[3D printing in surgery: relevance of technology maturity assessment in bioprinting research studies].

Abstract

Biological 3D printing (bioprinting) is an extension of what is defined as additive manufacturing in the American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards and is based on the automated printing of living cells and biomaterials. Researchers and experts in the field of biomaterial science, tissue engineering and regenerative medicine (TE&RM) are constantly pointing to the potential of biological 3D printing and scientific articles regularly announce the imminent clinical application. We argue in this article that these announcements are often premature and counterproductive as they focus heavily on technological progress but regularly ignore the critical stages that need to be completed in order to successfully translate a technology into the healthcare market. The technology readiness level (TRL) scale is a potentially useful tool for measuring the relative maturity of a technology in terms of overcoming a series of critical milestones. We propose an adaptation of the TRL scale and use it to discuss the current state of research on biological 3D printing. Finally, we provide specific recommendations for optimizing future research projects to pave the way for clinical applications of biological 3D printing and thus achieve a direct positive impact on surgical patient care.