Warfighter Brain Health (WBH) Technology Integration

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). Strategic oversight for the award(s) supported by this RPP will be provided by the Warfighter Brain Health Project Management Office (WBH PMO).

This “Warfighter Brain Health (WBH) Technology Integration” prototype project aims to create a systems integratory approach to developing an array of brain health medical solutions related to traumatic brain injury and behavioral health to meet the needs of the Warfighter. This prototype project is an innovative business arrangement for a system integrator to identify and rapidly test brain health medical solutions across the continuum of care that aids in the prevention, detection, and treatment of neurotrauma and behavioral health of our U.S. Service Members. Therefore, this RPP aims to establish an agreement with an organization able to provide the integration of technology, resources, and expertise required to translate technologies related to Warfighter brain health from early-stage development to transition to the Warfighter and the commercial marketplace.

This RPP also includes the development of a Non-Invasive Neuro-Assessment Device (NINAD) as the first prototype to be translated, but includes the innovative business component of identifying, rapidly prototyping, and testing additional medical solutions along the continuum of care for WBH. This prototype project includes prototyping projects that span the breadth of medical solutions intended to meet joint capability requirements for materiel prototypes that will protect, identify, assess, monitor, treat, and promote the recovery and restoration of Warfighters at risk/subject to TBI, behavioral health stressors and disorders (e.g., post-traumatic stress disorder), cognitive impairment, neurological injuries, and other means that impact the brain health and performance of our warfighters.

Scope of Work

The U.S. Department of Defense (DoD) has identified two (2) tasks for funding under this RPP. The intent of this RPP is to initially award Tasks 1 and 2 with a 12-month Period of Performance (PoP), with the potential for significant follow-on work. It is the Government’s intent that this initial award is part of a larger and longer project, potentially providing approximately $5-10M per year for follow-on work for up to ten (10) years (pending availability of funding and technical progress) as described in Section 3.4 of this RPP. All Enhanced White Paper submissions shall detail how the Offeror will accomplish/achieve all aspects of these Year 1 requirements to include a clear approach to execute all tasks based upon the Offeror’s unique methodology. Therefore, the Offeror shall also clearly identify the major milestones in the statement of work (SOW)/Milestone Payment Schedule associated with accomplishing these Year 1 requirements.

In Process Reviews (IPRs): As determined necessary by the Government, the Government may conduct periodic IPRs with the Awardee(s) to review the work completed and recommend modifications to the project’s plan and Awardee(s') team based on an assessment of the progress to date and the team(s') capabilities to meet the program’s technical requirements. These IPRs will ensure that the program maintains its maximum flexibility to adapt the direction and modify the team as new information develops and the technical requirements mature over the duration of the effort. Offerors are required to include the following within the Milestone Payment Schedule contained within the SOW (see Attachment 4 of the Proposal Preparation Guide (PPG) in the RPP):

• Awardees shall schedule an Initial Baseline Review with WBH PMO within 30 days of contract award.
• Offerors shall arrange a minimum of two (2) Reviews per year to provide the WBH PMO with updates regarding the status of the contract and prototype. IPRs shall occur: Within 150 to 180 days from the contract award date, repeated annually, and 30 to 60 days prior to the end of the performing year, repeated annually.

Following these Reviews, the Milestone Payment Schedule within the SOW shall include distinct Critical Decision Points (30 days following the IPRs). The Critical Decision Points will serve as discrete programmatic decision points, which will allow the Government to assess the progress to date, considering cost, schedule, and performance, and make a determination to proceed with subsequent milestones as awarded, renegotiate any aspect of the SOW/Milestone Payment Schedule, or end the project.

To meet the intent of this RPP, each proposal must address both Tasks 1 and 2 described below.

Task 1 – Prime Integrator Capabilities to Translate Brain Health Prototypes:

It is expected that MTEC will make a single award to a qualified team to accomplish all tasks. The project shall be led by a centralized point of contact at the prime performer to serve as the “Integrator.” It is possible that several subcontractors will be required to accomplish the full scope of the project and each effort thereunder.

