A New Set of Rules
Testing is becoming more challenging for both suppliers and OEMs.
Like everywhere else in their supply chains, medical device manufacturers want more from their testing partners—good documentation practices for test results, protocols, and other records have never been more important.
Driven by increased scrutiny from regulatory agencies, OEMs expect their testing labs to have
at least an ISO 9001-registered quality system or higher in place. More medical device companies also are requiring ISO 17025 quality system registration from their testing partners as well as evidence of a plan that will validate all testing techniques.
“Audits by customers are occurring more frequently and issues concerning detailed test validations are a hot topic,” indicated Al Gale, sales engineer with DDL Inc., an Eden Prairie, Minn.-based medical device-testing laboratory.
OEMs also want financially strong partners. During supplier audits, medical device firms are asking for tangible proof that suppliers are financially strong and have sustainable business goals.
“After the recent turbulence in the economy, medical device firms have made it a priority to verify that suppliers are capable of fitting into their short- and long-term business strategies,” said Caleb Rancourt, business intelligence specialist with Polymer Solutions Inc. in Blacksburg, Va., which partners with medical device companies to provide analytical testing.
Medical device companies also want fewer partners; OEMs are pushing their testing partners to do more types of testing, or to outsource testing they cannot handle so the OEM only has a single point of contact for testing. However, the number of vendors required to test a medical device still depends on the complexity of the device and materials used, compared to the knowledge, equipment, experience, capabilities, and quality systems of the testing providers.
Mark Fridman, sales and marketing manager for Mark-10 Corporation, a manufacturer of force and torque measurement products in Copiague, N.Y., has noticed customers increasingly looking for turnkey solutions for testing, particularly complete force or torque measurement solutions.
“If customers still need to perform some modification or customization on their end, they are often willing to do so, but are less inclined to source their testing hardware from multiple manufacturers,” he explained.
Although it requires significant investment, being a “one-stop” testing shop (or nearly so) adds value to both parties. Not only is it easier and faster for clients to receive results and feedback, the testing company can deepen its understanding of the clients’ materials, processes, products, and corporate goals to achieve better quality and success with their devices. A one-test house also eliminates multiple shipping fees, as well as variations in testing procedures.
“Being a one-stop shop allows us to build great relationships and, most importantly, trust with our customers,” said Yolanda Russell, account manager at Trace Laboratories Inc., a Hunt Valley, Md.-based testing and evaluation organization that serves the medical industry. “In the off chance we do not have a particular capability in-house, Trace partners with labs that we trust and facilitates subcontracting the work, which makes it easier for
What OEMs Need to Know
Testing is not a “one-and-done” activity—instead it is a continuous process of quality control intended to ensure the safety of the product over time.
“The biggest misconception customers have is that testing is simple and/or rote,” stated Trabue Bryans, vice president of RA/QA and service development for WuXi AppTec, a provider of discovery and development services for the medical-device industry (its U.S. operations are located in St. Paul, Minn.; Marietta, Ga.; and Philadelphia, Pa.). “Most standards tests have to be adapted or modified to fit the nuances of emerging products such as combination products. It can be very tricky because products are becoming more complex and using more sensitive materials.”
Another OEM misconception about testing is the need for familiarity with test standards—experts told Medical Product
Outsourcing that it is vital for OEMs to have copies of test standards and understand how those standards relate to their products. “Any lab should know its test standards inside and out and be able to assist the OEM with any interpretational issues as well as answer any of the OEM’s questions,” DDL’s Gale said. “Although it’s tempting for an OEM to rely on the test lab because of the lab’s knowledge, an OEM that is informed on the test standards makes for a stronger partnership between the lab and OEM.”
OEMs may think of testing as a regulatory hurdle to jump over in order to get products to market. However, testing providers are far more than that—they provide vital feedback to medical device manufacturers throughout the life cycles of their products, sometimes discovering significant flaws in the manufacturing processes. For example, during a recent job Polymer Solutions noticed dark specks in some molded parts that were being tested for lot release intrinsic viscosity and DSC (differential scanning calorimetry).
“We brought this to the client’s attention and subsequently performed additional testing to identify the particles,” Rancourt noted. “It was determined to be steel contamination from the raw polymer supplier’s process—the client was able to work with the supplier to eliminate the contamination.”
Inferior raw material is another problem that OEMs tend to underestimate. Typically when Trace Laboratories runs root cause failure analysis on parts from the field, the culprit is poor raw material. “Most OEMs do not realize the importance of performing supplier surveillance checks until they start having issues in the field,” Russell pointed out. “We work to educate customers on the importance of performing testing before finalizing their products. In health care, the key to successful health is prevention. In medical product manufacturing, recognizing and preventing failures prior to final design and assembly is key in ensuring a product line that maintains longevity.”
Adding Value to the Client Experience
Many medical device companies are asking for add-on services such as electronic schedules, custom reports, and trending of results. The add-ons do not improve testing or reduce the client’s cost—but customers do end up getting more services for the test dollar, Bryans noted.
