Problem Statement: Physicians had frequent complaints about the force needed to puncture the skin with the original incision tool. Risk of customers switching to Medtronic product due to headaches with our incision tool.

Problem Validation: Set up qualitative testing with users of the device. Identified incision tools with "bad" and "good" blades under microscope. Physicians were able to feel the difference in porcine tissue, but even the "good" blades were worse than competitors.

Test Development: Developed DOE to identify key factors in blade puncture force in synthetic tissue. Designed fixturing and Instron program to measure puncture force.  Validated the test method with Gage R&R to ensure validity of results across a range of blade designs.

Design Optimization: Worked with the blade manufacturer to vary blade angle, grind angles, and material. Ran extensive tests to determine impact of each variable.  Identified blade tip angle as the key attribute for sharpness and material for durability via drop testing. Due to constraints with incision width and depth a triple edged design was developed resulting in an 8X reduction in puncture force.