Pre-Annoucement for Solicitation Number 20-14-Ocular - Temporary Corneal Repair Soluction
The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on the development of a prototype that allows for temporary stabilization of corneal and corneoscleral injuries at a Role of Care (ROC) 1 battalion aid station. The desired prototype should be simple enough for a medic or physician’s assistant to administer it under austere circumstances with little to no additional equipment, safe enough to use on any suspected corneal or corneoscleral injuries, and effective at stabilizing the eye such that it preserves the Soldier’s eyesight.
Background
In future combat scenarios where the U.S. could face a peer or near-peer adversary, the ability to evacuate casualties from the battlefield, and even out of theater, will be severely hampered. Large-scale combat operations will put high numbers of Soldiers into a fight where tactical areas are highly contested and operationally degraded. Freedom of movement, whether by air or land, will be difficult such that moving supplies and causalities to/from the front lines could take days or weeks.
Unfortunately, blasts will continue to be a significant source of ocular trauma in the future fight. Without surgical intervention by an ophthalmologist, seriously injured ocular tissue is not viable after 24-36 hours. Given protracted evacuation timelines and a lack of specialists in theater, it will be impossible for the necessary specialists to treat these ocular injuries early enough to preserve the eyesight of these wounded Soldiers.
In order to address corneal and corneoscleral injuries earlier and in a way that is relevant to the future fight, a product that allows for temporary stabilization of corneal and corneoscleral injuries at a Role 1 battalion aid station is needed. The desired product should be simple enough for a medic or physician’s assistant to administer it under austere circumstances with little to no additional equipment, safe enough to use on any suspected corneal or corneoscleral injuries, and effective at stabilizing the eye such that it preserves the Soldier’s eyesight.
Solution Requirements
This program is intended to support the development of prototype technologies that allow temporary stabilization of corneal and corneoscleral injuries at a Role 1 battalion aid station.
Offerors should only propose technology solutions that meet the following two criteria:
Currently be at a Technology Readiness Level (TRL) of 4 or above [definition of TRL –
https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]; and
Currently be in development or commercially available.
An ideal solution would meet the following requirements (not listed in order of importance):
A product that will temporarily stabilize suspected full-thickness corneal and corneoscleral injuries that is capable of obtaining approval/clearance by the U.S. Food and Drug Administration (FDA) for this indication
Preserves ocular tissues
Effective at preserving ocular tissues in a clinical model (with intent to restore vision) such that they can be surgically repaired in 25-50% of cases, or greater
Capable of stabilizing suspected full-thickness corneal and corneoscleral wounds of various shapes and sizes, with or without prolapse of other ocular structures, contributing to the preservation of ocular tissue. Some examples could include:
Creates a watertight seal over the corneal or corneoscleral injury
Is oxygen permeable
Safe to use even in presence of intraocular foreign body(ies)
Prevents infection
Enables maintenance of intraocular pressure in safe ranges (product itself does not need to re-establish intraocular pressure)
A non-surgical solution that can be applied to the surface of the injured eye that does not require any specialized equipment (beyond an included applicator)
Topically administered to the eye
Simple to use/apply (based on design of applicator, process for administration, time to prepare, etc.)
Can be administered by non-licensed medical personnel quickly and easily (see attributes of Role 1 medical setting below)
Doesn’t require a surgical microscope, surgical loupes, specula, etc.
