SOURCES SOUGHT
A -- quote mark Hydration Status Monitor (HSM) Product Development quote mark
- Notice Date
- 4/26/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-13-R-0046
- Response Due
- 5/10/2013
- Archive Date
- 6/25/2013
- Point of Contact
- Myrsonia Lutz, 301-619-8896
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(myrsonia.lutz@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This Request for Information (RFI) is in accordance with the Federal Acquisition Regulation (FAR) Clause 52.215-3, Request for Information or Solicitation for Planning Purposes and is published only to encourage interested parties to gather information about commercially available products that meet or can be readily modified to meet the requirements discussed below. THIS IS NOT A REQUEST FOR PROPOSALS (RFI) OR A REQUEST FOR QUOTATIONS (RFQ); IT IS STRICTLY A RFI. NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1.SUBJECT: The United States Army Medical Materiel Agency (USAMMA) is conducting market research on technology solutions to develop a Hydration Status Monitor (HSM) device/sensor (s) for insertion into existing field medical equipment sets for primary use by medical personnel at the Battalion Aid Station (BAS) level. The development of a rapid, non-invasive device to aid in the diagnosis, treatment of dehydration. It is anticipated that the HSM will receive Food and Drug Administration (FDA) marketing clearances. Responses are due to this RFI by 10 May 2013; 4:00 PM EDT. 2.DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked quote mark Proprietary quote mark will be handled accordingly. Information and representative samples as responses to the RFI will not be returned. At this time, USAMMA will no entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future RFP. 3.BACKGROUND: Hydration assessment is a key component for the prevention and proper treatment of fluid and electrolyte imbalances during warfighter training and fighting, particularly in extreme environments such as Iraq and Afghanistan. Dehydration is one of the fundamental physiological mechanisms of extreme environment-related illness and injury. Dehydration degrades work capabilities and increases the risk of life-threatening heat illness, seizures and brain damage. Over aggressive re-hydration can cause serious health problems such as hyponatremia. Debilitating performance and health consequences of dehydration and hyponatremia could be exploited by an aggressive enemy. Despite the critical importance of proper fluid balance to warfighter performance and health, no valid, reliable, and field-expedient test currently exists for assessing hydration status. The commercial test shall be a simple hand-held device similar to the home pregnancy test. This device can be suitable for home and field use, and shall deliver results in minutes at a fraction of costs associated with the standard blood test. 4.REQUIREMENTS: The objective of the HSM is to create a rapid, non-invasive device to aid in the diagnosis and treatment of dehydration. To accomplish this, the ultimate HSM device shall contain a high diagnostic accuracy of 80% or greater. The services shall include the qualitative device capable of measuring dehydration to: 1)Measure the magnitude of dehydration. 2)Be able to differentiate between the two (2) types of dehydration: quote mark Isotonic quote mark (Viral illness, diarrhea or vomiting), and quote mark Hypertonic quote mark (Exercise heat exposure and insufficient fluid intake). 3)Be integrated into an existing Medical Equipment Sets (MES) for primary use by medical personnel at the Battalion Aid Station (BAS) level. The HSM shall receive Food and Drug Administration (FDA) marketing clearances. 4)The device shall measure biomarkers in saliva to provide a non-invasive aid in the diagnosis of fluid-electrolyte imbalances such as dehydration. 4A. MANDATORY REQUIREMENTS: The candidate HSM device shall satisfy the following top-level requirements: Base Period - Year I: Task 1. Validate analytical performance of laboratory assays for measuring SRP biomarkers in saliva. The Contractor shall conduct laboratory assays to evaluate the performance characteristics of specific biomarkers (proteins and other chemicals) identified in saliva, which has been obtained from human subjects under one of three (3) conditions? Euhydrated (normal hydration state); Hypertonic dehydration (fluid loss with concentrated body fluids); and, Isotonic dehydration (fluid loss with normal concentration of body fluids). The purpose of this task shall be to identify and validate the assay characteristics, including reagents and assay performance. Deliverables: Contractor shall provide written report of the validated reagents and assay performance characteristics. Milestones: Test results shall meet Clinical and Laboratory Standards Institute (CLSI) specifications for laboratory immunoassays. Task 2. Develop and validate breadboard prototype Technology Readiness Level 4 (TRL4) The Contractor shall conduct laboratory assays to evaluate the bench top sensitivity of biomarkers identified in saliva which has been obtained from Human Subjects under one (1) of three conditions: Euhydrated (normal hydration state); Hypertonic dehydration (fluid loss with concentrated body fluids); and, Isotonic dehydration (fluid loss with normal concentration of body fluids). The objectives of this task shall be to study the accuracy of the saliva biomarker by evaluating the sensitivity of the measurements for selected biomarkers. Deliverables: The Contractor shall provide written report describing the output of the laboratory scale breadboard test for saliva biomarkers. Milestones: Reference data interval for selected biomarkers. Task 3. Down-select Biomarkers, Step 1 The Contractor shall conduct laboratory assays to perform a preliminary determination of the accuracy of biomarkers to aid in subsequent down-selection