The dynamic and complex environment of the pulmonary system creates unique design and testing challenges for pulmonary devices compared to traditional cardiac arterial devices.  Diseased segmental airways undergo significant asymmetric radial compression during breathing and may completely close during coughing.  These conditions have dictated the design, manufacture and testing of the IBV^TM Valve System, which acts as a one-way valve to restrict distal airflow into diseased sections of the lung while allowing the natural proximal fluid clearance mechanism to function.  The valve utilizes a superelastic NiTi frame and a thin polyurethane membrane which, in combination, permits it to conform to the airway’s cyclic radial displacements.  Manufacturing challenges include tight control of the Af temperature during shape setting, laser welding and surface treatments to give the valve acceptable fatigue life and corrosion resistance.  Testing challenges include developing realistic airway models, establishment of acceptable boundary conditions for fatigue testing and corrosion testing.