Active Solicitations

MTEC understands the importance of sharing technical requirements as soon as possible with both members and to potential consortium members in order to allow the maximum possible time to prepare, team, and identify both public and private solicitation sponsors.  Draft Request for Project Proposals will be shared via email upon request and this website.  Understand that this information is draft in nature and changes could occur prior to publication of final documents.  For specific Request for Project Information or Request for Project Proposal inquiries, please direct your correspondence to the following contacts:

  • Questions concerning contractual, cost or pricing should be directed to the MTEC Contracts Administrator, Ms. Rebecca Harmon, mtec-contracts@ati.org
  • Technology Readiness Levels (TRLs) for most proposed projects must be identified and included with the Technical Proposal. TRL definitions are provided here.
  • Technical related questions should be directed to the MTEC Director of Research, Dr. Lauren Palestrini, Ph.D., lauren.palestrini@officer.mtec-sc.org
  • Questions concerning membership should be directed to Ms. Stacey Lindbergh, MTEC Executive Director, execdirect@mtec-sc.org
  • All other questions should be directed to Ms. Kathy Zolman, MTEC Program Manager, kathy.zolman@ati.org

“Assessment of the Psychological and Physiological Effects of Augmented Reality (APPEAR)”

Solicitation Number: MTEC-18-09-APPEAR

 The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) focused on conducting assessments to understand the psychological or physiological effects of augmented reality (AR) medical simulations that may impact learning effectiveness in humans. The ultimate goal of this research is to identify psychological and physiological limitations of AR medical simulation training in the diverse high pressure and stressful context anticipated in the various military echelons of care, which will help ensure optimal development and utilization of AR technology to address the identified capability gaps in military medical simulation training.

Technology Focus Areas

AR is the use of a computer-based simulation engine to add non-real sensory information to the real sensory world. Essentially, AR directs participants’ attention to either existing information that they would have not been consciously aware of or to new information that changes their perceptual information. Although this co-registered information can be visually projected directly onto real objects, AR information is often presented directly to the recipient by a device attached to the recipient.

APPEAR maps to DHA’s Joint Evacuation and Transport Simulation (JETS) and Point of Injury and Trauma Simulation (POINTS) programs, under the JPC-1/MSIS Medical Simulation portfolio. It addresses the capability gaps in the Virtual Patient System (VPS) of JETS and POINTS. The VPS provides intelligent, scalable, modular medical training products, tools, and devices across globally distributed, integrated, and interconnected Live, Virtual, Constructive, and Gaming training environments. Technology using AR is a significant piece of the VPS, at point of injury (POINTS) and point of demand across the complete chain of evacuation (JETS).

Offerors are allowed to submit more than one solution brief. Solution briefs are expected to address the following:

  • Propose a human study that focuses on one of the following:
    • Psychological effects of AR on the end user in training behavior (secondary assessments of cognitive load during learning using AR and/or assessment of neuropsychiatric conditions contraindicated for training with AR could be included), or
    • Physiological effects of AR on the end user in training behavior (secondary assessments of cognitive load during learning using AR and/or assessment of physical conditions contraindicated for training with AR could be included).
  • Justification for targeting psychological or physiological effects of AR, including ability of team to address that focus area;
  • Propose the assessment of AR prototypes currently under development or in use for military medical simulation training; and
  • Provide detailed information regarding the type of AR and specific scenarios that will be involved in the clinical assessments.

The requested work is separated into two tasks.

  • Task 1 includes all planning tasks for the human subjects study, including but not limited to, IRB/HRPO approvals or exemptions, hiring study staff, development of the clinical study protocol, and coordination with collaborators (if required). Task 1 will have a maximum period of performance of 6 months. An administrative review will be conducted after the completion of Task 1 to assess performance and approve continuation of the project onto Task 2.
  • Task 2 includes execution of the human subjects study. Task 2 will have a maximum period of performance of 18 months.

Proposed studies are not limited to a specific medical domain and all areas of medicine are encouraged for submission (i.e., dental, dermatology, obstetrics, ophthalmology, and surgical fields); however, medical domains that have higher alignment with (or must have at least one demonstrated tool with traumatic/multi-casualty) treatment of traumatic and acute injuries/multi-casualty are preferential.

This RPP is not interested in the procedural or therapeutic use of AR, nor is it interested in the routinization of actions, i.e., the automatic performance of an integrated set of actions. It is concerned with the effects of AR on participants’ cognitive, affective, and physical states. It is anticipated that the outcome of Tasks 1 and 2 will achieve at least one of the following (not in rank order):

  • Complete a human study that evaluates the physiological or psychological effects of AR, and/or assesses cognitive load, and/or determines conditions that would contraindicate AR exposure.
  • Enable efficiency in the design of future AR scenarios/prototypes in medical simulations.
  • Identify potential safety issues that should be accounted for in AR prototypes used in medical simulation training.
  • Provide recommendations and/or proposed mitigation strategies regarding any safety issues identified to improve or refine development of or existing AR prototypes.
  • It is anticipated that AR scenarios assessed will be relevant across the military and U.S. Department of Veterans Affairs and potential academic, clinics, rural healthcare settings, private and public hospitals, and international healthcare situations.
  • If applicable, support safety data in investigational device exemption or 510(k) applications or provide post-mark surveillance data for FDA-cleared AR technology.

