Gordon G. Wallace

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.

The deployment of structures that enable localized release of bioactive molecules can result in more efficacious treatment of disease and better integration of implantable bionic devices. The strategic design of a biopolymeric coating can be used to engineer the optimal release profile depending on the task at hand. As illustrative examples, here advances in delivery of drugs from bone, brain, ocular, and cardiovascular implants are reviewed. These areas are focused to highlight that both hard and soft tissue implants can benefit from controlled localized delivery. The composition of biopolymers used to achieve appropriate delivery to the selected tissue types, and their corresponding outcomes are brought to the fore. To conclude, key factors in designing drug‐loaded biopolymeric coatings for biomedical implants are highlighted.