The ability to regenerate damaged tissue is one of the great challenges in biomaterials and medicine. Successful treatments will require advances in areas ranging from basic cell biology to materials synthesis, but there have been major hurdles in translating the biomedical advances, such as scaffolds that direct stem cell differentiation, into marketed products. Careful consideration of the challenges going from bench to bedside is paramount in maximizing the chances that a good idea becomes a good treatment. We look at a variety of material-based platforms that have made it into the clinic, from biodegradable polymers for wound healing to organs grown ex vivo, and how they have been able to navigate the scientific, regulatory, and business hurdles into the market place.