A comparison between predictive modelling approaches for spirally reinforced composite catheter tubing using Classical Statistical DOE and a Custom DOE Design

Abstract The Medical Device industry lags other industries such as automotive and aerospace in terms of the use of predictive modeling as a design tool. This has started to change with growing experience being established with metal scaffold type structures (stents, Transcatheter aortic valve structures etc.). However, these computational methods are generally used with structures that are composed of a single material type as with Finite Element Analysis (FEA). Composite interventional catheters generally features 3-layer composite structures (polymer layer A/Metal reinforcement layer B/polymer layer C) which offer different challenges than single material structures in terms of predictive modeling. The results achieved with two different Experimental Design or Design of Experiments (DOE) based predictive modeling methodologies will be compared. The Classic DOE approach is based on a full factorial DOE with center points. The Custom DOE approach is based on the full factorial approach but is augmented with a series of experiments to fill the internal design space more completely rather than rely on just taking sample points predominantly around the boundaries of the design space as in classic DOE. Results generated from both approaches relate to catheter performance criteria of value in early stage composite catheter design. Strengths and drawbacks of both modeling approaches are discussed.