W81XWH-16-SN-0012

THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION/COMMENTS (RFI) SYNOPSIS ONLY. THE PURPOSE OF THIS RFI SYNOPSIS IS TO SEEK INFORMATION/COMMENT REGARDING EXTRACORPOREAL LIFE SUPPORT DEVICES FOR THE MEDICAL RESEARCH AND MATERIEL COMMAND (MRMC), FORT DETRICK, MARYLAND. REQUEST FOR INFORMATION TITLE: Extracorporeal Life Support Devices 1. Purpose The purpose of this Request for Information (RFI) as defined in FAR 15.201 is to gather information from interested parties for planning purposes in an effort to develop or procure extracorporeal life support (ECLS) devices for the battlefield. Medical Research and Materiel Command (MRMC) is specifically seeking information from industry and universities on the current availability of and future plans for extracorporeal lung and renal support. All interested sources are encouraged to respond. This RFI is NOT a solicitation for procurement or other acquisition proposals, proposal abstracts, or quotations. The government does not intend to award a contract on the basis of this RFI or to otherwise pay for the information solicited. This RFI does not commit the Government to the award of a contract. Availability of any formal solicitation resulting from this RFI, if a solicitation is released, will be synopysized separately on the Federal Business Opportunities (FedBizOpps) website (http://www.fbo.gov). PROPOSALS ARE NOT REQUESTED AT THIS TIME AND WILL NOT BE CONSIDERED. Submitting entities should review FAR 3.104 and FAR subpart 24.2 which sets forth the Government's obligations to protect information submitted in response to this RFI. Pursuant to FAR 15.201(f), information to be provided by the Government in a public forum to a potential respondent in response to such respondent's request must not be disclosed if doing so would reveal the potential Respondent's confidential business strategy, and is protected under FAR 3.104 or FAR subpart 24.2. (Nonetheless, Respondents should properly mark their responses if the information is confidential). The anticipated North American Industry Classification System (NAICS) code for this requirement is, 339999, All Other Miscellaneous Manufacturing. The small business size standard is 500 employees. Your response should identify your business size (large or small) in relation to the NAICS code. 2. Background MRMC envisions potential future battlefield scenarios of prolonged field care, which may result in the presentation of critically ill patients with severe lung and renal injury far-forward on the battlefield. The response to this scenario will include deploying lightweight, rugged, user-friendly extracorporeal life support devices to forward surgical teams and other forward units. These devices will replace all or part of the function of the lungs for patients with acute respiratory distress syndrome or other types of pulmonary failure, and/or of the function of the kidneys for patients with acute renal failure. Extracorporeal blood purification (removal of inflammatory mediators, bacteria, or their products via such devices) is also envisioned. 3. Description of Need Full extracorporeal membrane oxygenation is not feasible on the battlefield due to technical limitations requiring a high level of expertise currently lacking in such forward reaching facilities. Currently, low flow CO2 removal is not available in the United States. Continuous renal replacement therapy is not a capability that can be deployed regularly due to size and logistical burden. MRMC is soliciting a description of currently available technology which may meet these needs, or a portion of these needs. 3.1. Technical Capabilities Sought MRMC seeks information from industry and universities on the current availability of and future plans for extracorporeal lung and renal support devices. The government envisions an integrated or modular single device that may meet the following parameters derived from current known technologies as a starting point for developing/evaluating potential solutions that could meet the government's needs. 3.1.1. Extracorporeal lung support device - Device should be able to be cleared or approved by the Food and Drug Administration (FDA) for an indication related to lung injury - Should be low-flow (500-1000 cc/min) and use catheters of 13.5 - 15 French or equivalent - Should be lightweight and rugged for battlefield use (withstands temperature extremes, drops/vibration, dust/rain/humidity) - Should be able to operate on AC, DC and battery power - Should be easy to use to both begin and maintain therapy - Should have anticoagulation coatings on the extracorporeal circuit 3.1.2. Extracorporeal renal support device - Device should be able to be cleared or approved by the Food and Drug Administration (FDA) for an indication related to kidney injury - Should be low-flow (500-1000 cc/min) and use catheters of 13.5 - 15 French or equivalent - Should be lightweight and rugged for battlefield use (withstands temperature extremes, drops/vibration, dust/rain/humidity) - Should be able to operate on AC, DC and battery power - Should be easy to use to both begin and maintain therapy - Should not require a large logistical footprint to use (supplies, fluids, etc.) - Should have anticoagulation coatings on the extracorporeal circuit 3.1.3. Combined extracorporeal support for AKI and ALI - Device should be able to be cleared or approved by the Food and Drug Administration (FDA) for an indication related to lung injury, kidney injury, or multi-organ failure - Should be low-flow (500-1000 cc/min) and use catheters of 13.5 -r 15 French or equivalent - Should be lightweight and rugged for battlefield use (withstands temperature extremes, drops/vibration, dust/rain/humidity) - Should be able to operate on AC, DC and battery power - Should be easy to use to both begin and maintain therapy - Should not require a large logistical footprint to use (supplies, fluids, etc.) - Should have anticoagulation coatings on the extracorporeal circuit 3.2. Other Considerations Lifecycle considerations should include such factors as research and development costs, FDA requirements, ease of production, environmental exposure, versatility, modularity, maximum utilization of off-the-shelf components, initial acquisition cost, maintenance and repair requirements, operating and support costs, training requirements, technical support and recycle/disposal. 4. Information Requested The following information (where applicable) is requested: 1. A description and discussion of respondent's capabilities with respect to fulfilling the needs outlined in this RFI. 2. A discussion of an approach including consumable requirements and training that has the potential to meet the performance requirements, including regulatory strategy and a discussion of previous experience/accomplishments with the identified concepts. 3. A description of the offered solution(s), including the approach, past and present examples, associated technologies and their maturity, physiological impacts, production impacts, and present and predicted reliability. 4. A perspective on the current state of the art as well as the technological impediments and regulatory requirements that must be overcome to advance the development and application of extracorporeal life support technology over the next five years. 5. An identification of any needed R&D for the offered solution(s) relative to the requirements above, and a discussion of any further actions required on the part of the offeror to meet any and all of the desired capabilities. 6. Any additional information that will assist in understanding your response to the RFI. 4.1. Submission Format Responses to this RFI shall be submitted electronically via email. Limit responses to between shall not exceed 10 typed pages. Respondents shall submit an electronic copy of the response in MS Word (.doc) or portable document file (PDF) format that is compatible with MS Office 2010. Clearly mark submissions with RFI # W81XWH-16-SN-0012. The electronic document submitted must be formatted to print as typewritten on single-sided paper with one-inch margins on all sides and 1.0-spaced text. Use 12-point font with normal (uncondensed spacing). MRMC may choose to meet with respondents to this RFI. A meeting would be intended to obtain further clarification of respondent capabilities and technical details. Submissions should identify a point of contact in case meetings are requested. Please send submissions via e-mail to joy.d.kamara.civ@mail.mil. No phone calls accepted at this time.