Jennifer Whitney05.02.06
Walking the Line
How Med-Tech Firms Are Keeping the FDA (and Others) at Bay While Maintaining Competitive Advantages With Quality Initiatives
Jennifer Whitney
Editor
In the medical device industry, the old adage “time is money” is never truer as competition flourishes. For some med-tech firms, this means focusing on getting a product to market quickly and dealing with problems later. In this rush-hour world, quality assurance is one area that is sometimes overlooked in the process.
Controlled manufacturing environments provide a greater level of quality. Photo courtesy of CEA Technologies. |
Addressing all the needs of developing and maintaining a good quality system really comes down to three simple actions, according to Marshall Wenrich, group president for The Realtime Group in Plano, TX: “Say what you will do, do what you say and prove you did what you said you would do.”
However practical that sounds, such actions are often easier said than done. Javad Seyedzadeh, senior vice president of QA for Bayer HealthCare’s Diagnostic Division in Tarrytown, NY, said many medical device firms tend to rush their quality processes. Other quality experts also said many device manufacturers are relying on outdated manuals and corporate policies, while they should be auditing their systems on a regular basis.
To avoid falling into that trap, Avail, a leading outsourcing partner in the industry, has invested more than $1 million over the past 10 years to develop and implement a uniform quality system across all of its various locations. “Many companies claim to have a unified quality system, but what they really have is just have a manual and some corporate policies at the top level with different quality systems at each location,” acknowledged Don Young, a senior VP of quality assurance who is based in Avail’s San Diego, CA location (the company is headquartered in Fort Worth, TX). “We decided to flip the model upside down and created a system that is consolidated. You have to constantly be evolving.”
Outsourcing Shifts Quality Focus
With outsourcing increasing by double-digit percentages annually, manufacturers have realized that focusing on quality and compliance can give them a competitive advantage among OEMs looking to outsource. (As quality programs become more paramount—and complex—to organizations, many companies are turning to consultants for help. See sidebar on page 50 to find out why.)
The OEMs know that if quality standards are lacking in some area of manufacturing, the FDA and other notified bodies will hold the OEM responsible; therefore, these companies are expected to ensure that their outsourcing partners have adequate quality programs.
“Based on the interpretation of many regulatory bodies located in countries around the world, it is essential for the [OEM] to be able to objectively demonstrate central control and management of key activities that have been outsourced,” said Pedro Gonzales, manager of medical services for Lloyd’s Register Quality Assurance in Houston, TX. “The [OEM] holds ultimate responsibility for the products released to the marketplace.”
The good news, Wenrich noted, is that many outsourced service providers are better equipped with established quality systems and practices than the device owner.
To maintain an optimal system, contract manufacturers often collaborate with OEM customers to identify areas of concern and refine their quality system. However, this isn’t always easy, when you consider that most contract manufacturers are dealing with multiple customers.
“Every customer has its ‘hot’ buttons,” explained Marko Green, executive director of operations (and former quality director) for Colorado Springs, CO-based CEA Technologies. “That’s the real struggle for a contract manufacturer—not to convolute your system to be various pieces from each customer’s system. You have to take facets of their system that will fit into your own system without completely changing it.”
Bayer’s Diagnostic Division, which outsources about 70%-80% of its product manufacturing, sometimes helps its suppliers implement more optimal quality systems if a company’s existing system is deemed inadequate. And Seyedzadeh reported that Bayer doesn’t stop at evaluating the contract manufacturer performing the work—the outsourcing partner’s suppliers are also audited to ensure problems won’t occur as a chain effect.
“The OEM, from the beginning, should insist on a good process on how all parties will exchange information,” Seyedzadeh said. “The biggest misunderstanding in outsourcing is when these parties don’t treat each other as a partner. This has to be truly be a partnership.”
Avail’s OEM customers audit the company often to ensure that what’s on paper is actually what’s being put into practice, according to Young. And Avail, which is audited 50+ times annually by customers and notified bodies, supplements these inspections by performing continuous internal gap analyses.
“The OEMs expect you to take a leadership role in problem solving. They don’t want to hold your hand,” Young explained. “They want you to communicate and be responsive. It’s their reputation on the line. The biggest decision they make when outsourcing is to determine how it will affect their reputation. Risk management is a big concern.”
