The Ultimate Test
Companies that provide testing services to OEMs and other device manufacturers are testing the waters in new markets in order to stay competitive.
Feng Shui masters believe that our lives are shaped and influenced by three kinds of luck: Heaven Luck (driven by destiny), Earth Luck (controlled by the environment), and Human Luck (the fortune we create for ourselves).
Patrick J. Nolan knows just how powerful the last type of luck can be. His latest business venture came about entirely through self-made fortuity, though one could argue that Heaven Luck had a hand in it, too.
Nolan’s encounter with both types of luck occurred two years ago at a business conference in Florida. Nolan ran into a colleague from the packaging industry at the event, an occurrence that was more likely driven by probability than by luck. After talking to the colleague, however, it became clear that
Outsourcing lab management services can save medical device companies time and money, and lead to a better analysis of test results. Photo Courtesy of Nelson Labs.
Heaven Luck also was playing a part in the encounter: The colleague needed some help managing a package testing laboratory and was about to recruit an employment agency to find a new manager.That’s when Nolan created his own luck. He suggested that his company, DDL Inc., manage the lab’s services and employees, noting that such an agreement could help his colleague’s firm reduce turnover rates among technicians and give it access to DDL’s vast resources. Nolan’s sales pitch worked: His firm assumed control of the package testing laboratory at his colleague’s company several months after that random meeting.
“Since DDL took over in 2007, [the company] has been able to retain qualified lab managers and experienced technicians, which in turn slowed down the turnover rate,” said Nolan, the chief operating officer at DDL, a package, products and materials testing firm with offices in Eden Prairie, Minn. and Fountain Valley, Calif. “The efficiency of the [company’s] lab operations has increased … leading to faster project completion and swifter time to market for new products.”
With companies under constant pressure to cut costs and reduce time to market, Nolan seems to have stumbled upon a potentially untapped market for outsourcing testing laboratory management services. Outsourcing these services not only can save medical device companies time and money, it can also provide firms with a better analysis of test results. Plus, outsourcing lab management services allows product engineers to concentrate on other tasks.
“Time to market is what everybody wants, and the testing function is pretty much a mandatory function,” Nolan explained. “The packaging area is an afterthought of sorts. If a company has a packaging lab, it’s given a second-rate priority, and typically the company will have engineers who will do the testing themselves. There is no centralized staff there every day that knows testing methods. What we bring is a more centralized function to the lab—we do this every day, we know the testing standards and there’s no learning curve every time we step into the lab.”
In addition to boosting a company’s knowledge of testing standards, outsourcing testing laboratory management services allows medical device manufacturers to have minimal contact with the U.S. Food and Drug Administration (FDA), an agency often viewed as intimidating and contradictory. Companies that test medical devices and are knowledgeable about federal testing standards can better communicate with the FDA and keep abreast of any changes in requirements, contract manufacturers argued. Keeping up with changes in federal regulations may not be so easy, though.Industry experts who spoke to Medical Product Outsourcing said they expect the FDA to crack down on testing regulations to offset the negative publicity generated earlier this year by two reports from different watchdog groups.
The first report, issued in mid-January by the Government Accountability Office (GAO), concluded that medical devices are approved without undergoing a stringent review process because manufacturers claim the products are similar to older devices already on the market.
The GAO document, however, did more than simply rehash the FDA’s device classification and approval process for members of Congress. It cited the agency’s failure to execute a 1995 plan to overhaul the approval process for the most complex and risky medical devices (better known in the industry as Class III devices), and recommended that it take “immediate steps” to fix its sanctioning system for those kinds of products.
The second report was released about a month after the GAO dossier by the Project on Government Oversight, a nonpartisan group that exposes problems in government. That report claimed the FDA has dramatically reduced inspections of “good laboratory practices” at facilities that conduct early testing of medical devices. Inspections dropped from 33 in 2005 to seven in 2007 to just one last year, according to the document. No inspections are planned for this year, the report stated.
“The decision … to not enforce GLP (Good Laboratory Practice) regulation is stunning in its contempt for the protection of patients and its indifference to standards that comply with federal regulations. The decision … is a high-stakes, unknown-odds gamble with the lives of patients,” the group argued in its report.
“I’ve read the recent headlines, and I’ve heard the sound bytes. In looking at the news and seeing the new administration come in, I think the FDA is going to require more testing,” Nolan predicted. “I also think there’s also going to be an increase in warning letters. FDA auditors are going to visit companies and crack down on their testing standards. And that is going to result in more testing.”
The additional testing may not be limited to the most complex devices, either. Richard J. Malo, vice president of contract sales for Ethox International Inc., said recent criticism over the FDA’s classification and device approval process could prompt the agency to require more testing even for products that are similar to those already on the market.
“The FDA will probably require more testing now from companies to support the fact that the device is similar to other products and it is safe,” said Malo, whose Buffalo, N.Y.-based contract manufacturing firm was acquired in January by Moog, Inc., for $15.2 million. “And that may extend the approval process.”
Terry Langenderfer anticipates a different outcome. The director of global marketing at NorthAmerican Science Associates Inc. (NAMSA), a Northwood, Ohio-based provider of testing services and regulatory guidance to medical device manufacturers, said he has noticed a trend to minimize testing and reduce the use of in vivo models.
"I expect that trend will continue," Langenderfer said. "The overall goal really is to minimize testing without compromising safety but this is an ongoing challenge that will take some time to overcome."
Device manufacturers can achieve this goal in a number of ways, Langenderfer said.NAMSA's customers that successfully minimize testing do so by utilizing a well-designed biocompatibility evaluation plan. "This approach establishes a plan that can be applied to a product's lifecycle and leveraged over a greater period of time rather than a limited, concentrated focus on a single regulatory submission,"Langenderfer noted.
