NeuroWave Systems, Inc., AccuPump AP-400 System

Notice-of-Intent (NOI) PANMRA-21-P-0000 005522 The U.S. Army Medical Research and Development Command (USAMRDC) and the U.S. Army Medical Research Acquisition Activity (USAMRAA), in support of The Telemedicine and Advanced Technology Research Center (TATRC), intends to issue sole source, firm-fixed priced (FFP) solicitation W81XWH-21-Q-0173 for NeuroWave Systems, Inc., AccuPump AP-400 System. The authority for the sole source justification and other than full and open competition procedures will be in accordance with (IAW) FAR 13.106-1(b)(1)(i), Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements. NeuroWave Systems, Inc., is the sole manufacturer and distributor of the AccuPump AP-400 system. NeuroWave Systems, Inc., AccuPump AP-400 system is an advanced infusion pump device that allows for remote control of device settings and algorithmic control of fluids provision via an integrated system computer. TATRC has several research projects that involve remote control and monitoring of medical devices, as well as potential autonomous control of medical therapy systems. The capabilities of this device are novel and expand beyond those of other existing infusion pump devices due to the inclusion of an onboard computer module and its integration with the device's control systems. Other existing infusion pump devices have been designed with a simple user interface and control structure in mind, with the assumption that the user would only read or alter settings when in direct proximity to the device. The AccuPump system's onboard computer supports more complex control capabilities beyond just a standard physical "set and stay" paradigm, thus allowing the integration of remote control functionality or algorithmic control for the specific alteration of therapy directives. The unique integrated computer also supports the potential for system-wide inclusion of the device into a more complex fully integrated clinical environment, allowing interoperability with other medical devices. The North American Industry Classification System (NAICS) for this requirement is 339113 - Surgical Appliance and Supplies Manufacturing and the size standard of 750 employees. PSC 6515 Medical and Surgical Instruments, Equipment, and Supplies. This announcement fulfills the synopsis requirements under FAR 5.203(a). Interested concerns must identify their capability in writing (formats for submission: PDF, MS Word, or MS Excel) to Ms. Maribel C. Fratina, Contract Specialist, at email: maribel.c.fratina.civ@mail.mil and Mr. Thomas L. Hood at email: thomas.l.hood26.civ@mail.mil, no later than (NLT) seven (7) days after the publication of this notice 18 August 2021 at 1000 Eastern Standard Time (EST). This NOI announcement for NeuroWave Systems, Inc., AccuPump AP-400 system is not a request for competitive quotations. However, the Government will consider all responses received. After the publication of this NOI PANMRA-21-P-0000 005522, solicitation W81XWH-21-Q-0173 will be posted on or about 25 August 2021. The Government will not be responsible for any cost incurred in preparation of quotations. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a subsequent competitive procurement. All interested parties may submit a response for consideration via email to Ms. Maribel C. Fratina, Contract Specialist, at email: maribel.c.fratina.civ@mail.mil and Mr. Thomas L. Hood at email: thomas.l.hood26.civ@mail.mil. See attached NOI and redacted J&A for further details.