After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality

The med device industry and regulators continue working 
to promote practices that result in high-quality 
devices by focusing on manufacturing quality.
Five years ago we looked at the road blocks to improving product quality.  In the intervening years there has been little change by most Med-Tech Companies.  The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA.  The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and an integrated approached to product quality can help Med-Tech organizations improve product quality, compliance and the bottom line.
In 2009, we issued a research alert titled “Compliance-First Approach and Quality Silos are Obstacles to Improving Product Quality.”   Five years later industry and regulators are still working to promote practices that result in high-quality devices by focusing on manufacturing quality. In fact, our recent research on the state of process improvement initiatives points to the fact that the industry’s hyper-focus on compliance may in fact be an obstacle to improving product quality.
Improving product quality seems to be the renewed focus at the FDA, from the Commissioner on down.   “In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world…” commented FDA Commissioner Margaret Hamburg, M.D.  “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,” she added.

The Agency’s push towards 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.

This article is related to the Whitepaper:
Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
 To get the full details, please download your free copy.

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 goals are to provide stakeholders with understandable and objective information about medical device quality; facilitate medical device innovation and quality through data and analysis on device performance; and foster strategies that focus stakeholder interactions on device quality.
In today’s complex manufacturing processes, Med-Tech 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.
“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,” commented Steve Silverman, Director, Office of Compliance, FDA CDRH.

The data supports Mr. Silverman’s assertion.  According to FDA figures, the number of medical device recalls has increased by 97 percent from FY 2003 to FY 2012.  As many
as 400 recalls each year could be prevented if manufacturers addressed issues before product is shipped to the field.    
While the focus of Process Improvement (PI) initiatives should be on enhancing product quality, our research shows that most Med-Tech companies are still chasing defects. This in spite of Agency research showing that firms that drive 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.
While Med-Tech executives agree that process improvement is key to their survival, the reality of their day-to-day operations belies that belief.   Because of disjointed approaches to PI, the benefits have eluded most.  Changing the corporate culture cannot be accomplished overnight or by memo.  There needs to be a cohesive plan and a long-term commitment from the shop floor to the executive suite. 
At the June 2014  FDA Case for Quality Executive Forum, a number of leading medical device companies shared the results of their focus on product quality.
After receiving a Corporate Warning letter in 2006, Boston Scientific (BSC) went through a culture transformation with strong executive leadership and a focus on investing in prevention and product quality, which improved quality performance.
  • BSC revised its quality policy and shifted its culture to focus on product quality, where everyone owns quality.
  • BSC implemented a redesigned, globally standardized quality system and a new internal mindset and philosophy to focus on the proper execution of continuous improvement
As a result,
  • BSC saw a steady decrease in Field Actions:  from 66 in 2005 to 16 in 2013
  • BSC saw strong FDA Inspection results, one 483 observation out of 16 inspections in 2013
In 2011, Terumo Cardiovascular Systems entered into a consent decree. This event positively impacted its quality improvement journey.  Since Terumo’s consent decree was focused on quality system issues, the firm leveraged its momentum to implement technology that would provide a closed-loop system and become a competitive advantage, with the goal to continue to improve product quality.
As a result, Terumo’s quality system implementation realized business value from its investment in prevention: 
  •  6% - 10% increase in productivity 
  •  41% reduction in production NCRs 
  •  58% reduction in overall complaints 
  •  65% reduction in workmanship complaints 
  •  100% reduction in documentation errors 
While forward thinking companies have embraced and reaped the rewards of Process Improvement initiatives, our research shows that little improvement has been made by the industry as a whole.
About Axendia 
Axendia, Inc. is a leading trusted advisor to the Life-Science and Healthcare industries.  We provide trusted counsel to industry stakeholders on Business, Regulatory and Technology issues.
For more information, visit  or contact us at 
Read Axendia’s blog, Life-Science Panorama, at  
Follow us on Twitter at and LinkedIn at
"This article was originally published in Life-Science Panorama, a Journal for Industry executives covering business, technology and regulatory trends"

Copyright © 2015 Axendia, Inc.  All rights reserved. Reprinted with permission.

Daniel R. Matlis is Founder and President of Axendia, a firm providing trusted advice to Life-Science and Healthcare Executives on Business, Technology and Regulatory issues.

Dan has over 24 years of experience in the Industry spanning the entire value chain. He has been involved in projects covering R&D, Commercial Operations, Regulatory Compliance, Business Development and Information Technology.
Dan is the editor of Life-Science Panorama, a Publication covering the Business, Regulatory and Technology issues facing Industry Executives.He is a frequent lecturer at Industry events and has published numerous research reports and articles on key issues facing the Life-Sciences and Healthcare industries.

Dan holds a BS in Electrical Engineering from Polytechnic University in NY and a MS in Management from the New Jersey Institute of Technology.