Sources Sought Notice_BWIT.pdf

Sources Sought Notice (SSN)

Burn Wound Imaging Technologies

SSN No.: BWIT-BARDA-2023

PURPOSE

The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is issuing this Sources Sought Notice (SSN) to collect information of specific product and service suppliers supporting the mission. Information collected from this SSN serves as market research whereby BARDA could partner with one or more organizations to achieve the preparedness goals set forth by the U.S. Government (USG). The information collected in response to this SSN is intended to strengthen BARDA’s understanding of the current and future marketplace. This notice seeks information from Other than Small Businesses (OTSB) and Small Businesses (SB) regarding their qualifications, experience, and capabilities.

BARDA’s mission is primarily to build national preparedness by developing a broad range of medical countermeasures (MCM) that mitigate various threats as elaborated in the sections below. Under this SSN, BARDA is specifically seeking burn wound imaging technologies that could enable physicians to efficiently triage burn patients and make more informed treatment decisions. The technologies sought are expected to function in routine healthcare settings such as emergency departments (ED) as well as in specialized burn centers and trauma units. Imaging technologies that are well-integrated in routine healthcare settings inherently build national preparedness and the capability to apply these tools during mass casualties involving burn injuries. (See Objective section below for details).

Based on the unmet needs in burn care, BARDA is seeking technologies with two capabilities for burn injury imaging and evaluation.

(1) To provide rapid and reliable estimates of the percent total body surface area (%TBSA) of the burn injury.

(2) To provide well-demarcated areas of potentially non-healing and healing burn injuries with a high degree of sensitivity, specificity and accuracy compared to the current standard of care.

In addition, other desirable attributes would be for the technology to be non-invasive and to display rapid, easy-to-interpret, actionable information for clinical decisions. The technology should have high potential to integrate within the current US healthcare settings (EDs, Trauma/Burn Centers) so functional aspects such as patient data management would link to electronic health records (EHR), thus bolstering product adoption.

AUTHORITY

The Office of Contracts, Management and Acquisition (CMA) issues this Sources Sought Notice (SSN) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) pursuant to FAR paragraphs 5.205(c), 15.201(e) and FAR parts 10, 19. Information collected in response to this SSN will enhance BARDA’s ability to establish potential vendor source files and listings and lawfully execute the preparedness mission efficiently and lawfully.

BACKGROUND

Within the Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures Division of BARDA, the Burn and Blast MCM program has a responsibility to build comprehensive national preparedness for the management of burns and blast trauma caused by nuclear detonation, whether accidental or intentional. Since 2013, the Burn and Blast program has been systematically executing the strategic priority to develop effective medical countermeasures (MCMs) across the entire care continuum for burn and blast trauma. Multiple products for the management of initial and definitive care burns and blast trauma injuries are already in development under Advanced Research and Development or Project BioShield (PBS) contracts.

While the Burn and Blast program at BARDA has invested in a large portfolio of MCMs to address many other types of injuries, MCMs for early characterization of burn injury after a Mass Casualty Incident (MCI) remain an unmet need. In this SSN, we outline the objective as well as the performance characteristics and functional rationale for the products in routine care and in burn mass casualty.

OBJECTIVE: Imaging for efficient burn injury assessment to guide treatment decisions:

A large burn mass casualty incident could quickly overwhelm the US healthcare infrastructure.

Severe burn injuries (especially, >10% TBSA) typically require highly specialized care for effective delivery of resource-intensive therapies including surgeries. Nationally, this capability is critically limited at multiple levels and would challenge timely access and treatment of those injured even in a relatively small incident.

This makes it imperative to leverage technology in the early phases of care so that healthcare workers can rapidly and accurately assess the size of injury (%TBSA) and evaluate the healing potential (or trajectory) of burn injuries to help manage patient triage. Such capability would be vital to identify patients who should be transferred to burn centers for definitive burn care versus those who could be discharged to home care.

Current standards for burn size and burn depth/ healing potential assessments rely on the visual clinical judgement of burn care providers in both ED and burn centers. Such experience based subjective standards at a critical first step create a cascading effect leading to unnecessary transfers4, wasted resources, and loss in quality of patient health care. During a MCI, trained burn care providers are likely to be inaccessible to aid with visual triage, given the relatively low availability of providers with this expertise nationwide1. Additional complications arise from the evolving nature of the burn injury2 itself, particularly in children. A recent review article showed that burn experts are 75% accurate at predicting early healing potential of burn injuries using visual clinical judgement, while non-burn care providers are accurate 50% of the time3. This could result in a significant number of patients either receiving unnecessary surgery (for example, otherwise healing wound) or having delayed essential surgery (from missed early interventions for non-healing wounds).

Under this SSN, BARDA is seeking information from product developers on imaging devices that provide accurate assessment of the size of injury (as %TBSA) and guidance on the healing potential of burn wounds. Developers must include performance data from burn centers and from emergency departments to be responsive. The potential impact of the imaging device on resource utilization and length of hospital stay would also be important for evaluation as a rough estimate of its cost-effectiveness.

PRODUCT USE SETTINGS

As elaborated in the Objective section, BARDA is seeking information about burn wound imaging technologies that can be used at any appropriate ED and hospital-based burn center. The device would be capable of reliably assessing %TBSA as well as the likely burn depth in the injured area. When used in the ED, the device output would support prioritization of patient transfer to burn centers. In a burn center, the device output could provide decision support for burn surgeons on the delivery of care and/or surgical treatment priorities.

