDRH Office of Compliance, FDA
  • Steven Solomon, DVM, MPH, Acting Deputy Associate Commissioner for Regulatory Affairs, FDA/Office of Regulatory Affairs

silverman-photo-200px
To gain a deeper understanding about this strategic shift at the FDA, I recently spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health.

According to Mr. Silverman, FDA launched this initiative as a fact-based effort that drew from a close review of Agency data and feedback from both the Agency and Industry thought-leaders. The Agency’s analysis flagged manufacturing quality risks as a top issue. It showed that firms that managed those risks by driving quality across the organization 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.

Beginning in January, we will publish a series of “Executive Perspective” articles covering our discussion on the Case for Quality Initiative.

  • In Part I of the series, Mr. Silverman provides an overview of the Case for Quality Initiative, and discusses the Agencies drive for sustained conversations with industry to improve device quality.
  • In Part II, we discuss the expected benefits of Case for Quality Initiative for FDA and industry as well as the role metrics and analytics play in supporting the Case for Quality Initiative.
  • In Part III article of this series, Mr. Silverman discusses how firms can demonstrate to the Agency their commitment to quality. We also discuss FDA’s shift from “lagging” to “leading indicators,” and outline next steps for Case for Quality Initiative.

November 5th, 2013

Can You Succeed Without Commitment?

So why are most Med-Tech companies still trying?

In part three of the whitepaper series, we address the perceived lack of commitment in support of process improvement initiatives.

The research data clearly shows a wide gap in the levels of commitment across functional areas in Med-Tech organization.

  • Less than half of respondents (48%) perceive full Executive Management commitment in support of Process Improvement initiatives
  • Only 37% of respondents perceive full Shop Floor Personnel commitment in support of Process Improvement initiatives

We also reveal the challenges process improvement champions face implementing initiatives. Lastly, we discuss the industry’s firefighting mentality, a key barrier to process improvement initiatives.

Don’t have time to read the whitepaper?

Watch the accompanying One-Minute Briefing video.

To request a copy of these white papers or view the other 1 -Minute Briefings in the series, please visit the research home page at:

http://pages.camstar.com/axendia-chasing-defects

October 22nd, 2013

Are you Improving Processes or Merely Chasing Defects?

by Axendia Staff

While Medical Technology companies claim to embrace process improvement initiatives, most are chasing defect, according to our research shows

In this second installment in the whitepaper series, we discuss industry’s reactive nature and the need to shift to a proactive stance.

Defects are the primary driver for implementing process improvement initiatives.

  • Seventy-six percent of respondents cited reducing defects as a driver for implementing Process Improvement initiatives
  • Eighty-eight percent of respondents cited defects as the top form of Waste/Muda Impacting their organization

We challenge this focus on defects and discuss its impact on process improvement and the ability to implement real change within the manufacturing process.

Don’t have time to read the whitepaper?

Watch the accompanying One-Minute Briefing video.

To request a copy of these white papers or view the other 1 -Minute Briefings in the series, please visit the research home page at:

http://pages.camstar.com/axendia-chasing-defects