Testing and Inspection Providers Attempt to Stay Fluid in Changing Times

Daniel Grace

As medical products evolve, the methods and equipment used for testing them often must follow suit. In today’s climate especially, the sheer number of new and innovative medical devices is testing the problem-solving abilities of testing providers.

“We are seeing more drug-device combination products as well as more devices that interact with computers,” says Jeff Nelson, president and CEO of Nelson Laboratories Inc. (Salt Lake City, UT), which provides microbiology testing services to the medical device industry including sterilization validation, routine lot-release testing, and biocompatibility testing. “These devices are highly specialized and we are having to tweak our processes on a case-by-case basis in order to accommodate them.”

Another trend necessitating new testing methodologies is the increasing number of patient-specific devices, Nelson says. In these cases, each unit has unique dimensions and contours. Such customization requires special care in devising procedures for sterilization and microbial testing.

All of this can be difficult to navigate for OEMs, who are primarily concerned with validating their products as soon as possible in order to accelerate time to market. With that in mind, Nelson Labs has recently taken steps to improve communication with customers. “We know that customers like to stay up-to-date throughout the testing process and that they like to be able to discuss issues with technicians,” Nelson says. “To facilitate that, we recently assigned a customer service representative to each of our 12 lab locations who can take calls and direct technical inquiries to the appropriate person.”

Other OEMs take a more hands-on approach, handling some or all of their testing and inspection needs in-house. For them, flexible equipment can be a savior in instances requiring inspection of new or customized products. But there is often a tradeoff involved. “Some customers want manual systems that can be used with a wide variety of components, but they also don’t want the mistakes and delays than can occur when you move away from automated systems,” says Chuck Rasbach, vice president of sales and marketing at RAM Optical Instrumentation (Rochester, NY).

The company, a provider of inspection and measurement equipment, has attempted to bring together the best of both worlds with its line of manually operated video inspection systems. Usable in conjunction with many different surface types, the systems are designed to reduce operator fatigue, a leading cause of error. “The video interface allows the operator to look at a screen and click on the different areas that need to be magnified and confirmed, rather than having to squint into an eyepiece for hours on end,” Rasbach says.

Furthermore, the systems could increase workforce flexibility. “The systems are easy enough to use that a nonengineer can be trained to operate them effectively,” Rasbach says. “This can free up engineers to work on more technically challenging tasks.”

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