Despite its positioning as a translational field and 25 years of existence, tissue engineering has not had significant clinical impact. This is in large part due to the tension of complex therapies (new, resorbable materials plus biologics) juxtaposed with significant regulatory hurdles, requiring validation and quality systems for each therapy component (i.e. scaffold, coatings, biologics). They have adopted a philosophy of modularity, in which the therapy itself, the manufacturing processes used to produce the therapy and the design process are incorporated in separate modules that may be assembled to produce flexibility in therapy combinations. Specifically, they view 3D printing/additive manufacturing as the cornerstone of making patient specific scaffolds that can then be modified with add on processes like fluid based functionalization to create more complex therapies. In this talk, he will discuss the background of regulatory challenges in tissue engineering, followed by our implementation of modular tissue engineering therapies. He will then present their experiences translating these modular 3D printed scaffold centric therapies into pre-clinical animals models and human clinical use.

Scott Hollister is a Professor of Biomedical Engineering and Mechanical Engineering at the University of Michigan where he directs the Scaffold Tissue Engineering Group. His research focuses on the design, fabrication and evaluation of biomaterial platform systems for tissue reconstruction. He is a fellow of the American Institute of Medical and Biological Engineering. His work on a bioresorbable tracheal splint along with Glenn Green was awarded a Popular Mechanics 2013 Breakthrough Innovation award and featured on the Today Show, USA Today, NPR, Time magazine, Popular Mechanics among other media.