Test Smarter. Cover More.

Challenge

A hypodermic syringe family included multiple syringe sizes and needle gauges. Testing every possible configuration could have meant unnecessary duplication, additional samples, cost and time.

Our Strategy

Instead of testing every SKU, we developed a risk-based, worst-case testing strategy. The largest- and smallest-diameter needle configurations were assessed alongside syringe capacity, needle length and other design variables to identify the configurations most likely to challenge each performance requirement.

How It Helped

Testing focused on the configurations that provided the most meaningful evidence, with a documented rationale for how the selected worst cases supported coverage of the broader device family.

Impact

Fewer duplicative tests. Smarter use of samples and laboratory resources. A clearer, more defensible FDA testing strategy.

NKB Insight

The goal isn’t to test every configuration—it’s to identify the right worst case for the right performance requirement.

*Client, product and configuration-specific details have been anonymized to protect confidentiality.