SOLICITATION NOTICE
A -- Hemorrhage Detection Technology - 20-01-Hemorrhage Pre-Announcement
- Notice Date
- 10/28/2019
- Notice Type
- Presolicitation
- NAICS
- 54171
— Research and Development in the Physical, Engineering, and Life SciencesT
- Contracting Office
- Department of the Army, US Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-20-01-Hemorrhage
- Archive Date
- 12/12/2019
- Point of Contact
- Rebecca Harmon,
- E-Mail Address
-
rebecca.harmon@ati.org
(rebecca.harmon@ati.org)
- Small Business Set-Aside
- N/A
- Description
- 20-01-Hemorrhage Pre-Announcement This is a pre-announcement only. No response is required at this time. The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on the development of a noninvasive technology for early diagnosis and provider alert of decompensation due to hemorrhage and hemorrhagic shock in order to inform earlier lifesaving interventions and improve patient outcomes. Problem Statement Hemorrhage is the leading cause of trauma-related death in both civilian and military populations. More than 33% of prehospital deaths and 50% of deaths occurring within 24 hours of traumatic injury are from hemorrhage. Approximately 50% of combat-related preventable deaths that take place before reaching a military treatment facility (MTF) are hemorrhage related. A study of 4,596 battlefield fatalities from Operation Iraqi Freedom and Operation Enduring Freedom determined that hemorrhage accounted for 91% of potentially survivable fatalities occurring prior to arrival at an MTF. This supports the vital need for early detection and intervention. Technology Focus Area This program is intended to support the development or implementation of technological solutions that can provide early diagnosis information and alert of decompensation due to hemorrhage and hemorrhagic shock in order to inform earlier lifesaving interventions and improve patient outcomes. Offerors should only propose potential devices and technology solutions that meet the following three criteria: 1.Currently be at a Technology Readiness Level (TRL) of 5 or above [definition of TRL - https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf] 2.Currently be in development or commercially available; and 3.Must be capable of meeting the criteria for use in forward deployed environments and patient transport. Solution Requirements: An ideal solution would meet the following requirements (not listed in order of importance): •Have the ability to non-invasively monitor and alert the provider: owhen a patient is decompensating and at risk of impending hemorrhagic shock earlier than indicated by traditional vital signs or clinical practice, or othat a patient is experiencing significant hemorrhage that, if untreated, will inevitably lead to hemorrhagic shock •Be easily usable by combat medics and or physicians assistants at a Battalion Aid Station (or equivalent Service providers at Role 1) and during patient transport •Achieve FDA clearance/approval for use in trauma patients aged 18-65 •Provide data analysis and definitive output in real time or near real-time •Integrated into or replace an existing patient monitoring device; or be a small portable device (4 ounces, 4 cubic inches) •Requires no specialized personnel, maintenance requirements, or tools to operate or maintain the system •Be compatible with military operational environments (e.g., low visibility, extreme temperature variation, blackout conditions) •Be capable of passing airworthiness, safe-to-fly testing which includes electrical-magnetic interference testing, vibration testing, and crash testing •Be capable of meeting environmental testing parameters as stated in MIL STD 810G •Be capable of meeting Risk Management Framework requirements, as applicable (NIST Special Publication 800-37, Guide for Applying the Risk Management Framework) to gain authority to operate on military networks Government Furnished Information (GFI): Two Government laboratories have previously developed algorithms to detect decompensation due to hemorrhage using standard vital sign monitors: •The Automated Processing of the Physiologic Registry for Assessment of Injury Severity (APPRAISE) algorithm from the Biotechnology High Performance Computing Software Applications Institute (BHSAI) •The Compensatory Reserve Measurement (CRM) algorithm from U.S. Army Institute of Surgical Research (USAISR) Since Government laboratories are not eligible to serve as the prime contractor of white papers in response to MTEC funding opportunities, we encourage potential Offerors to partner with these laboratories as appropriate. The Sponsor neither endorses one algorithm as preferable over the other, nor over any algorithms developed by industry or academia. More information will be provided in the RPP. *NOTE: There is ample information publicly available regarding the APPRAISE and CRM algorithms. If you include one of these algorithms as part of your technical approach and you are invited for Full Proposal submission, then you will be provided with a point of contact at the respective Government laboratory to work with on your full proposal. Contact information for the Government laboratory partners will not be provided by MTEC at this time. Project Scope and Potential for Follow-on Work: The initial 12 month delivery schedule should be focused on tasks relevant to prototype development through proof of concept in a clinical study or system prototype demonstration in a relevant or operational environment for detection of decompensation due to hemorrhage and hemorrhagic shock. Allowable costs include subject matter expertise, consultation to develop a regulatory strategy, testing and evaluation, and clinical trial support. Potential follow-on work in subsequent years may be awarded to continue product development toward additional human clinical trial(s) and relevant FDA clearance/approval. Potential Funding Availability The U.S. Government (USG) currently has available approximately $2 million (M) Defense Health Program (DHP) Research, Development, and Engineering (RD&E) dollars for Fiscal Year (FY) 2020. An additional $2.75M of FY20 DHP funding may be available for potential follow-on work for the continuation of the development. Pending successful completion of the total effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f. MTEC anticipates that one or more awards will be made to qualified teams composed of teaming arrangements demonstrated to develop a hemorrhage detection technology prototype through demonstration in a relevant or operational environment. The initial Period of Performance (POP) is not to exceed 1 year. 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 format contained in the RPP. The Government will evaluate White Papers submitted and will select White Papers that best meet their current technology priorities using the criteria specified in the RPP. Offerors whose technology 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. The RPP will be posted to the MTEC website (mtec-sc.org) and FedBizOpps (fbo.gov) to notify interested parties. MTEC membership is required for the submission of a white paper in response to this upcoming MTEC RPP. To join MTEC, please visit http://mtec-sc.org/how-to-join/ MTEC The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel 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. MTEC Member Teaming While teaming is not required for this effort, Offerors are encouraged to consider teaming during the white paper preparation period (prior to submission of your white paper) if you cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government Sponsor. 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. Points of Contact For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts: •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 •MTEC Member Collaboration Database Tool - Ms. Melissa Sanchez, MTEC Program Administrator, melissa.sanchez@ati.org
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/MTEC-20-01-Hemorrhage/listing.html)
- Record
- SN05484017-W 20191030/191028230515-75d886002b203683082e2b84bd76d7f9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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