Recent updates to the ISO 10993 series have placed a higher emphasis on materials characterization. Companies are beginning to realize they need more information about their materials before they start generating biocompatibility data. This requires a test plan based on the type and use of material.
“There are two basic sides to materials characterization,” indicated Amy Hoffmann, product manager for analytical chemistry and materials characterization for North American Science Associates Inc. (NAMSA), a firm in Northwood, Ohio, that provides regulatory and quality systems consulting and testing. “The first consideration is that extractables can migrate from a device. It’s critical to choose the correct extraction conditions—you want to exaggerate over normal use, in some cases, even exhaustively extracting the device. But you don’t want to be so aggressive that you degrade the material and form products that would not be typical of the device. From there, analytical tests are chosen to best identify and quantitate the extractables. The other aspect of materials characterization is more structural, where you can use tools such as Fourier transform infrared spectroscopy, DSC, gel permeation chromatography, or even NMR (nuclear magnetic resonance spectroscopy) to understand the overall composition of the material.”
Degradation is a growing area of concern for many medical device companies. With the increasing use of both polymers and biomaterials in implants, the U.S. Food and Drug Administration is requesting information on the degradation pathways these materials undergo. This degradation testing mostly is based on ISO 10993-13, which deals with both hydrolytic and oxidative degradation of a polymeric material. There also are resorbable materials; even though they are designed to degrade and reabsorb into the body, developing an effective testing plan to thoroughly understand this pathway and the intermediate materials is highly challenging, experts said.
Another area of focus is the use of colorants. NAMSA tests for the migration of the colorants from medical devices—not only their pathway but also the form they take in the extractants.
“The specific methods are still being developed and may vary depending both on the colorants used and the form they are in,” Hoffmann said. “In a simple case there may be a single colorant that can be extracted and identified from techniques such as ultraviolet visible spectroscopy or HPLC (high performance liquid chromatography) analysis. In more complex cases, where several colorants may be added and the entire mix extruded into a device, the colorants may actually form new compounds, or break into different compounds.
These may require more sophisticated structural elucidation with different HPLC detectors, or NMR.”
With medical devices becoming more portable, there is a growing concern about increased human contact with phthalates, Bis-phenol A, and organotins and their potential leaching hazards. Counterfeit components also are an issue now for many electronic manufacturers, including medical device firms.
Trace Laboratories has become a key player in component verification for several large OEMs and continues to provide verification testing across the various industries it serves. “Supplier surveillance is a key step customers can take to ensure the quality of their products,” Russell said. “We assist customers with material quality checks, including PCBs, PCAs, and any raw material used in manufacturing. Our Highly Accelerated Life Testing allows customers to test the reliability and durability of their products when exposed to temperature shock
Developing these capabilities and providing custom test methods increases a testing lab’s ability to be a one-stop shop to its clients. This, of course, requires a substantial and ongoing investment in top analytical equipment, as well as the lab’s core areas of expertise, internal collaboration, partnership with clients, familiarity with materials, and a culture of continual learning and creativity.
“A specific example of an investment that has increased our ability to be a one-stop shop is our purchase and development of an inductively coupled plasma (ICP) instrument,” Polymer Solutions’ Rancourt said. “Previously we had to outsource our testing of heavy metals in plastics to another lab and we were becoming apprehensive about the quality of their science. As a result we purchased our own ICP and developed an internal expertise so we can support more aspects of our clients’ projects in a manner that meets strict quality standards.
We now frequently couple our ICP capabilities with other test methods to provide solutions to our clients.”
Rhythmlink International LLC also is a one-stop testing shop for all of its manufactured products, including design testing during the new product design phase, quality testing on raw materials, and quality in-process testing, which is performed during the manufacturing of devices. The Columbia, S.C.-based company has about 50 test procedures, including impedance testing, connector pull off and push on strength, wire break strength, cup break strength, pad stickiness, and sharpness.
“Statistical process control (SPC) testing is probably the most complex,” noted Gerald Keisler, Rhythmlink’s director of quality. “The complexity lies in how the test is set up and how the samples are pulled for testing. For example, let’s say our supplier produces 100,000 wires every month, or about 4,000 wires per day. These are produced by four injection molding machines run by at least two operators. Obviously, testing 100 percent of the wire is prohibitive, so SPC is used instead. Each machine is sampled every time there is an operator or shift change. These samples are tested and charted. If the values begin to drift to the limits, (either pull off force is too high or if pull off force is too low), then adjustments are made to the machinery or the materials to bring the average test value back to the center of the specification, without ever having a failure. A good SPC program can reduce or eliminate a raw material incoming test.”
One of the biggest challenges for testing suppliers is meeting shorter turnaround times. DDL has addressed this by streamlining the process as much as possible.
“Conversations with sales that are translated into a formal quotation are reviewed internally prior to customer release in order to be as accurate as possible,” Gale said. “Our project engineers review all background e-mails between sales and the client, make immediate contact with the client when the project is released, and keep the client in the loop during the test process.”
