Large-scale manufacturing of precisely patterned flexible soft tissue implants with high porosity

Area of Science:

• Biomaterials Engineering
• Regenerative Medicine
• 3D Printing Technology

Background:

• Stereolithography (SLA) 3D printing offers high precision for soft tissue construct prototyping.
• Clinical-grade manufacturing validation is crucial for FDA approval of medical devices.
• Nipple-areolar complex (NAC) reconstruction impacts aesthetic outcomes in breast reconstruction.

Purpose of the Study:

• To present a validated manufacturing process and post-manufacturing analysis for soft-tissue implants for NAC reconstruction.
• To establish standardized procedures for macroporous soft-tissue implant fabrication under Good Manufacturing Practice (GMP).
• To define minimum acceptable criteria for future soft-tissue implant production based on architectural and mechanical features.

Main Methods:

• Designed and 3D printed physiologically-sized NAC implants using Formlabs Biomed Elastic 50A (E 50A) and Biomed Flexible 80A (F 80A) resins in a GMP facility.
• Developed documentation and procedures for standardized macroporous soft-tissue implant manufacturing.
• Classified implants post-manufacturing based on architectural and mechanical properties.

Main Results:

• E 50A implants exhibited stiffness similar to soft tissue; F 80A geometries demonstrated superior reproducibility and preservation of fine features.
• SLA printing achieved implant porosities of 74.65% (0.4-mm) and 72.74% (0.5-mm).
• 3D printed implants showed >97% filling efficiency for gelatin methacrylate infusion, supporting biological cue delivery.

Conclusions:

• The developed manufacturing platform reproducibly fabricates soft-tissue implants meeting structural and mechanical requirements.
• The methodology is adaptable for various complex soft tissues, advancing regenerative medicine solutions.
• This approach facilitates regulatory approval and clinical integration of novel soft-tissue regenerative therapies.