Call for White Paper_Three-Dimensional Printing for Soft Tissue Simulants.pdf

BROAD AGENCY ANNOUNCEMENT (BAA) W911QY-20-R-0022

SOURCES SOUGHT NOTICE

REQUEST FOR WHITE PAPERS

BAA TOPIC: Topic F. Simulation and Training Technology, Medical Simulation and Training:

“Three-Dimensional Printing for Soft Tissue Simulants”

Introduction

Applications to the Fiscal Year 2020 (FY20) “Three-Dimensional Printing for Soft Tissue

Simulants” are being solicited by the Combat Capabilities Development Command Soldier Center

(CCDC SC), Simulation and Training Technology Center (STTC), Medical Simulation and

Research Branch (MSR).

Broad Agency Announcement (BAA) W911QY-20-R-0022 was publicized on Federal Business

Opportunities and Grants.gov on 28 February 2020. This Sources Sought Notice calls for White

Paper submissions in reference to the research, within the BAA, is Topic F. Simulation and

Training Technology, Medical Simulation and Training section. The BAA is issued under the

Federal Acquisition Regulation (FAR) provision 6.102(d)(2), provides for the competitive selection of proposals. Proposals submitted in response to this BAA and selected for award are considered to be the result of full and open competition and in full compliance with the provisions of Public Law 98-369, “The Competition in Contracting Act of 1984,” and subsequent amendments. The type of research solicited under this BAA attempts to increase knowledge in science and/or to advance the state of the art as compared to practical application of knowledge. Funding of research and development (R&D) within CCDC SC-STTC areas of interest will be determined by funding constraints and priorities set during each budget cycle.

Awards related to the submission of White Papers requested by this Notice are subject to funds availability and priorities. CCDC SC-STTC may choose not to select any new awards due to unavailability of funds or other factors.

The sequence of steps leading to award is:

(1) Request for White Paper initiated,

(2) Submission, via email, of a timely White Paper no more than five (5) pages in length to the

Technical Points of Contact (POC) Dr. Jack Norfleet (jack.e.norfleet.civ@mail.mil) and cc

Matthew Hackett (matthew.g.hackett.civ@mail.mil),

(3) Written or telephonic feedback provided to the Offeror regarding the White Paper’s scientific merit and potential contributions to the Army mission as per established criteria presented in this announcement,

(4) Request of a formal proposal(s) submission initiated by POC, if the White Paper merits a proposal request, mailto:jack.e.norfleet.civ@mail.mil

(5) Submission of a timely, formal proposal(s),

(6) Evaluation of the formal proposal from criteria noted in BAA solicitation W911QY-20-R-

0022, and

(7) Contract or grant award for selected proposal(s) based on availability of funds or other factors.

This sequence allows earliest determination of the potential for funding and minimizes the labor and additional costs associated with submission of full proposals that have minimal probability of being selected for funding.

BAA W911QY-20-R-0022 allows several potential instrument types (e.g., contract, grant, cooperative agreement) to result from a successful proposal. For this Notice, the intention of the

Government is to award a BAA contract.

Note that interested Offerors must submit a White Paper electronically in order to be eligible to submit a formal proposal under this Notice. This Notice requires that White Papers be submitted electronically no later than 07 May 2020, 5:00 P.M. Eastern Standard Time (EST). See Part V, Deadlines, for additional details.

THOSE SUBMITTING WHITE PAPERS/PROPOSALS ARE CAUTIONED THAT ONLY A

GOVERNMENT CONTRACTING OR GRANTS OFFICER CAN OBLIGATE THE

GOVERNMENT TO ANY AGREEMENT INVOLVING EXPENDITURE OF GOVERNMENT

FUNDS.

This Sources Sought Notice for White Papers consists of six parts as follows:

Background and Introduction

Part I: Research Objectives

Part II: Phase Based Approach

Part III: Preparation, Submission, Evaluation Criteria, Review and Selection Process

Part IV: Feedback

Part V: Deadlines

Part VI: Inquires

Technical POC:

Matthew Hackett, Science and Technology Manager

12423 Research Parkway

Orlando, FL 32826

407-384-5349

Matthew.g.hackett.civ@mail.mil (email contact preferred).

