SBIR Phase I: Bioengineered Next-Generation Tympanostomy Tubes to Improve Patient Outcomes

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the advancement of implantable medical devices through innovative use of natural biopolymers, specifically silk and chitosan. Through the development of a novel manufacturing approach optimized for biopolymers, this project addresses significant limitations in traditional manufacturing methods and unlocks the potential of biopolymers for complex medical applications. The anticipated commercial impact includes reducing healthcare costs and improving patient outcomes, particularly for the millions of children requiring tympanostomy tubes annually. This project aims to eliminate the need for surgical removal of tympanostomy tubes by creating degradable, biocompatible, and antimicrobial alternatives, ultimately enhancing the quality of pediatric care and expanding market opportunities for advanced biomaterials in medical devices. This Small Business Innovation Research (SBIR) Phase I project focuses on a groundbreaking method to manufacture biopolymer-based implants using 3D printed molds, centrifugation, and polymerization. Unlike traditional manufacturing techniques, this approach ensures high fidelity to intricate geometries, minimizes waste, and allows for rapid prototyping. The project aims to develop degrade on-demand tympanostomy tubes from natural biopolymers with inherent antimicrobial properties. The research objectives include optimizing the manufacturing process, testing mechanical properties, and ensuring consistent quality. Anticipated technical results include demonstrating scalable production of complex 3D structures with superior mechanical integrity and biocompatibility, paving the way for broader application of natural biopolymers in various medical fields. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.