The Quest for Quality
Good quality systems can help medical device firms increase their productivity and profit.
Michael Barbella, Managing Editor
“Quality is everyone’s responsibility.”
— W. Edwards Deming
W. Edwards Deming never thought that his work would bring him recognition. Once, when he was asked how he’d like to be remembered, he replied, “I probably won’t be remembered.” Then he paused and added, “Well, maybe…as someone who spent his life trying to keep America from committing suicide.”
Those who recognize Deming’s name remember him not for his role in saving America from itself (that is a matter of debate), but for his work in helping corporate America understand the true value of total quality management.
“Folklore has it that quality and production are incompatible: that you cannot have both,” Deming wrote in “Out of the Crisis,” a 1982 book that outlines a way to improve manufacturing through better quality
Medical device manufacturers say it is nearly impossible to define the word “quality.” Industry experts describe is as “a conformance to requirements,” but they tend to disagree over the source of the requirements.
Achieving quality was a problem for post-World War II Japan until Deming arrived in the country in 1950 to share his quality management theory with business leaders. Deming’s theory was a simple yet unconventional one: Most product defects are caused by management shortcomings rather than careless workers. He also believed that companies should give workers the proper tools to do their jobs and harness the efforts of willing employees to do things correctly the first time. These basic principles, Deming contended, are the key to improving quality.
To the casual observer, Deming’s philosophy might seem like nothing more than common sense. Most businesses, for example, provide their employees with the proper tools to do their jobs, and few would tolerate incompetence from workers. There’s nothing revolutionary about those principles.
Nevertheless, Deming’s theory works. Japan followed his principles and dramatically improved the quality of the products it shipped overseas. “Made in Japan” product labels went from being an embarrassment in the early 1950s to a sure sign of quality by the late 1970s and early 1980s.
Deming’s theory was virtually ignored in the United States until 1980, after NBC broadcast a documentary titled, “If Japan Can, Why Can’t We?”Business leaders credit the broadcast with igniting the quality renaissance that swept the nation in the 1980s.
The Ford Motor Company used Deming’s quality principles to stem four years of losses and return the company to profit. By 1986, after instituting changes that were based on Deming’s beliefs, Ford’s earnings exceeded those of arch rival General Motors for the first time since the 1920s.
Over the last two decades, Deming’s quality management principles have helped Ford and thousands of other companies achieve greater productivity and increase market share. Many of those companies were medical device firms, which constantly are in pursuit of better quality systems.
“The [medical device] industry is always looking at quality,” said Alan P. Schwartz, executive vice president of mdi Consultants Inc., a firm in Great Neck, N.Y., that provides quality assurance, regulatory compliance and clinical services to the medical device, pharmaceutical and food industries. “It’s always on the minds of [device] manufacturers.”
The concept of quality is a double-edged sword. While it can easily be measured and, to a certain extent, quantified, quality is still nearly impossible to define. Industry experts describe quality as “a conformance to requirements,” but they tend to disagree over the source of the requirements.
“Really, what is the definition of quality?” Schwartz asked. “Your definition of quality and mine might be different. And, what is the FDA’s definition of quality? The FDA had defined quality as, ‘the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.’ But, in realty to be a successful manufacture, quality is actually defined by the perception of the user.”
Maybe so, but most medical device firms are governed by regulations handed down by the U.S. Food and Drug Administration (FDA), Global Harmonization Task Force (GHTF), and the International Organization for Standardization (ISO).
The FDA’s Quality Regulation and ISO 13485
The Quality System regulation, published by the FDA as a final rule in October 1996, revised a GMP (Good Manufacturing Practices) directive drafted in 1978. That directive specified general requirements in areas of concern that applied to all medical device manufacturers, as well as additional requirements for high-risk devices (referred to as “critical devices” in the language of the directive). This two-tiered approach, according to the Association for the Advancement of Medical Instrumentation (AAMI), was intended to prevent excessive regulation of the medical device industry.