of biomarkers. This initial validation shall be conducted using existing saliva samples from subjects in euhydration, hypertonic dehydration, and isotonic dehydration obtained from previous studies conducted previous grants and contract. This initial validation shall provide preliminary data to guide in the further analysis of biomarkers and ultimate down-selection to the 3-5 markers that shall be used in the subsequent development of the prototype device. Deliverables: The Contractor shall provide written report demonstrating the diagnostic accuracy of dehydration test. Task 4. Conduct Feasibility Trial (N=30-60) and Collect Saliva Samples The Contractor shall conduct laboratory assays to perform a secondary determination of the accuracy of biomarkers to aid in subsequent down-selection of markers. This next step in validation shall be conducted using saliva samples from subjects in euhydration, hypertonic dehydration, and isotonic dehydration states from a clinical feasibility study, which the Human Subjects volunteers shall participate in dehydration experiments. Deliverables: The Contractor shall provide saliva samples and Clinical Data Report N=30-60 Subjects, n=23 time points. Milestones: Complete sample set that meets Quality Control (QC) specifications. Complete, audited clinical data. Option Period - Year II: Task 5. Down-select Biomarkers, Step 2 The Contractor shall continue laboratory validation of saliva biomarkers with the objective of down-selection of biomarkers for the prototype device. Contractor shall identify and verify the best time to administer the saliva test relative to the dehydration itself. This shall include further laboratory analysis of saliva from euhydrated and dehydrated Human Subjects from the clinical feasibility studies. The purpose of these analyses shall be to further validate the accuracy of specific biomarker molecules to give information for the device prototype development. Deliverables: The Contractor shall provide written report demonstrating the diagnostic accuracy of dehydration test and best timing to administer the test. Milestones: Full validation of intended use claims using Feasibility Samples. Task 6. Develop and Validate Advanced Prototype (TRL8) The Contractor shall utilize the information gathered in Tasks 1-5 with partnership with their Good Manufacturing Practices (GMP) manufacturing partner. The Contractor shall select the best biomarkers and develop a prototype saliva HSM device. This device shall be able to noninvasively detect the selected saliva biomarkers on a small stick device. Once a prototype device is developed, an investigational device exemption (IDE) application shall be submitted to the FDA for approval to further test the device in Humans Subjects. Deliverables: The Contractor shall provide test data report and demonstration of product viability via Governments' site visit. Contractor shall provide video evidence at the completion of Task 6. Milestones: Advanced prototype completed and qualified for IDE. Task 7. Apply for IDE The Contractor shall complete and submit a full IDE application for the prototype saliva HSM device. The Contractor shall communicate with the Food and Drug Administration (FDA) and address any and all queries or concerns raised by the FDA in the process of evaluating the IDE application. The objective of this task is a successful (FDA approved) IDE application. Deliverables: Contractor shall provide the FDA approval of IDE. Milestones: IDE for Advanced prototype. Option Period - Year III: Task 8. Manufacture advanced prototypes for Pivotal trial The Contractor shall manufacture advance prototypes based on FDA approved IDE. The Contractor shall assure that the manufacturer manufactures 3,000 to 5,000 prototype devices that meet the Governments' specifications and ready for use in the Device Pivotal Trial for FDA submission (510k or PMA, as appropriate). Deliverables: Contractor shall provide prototypes (n=3000-5000). Milestones: Complete set of prototypes meeting the Government's specifications. Task 9. Conduct Pivotal trial (N=300) The Contractor along with their scientific partners shall demonstrate FDA intended use claims through the process of a pivotal clinical trial involving ~ 300 human volunteers. This shall include studying saliva from people who are euhydrated, dehydrated hypertonically and/or dehydrated isotonically during the pivotal trials (studies of Human Subjects). The Contractor shall work with FDA, as well as scientific partners, to ensure that the tests being conducted satisfy all regulatory requirements regarding use of the saliva HSM device by humans and demonstration of intended use of the device. Deliverables: Contractor shall provide Clinical Test Data Report. Milestones: Demonstrate intended use claims. Task 10. Apply for FDA Clearances The Contractor shall complete and submit the Package of Submission documents for 510k or pre-market approval (PMA) approval from FDA. The Contractor shall provide to the Government and FDA all necessary information, including the analysis of Biomarker Data, as well as the validation of data from the prototype devices and Pivotal Trials. The Contractor shall accomplished FDA clearance of the saliva HSM Prototype Device. Deliverables: Contractor shall provide submission package for FDA approval. Milestones: FDA Clearance. The purpose of this requirement is to support the advanced development of the saliva HSM technology, including the optimization of the biomarkers to be included in the device, as well as the development of prototype device(s) to be tested. The device shall measure biomarkers in saliva to provide a non-invasive aid in the diagnosis of fluid-electrolyte imbalances such as dehydration. The non-invasive HSM for insertion shall be integrated into existing Medical Equipment Sets (MES) for primary use by medical personnel at the Battalion Aid Station (BAS) level. The HSM shall