Additional Testing—A Boon or a Bane?
Only time will tell whether the recent spate of criticism against the FDA’s device approval process will trigger more testing requirements. Additional testing would most likely pacify watchdog groups and consumer advocates who believe the FDA’s device approval process is flawed and endangers the lives of patients. But extra tests also could pose a challenge to companies that perform testing services to medical device manufacturers.
The testing that is required for most medical devices developed in the United States is driven by a universal set of worldwide standards. But the FDA may require additional tests, depending upon the nature and complexity of the device. For example, companies that manufacture tongue depressors, reading glasses or forceps would be largely exempt from FDA reviews, while firms that make drug-coated stents, ablation catheters, and implanted transducer probes would be subject to FDA scrutiny.
Most companies that provide testing services are fully aware of the kinds of tests that must be performed on medical devices and work diligently to stay informed of the latest requirements from the FDA.
Keeping up with the requirements, however, can be difficult, particularly when those mandates are not consistent among FDA reviewers. Requiring additional testing, industry experts said, would only complicate the process.
“The terms GMP [Good Manufacturing Practices] and GLP get thrown around a lot. A ‘c’ in front of either term means current, and what that really means in layman’s terms is ‘whatever the FDA is asking me,’ ” said Brandon H. Tillman, sales manager for Nelson Laboratories Inc., a Salt Lake City, Utah-based testing lab that specializes in microbiology. “You have to recognize that human beings are reviewing [device] applications, so there is some subjectivity involved, and that can be challenging.”
One issue that is particularly challenging to testing laboratories is dealing with new or inexperienced FDA reviewers. Some of these reviewers, industry experts noted, lack the necessary experience in the medical device field that can help them best determine the kinds of testing that is required for medical products. As a result, these reviewers tend to mandate more testing than would otherwise be required.
Nelson Laboratories helps new reviewers gain a better understanding of testing requirements by becoming involved in the development of ISOstandards.The company joins one of 208 technical committees that develop standards for ISO (the International Organization for Standardization) and discusses the need for such standards with FDA reviewers who also are serving on the committee. In addition, company representatives explain to the reviewers which tests would be required for the standard being developed, and why such tests are necessary, Tillman explained.
The testing group at Bodycote take a different approach: rather than trying to predict the kinds of tests that may be needed for device approvals, the United Kingdom-based supplier of testing and thermal processing services advises its customers to simply ask the FDA about required testing. “Companies are not always aware of what tests need to be done, and we don’t tell companies what testing needs to be done,” said David Cook, a senior scientist who deals with polymer technology in Bodycote’s materials testing division. “We advise companies to go to the FDA to determine what testing will be required. More firms are doing that, and it seems that the FDA has become more helpful in that regard.”
Trends Generating New Challenges
Despite its willingness to help, many OEMs remain hesitant to discuss medical device testing requirements with the FDA, preferring instead to outsource the task to testing laboratories or consulting firms.
Though it depends on the product and the company, testing laboratories are better at outsourcing this service, mostly because they know FDA regulations and they stay informed of developments in testing standards. In recent years, however, another trait has emerged that gives testing laboratories an advantage over consulting firms: their ability to determine and perform the necessary tests for medical devices that contain pharmaceuticals.
Drug-eluting stents, for example, are coated with medication that helps reduce the chance of an artery becoming reclogged with plaque (also known as restenosis).
The manufacturers of these stents—Abbott Laboratories, Boston Scientific, Cordis Corporation and Medtronic, among others—were required to test both the stent and the medication coating the stent before they could receive FDA approval for the device.
“When there is a medical device with a pharmaceutical attached to it, you have to test both the device and the pharmaceutical,” Nelson Laboratories’ Tillman explained. “If the OEMs are doing the testing, they have to become familiar with both the medical device side of the product and the pharmaceutical side of the product. But lots of medical device companies are not familiar with pharmaceutical testing standards, and lots of pharmaceutical companies are not familiar with medical device testing standards. Testing laboratories are familiar with both medical device and pharmaceutical testing standards.”
Similarly, companies that coat implanted devices with an antimicrobial agent to reduce infection rates must prove to FDA reviewers that these devices help cut the risk of infections after surgery. Demand for devices with antimicrobial coatings is expected to increase significantly in the next few years as cash-strapped hospitals look for ways to reduce hospital-acquired infections and prevent the loss of valuable reimbursement dollars. In October, the Centers for Medicare and Medicaid Services (CMS) stopped reimbursing hospitals for the costs of treating certain hospital-acquired infections, a move designed to improve patient safety and stem soaring infection rates.
Though the CMS directive specifically targeted hospitals, industry experts said the impact of the edict is trickling down to both suppliers and medical device manufacturers.
“Hospitals are not getting reimbursed for treating hospital-acquired infections,”said Dean A. Enrooth, vice president of business development for medical devices at Wuxi AppTec, a company that providesmanufacturing and laboratory services to the biopharmaceutical and medical device industries. “In response, hospitals are calling on the manufacturers of medical devices using antimicrobial agents to prove their antimicrobial efficacy. To obtain a marketing claim that their product has been shown to be effective against known infections, manufacturers need to submit their products to a new round of testing.”
Wuxi AppTec has created a validated in vivo model, accepted by the FDA and developed with its input, to test the efficacy of various antimicrobial agents used on medical devices. It also offers a neutralizing validation analysis and antimicrobial effectiveness test to determine the antimicrobial activity of medical devices, their components, or other materials treated with bacteria-fighting agents.
“While the FDA has not yet developed standards for proving the effectiveness of antimicrobial agents used on medical devices, Wuxi AppTec’s testing services represent an important step forward in helping medical device manufacturers and their hospital customers determine that their products protect patients from infections,” Enrooth noted.