Problem: The chosen material for the optical window in a laser ablation catheter (a Class III PMA product) was exhibiting a sporadic (<0.05%) but critical defect due to a processing sensitivity in the raw material. The desire was to find a material that did not possess this sensitivity and yet matched the original material in all other properties.
Solution: Using a cross-functional team, the key attributes of the existing material were identified and ranked using a Pugh Matrix to provide guidance on the properties that drove its functionality. Due to the rarity of the defect, significant testing (1200 samples) was conducted through the external component supplier to prove that the alternate material met all requirements. Because the design of the product was not changed, the data gathered were sufficient for a 90-day FDA review and approval cycle.