Burn Digital Assessment

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Materiel Development Activity (USAMMDA). Proposals selected for award as a result of this RPP will be awarded under the authority of 10 U.S.C. § 2371b (now 4022). Strategic oversight for the award(s) supported by this RPP will be provided by the Warfighter Expeditionary Medicine and Treatment (W-EMT) Project Management Office (PMO).

This RPP is 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, thus contributing to reduced surgical burden and increased Soldier return-to-duty.

Scope of Work

TECHNICAL REQUIREMENTS

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, fullthickness 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 with 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 BAS, Brigade Support Aid Station, FRSD, and FH to inform triaging, evacuation, and resourcing decisions, thus 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 vs. 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 definition of TRL 5 is summarized here.

TRL 5 Decision Criterion for Medical Devices: Investigational Device Exemption (IDE) review by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) results in determination that the investigation may begin. For a 510(k), preliminary findings suggest the device will be substantially equivalent to a predicate device.

TRL 5 Decision Criterion for Pharmaceuticals: A decision point is reached at which it is determined that sufficient data on the candidate drug exist in the draft technical data package to justify proceeding with preparation of an Investigational New Drug (IND) application.

TRL 5 Decision Criterion for Biologics: A decision point is reached at which it is determined that sufficient data on the candidate biologic/vaccine exist in the draft technical data package to justify proceeding with preparation of an IND application.

Required characteristics of the ideal solution: (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 Period of Performance (PoP) 1 and how they plan to satisfy all of the solution requirements in subsequent PoPs.):

• 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.
• Appropriate for use at Role of Care (ROC) 1 (unit-level medical care, i.e., Battalion Aid Station).
  • Purpose of Role 1:
    • Provides primary healthcare, specialized first aid, triage, resuscitation, and stabilization.
    • Casualty collection.
  • Providers:
    • Treatment provided by medics.
    • Expanded medical treatment provided by physician assistant, physician (if available), independent duty corpsman/medical technician, or pararescueman.
  • Role 1 facilities include:
    • Tent.
    • Limited power.
    • Limited space.
    • Highly mobile.
    • Not substantially climate controlled, if at all.
• Hand-held, self-contained device with size, weight, and cube that enables use at ROC1.
  • 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 a sunlight readable liquid-crystal display (LCD) (or similar) with 720p anti-reflection, anti-glare technology; is glovetouch capable; and has 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.
  • Hot-swappable, rechargeable batteries.
  • Meet MIL-STD-810 standards for vibration, temperature, humidity, altitude, and shock, and has an Ingress Protection rating of 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 U.S. Department of Defense (DoD) Cybersecurity requirements.
  • DoDI 8510.01 Risk Management Framework (RMF)
  • DoDI 8500.01 Cybersecurity
  • Complete the requirements under the RMF and obtain an Authority to Operate (ATO) and or Assess Only. 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: It can be marketed for the same or a different indication in the civilian market than what the 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.)

Proposers Conference

Points of Contact

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