Time Is Still Money
Contract Testing Service Providers Are Busier Than Ever, Thanks to Today’s Product Innovation
The threat of offshore outsourcing may have concerned some contract service providers in recent years, but not so much for companies who perform medical device testing. In fact, these businesses are busier than ever as the next generation of products with complex designs and newer materials makes testing more complicated. While some manufacturing operations have shipped overseas, the tangled regulatory web only has served to strengthen the desire for outside expertise in the testing realm.
Simply put, there is no shortage of work for today’s contract testing provider.
Ever since the Medical Devices Act of 1976 began driving development of standards for medical devices, both national and foreign governments have been intensifying the oversight of medical products, which, in turn, has heaped a slew of regulations and standards on the industry. Today, more than 100 organizations (eg, the American Society for Testing and Materials and the American National Standards Institute) set standards for the device community.
The technician above performs sterility testing. Photo courtesy of Nelson Laboratories.
“The aging population and surgeons are demanding improvements in surgical alternatives to pain management. Medical device technology is advancing quicker than it ever has because the needs of those individuals are not met by conventional product development channels. With that brings the challenge for medical device firms to deliver innovative solutions to the market faster than ever before—with considerable pressure on delivering shareholder value at the same time. Outsourcing testing and inspection of their products can help these companies deliver high-quality, cutting-edge goods to the market faster, with lower costs,” said John McCloy, president of Accutek Testing Laboratory, based in Cincinnati, OH.
The age-old “time is money” adage certainly has added to the need for outside partnerships. As McCloy explained, “It can be nerve wracking to see your design not meet expectations or another device make it to market sooner, or even worse, receiving a call from an attorney on patent infringement.”
Sending testing to an outside vendor not only can help speed time to market, it frees up internal resources—particularly regulatory and engineering personnel—to work on other issues that need attention. For example, perhaps an OEM is developing an improved guide catheter. According to Melissa Lachowitzer, product manager for Machine Solutions Inc. in Flagstaff, AZ, in this type of scenario, the OEM’s engineer could send a testing partner different concepts and prototypes for evaluation and, while the vendor completes testing, the engineer is free to perform documentation or make modifications to the project. Since this would be occurring while the evaluation is being performed at the vendor’s site, the data the engineer receives from the vendor—soon after his or her task is finished—can be applied instantly to the next round of modifications.
Brandon Tillman, a sales representative for Nelson Laboratories in Salt Lake City, UT, agreed that external service providers can leverage their expertise to solve problems in less time. “Trying to sort through regulations can be very time intensive for medical device manufacturers. In addition, the upfront purchase of needed testing equipment usually is too expensive, and the validations required are too time consuming to justify the investment,” he said.
Shown above is cyclic fatigue of catheter specimen in temperature-controlled water bath. Photo courtesy of DDL, Inc.
Some companies do prefer to maintain testing facilities in-house. However, many of these OEMs have been able to complement their internal resources by forming external partnerships. In particular, when internal labs become a bottleneck due to project overflow, outside expertise can play a vital role in ensuring that no deadlines are missed. Furthermore, outside testing firms can help guarantee quality assurance and objectivity, which helps avoid any potential conflicts of interest.
“Manufacturers are finding out more and more about their processes and are eager to take that extra step to outsource to increase the actual and perceived quality of their products and processes,” said Dan Dwyer, marketing director for Raven Labs in Omaha, NE. “Turning to outside expertise not only can offer non-objective results but also can validate what is being done in-house, giving greater assurance to process and product quality. Involving more experts in your manufacturing process will only increase the validity of your quality assurance.”
The Value Outsourcing Offers
Many of the companies MPO spoke with noted that they serve on committees for the various standards organizations. Their reasons are twofold: 1) to stay informed about the latest developments, and 2) to pass this information along to customers as soon as it becomes available, so that the customer can plan ahead if it appears a proposed standard will become a requirement within the next few years.
Since it can be so difficult to navigate how much or how little to test (too much or too little testing equally can pose risky scenarios), many testing providers are seeing a large influx of business from venture capital-funded or other startup companies, as these firms understand that outsourcing provides them with immediate access to technical expertise. Pat Nolan, chief operating officer of DDL, a medical device packaging and product testing provider in Eden Prairie, MN, said startup companies especially are well suited to the types of wide-ranging services his firm can provide them.
“One vexing aspect about package validation is the interpretation of the regulations,” Nolan explained. “Since this is not the [medical device manufacturer’s] core competency, and without this expertise in-house, in the long run [it] could spend more money and time to ensure compliance to regulations pertaining to their package system and process. Expert early stage guidance greatly improves project and product success and eliminates the frustration with non-compliance and possibly package testing failures.”
Indeed, proper guidance can be crucial even for large companies that have an experienced regulatory group. Sometimes in-house regulatory professionals have trouble understanding certain test results or are unable to convey the meaning of the test findings to the FDA or other official bodies when an adverse result is received, experts said.
On the other hand, a smaller-sized device manufacturer may not even know how to approach testing or what types of steps must be followed. “We clearly outline the process. These companies like to know what minimum testing and services are required to launch the product in compliance with local and national regulations, and we help guide them through that. We let them know the risks associated during each phase of development, so they can choose what to do in terms of risk management. We help them decide which tests must be adhered to and which steps in the process could be risky if not completed prior to the next phase,” said Jason Voisinet, program manager for Ethox International in Buffalo/Rochester, NY.
Ana Barbur, head of the chemical testing department for Ohio-based Akron Rubber Development Laboratory, acknowledged that providing value to customers through education is a large part of her job. “Ninety percent of my work is lent to the FDA submission process. If test results show a failure, we have the knowledge to examine why the test results failed and go through the whole process until he company is up to speed. We are in the heart of the rubber world, and we have the experience not just to perform the test, but also to provide troubleshooting. More and more compounds are coming onto the market, and they need new techniques to be analyzed. This is where our challenge is and where our experience will serve us.”