Can be left in place or reapplied for up to 3 days (even higher durations are ideal)
Removable and/or reversible
Does not cause disproportionate damage to eye when removed
Either sloughs off/is resorbed into the body; or can be safely removed by ophthalmologist in preparation for/during definitive repair surgery
Could be reapplied, if needed
Appropriate for use at Role 1 (unit-level medical care, i.e., Battalion Aid Station) [Refer to the Emergency War Surgery for Role of Care definitions:
https://www.cs.amedd.army.mil/FileDownloadpublic.aspx?docid=6f9e0685-1290-4e92-8277-c1e7b0f2fef0]
Capable of achieving a shelf life of at least two years at room temperature
Doesn’t require climate-controlled transit or storage
Commercially viable product or technology that will be brought to market (can be marketed for different indication in civilian market than what DoD is seeking)
Project Scope and Potential for Follow-on Work:
Project scope will be awarded based on the initial maturity of the proposed prototype. Potential follow-on work may be awarded based on the advancement in prototype maturity during the Period of Performance (POP). The work in the initial POP and potential follow-on awards could include, but are not necessarily limited to:
Prototype refinement/maturation progressing towards clinical product
Pre-clinical work (as needed) to support IDE (or other appropriate FDA) submission
GLP animal studies (as needed) to support IDE (or other appropriate FDA) submission
IDE (or other appropriate FDA) submission
Clinical feasibility studies (as needed) to support regulatory approval/clearance
Clinical pivotal studies (as needed) to support regulatory approval/clearance
Stability and shelf-life studies
Prototype delivery for military-relevant testing
Testing of prototypes at US Army Institute of Surgical Research (USAISR)
Testing of prototypes at Army Medical Department (AMEDD)
Product demonstrations
Establishment of GMP manufacturing for clinical trials and for market release
Initial production runs; first article testing, etc.
Low rate initial product runs to reach Full Operating Capability (FOC)
Draft product support documentation (e.g., training guides, product inserts, etc.)
Development of a business and/or commercialization plan for market release
Potential Funding Availability
The U.S. Government (USG) currently has available approximately $3.5 million (M) Defense Health Program (DHP) Research, Development, and Engineering (RD&E) dollars for Fiscal Year (FY) 2021. An additional $6.3M of FY22 and FY23 funding may be available for potential follow-on work for the continuation of the development. Pending successful completion of the total effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.
MTEC anticipates that one or more awards will be made to qualified teams composed of teaming arrangements demonstrated to develop a temporary corneal repair prototype through demonstration in a relevant or operational environment.
The initial Period of Performance (POP) is 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 Government 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.
The RPP will be posted to the MTEC website (mtec-sc.org) and beta.SAM.gov to notify interested parties. 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
The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel 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.
MTEC Member Teaming
While teaming is not required for this effort, Offerors are encouraged to consider teaming during the white paper preparation period (prior to submission of your white paper) if you cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government Sponsor.
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.
Point of Contact
For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@officer.mtec-sc.org
MTEC-20-14-Ocular Department of the Army Medical Command
6/1/20, 3:24 PM MTEC Pre-Announcement: Military Operational Medicine - Improving Protection through Metrics for Exposure to Blast, and Enhancing Cognitive Health, Performance and Psychological Health
The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on the development of the following 2 prototypes in support of MTEC’s Military Operational Medicine technology focus area:
FOCUS AREA #1 (Whole Body Blast): Development of survivability criteria and vital organ injury metrics for the whole body when exposed to extreme blast exposures (e.g., IEDs).
FOCUS AREA #2 (Cognitive / Brain Health & Performance): Development and validation of personalized training or materiel (pharmacological/technological) approaches to build and enhance cognitive/brain health, performance and psychological health.
PROGRAM BACKGROUND:
The U.S. Army’s Military Operational Medicine Research Program (MOMRP) focuses on the development of countermeasures that address military-relevant stressors and prevent physical and psychological injuries during training and operations in order to maximize health, readiness, and performance.
SOLUTION REQUIREMENTS:
The MOMRP has identified two focus areas for funding under this RPP. To meet the intent of this upcoming RPP, each proposal MUST specifically address only ONE of the two Focus Areas described below. Offerors are not limited to a single proposal submission. Projects not aligned to at least one of these Focus Areas will not be considered for funding.
FOCUS AREA #1 (Whole Body Blast): Development of survivability criteria and vital organ injury metrics for the whole body when exposed to extreme blast exposures.
Personal protection equipment (PPE) for the Warfighter has been designed to primarily protect against injuries from projectiles, shrapnel, debris and blunt object impact in training and combat operational environments. At present, there are no appropriate guidelines and test methodologies to evaluate the protective performance of PPE, such as body armor and bomb suits, against primary blast. Therefore, this project aims to develop survivability criteria and vital organ injury metrics relevant to personnel exposed to potentially lethal primary blast, such as that resulting from improvised explosive devices (IEDs).
