prehospital aortic occlusion device

Sources Sought Notice

The Naval Medical Logistics Command (NMLC) is seeking sources for the completion of testing required for the submission of a 510(k) (Premarket Notification) for a prehospital aortic occlusion device to the Food and Drug Administration (FDA). Additionally, following completion of testing, this proposed action also includes the subsequent submission of the 510(k) to the FDA.
The Naval Medical Research Center (NMRC) has a requirement for completion of testing required for the submission of a 510(k) (Premarket Notification) for a prehospital aortic occlusion device to the Food and Drug Administration (FDA). Completion of the testing is required for the subsequent submission of the 510(k) application to the FDA. Completion of the required testing must be inclusive of, but not limited to completion of the molded components that are ultimately part of the final design of the device. Additionally, Good Laboratory Practice (GLP) guidelines must be practiced and are required for the necessary biocompatibility testing, sterilization validation, aging & packaging testing and swine studies confirming observations in pre-GLP animal studies. The type of the proposed contract is Firm Fixed Price (FFP) with a period of performance is expected to be twelve (12) months from the date of contract award.
If capable sources are not identified through this notice, then NMLC intends to award a sole source contract under the authority of FAR 6.302-1 (one source) to MicroVention, Inc. for the performance of the described requirement. MicroVention is the only source that can complete the government's requirements as they are the sole manufacturer of the proprietary device that is protected under US Patent Application 2018/0055515 A1, Pub. Date: March 1, 2018.
This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.

Capability statements are due by 1:00 PM Local Time, 17 April 2019 Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: deborah.l.hagan.civ@mail.mil.

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