Since regulatory requirements play a large role in dictating what types of testing need to be completed before a device can gain approval and reach the market, many testing firms have strengthened their offerings by developing in-depth regulatory knowledge and offering consulting as a part of their value-added services. For many in the testing industry, this is just one more way they can play into the trend of becoming a “one-stop shop” for an OEM’s needs.
AppTec, headquartered in St. Paul, MN, is one such company that identified such needs and stepped up its offerings over time. “Companies are so lean now that a contract test lab has to have to have the expertise for what they themselves don’t have in-house. There’s a commitment to helping customers with all of their needs. We can help with documentation, guidelines, regulations and compliance in general,” said Trabue Bryans, executive vice president and general manager of AppTec’s Marietta, GA facility. As part of this all-encompassing effort to serve a customer, AppTec offers everything from consulting, training, scheduling, post-market services and supply chain management.
Ethox similarly has adopted a one-stop shop mentality for companies that need to outsource their services. In keeping with the company’s “Simplify Your World” motto, the company consolidated two labs into one facility last year so it could offer additional services such as biocompatibility and toxicology testing (in vivo and in vitro) that previously were outsourced by Ethox to other vendors.
Knowing that their customers’ needs are many, providers of testing services clearly have anticipated them and are striving to offer value while performing their jobs. For optimal utilization of their services, however, those in the trenches of testing believe their customers present certain challenges that still need to be overcome—but luckily, they offered some advice for dealing with these issues.
If you speak with any service provider in the medical device industry, short lead times usually are cited as a top issue plaguing the company—and it’s no different for the testing field. “On the contract lab side, we’re the last part of the process before a product can be released, go to market and before the OEMs can make money. That’s why time is critical,” Tillman noted.
Keeping this in mind, testing providers are doing their part to ensure deadlines are achieved. AppTec, for example, has expanded its hours of operation, working at least six days a week with extended hours (such as 7 am to 7 pm), with supervisors and management available at all times to service a wide range of times zones in both domestic and international regions.
Along with timing issues, certain communication breakdowns can present obstacles to getting the job done. “The contract laboratory, according to the FDA, must be considered an extension of the manufacturing facility,” explained Gary Swanson, president of Geneva Laboratories, Inc. in Elkhom, WI. “In reality, the contract laboratory many times is not privy to the details of a product or production methods. It is sometimes difficult to reach a point where the sponsor feels comfortable discussing the proprietary details of a new product with a contractor regardless of non-disclosure agreements. Conversely, the laboratory must have access to provide the highest level of service.”
Jacob Leidner, program manager/ R&D for Bodycote Testing Group in Missauga, Ontario, Canada, agreed. “When your client wants to tell you everything he knows about the product, he’s likely to get better service and better outcomes,” he said. “Some companies don’t tell you exactly what they’re doing; they’ll say it’s confidential and offer little information. It’s often then that you’re going to run into trouble. You can produce results that aren’t usable or results that the client didn’t expect. If you don’t know what the product should be doing or what’s expected, there’s no way to identify the problem.”
Another common problem testing providers have encountered is “too many cooks in the kitchen”—that is, the lack of one designated contact person on the OEM side. Testing firms find that projects tend not to run smoothly when one official contact person at the OEM is assigned to oversee the project.
It is helpful for both the service provider and OEM to have one person acting as a liaison to coordinate activities. However, if the OEM representative will be traveling during any phase of the testing process, Tillman of Nelson advises that alternate contacts be supplied in advance to the testing provider or, alternatively, that instructions be supplied as to how to reach the person traveling. Furthermore, the person assigned to the task on the OEM side should be able to answer any technical questions a testing provider may have. This will help ensure that a project doesn’t get held up if any snags occur and the point-of-contact needs to be reached immediately to ensure that deadlines are still met.
Ultimately, a beneficial partnership can be achieved if the OEM approaches an outsourcing partner with priorities clearly outlined. If cost is the most important consideration, or meeting deadlines is more important than saving money, or if your prototype most likely will change over time and be made again, make sure to discuss your main objectives with your partner, testing providers said. Honesty is key, even if you are worried about being perceived as cheap or unsure about your project’s direction.
If you currently are shopping around for a new outsourcing partner for your testing needs, the experts offered a few tips:
• Talk to other manufacturers and learn about who they use for this service. Also, attend committee meetings for standards organizations, if possible, and network with participants to gain recommendations. Talking with people who have used a company’s services will give you an opportunity to learn if any problems arose during their time working with the vendor and, more important, gain insight into the vendor’s troubleshooting approach.
• Call a prospective laboratory’s sales office. Experts say that you can learn a lot about the company from the sales force—are the representatives knowledgeable or clueless? Can they offer realistic timeframes or do their timelines dramatically differ from what other vendors promise? How responsive is the company with the testing quote?
• Evaluate a vendor’s quality systems. Ask what types of certifications the company holds, and visit the FDA’s Web site (www.fda.gov) to find out if the company ever had a 483 observation of problems within the facility. If the company has been cited for observations, don’t necessarily rule out the company, but do use the experience to learn how the company approaches problems and works to resolve them.
“When searching for a company to entrust with a potentially vital step or piece of the manufacturing process, the company should be simply easy to work with,” said Raven’s Dwyer.
Luckily for OEMs, testing service providers are approaching the large influx of projects they are receiving with enthusiasm.
“The OEMs are a pleasure to do business with,” McCloy of Accutek noted. “Their engineers are skilled and aggressive. This makes our jobs easier and, most often, the test is completed on time and at cost.”