SOLICITATION NOTICE
A -- Burn Digital Assessment
- Notice Date
- 4/14/2022 8:54:52 AM
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
- ZIP Code
- 21702-5014
- Solicitation Number
- MTEC-22-08-BDA
- Response Due
- 5/13/2022 9:00:00 AM
- Point of Contact
- Lauren Palestrini
- E-Mail Address
-
lauren.palestrini@officer.mtec-sc.org
(lauren.palestrini@officer.mtec-sc.org)
- Description
- The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement (OTA) for prototype projects Request for Project Proposals (RPP) which will be focused on a burn digital assessment capability that will be utilized at the Battalion Aid Station (BAS), Brigade Support Aid Station, Forward Resuscitation and Surgical Detachment (FRSD), and field hospital (FH) to inform triaging, evacuation, and resourcing decisions, contributing to reduced surgical burden and increased Soldier return to duty. BACKGROUND: It is anticipated that, in future conflicts, the Army will have to fight and win across multiple domains in contested locations where air, ground, and nautical evacuations of casualties will be extremely challenging. Additionally, the explosive weapons that will likely be used against U.S. forces will be more powerful than what has been used to date, resulting in higher numbers of casualties with significant burn injuries including larger, more severe burns. Evacuating casualties within theater could take days or weeks due to contested air space and other area denial maneuvers by the enemy. As such, medical providers will have to manage burn casualties for longer periods of time at earlier roles of care. This will require that those providers decide how best to resuscitate those casualties and whom to prioritize for evacuation. With only minimal burn wound management tools available in the pre-hospital environment, determining resuscitation needs and evacuation priority can significantly impact return to duty rates and survivability. However, extant burn management tools do not include an objective burn assessment tool. Providers currently assess burns using estimation methods such as the Rule of Nines or the Rule of Palm. The Rule of Nines breaks the body down into 9% increments (e.g., front of leg = 9%, back of leg = 9%, entire arm = 9%) to help medical providers make a quick estimate of the total body surface area (TBSA) burned. Similarly, the Rule of Palm states that the size of a person�s palm (not including fingers and thumb) is equivalent to approximately 1% of their TBSA. While this provides an approximate (albeit unreliable) measure of TBSA, it does not assist with discerning burn depth. This is a difficult task even for experienced burn surgeons because of the varying ways burn wounds can appear visually. Burn surgeons average only a 60% accuracy when discerning full-thickness burns from partial-thickness burns. This is because more serious, full-thickness burns can appear less severe than a less serious, partial-thickness burn. Because the degree of burn severity encompasses both TBSA and burn depth, it is extremely challenging for far-forward medical providers (with less training and experience than burn surgeons) to accurately assess burn severity. Therefore, a digital assessment device will enable providers an objective measure of burn severity, enabling them to more accurately resuscitate and later triage and prioritize burn casualties. This enables more severe (but savable) burn casualties to be prioritized for evacuation, while preventing unnecessary evacuation for less severe burn casualties who could be treated closer to (or at) their unit. The Government is seeking a burn digital assessment capability that will be utilized at the Battalion Aid Station (BAS), Brigade Support Aid Station, Forward Resuscitation and Surgical Detachment (FRSD), and field hospital (FH) to inform triaging, evacuation, and resourcing decisions, contributing to reduced surgical burden and increased Soldier return to duty. Technological advances that contribute to a product solution that meet these requirements will be considered as possible candidates for fielding by the Burn Treatment and Skin Repair acquisition program. SOLUTION REQUIREMENTS: The overall goal of this RPP is to develop a hand-held, rugged device capable of providing an objective measure of burn severity by calculating burn size (in terms of TBSA) and burn depth (e.g., partial-thickness, full-thickness), including the proportion of TBSA for the various burn depths. The minimum acceptable technology readiness level (TRL) at the time of submission of the White Paper is at least TRL 5. The following requirements are expected to be delivered / demonstrated by the end of the Period of Performance (PoP). Therefore, Offerors shall address within the proposal submission how and when each of these will be accomplished during the PoP: Food and Drug Administration (FDA) clearance for assessing burn size and depth Provides reliable, objective measure of burn size in terms of TBSA Provides an objective measure of the proportion of TBSA for various burn depths (e.g., partial- thickness vs. full-thickness) Non-invasive device that does not cause pain (e.g., non-contact) Simple to use such that a physician�s assistant or medic could make the assessment Provides simple output within minutes that does