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

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."

Striking a balance, therefore, may not be so easy, but it's imperative to create an efficient system, according to the experts. The FDA has intensified its focus on CAPA, paying especially close attention to these processes during audits. It's all about prevention--not just on how a company responded to a problem, but also the steps the firm took to ensure it doesn't occur again.

"If an organization has a strong audit system coupled with a robust CAPA system that finds deviations early and facilitates prevention, and management is fully apprised of what's going on, that's a good quality system in and of itself," said Wilson.

The CAPA system's design clearly is instrumental in determining how well it will function over time. However, consulting firms reinforce to their clients that upper management's commitment to continuously monitoring the system and evaluating whether any changes need to be made is crucial for ongoing success.

"Sometimes it takes a real push to get someone to finish documenting items, and it takes management's commitment to enforce that," explained Judith Andrews, PhD, director, quality and compliance services for Medical Device Consultants, Inc. in North Attleboro, MA. "I think that's the biggest issue: to raise these things to a high enough level in management to ensure it gets taken care of. If you don't have that, it won't work no matter what. Management will set the tone for what's expected."

Time and again, consultants visit their clients and find that even the best quality departments have a hard time conveying the value of their work to upper management. All too often, they said, management only gets the message after a problem shows up during an audit and an expensive fix is needed. Unfortunately, it's difficult to place a dollar value on a system that's running smoothly.

ISO Certification Brings Booming Business

One effort companies are throwing their dollars toward is racking up ISO certifications, particularly ISO 13485, which is the international quality management standard for medical device designers and manufacturers.

Many domestic companies--small and large alike--have realized the value of gaining entry into new markets such as Europe, Japan and Canada. Although certification isn't required in the United States, if a company wants to get a CE mark in Europe or market a product to one of the aforementioned countries, it must be certified to ISO 13485.

Realizing the lucrative potential of these markets, OEMs and their outsourcing partners have been achieving certification in record numbers. According to the International Standards Organization's 2005 report on ISO certifications, US firms received 1,310 ISO 13485 certificates that year, up from 770 in 2004. (The world total was 5,065 in 2005, compared with 2,403 in 2004.)

The good news for companies looking to pursue this particular certification is that about 85% of the requirements overlap with the FDA's Quality System Regulation, Schwartz said. His firm often helps companies perform gap analyses to determine where differences exist so they can make their systems efficient enough to be certified. "Some quality managers have never been involved in an ISO certification--only FDA registrations. When you're reading a guidance document and then trying to interpret it, you will find that there are always many ways to implement the standards. Companies should understand that there is a lot more gray areas to compliance then they may be aware of," Schwartz explained.

As outsourcing continues to flourish in the United States, many OEMs are looking to ISO certifications as proof of a vendor's strength in its quality system--in fact, many OEMs won't work with an outsourcing partner who doesn't have this certification, experts said. Given that this is a competitive advantage, contract manufacturers and other suppliers are keeping up with ISO 13485.

"For contract manufacturers or other outsourcing partners, an ISO 13485 certification may provide an important differentiation from their competitors," Noblitt explained. "Given a choice, manufacturers will want to deal with outsourcing partners that have the competency and resources to implement and maintain a certified quality system. To obtain and maintain your certification requires not only a strong commitment to quality, but also periodic inspections by an outside agency. Certainly, an established, properly implemented quality system can also provide for an advantage of lower cost and less time for products and services to be delivered efficiently to their medical device manufacturer customers."

Quality experts also have found that the proliferation in recalls related to design issues has led many design firms to increase their own efforts towards compliance with various FDA regulations and international standards.

"We've worked with several design and software houses to help them comply with the standards," Andrews reported. "They want to be able to show customers that they understand design control. We often put in place design controls and risk analysis for them."

One of the most common problems she finds in examining operations in the med-tech industry--especially among startup ventures--is that the companies don't start documenting their designs early enough and then scramble later to fill in the blanks. "You need to start the process fairly early to get the documentation in place," Andrews said. "Many companies resort to retroactive design control, which is inefficient and reduces the benefit of the process." The good news, she added, is that companies are getting more sophisticated about design control.