receive FDA marketing clearance. USAMMA seeks to gather information about commercially available products that meet or exceed the requirements discussed above. Minimum Specifications for Saliva Proteomics Hydration Status Monitor United States Army Research Institute of Environmental Medicine (USARIEM) and USAMMA require the development of a rapid, non-invasive device to aid in the diagnosis and treatment of dehydration as part of an overall Decision Gate Hydration Status Monitor Product Development Effort (HSM PDE). To accomplish this, the ultimate HSM device shall exhibit the following characteristics: a. The device shall utilize biomarkers (proteins) in saliva to noninvasively evaluate an individual's hydration state. This means that no invasive procedures (for example, no blood samples) shall be required for the device to work. b. The device shall be able to detect dehydration rapidly (under 2 minutes) and accurately (greater than 90% accuracy). c. The device shall be able to detect magnitude of dehydration (mild vs. severe dehydration). d. The device shall be able to detect isotonic dehydration (dehydration due to vomiting or diarrheal illness which does not result in a change in plasma osmolality), and to detect hypertonic dehydration (due to sweat loss and/or fluid restriction). The device shall be able to distinguish between these two types of dehydration. e. The device shall utilize specific stress response pathways detectable in saliva by detecting protein biomarkers indicative of these pathways. 5.CONTACT INFORMATION: Electronics responses to this RFI shall be addressed to: Myrsonia Lutz, Contract Specialist; E-mail: myrsonia.lutz.civ@mail.mil. Samples must be addressed to: U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Road, Fort Detrick, Maryland 21758, no later than (NLT10 May 2013, 4:00 P.M. This RFI is not a commercial solicitation and the Government will not pay for any information or items in reference to this RFI. 6.RESPONSE SUBMISSION: Responses in reference to this RFI shall be submitted via e-mail or mail. Responses that are mail shall be submitted in a sealed envelope or package with the Respondents' name and address clearly marked on the outside of each sealed envelope or package. Please include point of contact, phone number, e-mail address, and web site information inside the sealed envelope or package. Respondents shall certify whether the company they represent is a U.S. business. The response should describe the company's capability to develop the HSM device as characterized by the requirements addressed in this RFI. If unable to provide a HSM device capable of meeting all requirements, the Respondent should offer trade-off consideration for unmet requirements. Respondents should mark all proprietary data as appropriate. The USAMRAA and USAMMA will protect proprietary information from unauthorized use and disclosure. Unless clearly marked otherwise, submission of a response to this RFI signifies agreement to allow USAMMA personnel to use the information to aid in developing and acquisition approach. 7.LATE SUBMISSIONS: Failure to respond to this RFI does not preclude participation in any future competition, nor will information provided in response to this RFI be used to exclude anyone from responding to any future RFPs. Communications with USAMRAA in regards to this RFI shall be submitted in writing during duration of this RFI. Responses received after the closing deadline of this RFI may be considered. The Respondent assumes the risk of the method of dispatch chosen. Postmarking by the submittal date and time shall not substitute for actual response receipt. 8.OWNERSHIP OR RESPONSE TO RFI: All materials submitted in response to this RFI shall become the property of Government. 9.RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall the Government be responsible for any Respondent expenses in preparation of this RFI, such as: submission costs, any other expenses, costs, damages, or whatever nature incurred. Respondent understands and agrees that respond submission is at their own risk and expenses, and the Government is released from any claim for damages or other liability arising out of the RFI process. 10.ERRORS IN RESPONSE: USAMMA shall not be liable for any errors in Respondents response. The Respondent is responsible for careful review of its entire response to ensure that all information is correct and complete. Respondents are liable for all error or omissions contained in their responses. 11.ADDENDUM: USAMRAA reserves the right to issue and addendum to the RFI at any time for any reason. 12.SAMPLES: USAMMA requests the Respondents submit a sample copy of any or all products or services described and identified in the RFI response (s). All interested, capable, and responsible sources that wish to respond to this RFI are encouraged to submit documentation on their specific capabilities. In addition to relevant and relative capability statements, past performance, and other information, the Government requests responses to provide, as a minimum, the following: 1)Title Page: The capability package shall be assembled with a title page containing the following information: Company name, address, point of contact, telephone number, DUNS Number, Cage Code, and business size. Please include any socio-economic information. 2)Experience: Respondent shall provide prior/current experiences for the same or similar size and scope including contract number, point of contact (POC), and company or agency. Indicate whether a prime or subcontractor, contract value, and Government or commercial point of contact with current telephone number and e-mail address.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-13-R-0046/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN03046885-W 20130428/130426234406-d4677d2419221a588bee80f6753c9f69 (fbodaily.com)
- Source
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