Changes incorporated into the 1996 Quality System regulation include new requirements about the design, purchasing, and servicing of medical devices. The regulation also clarifies the requirements for process validation, product change control, and the collection and evaluation of quality data. Though it eliminates the term “critical device” (from the GMP directive), the regulation still allows manufacturers the flexibility to determine the amount or degree of action necessary, commensurate with the risk associated with the finished device, according to the AAMI.
As part of the revision, the FDA harmonized the Quality System regulation with ISO 9001 and 13485 standards for medical device manufacturers. Achieving ISO 13485 certification does not fulfill the requirements of the FDA or foreign regulators; it only serves as a framework that companies can use to build a quality management system based upon various regulatory and customer requirements, consultants said.ISO 13485 is a stand-alone document but is generally harmonized with the ISO 9001 standard. And though it is based on ISO 9001, the ISO 13485 document shifts its counterpart’s emphasis on continual quality improvement and customer satisfaction to other areas: meeting regulatory and customer requirements, risk management and maintaining safe design processes, manufacturing processes and the distribution of medical devices.
“The push for quality [in medical devices] has become much more intense in the last 10 to 20 years,” said Brent K. Noblitt, co-founder and senior partner
of Noblitt & Rueland, a medical device consulting firm based in Irvine, Calif. “To sell international now, many countries worldwide require ISO 13485 certification as the medical device manufacturing quality standard.”
And more countries are expected to do so in the future. According to the most recent survey by ISO, the number of countries that recognize 13485 certification jumped 62 percent between 2006 and 2007. There were a total of 12,985 ISO 13485 registrations across 84 countries in 2007, with about 16.8 percent of those registrations (2,186) issued in the United States, ISO’s survey showed. By comparison, only 3 percent to 4 percent of all ISO 9001 and ISO 14001 registrations were issued to American companies.
The total number of ISO 13485 certifications issued worldwide in 2007 more than doubled compared with 2005, when 5,065 registrations were issued across 67 countries. Since 2004, the number of ISO 13485 registrations have increased more than six-fold (2,403 registrations were reported in 2004) and the number of countries recognizing the certification have increased 52.7 percent, ISO’s survey found.
The sharp increase in the number of ISO certification activity in 2007 clearly demonstrates that the organization’s standards have become “essential tools of the world economy,” the survey concluded.
Such essential tools are helpful to medical device companies that have global operations. Industry experts told Medical Product Outsourcing that firms with overseas facilities must achieve ISO 13485 and ISO 9000 certifications to stay competitive. These standards can help companies gain an international recognition of compliance with the FDA’s Quality System regulations and facilitate global business as well as attain a more cost-efficient, stable manufacturing process.
“Most other countries have a reliance on certification to ISO 13485 and/or in combination with their own regulations, such as Canada’s medical device regulations,” Noblitt said. “Companies must carefully decide on their desired distribution strategy, overlay it with their regulatory strategy, and understand the regulations of each country they want to sell in.”
Obviously, achieving ISO certification is good for business. But it may not be the best way for companies to ensure their products comply with the industry’s top quality standards, some consultants said. One expert claimed that ISO certifications merely allow companies to satisfy customers, not improve the quality of their products or manufacturing processes. “ISO is nothing more than a standard of quality companies use to provide customers with a level of satisfaction,” the expert said. “There’s a big difference between that and making sure your product meets [quality] specifications.”
Medical device firms that want to be sure their product meets quality specifications should implement a methodology called Failure Modes and Effects Analysis (FMEA), industry experts contend.
This tactic—used sparingly, if at all by most device companies—analyzes potential reliability problems early in the product development cycle and corrects them. FMEA is used to identify potential failure modes, determine their effect on the product’s performance, and come up with ways to prevent the failures. FMEA is generally more challenging than other types of evaluations, experts said, because the people involved in the assessment must anticipate the kinds of problems that can plague a product.
Consistent use of this kind of product evaluation enables engineers to design out failures and produce reliable, safe goods that are valued by consumers. FMEAs also help development teams gather historical information about the product that can be used for future updates.