Potential Funding Availability

The U.S. Department of Defense (DoD) currently has available a minimum of $2.5 Million (M) for this effort.  A period of performance no greater than 24 months is expected, and faster timelines are acceptable.

It is expected that MTEC will make at least two awards of $1.25M each to a qualified team to accomplish all tasks. Up to four awards may be made, contingent on the availability of additional funds.

Acquisition Strategy:

The MTEC will use a streamlined, accelerated approach for this acquisition. This approach will consist of the following steps:

Step 1: MTEC members who wish to offer a solution to the RPP must submit a Solutions Brief. The Solutions Brief will contain the MTEC Offeror’s technical concept and approach along with their viability toward the specific effort. To meet the statutory requirement of the Other Transaction authority, Offeror Solutions Briefs will also have to address the significant participation of a Nontraditional Defense Contractor or Nonprofit Research Organization on the team or the willingness to provide 1/3 cost share to the project. The Offeror will also be expected to present a rough order of magnitude (ROM) cost and schedule.

Step 2: As part of the Government review of the Solutions Brief, MTEC members who have submitted a favorable Solutions Brief based on the RPP criteria may be invited to present and discuss their solution with the Government sponsors for the research via a virtual or in-person “pitch” of the proposed project along with a SOW/Milestone Payment Schedule and cost information.

Step 3: MTEC Offeror(s) will be notified of the down select recommendation(s), and if selected, will be invited to submit a detailed Cost Proposal in accordance with the MTEC Proposal Preparation Guide (PPG).

Because of the nature of the requirements set forth in the forthcoming RPP, this streamlined, interactive approach is anticipated to be a better means to highlight company methodologies and skills and allow the government to gain a fuller appreciation of the work  required to be completed.  It provides more freedom and initiative to the Offeror to describe how they would approach and solve such an action.  The full description of this contracting approach is included in the RPP.

MTEC:

The MTEC mission is to assist the U.S. Army Medical Research and Materiel Command (USAMRMC) by providing cutting-edge technologies and 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.

Administrative Information:

Solution Briefs are due no later than September 21, 2018 at 12:00pm EST. This RPP is posted to the MTEC website (www.mtec-sc.org) and FedBizOpps (www.fbo.gov) to notify interested parties. MTEC membership is required for the submission of a Solution Brief response to this MTEC RPP. Offerors submitting Solution Briefs as the prime contractor must be MTEC members of good standing by September 18, 2018. To join MTEC, please visit http://mtec-sc.org/how-to-join/

A Proposers Conference via webinar will be held for interested parties to have their questions answered by the Government after the RPP is posted.  MTEC Members will be notified when the Proposers Conference is scheduled.

For inquiries regarding this announcement, please direct your correspondence to the following contacts:

To view this solicitation, click Amendment 1 MTEC-18-09-APPEAR RPP.


Development and Evaluation of a Cryopreserved Platelet (CPP) Product for the U.S. Military

Solicitation Number: MTEC-18-06-CPP

The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) focused on the development of a dimethyl sulfoxide (DMSO) cryopreserved platelet (CPP) product that has an extended shelf life (minimum of 2 years). The overall end goal of the program is a commercial product that is approved by the U.S. Food and Drug Administration (FDA) to enhance the battlefield management of severe hemorrhage resulting from combat trauma.

Technical Background:

Management of severe hemorrhage due to trauma and/or surgical repair of damaged organs and tissues, requires the contemporaneous replacement of large volumes of blood products, including platelets. Platelets are a normal component of blood and a key initiating factor in hemostasis (blood clotting).  Current standard of care in both civilian and military settings consists of walking donor, room-temperature stored, apheresis platelets (i.e., LSP), which only have a shelf-life of 5-7 days with decreasing efficacy during this period of storage.  Platelet supply in an unsettled military theater of operations is inherently limited due to the inability to store current platelet products for more than 5-7 days.  In the event of in-theater mass casualty situations, the supply of walking donor apheresis platelets will not meet demand; compromising the ability (and capacity) of U.S. Army field medical teams to curtail bleeding and stabilize patients.