During the PoP, the Awardee shall establish medically-based criteria (i.e., blast injury risk curves) for evaluation of the protective efficacy of PPE (i.e., bomb suits and body armor) for Warfighters. The Awardee shall coordinate with research leads at the Walter Reed Army Institute of Research (WRAIR) and non-medical investment stakeholders to address one or more of the following gaps that is not redundant with the expertise of WRAIR researchers:
Establish metrics to assess the effectiveness of PPE against primary blast using biological surrogate models.
Develop survivability dose-response relationships and vital organ blast injury criteria for primary blast exposure.
Utilize different animal experimental models (i.e., differently scaled species) in conjunction with surrogate models to define blast-induced injuries and scaling factors for blast-induced vital organ injury (e.g., brain and lung) that can be readily translated to humans.
Define biomechanical parameters associated with established injury levels for individual vital organs and cognitive functional outcomes.
Multi-institutional partnerships are highly encouraged particularly with expertise in scaling animal research to biological surrogate models and developing Warfighter-relevant injury metrics.
END GOAL: Provide whole body blast injury criteria to evaluate the next generation bomb suit and body armor blast personal protection equipment.
2. FOCUS AREA #2 (Cognitive/Brain Health & Performance): Development and validation of personalized training and/or materiel (pharmacological/technological) approaches to build and enhance cognitive/brain health, performance and psychological health.
Multi-domain operations will involve significant demands on Warfighter cognitive agility and resistance to a multitude of stressors. There is a lack of rigorously tested cognitive training and enhancing tools and a dearth of data demonstrating effectiveness of such tools on operationally relevant tasks, psychological health outcomes, and brain health. There is also a lack of prospective longitudinal data to understand appropriate training protocols and requirements (e.g., training dosing, duration).
During the PoP, the Awardee shall:
Develop or adapt cognition-promoting training or materiel solutions suitable for military application and training pipelines (e.g., feasible, scalable, efficient, low-cost).
Demonstrate efficacy of training or materiel to positively impact cognitive performance (as measured by operationally relevant tasks including, but not limited to, perception, attention and memory) and psychological health outcomes in healthy as well as injured Warfighters.
Elucidate active components of the cognitive training or materiel and relative contribution to outcomes in order to streamline and optimize military-relevant training.
END GOAL: Deliver an efficient and effective method for personalized training to build and enhance cognitive/brain health, performance and psychological health.
POTENTIAL FUNDING:
The U.S. Department of Defense (DoD) currently has available approximately the following Defense Health Program (DHP) Fiscal Year 2019 (FY19) funds for each focus area:
FOCUS AREA #1 (Whole Body Blast): $2.78 Million
FOCUS AREA #2 (Cognitive / Brain Health & Performance): $2.36 Million
It is expected that MTEC will make a total of 2 awards (a single award for each focus area) to qualified teams to accomplish the statement of work. Each project shall be led by a centralized point of contact at the prime contracting organization. If a single proposal is unable to sufficiently address the entire scope of each focus area, several Offerors may be asked to work together in a collaborative manner.
The Period of Performance (POP) is not to exceed three years.
ACQUISITION APPROACH:
Full proposals will be required in response to this upcoming RPP. The RPP will be posted to the MTEC website (mtec-sc.org) and a notice will be posted on www.beta.SAM.gov to notify interested parties. The RPP is expected to be released by the end of February 2020 and will have a short proposal preparation period (approximately 30 days). MTEC membership is required for the submission of a full proposal 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.
POINTS OF CONTACT:
For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts:
Technical and membership questions – Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@officer.mtec-sc.org
Programmatic questions – Ms. Kathy Zolman, MTEC Director of Program Operations, kathy.zolman@ati.org
MTEC Member Collaboration Database Tool – Ms. Melissa Sanchez, MTEC Program Administrator, melissa.sanchez@ati.org
MTEC-20-06-MOM Department of the Army Medical Command
2/21/20, 1:37 PM Noncompressible Hemorrhage (NCH) Control Technology
The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for a Request for Project Proposals (RPP) focused on a solution that can stop life threatening bleeding in the intracavitary region of patients who are delayed in receiving definitive surgical care.