Despite its effectiveness in weeding out potential problems and improving the overall quality of products, the FMEA is not used much by companies, quality experts said. Reasons for its underutilization include a lack of understanding about the process, and the time it takes to properly analyze a product for potential pitfalls.
"FMEA is a very valuable tool but many companies are not using it, or if they are using it, they are not getting their full value from its use. For example, some companies perform an FMEA because they are just trying to meet a requirement for risk management and then they stick it on a shelf and never refer to it again,” noted Kristen Grumet, Director of medical device quality systems and validation for Quintiles, a Durham, N.C.-based firm that conducts clinical trials and market research for drug manufacturers.
“For an FMEA to be really effective, it needs to be a living document,” she continued. “You start out the FMEA process with a baseline knowledge of your product and processes and you use that information to make decisions about the various hazards that can occur and the mitigating factors that must be put in place to prevent their occurrence, but the FMEA needs to be updated as more quality data about the product is obtained over time.The upfront effort needed to develop a comprehensive and robust FMEA is time consuming and resource-intensive since it takes a cross-functional group of people who are knowledgeable about the product to conduct the evaluations, and then to maintain the FMEA and keep it living and current also takes time and diligence. But in my opinion, the value that can be obtained from an FMEA, such as truly understanding your product and mitigating its risks, makes the effort definitely worth it.”
Who is Responsible for Quality?
Most medical device manufacturers out-source part of the product development process, relying on third-party suppliers for their raw materials, parts, subassemblies and, in some cases, original equipment. These suppliers (not unlike the manufacturers they work with) can be located anywhere—locally, on the opposite end of the continent, or on the other side of the world.
Regardless of where the supplier is located, device manufacturers must establish efficient supplier control programs to assure the quality of materials or services used to make the finished product. Though manufacturers have become adept at weeding out inferior materials or services from suppliers, some still slip by the quality control process and enter the consumer market. When that happens, the FDA might issue a device recall (depending on the severity of the problem with the compromised product) and force companies to re-examine their quality control systems.
Stryker Corp. was forced to re-examine its quality control system last year after two voluntary recalls of its products. The first occurred in January 2008 and affected two Trident hip implant cups; company executives were concerned about “manufacturing residuals” potentially contaminating the parts.
In October, Stryker pulled 26,000 of its Cordless Driver III Hand Pieces off themarket. According to a safety notice posted on the Internet, the surgical tool could potentially “continually run” even when the trigger was not depressed.
Though it quickly resolved the issue and the surgical tool resumed shipping, Stryker executives used the recall as a springboard to improve its quality systems.
“What we realize is we’ve got a lot of good quality product,” Stephen MacMillan, Stryker’s president and CEO, said last fall. “Be we haven’t had the compliance systems all the way through the company as rigorous as we would like.”
That is about to change. Stryker is spending at least $50 million through next year to standardize quality throughout its 12 divisions and across its supply base. Katherine A. Owen, vice president of strategy and investor relations for the $6 billion firm, said Stryker will spend between $60 million and $90 million this year on compliance efforts, including validating its vendors, stepping up facility inspections, and monitoring key quality data. The company, she noted, also is introducing a more formal quality system that sets minimum, consistent standards at all company locations in areas such as compliance investigation, design controls for new product development, and production processes.
With its profits and reputation in the industry at stake, Stryker wisely assumed responsibility for improving its quality systems. In a way, it had no choice: The FDA sent the company two warning letters about conditions at two facilities that manufacture hip implants, and it threatened to penalize the company if conditions did not improve.
Outsourcing partners and medical device suppliers are rarely in the FDA’s crosshairs for quality systems. Since most of them are not registered medical device manufacturers, they are not subject to FDA inspections, and therefore, cannot be held responsible by the federal government for their lack of quality programs. Also, many outsourcing companies serve various industries and may not want to invest the time and money to comply with the FDA’s requirements, industry experts noted.
Thus, OEMs are left holding the bag when supplier quality is questionable.
“From a regulator’s point of view, the medical device organization is ultimately responsible for the quality of their products,” explained Ron Koronkowski, director of quality assurance for Aptus Endosystems Inc., a privately held company that develops minimally-invasive endograft devices (used to treat abdominal aortic aneurysms). “The requirements must be fulfilled and satisfied.”
