Streamlining Orthopedic Device Testing with Product Families
Brian Nissen, Director of Engineering at Cretex Medical | QTS, was recently featured in ODT Magazine’s Orthopedic Innovators Q&A series.
September 25, 2025
Brian Nissen, Director of Engineering at Cretex Medical | QTS, was featured in ODT Magazine.
Streamlining Orthopedic Device Testing with Product Families
Featuring Brian Nissen, Director of Engineering at Cretex Medical | QTS
Brian Nissen, Director of Engineering at Cretex Medical | QTS, was recently featured in ODT Magazine’s Orthopedic Innovators Q&A series. In the article, “Streamlining Orthopedic Device Testing with Product Families — An Orthopedic Innovators Q&A,” Brian discussed how using product families in validation testing can help customers accelerate their path to market while maintaining quality and compliance.
What Are Product Families?
Product families are groups of devices that share common characteristics such as materials, geometry, or manufacturing processes. By validating these products as a group rather than individually, manufacturers can streamline testing, reduce redundancy, and still demonstrate safety and effectiveness across the family.
For example, a line of bone screws that differ only in length or diameter but share the same manufacturing process could be validated as one family. Depending on the type of testing — such as packaging, sterilization, or cleaning — different family groupings may apply.
“At QTS, our experts work with customers to help them analyze their products, organize families to reduce costs, and maximize speed to market,” Brian explained.
Selecting Representative Samples
When determining which samples best represent a product family, QTS focuses on identifying the devices that are most challenging to the process being validated.
“For cleaning and sterilization, we may select the instrument with the longest or narrowest lumen — because that’s the hardest to clean,” Brian said. “For packaging validation, the heaviest or sharpest instrument might be chosen since it’s most likely to damage the packaging system.”
By validating the most difficult member of the family, manufacturers can be confident that the other designs will also meet requirements.
Applying Common Cleaning Processes
Ideally, a single cleaning process can be applied across multiple product families. This approach simplifies operations, minimizes validation complexity, and helps control costs. However, achieving that consistency can be challenging when dealing with differences in design or materials.
“A family of additive-manufactured devices, for example, can be difficult to clean due to contaminants trapped in porous surfaces,” Brian noted. “Or, a unique manufacturing process might introduce a specific contaminant that requires a special detergent.”
Partnering for Efficiency and Quality
Maximizing validation efficiency helps manufacturers control costs and accelerate time to market. At QTS, our experts have years of experience developing test strategies and designing product families that make cleaning and validation as efficient as possible.
Product family groupings help simplify and streamline the validation process — so customers can focus on delivering high-quality orthopedic devices with confidence.
To read the full article, visit ODT Magazine.
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