Clinical Trials

Biography

Biography: Guiyong (Nick) Song

Abstract

Drug delivery devices and drug-device combination products involve complex working mechanisms, nonlinear materials with complex mechanical behaviors, and interactions between fluids and structures. The development and manufacturing of combination products entail the deep understanding of the design, manufacturability, and reliability, where modeling and simulation offer unparalleled capabilities and complement testing based on physical prototypes. This presentation will provide a few case studies of device and combination products modeling at Abbvie. Bio-compatible polymers including thermoplastic polyurethane and thermoplastic elastomer are commonly used in medical devices such as drug delivery tubing and connectors. They provide excellent durability and resistance against oils and chemicals. Their mechanical properties are complex, exhibiting nonlinear large strain nonlinearity, hysteresis, and permanent set under cyclic loading. Hi-fidelity finite element modeling was utilized to study the performance of a delivery system under various conditions. Results showed the high margin of safety. Auto-injector is a combination of drug and device. A syringe pre-filled with a drug is installed into a spring-loaded pen device to achieve automatic subcutaneous drug delivery. Finite element simulations of the firing/activation process provided deep insights into the working mechanism that were not known from prior experiments. An infusion pump is an electro-mechanical device used to deliver the drug into the human body at large volumes and over the long period of time. Simulations showed the working mechanism of the complex device that includes components made from nonlinear silicone rubber and thermoplastic polyurethane materials. Multiphysics modeling of auto-injector provided deep insights into the drug solution fluid flow driven by the device which was not easily measurable.