Suppliers, however, are not completely off the hook. Many suppliers, particularly those that partner with OEMs, have had to obtain ISO 13485 certification in recent years to stay competitive in the industry and please their outsourcing cohorts.
“It’s a fact of life if you are a manufacturer, you are expected to control your supply chain,” said Dr. Judy Andrews, director of quality and compliance services for MDCI, a full-service contract research organization and consulting firm based in North Attleboro, Mass. “It’s also a fact of life that if you are a supplier to a large company, you are expected to comply with quality system standards and regulations. Many large companies have departments whose primary function is to audit subcontractors to ensure the quality of their products.”
Suppliers that escape the audit process still may be subject to the regulatory whims of the FDA through the quality requirements of their outsourcing partner. For example, the FDA has kept a close eye on supplier controls lately, particularly during the evaluation of manufacturers’ process and purchasing controls. As a result, device manufacturers have been forced to look at these controls more critically, quality consultants said.
“Purchasing controls is an area in which manufacturers can expect additional emphasis during inspections and guidance by the FDA,” Noblitt noted. “Purchasing controls need to be looked at more critically as part of a company’s overall risk management process. No longer should a company simply buy widgets based only on price and quantity. Now, device manufacturers need to look at how their vendors’ quality systems will coordinate and communicate with their own and write that into their purchasing agreement.”
Change Coming to the FDA
The last six months have been challenging ones for the FDA. The agency has had to contend with a peanut butter contamination and recall late last year, and watchdog groups (as well as frustrated scientists) accusing it of scaling back federal quality regulations at laboratories that develop medical devices.
In February, the Project on Government Oversight claimed theFDA dramatically reduced inspections of “good laboratory practices” at facilities that conduct early testing of medical devices. A report released by the group said such inspections declined from 33 in 2005, to seven in 2007, to just one last year. The report also said that no inspections are planned for this year.
The FDA argued that it could make better use of its scarce resources—and still protect the public—by focusing its enforcement on clinical trials that involve human test subjects, and not on early experiments in the lab. It also noted that manufacturers are required to abide by “good laboratory practices” standards and must certify in writing that they do so.
While the FDA’s points are valid, the scrutiny the agency has been under lately will most likely lead to some radical changes when a new commissioner is appointed. Some of the changes that will most likely impact device manufacturers are the development of a Unique Device Identification system, the reclassification of Class III devices, and the proposed Drug and Device Accountability Act, industry experts said.
The Drug and Device Accountability Act could trigger more FDA inspections and result in a greater number of violations for manufacturers, some consultants claimed. The legislation, introduced by Sens. Chuck Grassley (R-Iowa) and Ted Kennedy (D-Mass.) would give the FDA more resources to inspect domestic and foreign-made prescription drugs and devices. The bipartisan legislation also calls for an Institute of Medicine study to examine the FDA’s system for approving devices. The bill also would expand the FDA’s authority, including new subpoena powers, for ensuring the safety of drugs and medical devices made domestically and in other countries.
Quality and safety are synonymous concepts in the medical device industry. One exists because of the other. The regulations and standards governing quality in medical devices were written to provide companies with a reference and framework for constructing a quality system that addresses product safety.
Over the last several decades, the FDA and foreign regulators have recognized the need to establish a set of standards governing the review and approval of medical devices.
Worldwide standards created by ISO and other regulatory bodies serve as a framework that companies use to build a quality management system and improve efficiency. The number of device companies complying with harmonized standards has grown significantly over the last five years as firms realize the benefits of developing internationally recognized quality systems (improved overseas markets access, increased efficiency, and reduced cost of sales).
Besides gaining a competitive edge, good quality systems can help companies increase their productivity and profit. As Aptus’ Koronkowski noted, “Quality has an impact on a number of vital aspects, including product safety, product performance and reliability, and customer satisfaction. The bottom line is protecting the organization from costs directly related to loss in market share.