BACKGROUND AND INTRODUCTION

The military healthcare system is faced with multiple challenges, combining the rigors of the battlefield with the need to provide urgent, life-saving care. The military utilizes a variety of training aids to ensure providers are proficient in the medical care necessary in these difficult circumstances. These training aids range from serious games to high-fidelity patient simulators. When training hands-on skills, patient simulators and part-task trainers are a key component to conveying the psycho-motor skills associated with medical treatment. For point of injury care, these skills include tourniquet application, airway management, needle decompression of the chest, hemorrhage control, and more. Of note, simulation based training provides a risk-free platform to repeat those skills until proficiency is reached.

However, repetition does have an associated cost, in terms of both time and resources.

Specifically, many simulators have consumable pieces which need to be replaced after a procedure is complete, such as skin or muscle patches.

In addition to consumable components, the fidelity of soft tissue is a persistent balancing act between cost, realism, and ruggedness. It has also been identified that current training aids do not sufficiently replicate the material properties or result in psychological behaviors associated with live tissue. At present, simulated tissues are often molded using materials such as latex, silicone, and proprietary blends. The emergence of 3D printing has advanced simulated tissues, initially focusing on hard tissue such as bone. However, newer techniques in 3D printing allow the printing of soft materials, with a variety of material properties [1].

The 3D printing of soft materials opens the door for printing soft tissue simulants, including skin, muscle, fascia, adipose, etc.

I. RESEARCH OBJECTIVES

The objective of this effort is to advances in 3D printing to conduct research into soft tissue simulants. The target training population are primarily military medical personnel but applications also exist in training civilian responders as well. Key capabilities sought are as follows:

1) Ability to 3D print soft tissue simulants which are mechanically similar to live human tissue

2) Ability to print a variety of soft tissue types, with a focus on skin and muscle

3) Ability to print at the point of need, such as printing within a medical training facility or hospital

4) Examine feasibility of low-cost materials

5) Enable printing for operators with minimal technical expertise

References:

1. Truby, R. L., & Lewis, J. A. (2016). Printing soft matter in three dimensions. Nature, 540(7633), 371-378.

2. Vithani, K., Goyanes, A., Jannin, V., Basit, A. W., Gaisford, S., & Boyd, B. J. (2019). An overview of 3D printing technologies for soft materials and potential opportunities for lipid-based drug delivery systems. Pharmaceutical research, 36(1), 4.

II. PHASE BASED APPROACH (Phase I & II)

PHASE I

A successful Phase I will culminate in a demonstrative prototype with emphasis placed on the printing of simulated material with suitable soft tissue characteristics. The performer would ideally demonstrate more than one material. Soft tissue materials shall also be printed in a variety of form factors, such as a neck skin or a chest skin. Tissue should be benchmarked against known mechanical properties of tissue. Expected Phase I will be twelve (12) months from time of award.

PHASE II

Phase II would focus on ensuring the printing capability can be delivered at the point of demand.

This includes the ability of the printer to be installed in a medical training facility or hospital. The printing capability should be operable by users with minimal technical expertise. The end state of this phase is to demonstrate a user operating the 3D printing capability to create 3D printed soft tissue simulants.

III. PREPARATION, SUBMISSION, EVALUATION CRITERIA, REVIEW AND

SELECTION PROCESS

Preparation & Submission:

The process of execution begins with White Paper evaluation and a down-selection process. From among the whitepapers submitted, the Government will notify the Offeror if their White Paper is selected, and formally request a full proposal. The full proposals undergo a full scientific review and programmatic review prior to being funded.

The approach for accomplishing this research and development is to utilize a phased process.

White papers should include a technical solution with a twelve (12) month base award (Phase 1 /

Year 1) and one (1), twelve (12) month option period (Phase II). The white paper must include the anticipated period of performance, a technical description of the proposed concepts, the technical objectives, and a planned approach to accomplish the stated objectives as well as a rough order of magnitude (ROM) cost per year. The ROM cost should consist of the total cost plus profit/fee/ overhead.

White Papers shall not exceed five (5) pages of computerized text at 12 pitch (excluding resumes).