The Integrator’s main role will be to support the development activities required to advance prototypes related to WBH along their maturation pipeline. The integrator’s role may include (but is not limited to) the following activities (as necessary for each effort):

1. Scout (on-going market research) and propose promising prototypes for development related to WBH for approval by the USAMMDA WBH PMO and its associated DoD Integrated Product Team, with the goal for add-on to this award for the execution of activities required for prototype translation.

2. Conduct strategic planning with the WBH PMO to ensure successful transition of market candidates and/or transitions from USAMRDC’s science and technology programs to USAMMDA for advanced product development.

3. Provide resources for early translational activities, such as team building, strategy, project management and planning, etc.

4. Provide access to vetted translational services and expertise related to the prototype development, including but not limited to:

• Non-clinical testing (to include pre-clinical, bench, and animal testing).
• Biocompatibility studies.
• Prototype refinement/maturation progressing toward a clinical product.
• Stability and shelf-life studies.
• Establishment of Good Manufacturing Practice capabilities for clinical trials and for market release [Contract Manufacturing Organization (CMO) capabilities].
• Clinical feasibility and pivotal studies (as needed) to support regulatory approval/clearance.
• Regulatory and reimbursement strategy.
• Clinical Research Organization (CRO) capabilities.
• Regulatory affairs and compliance capabilities.
• Investigational New Drug/Investigational Device Exemption Holder/Sponsor Responsibilities as per 21CFR312 subpart D.
• Prototype delivery for military-relevant testing.
• Draft product support documentation (e.g., training guides, product inserts, etc.).
• Development of a business and/or commercialization plan for market release.
• Development of DoD 5000 documentation and activities to support acquisition maturation.

5. Work closely with the USAMMDA Brain Health PMO to ensure alignment with the military requirement and to conduct military user testing as appropriate.

It is preferred that the Integrator has established experience in the advancement and commercialization of technologies related to brain health. It is also preferred that the Integrator has already had an established network of translational service providers at the time of Enhanced White Paper submission.

In the Enhanced White Paper, Offerors are expected to outline how they will conduct Activities #1-5 listed above. However, since Activities #3, 4, and 5 will ultimately be tailored to the specific prototype to be translated, Offerors will be evaluated on their general approach to conducting these activities for any prototype translation effort.

Furthermore, the Government recognizes that the composition of the team may change as the project requirements evolve over time. Therefore, the Offeror shall include the overall project management plan as part of the Enhanced White Paper submission (as required in Section 8). The Offeror shall also describe its strategy to adjust (i.e., expand) the team, as needed, throughout the period of performance (to include potential follow on tasks) to ensure the proper level of effort, access to the necessary subject matter experts, etc.

In order to obtain objective, unbiased integration solutions under Task 1, offerors are hereby notified that the Awardee for this effort will be permitted to submit, for government awareness, prototype solutions developed by the Awardee. However, the Awardee will not be permitted to conduct assessments or evaluations for their prototype solutions under Task 2 or any potential follow-on tasks.

Task 2 – Refinement of the Concept of Operations (CONOPS) and Analysis of Alternatives (AoA) for a far-forward assessment of TBI called the Non-Invasive Neuro-Assessment Device (NINAD):

The goal for a NINAD solution is currently defined as translation of a prototype technology to detect and assess the severity of Warfighter casualties suspected to have TBI in Multi-Domain Operations (MDO) that include austere environment(s) and prolonged field care with focus on use in Rehab and Outpatient Care 1 and 2 (ROC 1 and ROC 2). The NINAD solution is intended to be used by the Combat Medic (CM) to inform triage, evacuation, and treatment decisions far-forward in the field with low logistical footprint and (preferably) low unit cost. NINAD solutions should also be able to assess the status of confirmed TBI casualties that remain in theater and enable return to duty decisions. This latter part may contain cognitive assessment aspects.