How to Ensure Quality Endures
A good quality system relies on several factors for success, whether the company is a large OEM or a smaller supplier. Following are some of the most important considerations experts believe play a large role in determining the success of a quality system:
Management Buy-In. The opinions are almost unanimous: This is the top priority. With the FDA placing the onus on management to ensure a system’s efficacy, companies are taking note.
Dan Whelan, principal consultant for Quality Assessment Services in Plymouth, MA, had a client whose quality manager worked long hours and basically “held the quality system together with his own sweat.” Not surprisingly, this approach failed and Whelan was called in to help streamline the system. He soon realized that upper management had to be re-educated about the scope of the work necessary and reinforce the importance of dedicating ample resources towards QA and compliance efforts.
“It took months to get the support needed to staff at that level,” Whelan recalled. Noting that quality experts are consistently challenged to prove the value of allocating more funds to implementing and maintaining a sound quality system, Whelan also said, “If we don’t talk in dollar sense, nobody listens. We have to be able to demonstrate that we can offer fewer complaints, reduced cycle times and overall performance metrics improvement.”
Experts say management also shouldn’t overlook the value of hiring personnel who are solely dedicated to achieving quality initiatives. These individuals should be given sufficient access to top corporate executives, according to quality experts.
Training. Management is also responsible for ensuring that proper training is occurring at all levels of an organization. Since some turnover is a reality for most companies, continuous training is essential—and management should keep careful records on training.
Consultant Wenrich believes quality system manuals should be concise and only contain about 10-13 policies or practices. In addition, training should be a part of each employee’s job description and not something that is done “above and beyond” or “on your own time,” he said.
Avail also has found that implementing a few simple tactics into its training programs has helped ensure uniform adoption of processes. Procedures are illustrated in manuals with pictures and flow charts. In addition, Young said employees view PowerPoint presentations and then complete an assessment test to ensure that they truly understood and learned the presented concepts.
Instilling the belief that quality is paramount to an organization also is key to success. “You need great people who are highly motivated and will look at the system as less of a quality system and more of a business system,” Young explained. “Our quality system touches every critical business function. Everyone in the company has to adopt that and buy into that it’s how we do business.”
CAPA systems. According to many sources, corrective and preventive action (CAPA) is one of the top quality programs the FDA evaluates during audits—and the one that often gets cited in observation reports for failing to properly investigate root cause when problems occur.
Quality has a visual aspect to it that creates a positive perception. Photo courtesy of CEA Technologies. |
Validation. As technology ad-vances, validation becomes extremely important. With items such as drug/device combination products proliferating in the market, contract manufacturers are often finding they must remain mindful of adjusting their systems to accommodate these changes in technology—and with that comes the need to constantly re-assess validation needs.
In addition, as many companies automate their processes, the FDA is keeping tabs on these refined systems. As a result, every time a process is changed, a company must determine if revalidation is necessary. Less savvy companies often forget to perform this crucial step and pay for it later during an FDA audit, according to Alan Schwartz, executive VP of MDI Consultants in Great Neck, NY.
Continuous improvement. As previously noted, many companies rush to get a quality system in place and don’t take the time to truly evaluate how well the system is working over time. Quality experts say the hallmark of success is an ability to perform gap analyses—that is, examining the present system and identifying where problems exist and how to improve.
Sometimes, experts find employees are using another procedure that they believe works better; this can lead to inconsistencies. And though in many cases, the newer changes may be beneficial, they can still hurt the company when auditors observe discrepancies between what they read in manuals and see in operation.
A Return on Investment
Many experts forecast that the various worldwide quality standards will harmonize in time, as FDA regulations and ISO standards—among others—become more like-minded. However, the harmonization will most likely never eliminate the possibility of different interpretations and/or policies followed by the regulatory bodies; therefore, the reality of where quality requirements are going is really anyone’s guess.
In the meantime, companies would be wise to look at investments in quality as a necessary measure of doing good business and assurance of compliance. While quality experts at the front lines still find that too many executives view quality needs as a “necessary evil,” experts believe a good quality system will save both time and money.
“Not much in the quality system is a waste of time,” consultant Schwartz noted. “A company should look at this investment as making good business sense.”
And in the medical business, quality is everything.