MTEC-20-08-NCH Department of the Army Medical Command
3/24/20, 2:13 PM Pre-Announcement - Navy Multi-Topic - Advanced Biomedical Product Development for Naval Operations
The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for multiple Requests for Project Proposals (RPPs) focused on the advancement of engineering and medical prototypes and knowledge products related to a broad range of medical technological needs identified below. Relevance to the enhanced readiness and resilience of Navy and Marine Corps health and performance is a key feature of these upcoming RPPs (a total of two RPPs are anticipated).
Problem Statement
Due to the Navy and Marine Corps’ diverse warfighting capabilities, Sailors and Marines operate in a vast array of challenging and austere environments. Combination of physical and mental stress from extreme conditions compromise human performance capability, increasing risk and possible failure of mission objectives. In addition, operating environments cause complications and challenges in medical logistics and casualty management, both vital elements to ensuring survivability of combat casualties. To maintain warfighter lethality and operational effectiveness in challenging environments, next generation biomedical products are required.
Technology Focus Areas
The upcoming multiple topic area (“multi-topic”) RPPs will require white paper submissions that describe projects that are based on logical reasoning and sound scientific rationale. Projects shall not be exploratory in nature and do require a foundation of preliminary data. Note that MTEC-sponsored projects must result in “prototype” research deliverables that transition medical solutions to industry. Proposed prototypes shall be at a minimum of a Technology Readiness Level (TRL) of 5 at the time of white paper submission. [Note: TRL definitions can be found here: https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]
Subsequent to the completion of performance under the prototype awards resulting from the upcoming RPPs, the Government reserves the right to award follow-on work. Any follow-on work for the continuation of the prototype development is contingent upon availability of future funding and the successful completion/progression of milestones. Proposed prototypes considered for further development should be at a TRL of 6 or 7 at the conclusion of the prototype award. A TRL of 6 or 7 means that the prototype solutions are ready, currently going through, or completed the Technology Maturation and Risk Reduction phase of the Defense Acquisition System framework or equivalent.
Proposed prototype solutions shall address at least one of the following Technology Focus Areas. These areas of interest are not listed in order of importance. Specific areas of interest within each overall focus area will be included in the upcoming RPPs.
TECHNOLOGY FOCUS AREA #1: CASUALTY CARE - This area focuses on patient and personnel recovery, remote health monitoring, wound (combat-injury) care, and immersion injuries.
TECHNOLOGY FOCUS AREA #2: MEDICAL LOGISTICS ENHANCEMENT - This area focuses on resupply efficiencies and medical product stability or other enhancements for medical logistics support in austere or disaggregated operations.
TECHNOLOGY FOCUS AREA #3: HUMAN PERFORMANCE - This area focuses on the prediction of health status and outcomes from various sources of combat related stressors and advanced biomedical devices and components such as sensors and advanced electronics miniaturization.
TECHNOLOGY FOCUS AREA #4: PROLONGED AND EN ROUTE CARE - This area focuses on patient care at and through the continuum of care as well as products and services that sustain patient health in austere environments such as expeditionary, littoral, and deep water.
TECHNOLOGY FOCUS AREA #5: OPERATIONAL READINESS - This area focuses on preventive measures against dental disease and optimization of baseline warfighter performance and resilience.
Proposed prototype solutions must be either “engineering and medical prototypes” or “knowledge products”. See below for the definition of each.
Engineering and medical prototypes: System, subsystem, component, or material directly or indirectly delivering or supporting a biomedical product or critical capability. These are physical, in-hand products which can be examined, tested, and demonstrated. This may also include products that require approval by the U.S. Food and Drug Administration (FDA).
Knowledge products: Non-materiel solutions that include methodology, technology, or technical process directly or indirectly supporting a biomedical product or critical capability. This may also include products such as technical reports or manuals impacting training and/or operations.