Another quality standard that has been keeping consultants busy is ISO 14971, which pertains to risk management. The newest version of this standard (ISO 14971:2006) was just released in February, but understanding the impact of the revised standard on how risk analysis is conducted will take some time.

"There are substantial changes of substance, but there's a lot of clarification of what is expected after your risk analysis," Andrews said. For example, more emphasis is placed on medical device manufacturers in consideration of "acceptable risk" after controls are put in place. She noted that this version will strengthen the requirement for management to define risk and sign off on what is deemed "acceptable."

The FDA also has placed a much greater emphasis on risk management, and companies are taking notice. "We'll see more cooperation, more risk assessments at firms where they [regulatory bodies] will inspect firms based on their perceived compliance risk. That needs to be studied more and it needs to be done right," said Schuyler Ritter, senior vice president, business development for Beaufort Advisors.

The good news for companies dealing with both the FDA's Quality System Regulations and ISO requirements is that the Global Harmonization Task Force (GHTF) has been steadily working toward developing standards that would--for lack of a better word--harmonize audit standards and audit reporting requirements in the United States and abroad. These activities, when they come to fruition, will save companies valuable time and money ... and it's probably not too far off, according to one expert.

"I imagine that it won't be terribly long--within the next couple of years at most--that you will find adoption of these principles," said Niedelman. He should know: Prior to joining Quintiles last July, he spent 34 years working for the FDA and even served as a member of the steering committee for the GHTF.

The United States and Canada already are working in tandem on a pilot program in which each country's regulatory agency shares and exchanges inspectional information. In addition, in the FDA's proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 for fiscal years 2008 through 2012, the agency wrote, "We are proposing to permit device companies to voluntarily submit to FDA reports by third parties assessing conformance with an appropriate international quality systems standard, such as those set by the International Standards Organization. We would consider the information in these reports in setting our inspectional priorities."

As the FDA continues to face a shortage of resources (ie, personnel to perform audits), Niedelman said the agency realizes the importance of obtaining as much intelligence as possible from every resource possible.

"I think there's an eagerness by the FDA to work with their counterparts and to accept ISO reports as--at the very least--preliminary information about a firm, because having this information available is more reassuring than not having any information at all," Niedelman explained. "It would be ideal if industry would be able to get their product to market as quickly as possible and satisfy as many regulatory bodies at one time by harmonizing the different regulatory requirements."

The Value of Outside Expertise

With harmony still not complete, it's up to companies to figure out which standards they must satisfy to keep their business flourishing. A consultant can offer the objective perspective a company may need in navigating all the quality standards.

For example, just as many domestic companies seek help with gaining ISO certifications, the flip side is that foreign manufacturers coming to the United States need help with fulfilling FDA requirements. "Half of our business is international, helping clients negotiate with the FDA, making sure they have compliant cGMP systems, making sure they understand the regulations," Ritter said.

Even well established US-based companies aren't immune to feeling confounded by all the requirements needed to stay compliant and efficient. Noblitt said his company often is called in to perform compliance audits or gap assessments to figure out where the system is deviant or to help employees understand how quality impacts each individual and his or her area in the company.

"A compliance audit is helpful to fix the immediate problem, but unless employees understand the basis for the issue and the requirements, then compliance will not be maintained over the long haul," he said. "We help manufacturers solve these issues long term by providing in-house training that is specific to their issues and area of need."

Ritter of Beaufort Advisors doesn't expect a slowdown in business any time soon. After all, he said, "The last thing you want to do as a manufacturer is fail--that is, have a manufacturing line, facility or your business shut down--because of poor attention to quality."

Jennifer Whitney

COPYRIGHT 2007 Rodman Publishing
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Copyright 2007 Gale, Cengage Learning. All rights reserved.

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Title Annotation:QUALITY
Author:Whitney, Jennifer
Publication:Medical Product Outsourcing
Date:May 1, 2007
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