The regulatory challenge of 3D bioprinting

New developments in additive manufacturing and regenerative medicine have the potential to radically disrupt the traditional pipelines of therapy development and medical device manufacture. These technologies present a challenge for regulators because traditional regulatory frameworks are designed for mass manufactured therapies, rather than bespoke solutions. 3D bioprinting technologies present another dimension of complexity through the inclusion of living cells in the fabrication process. Herein we overview the challenge of regulating 3D bioprinting in comparison to existing cell therapy products as well as custom-made 3D printed medical devices. We consider a range of specific challenges pertaining to 3D bioprinting in regenerative medicine, including classification, risk, standardization and quality control, as well as technical issues related to the manufacturing process and the incorporated materials and cells. Tweetable abstract3D bioprinting poses a challenge to regulators by combining complexities of 3D printing, cell therapy and custom implants. This perspective considers regulatory challenges including classification, risk, standardization and quality control.

Automated summary

New developments in additive manufacturing and regenerative medicine have the potential to disrupt traditional therapy development and medical device manufacture. Regulators face challenges in adapting traditional regulatory frameworks for bespoke solutions and incorporating living cells in 3D bioprinting. This perspective discusses the regulatory challenges of 3D bioprinting in comparison to existing cell therapies and custom-made medical devices, including classification, risk, standardization, and quality control.