not require further interpretation Hand-held, self-contained device with size, weight, and cube that enables use at Role 1 The system shall be no greater than 12 x 8 x .5 inches The system shall weigh between 1 to 6 pounds Display: The system shall have a 5� � 13� display that is sunlight readable LCD (or similar) display with 720p anti-reflection and anti-glare technology and glove-touch capable. A minimum brightness of 800 up to 1400 nits for optimal field usability and readability in direct sunlight. The system shall operate off of 100-240 VAC 50/60 Hz and 12-24 VDC powers sources. Power sources shall be capable of charging internal batteries while the system is running. Battery life span shall be at least 6 hours Meet MIL-STD-810G standards for vibration, temperature, humidity, altitude, and shock, as well as Ingress Protection (IP) rating IP65 dust and water compliant Designed to be maintained at the lowest level possible as appropriate for the system (e.g., field level, depot level, contractor logistics support). It is understood that this will need to be worked out iteratively as the prototype matures. Compatible with other burn and lifesaving treatments Has minimal training requirements Compliant with DoD Cybersecurity requirements DoDI 8510.01 Risk Management Framework (RMF) DoDI 8500.01 Cybersecurity Complete the requirements under the RMF and obtain an ATO. This will facilitate software updates, diagnostics, and other sustainment tasks that require computer resources. Prototype must eventually become a commercially viable product or technology that will be brought to market. (NOTE: can be marketed for the same or a different indication in civilian market than what DoD is seeking. If a different indication will be sought for the civilian market, FDA approval for the military�s intended use/indication will still need to be secured.) ADDITIONAL IDEAL CHARACTERISTICS: Beyond the requirements outlined above, additional ideal characteristics that are desired include: In cases of very large or circumferential burns, device can aggregate multiple readings from a single casualty into a total reading (i.e., total measure of burn size) Maps mixed-depth burns such that regions of full-thickness burns can be identified Can be used in a variety of light conditions Is multipurpose and can be used to assess other types of combat injuries (e.g., perfusion, amputation, critical wound ischemia) Potential Follow-On Tasks: There is the potential for award of one or more non-competitive follow-on tasks based on the success of the project (subject to change depending upon Government review of completed work and successful progression of milestones). Potential follow-on work may be awarded based on the advancement in prototype maturity during the PoP as well as a Go/No-Go decision point based on an in-process review. Follow-on work may include tasks related to advancement of prototype maturity, and/or to expand the use or utility of the prototype. POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE: The U.S. Government (USG) currently has available a total of approximately $4.8 million (M) for anticipated awards to be made during FY2023. Award and funding from the Government is expected to be limited to the funding specified above and is contingent upon the availability of federal funds for this program. Awards resulting from this RPP are expected to be made under the authority of 10 U.S.C. � 2371b. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the Government funding to be provided under the resultant award(s). � MTEC anticipates that multiple awards may be made. Award funding will be structured incrementally and based upon completion of Milestones and Deliverables. The initial Period of Performance (PoP1) is expected to be 24 months, dependent upon product type and level of maturation required. ACQUISITION APPROACH & ROLLING DOWNSELECT: This RPP will be conducted using a White Paper approach. The two-stage approach for this RPP is intended to streamline the initial proposal preparation time and effort for MTEC members. The USG 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. 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 upcoming 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). Additional details will be providing in the upcoming RPP regarding the Go/No-go Decision Point, the estimated timeframe of the IPR, etc. This upcoming RPP will be posted to the MTEC website (https://www.mtec-sc.org/solicitations/) and a summary version will be available on sam.gov to notify interested parties. The RPP is expected to be released as soon as possible and will have a short proposal preparation period (approximately 30 days). 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 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 For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Lauren Palestrini, MTEC Director of Research Programs, lauren.palestrini@mtec-sc.org.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/30ffee9f71574744afaf4ba03e6fa699/view)
- Place of Performance
- Address: Frederick, MD 21702, USA
- Zip Code: 21702
- Country: USA
- Zip Code: 21702
- Record
- SN06298130-F 20220416/220414234140 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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