Potential Funding Availability
The U.S. Government (USG) currently has available a total of approximately $20-30 million (M) of Fiscal Year (FY) 2019 and 2020 Research, Development, Test, and Evaluation (RDT&E) funds for anticipated awards to be made during FY2020 and FY2021. The estimated total available funding per Technology Focus Area is:
TECHNOLOGY FOCUS AREA #1: CASUALTY CARE ~ $10M
TECHNOLOGY FOCUS AREA #2: MEDICAL LOGISTICS ENHANCEMENT ~ $2.5M
TECHNOLOGY FOCUS AREA #3: HUMAN PERFORMANCE ~ $5M
TECHNOLOGY FOCUS AREA #4: PROLONGED AND EN ROUTE CARE ~ $3M
TECHNOLOGY FOCUS AREA #5: OPERATIONAL READINESS ~ $10M
MTEC anticipates that multiple awards may be made under each Technology Focus Area with average budgets ranging from $500,000 to $2,000,000 for the base period of performance (exclusive of any proposed options), with a maximum award amount of ~$15,000,000, inclusive of optional tasks/years options for selected topic areas.
The base Periods of Performance (POP) may range from 12 to 36 months, dependent upon product type and level of maturation required. Note that projects may be phased, as appropriate, with contract options to enable the exercise of additional milestones to allow maximum flexibility in terms of the progression of work, availability of funding, and duration of the awarded project(s).
Pending successful completion of the total effort, the Government may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.
Acquisition Approach
As the Government will solicit five Technology Focus Areas, multiple RPPs are anticipated (a total of two RPPs are anticipated as reflected in the table below). The anticipated schedule for the RPP release dates and due dates is as follows (subject to change):
1. Anticipated RPP Solicitation #: MTEC-20-02-NavyMulti
Anticipated RPP Release Date: early January 2020
Anticipated White Paper Due Date: early February 2020
Technology Focus Areas:
Technology Focus Area #1 - CASUALTY CARE
Technology Focus Area #2 - MEDICAL LOGISTICS ENHANCEMENT
Technology Focus Area #3 - HUMAN PERFORMANCE
2. Anticipated RPP Solicitation #: MTEC-20-03-NavyMulti
Anticipated RPP Release Date: early March, 2020
Anticipated White Paper Due Date: late April, 2020
Technology Focus Areas:
Technology Focus Area #3 - HUMAN PERFORMANCE
Technology Focus Area #4 - PROLONGED AND EN ROUTE CARE
Technology Focus Area #5 - OPERATIONAL READINESS
These upcoming RPPs will be conducted using a two-staged approach for proposal submission. In Stage 1, current MTEC members are invited to submit White Papers using the format contained in the RPP. The Government will evaluate White Papers submitted and will select White Papers that best meet their current Technology Focus Areas 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. The Stage 2 process may vary, for example, some Stage 2 processes may require a solution pitch (i.e., oral presentation) or submission of a full proposal using the MTEC Proposal Preparation Guidelines (PPG).
The RPPs will be posted to the MTEC website (mtec-sc.org) and the Contract Opportunities website (beta.SAM.gov) to notify interested parties. MTEC membership is required for the submission of a white paper in response to these upcoming MTEC RPPs. To join MTEC, please visit http://mtec-sc.org/how-to-join/
MTEC
The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel 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” government contractors, academic research institutions and not-for-profit organizations.
MTEC Member Teaming
While teaming is not required for this effort, Offerors are encouraged to consider teaming during the white paper preparation period (prior to submission of your white paper) if you cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government Sponsor.
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.
Points of Contact
For inquiries regarding this pre-announcement, please direct your correspondence to the following contacts:
Technical and membership questions – Dr. Lauren Palestrini, MTEC Director of Research, Lauren.Palestrini@officer.mtec-sc.org
Programmatic questions - Ms. Kathy Zolman, MTEC Director of Program Operations, Kathy.Zolman@ati.org
MTEC Member Collaboration Database Tool – Ms. Melissa Sanchez, MTEC Program Administrator, Melissa.Sanchez@ati.org
MTEC-20-03-NavyMulti Department of the Army Medical Command
12/10/19, 12:47 PM MTEC - Far Forward Burn Treatment (FFBT) Pre-announcement
The Medical Technology Enterprise Consortium (MTEC) is excited to post this pre-announcement for an Other Transaction Agreement for prototype projects Request for Project Proposals (RPP) focused on the development of treatments for severe burn injuries in a far-forward, austere environment to address the harmful sequelae of the burn injury during prolonged care, which could extend for several weeks post-injury. This upcoming RPP will address the following four capability gaps: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing cover.
