Medical Device Tensile Testing & Fixture Development
Standardized tensile test methods and custom fixtures built for a clinical-stage medical device.
01Problem
Design validation and future commercialization of a clinical-stage medical device depend on tensile test data that's repeatable across operators and test sessions — which meant the test method and fixtures behind it needed to be standardized, not ad hoc.
02Requirements / Constraints
- Establish repeatable procedures to support design validation and future commercialization.
- Design fixtures using design-for-manufacturability principles.
- Keep the method and fixtures usable by other engineers, not just the original designer.
03Concept Development
Fixture concepts were developed around design-for-manufacturability principles from the outset, aiming for hardware that could be produced and used consistently rather than optimized for a single test run.
04Design
Custom test fixtures were designed and manufactured to hold specimens consistently through repeated tensile tests, supporting a standardized test method.
05CAD / Analysis
Fixture geometry was modeled and refined to support consistent specimen alignment and clamping across repeated tests.
06Prototyping
Fixture concepts were iterated using 3D-printed prototypes, letting design changes be evaluated quickly before committing to final fixture hardware.
07Testing
Fixtures were evaluated through experimental testing to check fit, usability, and repeatability, with test data analyzed to guide further design decisions.
08Iteration
Findings from testing were communicated to guide design decisions and strengthen the product verification process, feeding back into fixture and method refinements.
09Final Design / Outcome
The result is a standardized tensile test method with supporting fixtures, developed in collaboration with engineering, quality, and regulatory teams to support design validation.
10Key Results
Add measurable results here as they become available and shareable — for example, repeatability metrics or adoption of the method across the test program.
11What I Learned
Add a short technical reflection here — what you learned about fixture design for repeatability, or about collaborating across engineering, quality, and regulatory functions.