Portable Ultrasound for Transcranial Imaging

Notice of Intent No.: W81XWH-18-J-1867

The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue an out of scope modification to contract W81XWH-15-C-0115 on a sole source basis under the authority of FAR 6.302-1(a)(2) to UltraDiagnositics, Inc.; Waltham, MA 02451-7542. UltraDiagnostics, Inc. holds the current Joint Warfighter Medical Research Program (JWMRP) contract (W81XWH-15-C-0115) to develop a prototype of their ultrasound system capable of transcranial imaging to assess brain trauma. At this point the prototype has been developed. The Government now seeks to gain FDA authorization for the device by conducting feasibility and pivotal clinical trials. This is the only Technology Readiness Level (TRL) 5 product on the market, and was developed by UltraDiagnostics, Inc. who currently holds the patent for this product. The Government intends to conduct a sole source modification to the existing contract (W81XWH-15-C-0115) to advance from a TRL 5 ready product, to TRL 6. This effort is determined to be non-severable, and entails a project duration of 36 months.

TRL 5 Definition: Component and/or breadboard validation in relevant environment. Fidelity of breadboard technology increases significantly. The basic technological components are integrated with reasonably realistic supporting elements so they can be tested in a simulated environment. Examples include "high-fidelity" laboratory integration of components.

This modification is considered to be out of the scope of the original size of the current contract, W81XWH-15-C-0115, based on the dollars awarded. However, the tasking and time being added to the award is deemed within the general scope of the contract. The new tasking being added is deemed to be the logical maturation of the original requirements that both parties could have foreseen developing from the original requirements at time of original contract award.

This notice of intent 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 modification to the existing contract.

Capability statements are due by 9:00 AM Local Time, April 30, 2018. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to Matthew Teel at, matthew.d.teel.civ@mail.mil.  No Phone calls will be entertained at this time.  Only written responses will be accepted.