The Century of Quality: quality experts find no shortage of work thanks to an ever-increasing number of regulations and certifications

Medical Product Outsourcing, May, 2007 by Jennifer Whitney

In 1999, quality guru Joseph M. Juran predicted that historians someday would characterize the 21st century as the Century of Quality. To be worthy of such a legacy, however, Juran said more companies would need to "scale up" efforts related to their quality systems if they wanted to attain such a level of distinction.

"Right now, the companies that have reached the state of being quality leaders represent a very small part of the economy," he told Quality Digest magazine at the time. "People are too reluctant to tackle those activities engaged in by the leaders. They are afraid: 'For us, that's unknown territory. We're not sure where it will lead us.'"

Although fear can be a paralyzing influence, the medical device industry has not necessarily succumbed to it. In fact, quality has been an increasing focus at medical device trade shows and conferences, and the industry seems more engaged in the topic than ever before.

This dedication to quality is with good reason. Although the number of FDA warning letters has declined over the years--a report released last year showed the number of warning letters to the device industry dropped 66% between 2000 and 2005--the agency appears to be taking a harder line more recently, thanks to highly publicized recalls with defibrillators and other medical products. The recent political power shift that put Democrats back in control of Congress also may have an impact. In April, the FDA's raid at Union, NJ-based Shelhigh resulted in the seizure of all the company's products, including pediatric heart valves (for more information, see Top of the News on page 12).

"Congress feels that the FDA has not been taking a tough enough stance on the industry in the past. More warning letters and legal actions are in the future for the industry. The FDA has to make the most of its budget restraints and has to make the most of its legal actions to show the industry it means business," predicted Alan Schwartz, executive vice president of MDI Consultants in Great Neck, NY.

Realizing the unarguable importance of having a top-notch quality system, many firms are opting not to rest on their own laurels and, instead, are turning to outside expertise for help with fulfilling their quality journey.

The reason for consultations with quality experts vary, but some of the more common reasons medical device firms seek outside expertise are that:

* An extra resource is needed when quality departments are swamped

* An objective and independent assessment is desired to spot potential problems before they get out of hand

* Assistance is needed in preparing for an FDA audit--or to deal with the aftermath of one that revealed certain problems

* On-site training is desired

* Audits need to be performed on outsourcing partners' facilities

* Quality staff--or even startups with no staff--lack expertise with newer certifications or regulations

* New quality managers have so many duties that they can't necessarily identify and create action plans for every single facet of the organization's quality system

Whatever the need, consultants have found that their customers are more focused on prevention today, rather than simply reacting to problems after they surface.

"Companies want to be compliant," said John R. Wilson Jr., PhD, senior vice president, clinical operations for Norfolk, VA-based Beaufort Advisors LLC. "Word got on the street some time ago that it's optimal to get your quality system in place prior to a regulatory problem. The pendulum is shifting toward prevention, and our forte is keeping people out of trouble."

As the FDA strengthens its focus on post-market surveillance with its Postmarket Transformation Initiative, proactive companies will likely become hyper-vigilant about how their devices are performing in the market.

"In the past, there has been a lot of focus by FDA on the pre-market aspects of the device industry. As post-market safety is becoming an increasing concern to everyone, risk assessment, product vigilance, trend analysis, complaint handling--all post-market principles-will play increasing roles as people become more concerned about how these products are working and performing in the market," said Steve Niedelman, executive vice president of Quintiles Consulting, based in Rockville, MD. "Companies need to pay close attention to post-market issues, as they will likely continue to surface and result in increased scrutiny by FDA."

CAPA in Focus

In line with this vigilance, lingering questions regarding corrective and preventive action (CAPA) systems have led many companies to call on outside expertise. These systems can be one of the more confounding operations within a medical device company.

Brent Noblitt, co-founder and senior partner of Irvine, CA-based Noblitt & Rueland, offered this explanation: "CAPA system issues are very broad and can be found anywhere between--and including--the two extremes of not defining and capturing all the activities that should fall under a CAPA system, to the other extreme of placing everything in a CAPA system and bogging down the system."