Burn Digital Assessment

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for an Other Transaction Agreement (OTA) Request for Project Proposals (RPP) 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. While this provides an approximate (albeit unreliable) measure of total body surface area (TBSA), it does not assist with discerning burn depth. 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.Project Objective: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 required characteristics of the ideal solution are as follows [Note: Proposed prototypes do not have to meet all of these specifications at the time of white paper submission, but Offerors must describe what they do plan to accomplish in the initial period of performance (PoP1) and how they plan to satisfy all of the solution requirements in subsequent PoPs.]:FDA clearance for assessing burn size and depthProvides reliable, objective measure of burn size in terms of TBSAProvides an objective measure of the proportion of TBSA for various burn depthsNon-invasive device that does not cause painSimple to use such that a physician’s assistant or medic could make the assessmentProvides simple output within minutes that does not require further interpretation.Appropriate for use at Role of Care (ROC) 1Hand-held, self-contained device with size, weight, and cube that enables use at ROC1Compatible with other burn and lifesaving treatmentsHas minimal training requirementsCompliant with DoD Cybersecurity requirementsPrototype must eventually become a commercially viable product or technology that will be brought to marketRefer to the full RPP for details regarding the required characteristics and additional preferred characteristics of the burn digital assessment tool.Scope of Work:The minimum acceptable technology readiness level (TRL) at the time of submission of the White Paper is TRL 5.  The proposed scope of work should be focused on tasks relevant to advance the prototype to the next TRL. Project scope should be proposed based on the prototype’s maturity at the time of submission. Examples of the work that could be included are described in the RPP.Potential Follow-On Tasks:Prior to the end of the initial PoP (PoP1), the 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 performer. 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 in a subsequent PoP (PoP2) of the prototype project. This down-select represents the Go/No-go Decision point between PoP1 (initial) and PoP2 (subsequent).  Subsequent Go/No-go decisions may also be implemented.Potential Funding Availability and Period of Performance:The U.S. Government (USG) currently has available a total of approximately $4.8 million (M) for this effort.It is expected that MTEC will make multiple awards to qualified Offerors in Fiscal Year (FY) 2023 to accomplish the scope of work. If a single proposal is unable to sufficiently address the entire scope of the RPP, several Offerors may be asked to work together in a collaborative manner.The initial PoP1 is not anticipated to exceed 24 months.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 USG will evaluate White Papers submitted and will select White Papers that best meet their current priorities using the criteria specified in the RPP. Offerors whose 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.For more information regarding the requirements of the White Paper process and template, refer to the RPP.This RPP is posted to the MTEC website (mtec-sc.org) and SAM.gov to notify interested parties. MTEC membership is required for the submission of an Enhanced White Paper. To join MTEC, please visit http://mtec-sc.org/how-to-join/.MTEC will host a Proposers Conference that will be conducted via webinar within two (2) weeks after the release of the RPP. Further instructions will be forthcoming via email and posted to the MTEC solicitations webpage: https://www.mtec-sc.org/solicitations/MTEC Member Teaming:While teaming is not required for this effort, Offerors are encouraged to consider teaming during the proposal preparation period (prior to Enhanced White Paper 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. Refer to Section 2.5 of the RPP for resources that may help Offerors provide a more complete team for this requested scope of work.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.Points 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.orgTechnical and membership questions – Dr. Lauren Palestrini, Ph.D., MTEC Director of Research, lauren.palestrini@mtec-sc.orgAdministrative and membership questions – Ms. Kathy Zolman, MTEC Director of Program Operations, kathy.zolman@ati.orgTo view this solicitation, visit www.mtec-sc.org/solicitations/