Chapter 12 – Biomaterials in Regenerative Medicine: Considerations in Early Process Development

When developing a biomaterial-based technology into a commercially available product, the scientific and technical merits of the technology are not the only obstacles to success. Process development includes many additional hurdles, such as intellectual property, manufacturing, and logistical concerns. By fully considering the entirety of process development, proactive steps can be taken throughout the design process to mitigate risk and facilitate success. This chapter is designed to provide biomaterial-specific considerations to be made before embarking upon process development. Specifically, this chapter covers the important components of a design team, identifying an unmet clinical target, key aspects of a biomaterial-based strategy, and the regulatory challenges associated with various product designs. Modern biomaterials have the potential to bring regenerative medicine to the clinic and revolutionize patient care. But in order for this goal to be fully realized, ideas developed in the laboratory need to be taken through process development and transformed into commercial products.