1 Where There’s Smoke, There May Not Be a Burn Center. General Surgery News. April 1, 2019:

https://www.generalsurgerynews.com/In-the-News/Article/03-19/Where-There-s-Smoke-There-May-Not-Be-a-Burn-

Center/54309?sub=AE71C110BFBDFD1E89C24A693D937BA1FDD79031D7BA9664E7D6C12AA1EDB 2Herndon’s Total Burn Care 5th ed 2018 chapter 35 The pediatric burn patient page 379 3 Assessment of burn depth and burn wound healing potential. Burns. Volume 34-6, September 2008, Pages 761-769.

4 Swords et.al. Am Surg2015 Jan;81(1):56-63 https://www.generalsurgerynews.com/In-the-News/Article/03-19/Where-There-s-Smoke-There-May-Not-Be-a-Burn-Center/54309?sub=AE71C110BFBDFD1E89C24A693D937BA1FDD79031D7BA9664E7D6C12AA1EDB https://www.generalsurgerynews.com/In-the-News/Article/03-19/Where-There-s-Smoke-There-May-Not-Be-a-Burn-Center/54309?sub=AE71C110BFBDFD1E89C24A693D937BA1FDD79031D7BA9664E7D6C12AA1EDB

DEVELOPMENT STATUS:

Under this SSN, BARDA is seeking information from product developers on imaging devices that could already be cleared by the US Food and Drug Administration (FDA) or still under advanced development with a well-defined regulatory strategy, established in discussions with FDA. The product should at least have initial clinical performance data from a variety of adult and pediatric populations. Product developers should have a product development strategy and capability to execute commercialization in the US health care system. The product supply chain should be reliable with traceable components with US manufacturing preferred.

CAPABILITY STATEMENT/SUBMISSION INSTRUCTIONS:

1. Respondents must submit separate narratives covering technical and business-related information, each not exceeding 5 pages (total 10 pages)

2. The technical narrative shall cover only the most pertinent information, such as performance data, use-case settings, capability of the product and the company to adequately meet the objective and purpose described. If there are multiple product/combinations available, we recommend that you ideally select only one product (and not more than two) for which information is provided in your narrative. The narrative may include figures, schematics, diagrams, and photographs as needed within the page limit. Please ensure the narrative covers the following:

a. A clear description of the product’s intended use, functionality and use case setting (in line with the objective defined in the SSN).

b. Product use data supporting burn wound size estimation and potential for burn wound healing prognosis.

c. Ease of use and justification for use in routine burn care and especially in the context of a mass casualty incident.

d. User training requirements for use and communication for use in an emergency, capability to integrate with a hospital patient record system, software upgradability, remote performance monitoring/recalibration, or any other relevant functionality.

e. Ongoing training programs or widespread product use information or willingness/capabilities of the company to provide them, if applicable.

f. Summary information on relevant guidance from the most recent, FDA meeting regarding the product’s regulatory path towards approval for a burn healing assessment indication, if available.

g. Brief description of regulatory pathway status and summary of results of a pilot or pivotal study completed to support efficacy for accurate burn healing assessment

h. Description of product development and regulatory activities still needed to achieve FDA clearance.

i. Other potential uses of the same device in routine medical care and the stage of development for these other indications.

j. Company’s strategy and investments in other medical care market segments that may make the product sustainable.

3. The business narrative shall cover company information, including capability to supply the product.

This includes the following:

a. Company mission and description of the business information (registered as small business/NAICS code), including locations, management, and employees.

b. Organizational capability across the US, manufacturing and supply chain management of product including key product components, and risk mitigation strategies.

c. Relevant market information about the proposed product.

d. Market list price and typical commercial service operations for management of the components (if applicable).

e. Organizational experience in working with governmental agencies including federal, state, and local agencies.

f. Sources of investments (outside of USG investments, if any) that offer the company financial stability and capability to build broader markets for other investments.

4. The respondent shall complete the product information table in Appendix 1 of this SSN.

5. Respondents may mark the information as confidential, privileged, proprietary, trade-secret, copyrighted information, data, and materials with appropriate restrictive legends, as appropriate.

ASPR/BARDA will presume that any unmarked information, data, and materials were furnished with an “unlimited rights” license, as FAR subpart 27.4 defines that term. ASPR/BARDA assumes no liability for the disclosure, use, or reproduction of the information, data, and materials.

DISCLAIMER AND IMPORTANT NOTES

This notice is issued solely for information and planning purposes and does not obligate the US Government to award a contract. No entitlement to payment of direct or indirect costs or charges by the US Government will arise because of the submission of the requested information. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow up information requests. The US Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the US Government to determine the organization’s qualifications to perform the work. Respondents are advised that the US Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on SAM.gov under Contract Opportunities in accordance with FAR part 5. However, responses to this notice will not be considered adequate responses to a solicitation.

Responses shall be sent electronically to Kevin.Dean1@hhs.gov. Responses are due no later than February 28 by 3PM US EDT.

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY.

Contact POC: Kevin Dean (kevin.dean1@hhs.gov, (202) 730-8653)

Posting Date: February 2, 2023 mailto:Kevin.Dean1@hhs.gov mailto:kevin.dean1@hhs.gov

APPENDIX 1:

Product Company Latest Regulatory Activity

Stage of Development (POC, pilot, pivotal)

Intended Use for Burns (include clinical usage environments)

Capabilities (non-invasive /Image size/image speed/EMR integrated)

Hardware Size (footprint, weight, power needs, mobility)

Other Indication(s) & Stage of Development

Cost per unit Yearly Maintenance Cost & Schedule

Manufacturing Status (GMP) Capacity (annual/surge)