The Challenge

A pacemaker is a small electronic device, implanted under a patient’s collarbone, which helps a patient’s heart beat more regularly. It's composed of three main parts: a pulse generator, one or more leads, and an electrode on each lead. The pulse generator consists of a small case that contains circuitry, a battery, and a computer chip that regulates the electrical impulses sent to the heart. The lead is an insulated wire that connects to the pulse generator and extends to one of the heart’s chambers. The electrode on the end of the lead makes contact with the heart wall and is responsible for the delivery of electrical impulses to the patient’s heart. Considering that each component of a pacemaker is critical to its function, all three components must undergo rigorous testing. The variety of tests, including shear testing on the microelectronic components, compression testing on the battery, and tensile testing on the leads, can be challenging to meet with just one system.