Overall Program Objective:

The leading candidate for a long-term stored platelet product, by virtue of technological maturity and risk, is DMSO CPP. DMSO CPP is a frozen platelet product (regulated as a biologic by the U.S. FDA) composed of γ-irradiated [2500 centi-gray (cGy)] leukocyte reduced apheresis platelets stored in plasma and anticoagulant citrate dextrose solution A (for up to 57 hours after apheresis), concentrated, and frozen in approximately 6% DMSO at -80°C and stored at ≤ -65°C.  Hence forward, this candidate will be referred to as CPP.  Development of CPP is in direct support of the USAMMDA’s line of effort to enhance battlefield management of severe hemorrhage due to combat trauma.

The objective of this program is to achieve an FDA licensed, commercially viable CPP product.

Offerors are expected to conduct all manner of development, test and evaluation activities (as necessary) to achieve an FDA-licensed CPP product that is suitable for use by the U.S. Military.  Anticipated activities include (but are not limited to):

  1. Design and development of a CPP manufacturing process that is compliant with FDA regulations and applicable guidance for current good manufacturing practices (cGMP).
  2. Design, development, and validation of processes (inclusive of any necessary materials, equipment, and tests/assays) to enable storage and shipment of CPP for U.S. Military use.
  3. Performance of all necessary non-clinical (in-vitro) studies and clinical trials.
  4. Execution of all activities commensurate with serving as the IND holder and regulatory sponsor in accordance with 21 Code of Federal Regulations (CFR) 312 subpart D, including all regulatory submissions and regulatory sponsorship.
  5. Development and maintenance of various management, risk, project, and quality plans/reports (as necessary) to provide documented evidence that the development effort is being effectively managed in accordance with the risk profile.

Financial Framework:

The U.S. Department of Defense (DoD) currently anticipates up to $36 Million (M) in funding for Fiscal Years (FY) 18-24, with an expected start date of December 31, 2018 (subject to change).

It is expected that MTEC will make a single award to a qualified team to accomplish all tasks. The program shall be led by a centralized point of contact at the prime contracting organization. If a single Solution Brief is unable to sufficiently address the entire scope of this RPP’s objectives, several Offerors may be asked to work together in a collaborative manner or MTEC may make multiple, individual awards to Performers(s) to accomplish subset(s) of the key tasks.

Acquisition Strategy:

The MTEC will use a streamlined, accelerated approach for this acquisition. This approach will consist of the following steps:

Step 1: MTEC members who wish to offer a solution to the RPP must submit a Solutions Brief. The Solutions Brief will contain the MTEC Offeror’s technical concept and approach along with their viability toward the specific effort. To meet the statutory requirement of the Other Transaction authority, Offeror Solutions Briefs will also have to address the significant participation of a Nontraditional Defense Contractor or Nonprofit Research Organization on the team or the willingness to provide 1/3 cost share to the project. The Offeror will also be expected to present a rough order of magnitude (ROM) cost and schedule.

Step 2: As part of the Government review of the Solutions Brief, MTEC members who have submitted a favorable Solutions Brief based on the RPP criteria may be invited to present and discuss their solution with the Government sponsors for the research via a virtual or in-person “pitch” of the proposed project along with a SOW/Milestone Payment Schedule and cost information.

Step 3: MTEC Offeror(s) will be notified of the down select recommendation(s), and if selected, will be invited to submit a detailed Cost Proposal in accordance with the MTEC Proposal Preparation Guide (PPG).Because of the nature of the requirements set forth in the forthcoming RPP, this streamlined, interactive approach is anticipated to be a better means to highlight company methodologies and skills and allow the government to gain a fuller appreciation of the work  required to be completed.  It provides more freedom and initiative to the Offeror to describe how they would approach and solve such an action.  The full description of this contracting approach is included in the RPP.

MTEC:

The MTEC mission is to assist the U.S. Army Medical Research and Materiel Command (USAMRMC) by providing cutting-edge technologies and 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, “non-traditional” government contractors, academic research institutions and not-for-profit organizations.

Administrative Information:

Solution Briefs are due no later than August 17, 2018 at 12:00pm EST. This RPP is posted to the MTEC website (www.mtec-sc.org) and FedBizOpps (www.fbo.gov) to notify interested parties. MTEC membership is required for the submission of a Solution Brief response to this MTEC RPP. Offerors submitting Solution Briefs as the prime contractor must be MTEC members of good standing by August 14, 2018. To join MTEC, please visit http://mtec-sc.org/how-to-join/

For inquiries regarding this announcement, please direct your correspondence to the following contacts:

To view this solicitation, click  Amendment 1 MTEC-18-06-Cryopreserved Platelets RPP.


MTEC-18-06-CPP Proposers Conference

A Proposers Conference via webinar will be held on July 27, 2018 at 10:00 am EDT for interested parties to have their questions answered by the Government regarding the 18-06-CPP Request for Project Proposals (RPP).
Register at:  https://attendee.gotowebinar.com/register/57624697182024194