3D-bioprinting attribute to major advances in the medical field of tissue engineering by allowing researches to be done on novel materials called biomaterials. Biomaterials are the resources used for printing three-dimensional objects. Some of best bioengineered substances that are usually stronger than bodily materials include bone and soft tissue. The advantages, regulations and future of 3D printing are listed below.
Advantages of 3D Printing Technology
The advantages of 3D printing technology are: Ability to alter products quickly for rapid prototype iteration, produce small batches of multiple product designs in each batch. The 3-D computer models can be created using traditional computer aided design techniques or directly from 3-D images, designers can also use a combination of techniques, anatomically matched devices or surgical guides by utilizing a patient's own medical imaging. It can also facilitate the production of devices with intricate structures that were previously impractical or impossible.
Types of 3D Printed Products in Development
Types of 3D printing devices include, custom devices, surgical cutting guides, orthopedic devices: bones, prosthetics, dental implants, synthetic or semi-synthetic biologics, peptides and proteins, DNA, RNA, si-RNA, Bioprints: skin, cartilage, skin, tissues and organs, blood vessels.
Current FDA Jurisdiction
Current FDA Jurisdiction include, 3D printed products are personalized medicine, most will also be orphan products. 3D printing is regulated primarily by the Office of Special Medical Programs (OSMP) under Office of the Commissioner, additionally by the Personalized Medicine Staff within CDRH’s Office of In Vitro Diagnostics and Radiological Health (OIR, previously OIVD), Office of Orphan Product Development (OOPD) and Office of Combination Products.
Issues with FDA Approval of 3D Printed products
The key issues with 3D printed products are: Each individual batch is unique, process can be approved not the product, traditional models of manufacturing not feasible: GMP and QSR compliance, traditional testing models not feasible, animal testing and clinical testing requirements need to be redefined and status of technological maturity.
Preprinting Considerations for 3D printing
Preprinting considerations for 3D printing are: Material chemistry, Raw material, components, Physical properties, Intermediates and finished products, Recyclability, Resorbable, absorbable, metabolizable, etc, Reproducibility and Process validation.
Here are some of the post printing considerations, Cleaning/excess material removal, effect of complexity on sterilization and biocompatibility, final device/product mechanics, design envelope/packaging/labeling and verification and release testing.
Future developments in 3D printing
The future developments in 3D printing could be FDA guidance on 3D printed products. First product to be approved: medical devices, Low to medium risk devices: Bones, dental implants, prosthetics. Custom Class III devices for emergency use, increased manufacture of complex hard to manufacture orphan products and scaffold cell-based combination products.