BACKGROUND
It is anticipated in future conflicts that 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. Evacuating casualties within theater may take days or weeks. Additionally, the explosive weapons that will likely be used against US 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. Only minimal burn wound management tools are available in the pre-hospital environment, consisting primarily of silver-containing wound dressings to prevent/minimize infection until the casualties’ expedient evacuation to the San Antonio Military Medical Center Burn Center for definitive treatment. Unfortunately, the future burn casualty may not have the benefit of the early evacuation to the burn center that was available during recent conflicts. As such, there is a significant need to push burn treatment capabilities much farther forward in order to begin burn treatment as early as possible. By closing the time gap between burn injury and burn treatment with solutions that can be reasonably provided by non-medical personnel (i.e., buddy care) or medical first responders (e.g., medics) in a pre-hospital setting, morbidity and mortality rates can be significantly decreased.
The U.S. Government (USG) is seeking burn interventions that are simple and effective enough to be used in a pre-hospital setting. These tools will need to enable providers from the point of injury through Role 3 Hospital Centers to treat severe burn injury for up to several weeks post-injury. It is imperative that these solutions be simple enough that non-licensed medical providers (e.g., medics) can administer them, and effective enough to decrease morbidity and mortality rates and improve outcomes over current in-theater burn treatment options.
It is expected that multiple burn treatment solutions will be needed, and may be used in concert with one another, to provide the needed burn treatment capabilities in theater. These solutions will need to address: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing coverage/dressings that protect the burn wound and may promote early healing. Technological advances that contribute to product solutions that meet these requirements will be considered as possible candidates for fielding by the Burn Treatment Skin Repair acquisition program.
SOLUTION REQUIREMENTS
Simple and effective solutions are required to treat severe burn injuries as early as the point of injury and throughout in-theater care. The Army has identified four capability areas that would enable this far-forward burn treatment: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing cover. The desired prototype(s) will address one or more of these capabilities. Prototypes could include (but are not limited to) hydrogels, wound coverings, intravenous (IV) medications, topical medications, or bandages. While there are specific requirements for each of the burn treatment capability areas being sought, there are some requirements that are common to them all. It is also anticipated that some product solutions may satisfy, or have the potential to satisfy, more than one of these capabilities. In instances where a product has sufficient data supporting its use in one area (e.g., infection prevention), but there is evidence that is may also be useful in another area (e.g., burn conversion prevention), optional tasks can be incorporated into any award to work to address indications for additional areas where the product solution may have utility.
COMMON CHARACTERISTICS FOR ALL CAPABILITIES
In the far forward environment, it is important for interventions to be as simple, safe and effective as possible. As such, the following characteristics apply to all four desired capabilities. All prototypes must currently be at a technology readiness level (TRL) of 5 or higher in order to be considered (see the document attached to this posting for a definition of TRL 5):
Prototype must be capable of achieving an indication for use on large (>20% total body surface area (TBSA)) burns.
Prototype must be capable of achieving an indication for use on full-thickness burns. Regulatory strategies can include a seeking a deep-partial thickness indication as a bridge to a full-thickness burn indication.
Prototype must not negatively impact use of other downstream burn or lifesaving treatments in the care of burn-injured individuals, specifically those treatments being sought after within this RPP. (Most casualties will have polytrauma beyond their burn injuries.)
Prototype must be capable of being administered by a medic quickly and easily at the point of injury and Role 1. This includes minimal preparation time (no more than five minutes) prior to administration. Topical solutions are preferred, but not required. Products that could be administered by a non-medical responder (a “buddy” or even self-administration) are encouraged but not required.
Prototype must be capable of achieving a shelf life of at least two years at room temperature.
Prototype must not require climate-controlled transit or storage at maturity.
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.)
CAPABILITY-SPECIFIC CHARACTERISTICS
In addition to the Common Characteristics for All Capabilities listed above, each capability has specific desired characteristics listed below.