Clients increasingly expect quick results while still complying with strict quality standards. It is essential for testing firms to continuously strengthen and grow their quality systems as well as streamline operating procedures so they can meet or exceed client expectations for speed, compliance, and quality.
“We frequently examine our systems and processes to identify ways we can improve them,” Rancourt said. “One such examination of our sample receiving process revealed it was an administrative burden to multiple departments. As a result we developed the position of project administrator to receive client samples, set up projects, and handle administrative functions during and after the project. This allows our technicians to concentrate on testing and has freed up our project managers to work more directly with clients and lab managers on projects.”
Another big challenge is the demand for more tests, which slows down the overall process, creates testing overlap, andincreases costs. “In the last year alone we have added about 20
different part types,” Rhythmlink’s Keisler said. “Some of these are easy to add to our incoming testing because they are simplyvariations of what we already do. However, some are completelydifferent and for totally new products. We obviously need to add some type of testing for the new products, so the number of tests we do is ever-increasing. To counter this we may decide to ask a raw material vendor to do the testing instead of ourselves, or we may modify the test. For example, instead of doing a sampleinspection and screen of an incoming product, we may change over to an SPC program that keeps the process under better control and still eliminates some testing.”
The third big challenge is keeping up with a changing, expanding body of regulations. Although many clients appreciate faster testing, they are more concerned with being internationally compliant, experts claim. “We have a regulatory team at each site that stays on top of regulations for their particular areas of expertise,” Bryans said. “We also
dedicate several people to national andinternational committee memberships and co-chairships in order to stay on the forefront of regulatory changes.”
DDL’s advanced quality system drives the company to collect more digitally acquired test data every year, reduce human errors, and improve the efficiency of the testing processes, thereby reducing lead times. “This allows us to meet the demands of medical device customers for strict adherence to data integrity and high-quality reporting,” Gale said.
Trace Laboratories is constantly attempting to expand and improve its capabilities,
investing in equipment that helps the company perform testing faster or in greater quantities. The company recently upgraded its equipment, purchasing chambers with more space and an improved ion chromatography device, Russell told MPO. Earlier this year, the firm also acquired a new high-power scope for visual inspections.
A frequent request from Mark-10’s medical device customers is more sophisticated and tailored testing solutions, largely a result of increased automation and testing volume. To meet these requests, Mark-10 has implemented a major redesign of its core instrument line, improving upon important specifications such as data sampling, accuracy, user interface, and other areas.
“These advancements have yielded more accurate test results and improved testing efficiency,” Fridman said. “We have also introduced PC-controlled motorized test stands which can be programmed to perform custom-testing sequences, as required for the application.”
Because of the increased demand for deeper understanding of material behavior, the analytical equipment required for identifying extractables and degradation products is becoming more sophisticated. To keep up with this, NAMSA has invested significant resources in its analytical equipment, bringing current instruments up to the latest models and adding more equipment, such as ICH-certified stability chambers, for example.
“With the increase of combination products and drug delivery devices, we want to provide the extractables/leachables analysis for these devices, but also actually age the samples in house,” Hoffmann explained. “Previously our clients needed to age their samples at their own facilities, or at another location, and provide us with samples at the various stages with the pull points. Now we can age samples in-house to allow for faster turnaround time on the results.”
The speed of client innovations with materials, designs, and devices evolves exponentially quicker than analytical testing equipment and the principles of chemistry. In order to remain
relevant and cutting edge, it is imperative for testing labs todevelop multiple areas of expertise that are complimentary,industry experts noted.
“We have seven core areas of expertise (applied chemistry, gas chromatography, liquid chromatography, physical testing, microscopy, spectroscopy, and thermal analysis) that we continuously grow and develop,” Rancourt said. “By reading trade journals and requesting innovative materials to test at our expense, we remain proficient and use our multiple areas of expertise in unison to achieve innovative, proprietary testing solutions for our clients’ toughest challenges.”
Early Involvement is Key to Success
Experts told MPO that it is important to involve testing laboratory as early as possible in the medical device development process. This gives the lab time to prepare for testing challenges and also provides another source of input for changes that might make sense at the initial stages of development that will save headaches later on.
“In evaluating products for testing,” Bryans said, “we have often found design issues that would be a problem when testing the final product, either by being prohibitory to current methodology or more costly to test, so these can be corrected before the product gets to the next stage. Also, we have been able to suggest improvements to things such as packaging, knowing what some of the pitfalls are from experience.”
Best practices constantly are evolving and being debated, Keisler noted. “This is a complex subject and there are entire courses that are offered at the college and professional levels to deal with this topic,” he said. “First, you have to closely monitor what is going on in your industry. Encourage reporting so management gets accurate answers. Read, understand, and practice Deming’s 14 points. Listen to everyone across the entire manufacturing line from end to end—remember that sometimes the best and most useful knowledge comes from the least-trained, least-experienced operators at the bottom of the corporate ladder.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders such as Kohler. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at firstname.lastname@example.org.