Contractor format is acceptable. Submit White Papers electronically to the Technical POC jack.e.norfleet.civ@mail.mil and cc matthew.g.hackett.civ@mail.mil. If mailing a White Paper submission, parcels must be postmarked by due date/time. Mailed White Papers should be provided in hardcopy and CD form and both must be received together. The deadline for White

Paper submission no later than COB on 07 May 2020. If mailing submissions, address them to:

SFC Paul Ray Smith Simulation & Training Technology Center (STTC), Attn: Matthew G.

Hackett, Medical Simulation and Human Performance Branch, 12423 Research Parkway, Orlando, FL 32826.

THIS ANNOUNCEMENT CONSTITUTES THE ENTIRE SOLICITATION FOR THIS

EFFORT. DO NOT SUBMIT A FORMAL PROPOSAL AT THIS TIME.

Evaluation Criteria

White Papers will be evaluated by technical/scientific personnel who are knowledgeable within the particular topical area/specific interest area to determine if the paper presented is consistent with the intent of the BAA and of interest to the Government. White Papers will be evaluated using the following criteria:

a) scientific/technical merit,

b) management approach,

c) importance to agency programs, and

d) proposed cost/price

Based on these evaluation criteria, the highest rated concept papers will show considerable potential to develop into highly qualified proposals that could likely lead to an award.

Review and Selection Process:

Upon completion of White Paper evaluations, Offerors will be notified whether or not their White

Paper was favorably received. Favorable review of a White Paper does not constitute selection of the proposed effort for contract award and will not establish a binding commitment for the

Government to fund the effort in whole or in part. Upon notification, the Government will issue a request for proposal letter to the qualified Offeror(s), who best meet the program objectives. If proposals are solicited, proposals are due no later than 07 May 2020, 5:00 P.M. EST. The requirements for proposal preparation and submission can be found at https://beta.sam.gov/opp/3c626456ada845628790f50ccc306e47/view?keywords=W911QY20R0

022&sort=-relevance&index=opp&is_active=true&page=1

This announcement is an expression of interest only and does not commit the Government to reimburse any proposal preparation cost for responding. The cost of proposal preparation in response to this announcement is not considered an allowable expense to the normal bid and proposal indirect costs as specified in FAR 31.205-18, Independent Research and Development and Bid and Proposal Costs. Any request for White Paper or submission of a full proposal does not guarantee award. The Government reserves the right to cancel this requirement at any time and shall not be liable for any cost of proposal preparation or submission. This announcement constitutes the Government's solicitation for this effort. There will be no other solicitation issued mailto:jack.e.norfleet.civ@mail.mil https://beta.sam.gov/opp/3c626456ada845628790f50ccc306e47/view?keywords=W911QY20R0022&sort=-relevance&index=opp&is_active=true&page=1 https://beta.sam.gov/opp/3c626456ada845628790f50ccc306e47/view?keywords=W911QY20R0022&sort=-relevance&index=opp&is_active=true&page=1 in regard to this requirement. Offerors should be alert for any BAA amendments that may be published.

IIII. FEEDBACK

Written or telephonic feedback will be provided to the Offeror regarding the White Paper’s scientific merit and potential contributions to the CCDC SC mission. If the Government decides to request a full proposal, a written request will be sent to the Offeror. The request may also include feedback intended to improve the proposal.

V. DEADLINES

White Paper submissions, no more than five (5) pages in length, are encouraged to be submitted as early as possible but must be received, via email, by Dr. Jack Norfleet

(jack.e.norfleet.civ@mail.mil) and cc Matthew Hackett (matthew.g.hackett.civ@mail.mil) no later than 07 May 2020, 5:00 P.M. EST. No extensions will be granted. Only unclassified

White Papers will be accepted. The White Papers will be reviewed to determine that the proposed effort is within the scope and interest of this solicitation. A proposal will only be solicited from White Papers deemed the best to meet program objectives.

VI. INQUIRIES

Inquiries for additional information should be made with the CCDC SC-STTC POC, Matthew

Hackett, whose contact information is listed above.

mailto:jack.e.norfleet.civ@mail.mil mailto:matthew.g.hackett.civ@mail.mil