Temporary Corneal Repair Solution

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Department of Defense (DoD) U.S. Army Medical Materiel Development Activity (USAMMDA). Proposals selected as a result of this RPP will be awarded under the authority of 10 U.S.C. § 2371b. The award(s) will be managed by the Warfighter Expeditionary Medicine and Treatment (W-EMT) Project Management Office (PMO); specifically, by the chairperson of The Temporary Corneal Repair Integrated Product Team (IPT). The IPT will provide consultative input into the project as needed in preparation for their annual in-progress reviews with the Milestone Decision Authority, as well as interim reviews if needed more frequently.

This Request for Project Proposals (RPP) is focused on the development of a prototype that allows for temporary stabilization of corneal and corneoscleral injuries at a Role 1 battalion aid station. The desired prototype should be simple enough for a medic or physician’s assistant to administer under austere circumstances with little to no additional equipment; is safe enough to use on any suspected corneal or corneoscleral injuries; and is effective at stabilizing the eye such that it preserves the Warfighter's eyesight.

Scope of Work

Project Scope Period of Performance 1 and 2 (PoP1 and PoP2) and Non-competitive Follow-on Work:

The Government and MTEC expect that the Offerors’ proposed project scope and maturity will vary based on the initial maturity of the proposed prototype and the ability to meet the solution requirements listed in the RPP. Therefore, Government decisions regarding both the rolling down select and potential non-competitive follow-on work will be based on the advancement in prototype maturity (among other considerations) as it applies to each resultant award(s) during the performance of the prototype project(s). The Government may consider funding any of (but not necessarily limited to) the following work during any period (i.e., PoP1, PoP2) of the awarded prototype project(s) to include any non-competitive follow-on work (which may proceed PoP2 tasks):

• Prototype refinement/maturation progressing toward clinical product.
• Pre-clinical work (as needed) to support an Investigational Device Exemption (IDE) (or other appropriate U.S. Food and Drug Administration (FDA)) submission.
• Animal studies under Good Laboratory Practice (GLP) (as needed) to support IDE (or other appropriate FDA) submission.
• IDE (or other appropriate FDA) submission.
• Clinical feasibility studies (as needed) to support regulatory approval/clearance.
• Clinical pivotal studies (as needed) to support regulatory approval/clearance.
• Stability and shelf-life studies.
• Prototype delivery for military-relevant testing: (A) Testing of prototypes at U.S. Army Institute of Surgical Research (USAISR). (B) Testing of prototypes at Army Medical Department (AMEDD). (C) Product demonstrations.
• Establishment of Good Manufacturing Practice (GMP) manufacturing for clinical trials and for market release.
• Initial production runs, first article testing, etc.
• Low rate initial product runs to reach Full Operating Capability (FOC).
• Draft product support documentation (e.g., training guides, product inserts, etc.).
• Development of a business and/or commercialization plan for market release.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.