A. Burn conversion prevention
Prevents conversion of partial-thickness burns to deep partial-thickness or full-thickness burns, ideally within 24 hours of being administered
Single dose/application per 24 hours is preferred, but not required
Shows efficacy in limiting the expansion and/or depth progression of burns
B. Infection prevention
Topically administered product that can be applied immediately after a burn to prevent infection and/or after infection has set in as a treatment
Control broad range of bacterial infections; control of fungal infections and resistant pathogens preferred
Low risk of causing resistance
C. Non-surgical debridement in pre-hospital setting
Complete procedure/course of treatment is 24 hours or less
Does not require sedation or anesthesia for pain management; causes minimal pain per FDA-approved scales preferred
Fully mitigates the toxicity of eschar
Requires minimal ancillary equipment such as batteries, power supply, etc.
D. Temporizing coverage/dressing for burn wounds that may promote healing
Can be used to cover/dress burn wounds both at initial treatment and also after debridement
Provides a barrier over the burn wound in the absence of grafting
Coverage material is thin, conformable, breathable, able to move with patient and non-toxic; preference for coverage materials that are bio-absorbable, and enable healing of the burn wound preferred but not required
Can be left in place for up to 5 days, preferably longer
Does not require multiple dressing changes and/or mitigates/eliminates the deleterious effects of dressing changes
PROJECT SCOPE (POP1 & POP2) AND NON-COMPETITIVE FOLLOW-ON WORK:
The USG and MTEC expect that Offerors’ proposed project scope and maturity will vary based on the initial maturity of the proposed prototype and the ability to meet the solution requirements listed above. Therefore, USG decisions regarding both the rolling down-select and potential non-competitive follow-on work will be based on the advancement in prototype maturity (among other considerations), as it applies to each resultant award(s) during the performance of the prototype project(s). The USG may consider funding any of the following (but not necessarily limited to the) work listed below during any period (i.e., PoP1, PoP2 – see the section below entitled “ACQUISITION APPROACH & ROLLING DOWNSELECTION” for additional information and an explanation of “PoP1” and “PoP2”) of the awarded prototype project(s) to include any non-competitive follow on work (which may proceed PoP2 tasks):
Prototype refinement/maturation progressing towards clinical product
Clinical feasibility studies (as needed) to support regulatory approval/clearance
Clinical pivotal studies (as needed) to support regulatory approval/clearance
Stability and shelf-life studies
Prototype delivery for military-relevant testing
Testing of prototypes at US Army Institute of Surgical Research (USAISR)
Testing of prototypes at Army Medical Department (AMEDD)
Product demonstrations
Establishment of Good Manufacturing Practice (GMP) manufacturing for clinical trials and for market release
Initial production runs; first article testing, etc.
Low rate initial product runs to reach Full Operating Capability (FOC)
Draft product support documentation (e.g., training guides, product inserts, etc.)
Development of a business and/or commercialization plan for market release
POTENTIAL FUNDING AVAILABILITY AND PERIOD OF PERFORMANCE:
The USG currently has available approximately $3 million (M) for Fiscal Year (FY) 2022. Additional FY23 funding may be available for PoP1 work; and FY24 funding may be available for potential follow-on work for the continuation of the development and/or for expanded indications that will satisfy additional capability areas sought under this upcoming RPP. Pending successful completion of the total effort, the USG may issue a non-competitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.
MTEC anticipates that one or more awards will be made.
The initial Period of Performance (POP1) is expected to be 24 months.
ACQUISITION APPROACH & ROLLING DOWNSELECTION
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 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.
The RPP will be posted to the MTEC website (mtec-sc.org) and beta.SAM.gov to notify interested parties. 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
The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel 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.
MTEC MEMBER TEAMING
While teaming is not required for this effort, Offerors are encouraged to consider teaming during the white paper preparation period (prior to submission of your white paper) if you cannot address the full scope of technical requirements of the RPP or otherwise believe a team may be beneficial to the Government Sponsor.
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.
POINT OF CONTACT
For inquiries regarding this pre-announcement, please direct your correspondence to Dr. Lauren Palestrini, MTEC Director of Research, lauren.palestrini@officer.mtec-sc.org
MTEC-21-02-FFBT Department of the Army Medical Command
10/27/20, 4:19 PM