SPECIAL NOTICE
99 -- MTEC 20-14-Ocular RPP Annoucement for Temporary Corneal Repair Solution
- Notice Date
- 7/7/2020 9:47:17 AM
- Notice Type
- Special Notice
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-20-14-OcularRPPAnnoucement
- Response Due
- 8/6/2020 9:00:00 AM
- Archive Date
- 08/21/2020
- Description
- The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) 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 it under austere circumstances with little to no additional equipment, safe enough to use on any suspected corneal or corneoscleral injuries, and effective at stabilizing the eye such that it preserves the Soldier�s eyesight. BACKGROUND: In future combat scenarios where the U.S. could face a peer or near-peer adversary, the ability to evacuate casualties from the battlefield, and even out of theater, will be severely hampered.� Large-scale combat operations will put high numbers of Soldiers into a fight where tactical areas are highly contested and operationally degraded.� Freedom of movement, whether by air or land, will be difficult such that moving supplies and causalities to/from the front lines could take days or weeks.� Unfortunately, blasts will continue to be a significant source of ocular trauma in the future fight.� Without surgical intervention by an ophthalmologist, seriously injured ocular tissue is not viable after 24-36 hours.� Given protracted evacuation timelines and a lack of specialists in theater, it will be impossible for the necessary specialists to treat these ocular injuries early enough to preserve the eyesight of these wounded Soldiers.� In order to address corneal and corneoscleral injuries earlier and in a way that is relevant to the future fight, a product that allows for temporary stabilization of corneal and corneoscleral injuries at a Role 1 battalion aid station is needed.� The desired product should be simple enough for a medic or physician�s assistant to administer it under austere circumstances with little to no additional equipment, safe enough to use on any suspected corneal or corneoscleral injuries, and effective at stabilizing the eye such that it preserves the Soldier�s eyesight. SOLUTION REQUIREMENTS: This program is intended to support the development of prototype technologies that allow temporary stabilization of corneal and corneoscleral injuries at a Role 1 battalion aid station. Offerors should only propose technology solutions that meet the following two criteria as the following specifications define the minimum prototype requirements that all proposals must demonstrate: Currently at a Technology Readiness Level (TRL) of 4 or above [definition of TRL � https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf] Currently in development or commercially available. An ideal solution would meet the following requirements (not listed in order of importance). Although White Papers that propose to meet all of the solution requirements outlined below are preferred, we encourage you to submit even if you cannot currently meet all these specifications within the project period of performance (refer to full RPP for more detail): A product that will temporarily stabilize suspected full-thickness corneal and corneoscleral injuries that is capable of obtaining approval/clearance by the U.S. Food and Drug Administration (FDA) for this indication Preserves ocular tissues Capable of stabilizing suspected full-thickness corneal and corneoscleral wounds of various shapes and sizes, with or without prolapse of other ocular structures, contributing to the preservation of ocular tissue.� A non-surgical solution that can be applied to the surface of the injured eye that does not require any specialized equipment (beyond an included applicator) Topically administered to the eye Simple to use/apply (based on design of applicator, process for administration, time to prepare, etc.) Doesn�t require a surgical microscope, surgical loupes, specula, etc. Can be left in place or reapplied for up to 3 days (even higher durations are ideal) Removable and/or reversible Does not cause disproportionate damage to eye when removed Either sloughs off/is resorbed into the body; or can be safely removed by ophthalmologist in preparation for/during definitive repair surgery Could be reapplied, if needed Appropriate for use at Role 1 (unit-level medical care, i.e., Battalion Aid Station) [Refer to the Emergency War Surgery for Roles of Care definitions: https://www.cs.amedd.army.mil/FileDownloadpublic.aspx?docid=6f9e0685-1290-4e92-8277-c1e7b0f2fef0] Capable of achieving a shelf life of at least two years at room temperature Doesn�t require climate-controlled transit or storage Commercially viable product or technology that will be brought to market (can be marketed for different indication in civilian market than what DoD is seeking) Project Scope (Periods of Performance 1 & 2, PoP1 & PoP2) and non-competitive Follow-on Work: The Government and MTEC expect that 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 above.