The ideal NINAD solution shall meet the following requirements:

• Prototypes that are currently at a Technology Readiness Level (TRL) 3 or above, and are currently in development and commercially available (in at least prototype status) to enable use in an Early User Evaluation; specifically, to inform CONOPS that will provide criteria for use in an AoA.
• Prototype solutions must be capable of use at ROC 1 and ROC 2 in austere environments. As such, logistics footprint should be minimal. The need for cold chain is discouraged. Any potency and dated related consumables (if required) should not require cold chain and should have a shelf life of at least 12 months.
• Solutions, ultimately, must have the ability to achieve high sensitivity and specificity (>85%).
• It is desired that the candidates will be of low unit cost. (Upon award, a market research report will be provided to the Performer for further information.)

The WBH PMO realizes achievement of all the above requirements of the ideal NINAD solution may not be contemporaneously possible, necessitating the assessment of available candidates to inform CONOPS. Subsequently, the Government will use the assessment data to develop CONOPS, which will provide specifications to assist in the AoA (or equivalent) and a subsequent down-selection process.

The objective of Task 2 is for the Integrator to assist the WBH PMO through the Materiel Solutions Analysis Phase of the Defense Acquisition Process (as outlined in the DoD Instruction (DoDI) 5000 series) as it relates to the NINAD, including an analysis of alternatives and implementation of a sound, evidence-based down-selection process. The results of this assessment and the technology platform down-selection will be subject to review by the Milestone Decision Authority (MDA) at a forthcoming Milestone A decision. [Note: The MDA determines the point at which an activity enters the acquisition process and approves the program into subsequent phases of the acquisition process. More information about the MDA, Milestone A, and the DoDI 5000 series can be found here.

The end deliverables of Task 2 are to:

• Plan and conduct the activities required to enable a successful Milestone A (i.e., obtain approval by the Milestone Decision Authority (MDA)) to enter the Technology Maturation and Risk Reduction (TMRR) Phase, including activities to enable refinement/maturation of the existing CONOPS, New Concepts of Employment (CONEMPs), and the Capability Development Document (CDD) related to the NINAD;
• Plan and conduct an Early User Evaluation;
• Plan and conduct an AoA (or equivalent) using input/data from the aforementioned activities; and
• Propose a strategy for and produce other Milestone A related DoDI 5000 series documentation using an approach to “tailor in” necessary documentation.

Offerors are expected to describe the strategy and plan that will be employed to enable the assessment of available candidates and provide how the assessment data will be used to refine the CONOPS/CONEMPS, and establish specifications/attributes that will be used in a subsequent AoA (or equivalent), enabling the down-select a candidate technology platform. The Government will provide, as Government Furnished Information, upon award: the Market Research Report, Draft CONOPS, and a draft CDD.

In order to achieve the above, the Offerors shall describe in their Enhanced White Papers (as applicable) the strategy and plan they will use to conduct preliminary user assessment(s) of up to five different NINAD candidate solutions that will enable refinement of the existing CONOPS, CONEMPs, and the CDD, ensuring that the Government can substantiate the AoA and resulting technology platform down-selection, and provide other Milestone A requirements (per DoD 5000I series) for presentation to the MDA. These activities, and the subsequent Milestone A decision (if successful) will ensure that the Government is developing the correct technology platform in (potential) follow-on NINAD translation effort(s). Offerors should describe how they will interact with the WBH PMO to develop a plan to enable a successful Milestone A, including refinement/maturation of CONOPS, CONEMPS, CDD, and the subsequent planning and facilitation of the AoA to include development of the AoA report to support the Milestone A. The completed AoA report will enable a recommendation (to the MDA) for down-selection to a technology platform that will best meet the needs of the end user. The Offeror will also propose an acquisition strategy and produce other milestone documentation as appropriate to fulfill the requirements for a successful Milestone A decision.

At the time of submission, the Offeror is not required to have contractual relationships with the NINAD candidates that are proposed, but should describe how they will gain access to the proposed prototypes for evaluation.

Points of Contact

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