The Translational Mindset Is Essential for Taking Tissue-Engineered Therapeutics from Lab to Clinic.

Many academic researchers are familiar with the technical challenges inherent in creating patient-specific, tissue-engineered therapeutics for clinical applications. However, for the potential of these products to mature into clinical practice and the profound possibilities to be realized, developers must apply not only technical expertise but also a comprehensive translational strategy─making a product marketable, scalable, manufacturable, and approvable by regulators, while providing genuine advantages to patients. Here, we provide a brief overview of three crucial steps for successful translation: adoption of a "translational mindset," consideration of three categories of core challenges (economic, regulatory, and manufacturing), and detailed planning at the earliest stages of development.