� 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 the following (but not necessarily limited to the) work listed below 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 towards clinical product Pre-clinical work (as needed) to support an Investigational Device Exemption (IDE) (or other appropriate 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 Testing of prototypes at US Army Institute of Surgical Research (USAISR) Testing of prototypes at Army Medical Department (AMEDD) 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 Go/No-go Decision Point for Downselect: Prior to the end of the base PoP1, Government will conduct an in process review (IPR), in which the Awardees will attend and participate in, to assess the work completed for each PoP1 Awardees. The IPR will be an in-person meeting at USAMRDC at Fort Detrick, MD. Following the IPR, the Government intends to down-select Awardees to a smaller number for continuation of funding for the conduct of follow-on work representing PoP2 or the subsequent PoP of the prototype project. This down-select represents the Go/No-go Decision point between PoP1 (base) and PoP2 (subsequent). ACQUISITION APPROACH: This RPP will be conducted using a two-staged approach. In Stage 1, current MTEC members are invited to submit White Papers using the mandatory format contained in this RPP. The Government will evaluate White Papers submitted and will select White Papers that best meet their current technology priorities. Offerors whose proposed solution is selected for further consideration based on White Paper evaluation will be invited to submit a proposal in Stage 2. Notification letters will contain specific Stage 2 proposal submission requirements.� Offerors are hereby notified that the Government intends to utilize a rolling downselect approach during the performance of prototype projects awarded as a result of the RPP. Using this approach, the Government intends to award projects, structured into two Periods of Performance (PoPs), with an initial base period (PoP1) reflecting the first of the two PoPs. After an In-Process Review (IPR), an evaluation of project deliverables and other considerations to include progress towards completion of the base PoP tasks, the Government intends to award a second PoP, referred to as the subsequent PoP (PoP2),� to the performer(s) that demonstrates a best value approach for follow-on tasks. Award decisions for the subsequent PoP (PoP2) work will be completed during the Go/No-go Decision Point which is expected to occur prior to the end of the base PoP (PoP1). White Papers are due no later than August 6, 2020 at 12:00pm Eastern Time. The RPP is posted to the MTEC website (mtec-sc.org) and a notice is posted on www.beta.SAM.gov to notify interested parties. MTEC membership is required for the submission of a full proposal in response to this MTEC RPP. Offerors submitting White Papers as the prime contractor must be MTEC members of good standing by August 3, 2020.� To join MTEC, please visit http://mtec-sc.org/how-to-join/ A Proposers Conference via webinar will be held for interested parties to have their questions answered by the USG after the RPP is posted.� MTEC Members will be notified when the Proposers Conference is scheduled. POTENTIAL FUNDING: The U.S. Government (USG) currently has available approximately $3.5 million (M) for the base period of performance (PoP1) of up to 24 months.� MTEC anticipates that multiple awards will be made. An additional $6.3M of funding is anticipated for the performer(s) that is selected for the continuation of prototype development under the subsequent PoP (PoP2) of the resultant award(s), after the Go/No-go Decision Point. � MTEC MEMBER TEAMING: While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to proposal submission) if they cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government. MTEC members are encouraged to use the MTEC Database Collaboration Tool to help identify potential teaming partners among other MTEC members. The Database Collaboration Tool provides a quick and easy way to search the membership for specific technology capabilities, collaboration interest, core business areas/focus, R&D highlights/projects, and technical expertise. Contact information for each organization is provided as part of the member profile in the collaboration database tool to foster follow-up conversations between members as needed. The Collaboration Database Tool can be accessed via the �MTEC Profiles Site� tab on the MTEC members-only website. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters� health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, �nontraditional� defense contractors, academic research institutions and not-for-profit organizations. POINT OF CONTACT: Please direct your inquiries and correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator at� mtec-contracts@ati.org Technical and membership questions � Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@officer.mtec-sc.org Administrative questions � Ms. Kathy Zolman, MTEC Director of Program Operations, kathy.zolman@ati.org To view this solicitation, click here.
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- Record
- SN05713095-F 20200709/200707230149 (samdaily.us)
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