Development and Commercialization of an Ideal Mechanical Wound Therapy System
Technical Report,30 Jan 2014,29 Sep 2015
J and M Shuler Medical, Inc Athens United States
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This was a 15-month pilot study, the purpose of which was to progress the development and commercialization efforts of a novel advanced wound care device. The SubAtmospheric Woundcare System SAWS is a next-generation dressing for Negative Pressure Wound Therapy NPWT systems, which answers unmet needs of combat casualty care and civilian providers that have been known and unaddressed over the last decade. The innovative features of this dressing are its unified and universally customizable fabrication, integration of active irrigation and overcoming in-growth and other adverse events related to non-ideal COTS wound filler. This project had 2 primary phases. In the initial phase, design work and bench testing led to an optimized prototype for animal testing. The second phase included a 3-tier animal testing protocol IACUCACURO approved, which identified areas for iterative improvement of the prototype and served as a basis for burden of proof data needed to support a FDA 510-K application for this dressing system and future grant applications to address additional critical unmet needs in combat casualty wound care, specifically for wounds about the face, scalp and special areas. The stated tasks of this proposal were all accomplished on-time and on-budget. The outcome of this work is a mature, TRL 8 design frozen prototype that has successfully overcome sealing issues which plague all COTS NPWT dressings and is the first to provide safe and effective care for 6 continuous days. The prolonged use, negates repetitive and painful dressing change procedures, that are required 2-3x more frequently with COTS dressings. While great advance was made, especially given the small budget of this pilot project, work remains to translate the findings of this project into clinically available solutions to unmet military and civilian advanced wound care needs.