SBIR Phase II: Additive Manufacturing for Soft Tissue Repair by Three-Dimensional Microfiber Fabrication (3DMF)

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve the outcomes for upwards of 500,000 Americans each year who undergo shoulder soft tissue repair surgeries. Shoulder repair surgeries have an unacceptably high failure rate of around 25% and lack effective, economical, and easy-to-use treatment options in this $7B market. This NSF Phase II SBIR campaign will develop a multi-axial filament winding process (3DMF) for robotically positioning biological materials to medical device implants. 3DMF implants will be made more rapidly and economically than existing technologies, with extraordinary biomechanical performance, and, importantly, designed for facile surgical use without additional tooling or fixation for delivery, based on extensive surgeon-guided inputs. Upon commercialization, this technology will significantly reduce the cost of surgical implant augmentation and minimize surgical touch time, surgical complexity, and overall costs while providing a superior healing implant for challenging rotator cuff repairs. This Small Business Innovation Research (SBIR) Phase II project will biomanufacture 3DMF orthobiologic implants using human collagen resin and biopolymer yarns to form physiologically high-strength microfibrous implants that mimic native tissue strength and biology. This research advances knowledge in the field, progressing beyond existing limited additive and fiber-based manufacturing technologies (i.e., electrospinning, weaving, braiding, 3D printing, etc.) to provide features critical for the end-user surgeon. The work’s main objectives include: 1.) To biomanufacture quality-controlled 3DMF implants at the clinical scale; 2.) To optimize 3DMF arthroscopic surgical delivery and human factors, 3.) to determine 3DMF biomechanical performance, and 4.) To determine 3DMF device biocompatibility. Completing this work will progress product development of the 3DMF device with proven manufacturability, yielding implants with the required strength and accessible surgical approach for facile implantation within the existing surgical workflow to drive commercial adoption and reimbursement. This work specifically targets research and development of 3DMF implants for the rotator cuff repair niche with a large market with an unmet need for an accessible, economical, and effective solution. 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.