The Third Era of Tissue Engineering: Reversing the Innovation Drivers

This is the authors' abstract. We don't add key points for this paper.

Ever since the introduction of the concept of tissue engineering (TE), the field has developed and matured from a hype to a proper scientific discipline. Recently, the field is witnessing a reversal of the innovation drivers as it has started to move from a technology-driven science-focused field toward a patient-driven, manufacturing-focused one. This evolution is made possible through innovations at the interface between biology and technology, including robust biological building blocks, precise biomanufacturing technologies, in-depth characterization methods, and in silico models. Combining this with novel insights on TE-related regulatory sciences and business strategies, the field is ready to meet the grand challenge of designing, developing, and delivering living implants with the accuracy and robustness expected from inanimate implants, leading to sustainable, predictable, and vastly superior biological and clinical results. Impact Statement From this perspective, we discuss the different stages of development the tissue engineering (TE) field has gone through in its relatively young history. We discuss how TE is evolving from a technology-driven, science-focused field toward a patient-driven, manufacturing-focused one where patients' needs are translated into production process requirements, and subsequently into technological and biological innovations needed to meet the regulatory and clinical demands.