Donaldson Decompression Needle for Automated Treatment of Tension Pneumothorax

The Defense Health Agency seeks to develop a technology for automating needle decompression to more effectively manage tension pneumothorax on the battlefield. Critical Innovations, in conjunction with KARA & Associates, Benchmark Biotech, and consultant Captain David Tanen, MD, FAAEM, FACMT (USN, Ret.), have formed a team of experts to address this important need. During this Sequential Phase II project, our objective will be to develop the paradigm-shifting Donaldson Decompression NeedleÖ (DDNÖ), a universal, minimally-invasive, automated needle decompression device tailored to the battlefield environment. Sequential Phase II technical objectives include: completion of program-specific onboarding of requirements, goals, and schedule; production of human-usable devices for use in cadaver testing; performance of a cadaver study to evaluate DDNÖ placement in non-traditional sites; and maintenance of all project-specific regulatory compliance requirements and preparation to update device IFU.