BME Seminar Series: Scott J. Hollister
3D Printed Modular Scaffolds: Pre-clinical and Clinical Experiences
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). We 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, we 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, I will discuss the background of regulatory challenges in tissue engineering, followed by our implementation of modular tissue engineering therapies. I will then present our experiences translating these modular 3D printed scaffold centric therapies into pre-clinical animals models and human clinical use.