AN43--508-21-2-1103-0148/ Prototype Development/ Atlanta CVNR (VA-21-00039067)
The Veterans Administration Atlanta VA Research and Development Group intends to negotiate on a sole source basis with Global Center for Medical Innovation (GCMI) to provide services relating to the development of a prototype device that is wearable, non-invasive ERG diagnostic system to detect early stage diabetic retinopathy (DR) . GCMI will work with VA researchers to create a wearable frame, electronics, light stimulus encased in the device, and design a device interface. GCMI is located in the greater Atlanta area, which is important to enable them to work closely with the Atlanta VA researchers in the development of this product. GCMI has the regulatory specialists on staff to ensure all documentation, schematics, etc. meet regulatory requirements (such as FDA device requirements) and have the ability to produce the protype in a short time frame.
This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Friday, February 26, 11AM, EST. Interest/capability statements may be sent to Elaine DiBucci at elaine.dibucci@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
36C24E21Q0064 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4
2/23/21, 5:51 PM A Portable Virtual Reality (VR) Headset for Detecting Deficits in Balance, Vestibular, and Oculomotor Function Following TBI, PTSD, and/or Other Disease/Injury
The Government has awarded a sole source contract to Temple University through the FY20 Joint Warfighter Medical Research program. See attached J&A for the sole source rationale.
Temple University has developed a novel virtual reality (VR) head-mounted display (HMD) solution that is ultraportable, highly adaptable, and easy to use for accurately identifying balance and vestibular/oculomotor deficits and guiding effective treatment plans. The technology solution being developed and tested here will help identify these risk factors in Veterans, but can be applied to any population at increased risk for falls. The objectives of this project are: 1) Test accuracy of the novel device for assessing balance and oculomotor function in civilians; 2) Test accuracy of the novel device for assessing balance and oculomotor function in Veterans; and 3) Establish validity and reliability of the novel HMD-based assessments in each population. Awarded contract W81XWH-21-C-0048 to TEMPLE UNIVERSITY-OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION for 1201221.00 on 2021-07-09.
W81XWH-21-C-0048-Notice-of-Award Department of the Army Medical Command
8/18/21, 7:57 AM MTEC Pre-Announcement: Development of an Expeditionary Medical (EXMED) mobile Command, Control, Communications, and Computers IT (C4IT) solution for integration into Expeditionary Fast Transport (T-EPF) Flight II
The Medical Technology Enterprise Consortium (MTEC) is seeking proposals to develop an expeditionary medical (EXMED) command, control, communications, and computers information technology (C4IT) prototype for the Defense Health Agency. The objective is to enable secure and interoperable health care delivery, medical command and control, medical logistics, and patient movement in austere and contested environments. Key requirements include designing a mobile and rugged EXMED C4IT system, implementing a prototype, and planning for testing and transition. Proposals will be evaluated on factors like solution requirements, design, and transition planning. Due to the urgency of this effort, MTEC plans to use an accelerated 21-day proposal submission timeline.
This is not a set-aside opportunity. MTEC expects to make a single award up to $2.075 million, with potential for additional follow-on funding. Interested offerors must be MTEC members to submit proposals. There are no incumbent contractors mentioned, and the Period of Performance is not to exceed 18 months, with faster timelines highly encouraged.
MTEC-24-EXMED Defense Health Agency
7/29/24, 8:10 AM AN43--Intent to Sole Source Vaccine Research Services
The Department of Veterans Affairs, James J. Peters VA Medical Center (JJP VAMC) intends to negotiate on a sole source basis, pursuant to FAR 6.302-1, with the University of Wisconsin - Madison for vaccine research services. Investigators at the JJP VAMC are conducting HIV vaccine research. As part of this study, investigators require the production of DNA and protein in accordance with cGMP (current Good Manufacturing Practice) specifications in support of proof of concept studies. The Waisman Center at the University of Wisconsin Madison is the only known vendor able to produce the necessary specific DNA and specific protein under cGMP standards, and the Waisman Center has experience manufacturing cGMP-grade DNA and protein vaccines for a phase I clinical trial run by the HIV Vaccine Trials Network.
This is a notice of intent and is not a request for competitive quotes; however, any responsible source who can provide an equivalent service with the features described above may submit a capability statement to the contracting office no later than Monday, September 19, 2022, 3:00 PM EDT. Interest/capability statements which specifically detail how your service meets the requirement may be sent to Shannon Hukriede at shannon.hukriede@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.
36C24E22Q0306 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 4
9/14/22, 9:34 PM 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.
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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 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
Non-invasive device that does not cause pain
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
Hand-held, self-contained device with size, weight, and cube that enables use at ROC1
Compatible with other burn and lifesaving treatments
Has minimal training requirements
Compliant with DoD Cybersecurity requirements
Prototype must eventually become a commercially viable product or technology that will be brought to market
Refer 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.org
Technical and membership questions – Dr. Lauren Palestrini, Ph.D., MTEC Director of Research, lauren.palestrini@mtec-sc.org
Administrative and membership questions – Ms. Kathy Zolman, MTEC Director of Program Operations, kathy.zolman@ati.org
To view this solicitation, visit www.mtec-sc.org/solicitations/
MTEC-22-08-BDA Department of the Army Medical Command
6/17/22, 2:07 PM