SOLICITATION NOTICE
A -- Sources Sought Notice-NAMRU-D ENHANCED PULSE OXIMETER PROTOTYPE DEVELOPMENT
- Notice Date
- 8/2/2017
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N4181717RC00063
- Archive Date
- 8/11/2017
- Point of Contact
- Jennifer M. Reed, Phone: 3016191200
- E-Mail Address
-
jennifer.m.reed20.civ@mail.mil
(jennifer.m.reed20.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Sources Sought Notice The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR 6.302-1 (One responsible source) to Thera Tactics, Inc., located at 2711 Centerville Rd., Suite 400, Wilmington, DE, 19808. This requirement is to provide an enhanced pulse oximetry capability that will provide accurate, real time monitoring in a tactical aviation environment. The requirement is for the ongoing research efforts conducted at the Naval Medical Research Unit Dayton (NAMRU-D), located at Wright-Patterson Air Force Base, Ohio. The enhanced pulse oximetry capability is necessary to understand and address the significant increase in hypoxia-life physiologic episodes (HL-PE's) that have been experienced in Naval Aviation. The Government requires that the pulse oximetry system be able to measure blood oxygen saturation (SpO2) at the capillary bed that is supplied by the supraorbital artery. The Thera Tactics pulse oximeter (TTPO) is specifically designed for high performance tactical aviators, as it uses a forehead sensor that is placed over the microcirculation fed by the supraorbital artery that arises from the internal carotid artery and lacks vasoconstrictor properties. The Government requires that the pulse oximetry system to include a method to quickly identify the correct placement of the pulse oximeter to accommodate the location of the supraorbital artery for each operator. Thera Tactics has a patent pending for an infrared photometric technique to locate this microcirculatory bed (Bebout, D.E. and W.L, Bednarski, Method for Monitoring Non-Invasive Arterial Oxygen Saturation, Pulse Rate and Detection of Carboxyhemoglobin. United States Patent 15612933 (pending), 2016.). Because this method is pending intellectual property of Thera Tactics, no other pulse oximeter (PO) can offer this technique which is integral to the research protocol. Similarly, the Government is unaware of any other potential offeror with a similar capability. The Government requires that the pulse oximetry system to include state of the art noise reduction algorithms to accommodate the harsh vibration forces present in tactical aviation. The TTPO has an integrated three dimensional accelerometer that will be used to quantify vibrations in all three directions simultaneously to be used for algorithm development to improve performance under these extreme conditions. Studies will be conducted on a vibration table that simulates the high frequency vibrations of high performance tactical aircraft. There are no commercial POs that have a three dimensional accelerometer for this purpose, and the Government is unaware of any non-commercial potential offerors with this capability. The Government requires that the pulse oximetry system employ an altimeter into the system to identify and record significant deviations from scheduled cabin pressurization. The TTPO contains an altimeter to measure cabin pressure and enhance performance and accuracy. Studies will be conducted in a hypobaric chamber up to 20,000 ft and data will be submitted to FDA in a 510k for clearance and use under these conditions. No commercial PO has claims or indications for use during reduced atmospheric pressures. The Government requires that the pulse oximetry system employ an algorithm that will enable the system to identify when a significant exposure to carbon monoxide has occurred. The TTPO has a patented algorithm to detect carboxyhemoglobin using the forehead sensor with two wavelengths of light (Bebout and Bednarski, patent 15612933, pending, 2016). No other commercial PO has this capability, and the Government is unaware of any non-commercial potential offerors with this capability. The TTPO is designed with sufficient battery capacity to last three hours and record data at 80-100 Hz. Commercial pulse oximeters only save data at 1 Hz because of limited memory and battery life and cannot fulfill the objectives of our research protocol. Furthermore the TTPO is designed with sufficient battery capacity to last three hours and record data at 80-100 Hz. Commercial pulse oximeters only save data at 1 Hz because of limited memory and battery life and cannot fulfill the objectives of our research protocol. Thera Tactics has an original equipment manufacturer agreement with Nellcor (Medtronic) that allows them to incorporate a FDA cleared Nellcor pulse oximeter board into their monitoring system. For these reasons, Thera Tactics is the only company that can meet the Governments requirement. If capable sources are not identified through this notice, NMLC intends to award a sole source contract under the authority of FAR 6.302-1 (one responsible source) to Thera Tactics, Inc., 2711 Centerville Rd., Suite 400, Wilmington, DE, 19808, to provide the described requirement. This sources sought notice is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract. Capability statements are due by 4:00 PM Local Time, 7 August 2017. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following addresses: jennifer.m.reed20.civ@mail.mil and thomas.l.hood26.civ@mail.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N4181717RC00063/listing.html)
- Place of Performance
- Address: NAMRU-D, Dayton, Ohio, 45433, United States
- Zip Code: 45433
- Zip Code: 45433
- Record
- SN04608687-W 20170804/170802231908-171137ce02051a927afb83df7505319f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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