SOURCES SOUGHT
A -- Transport Telemedicine Systems (TTS) Program
- Notice Date
- 5/10/2020 8:16:24 AM
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W6QK ACC-APG NATICK NATICK MA 01760-5011 USA
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY20S0010
- Response Due
- 5/19/2020 9:00:00 AM
- Archive Date
- 06/03/2020
- Point of Contact
- Richard Totten, Phone: 3016192446, Kenneth V Janosko, Phone: 3016197468
- E-Mail Address
-
richard.w.totten2.civ@mail.mil, kenneth.v.janosko.civ@mail.mil
(richard.w.totten2.civ@mail.mil, kenneth.v.janosko.civ@mail.mil)
- Description
- W911QY-20-S-0010 Responses to Questions: 1.������ The scope of the RPP is somewhat� unclear.� In specifics: a.����� Section 4 states that, �the award of Prototype OTAs shall be for the development of prototypes�� b.���� The paragraph above the heading �STUDY OBJECTIVES� say, �The scope of this effort is focused on Food and Drug Administration (FDA) regulatory approval and developing manufacturing capacity ventilators to support potential follow-on production.� c.����� Is the Army asking for a proposal for creating prototypes as is stated in Section 4� or is the expected response to address the paragraph cited in b. above and detailed in the language below the heading �STUDY OBJECTIVES�? RESPONSE: The proposal is for development, regulatory approval, and manufacturing scaling in order to support follow-on production for up to 10,000 units. Different offers' products may be at different maturity levels and may have different resource requirements in order to meet the proposed goals. The proposal should be tailored to individual project needs to meet the proposed goals. 2.����� Assuming the answer to question #1 is the scope listed under and directly above the heading �STUDY OBJECTIVES�.� Is it the intent to include tooling costs to be ready ramp quickly to the 10,000 units?� This does not seem to be included in either the �Manufacturability� or the �Cost� sections. RESPONSE: As each product is at a different technological and manufacturing maturity level, offers should tailor their individual proposal to meet the proposal goals for FDA approval and manufacturing scale-up and include resources required in order to quickly ramp up to 10,000 units. Offerors are encouraged to include information regarding tooling costs. If selected for an award, the offeror and government may negotiate specific statements of work prior to award. 3.����� Is the requirement to be �Able to use ambient air or low pressure oxygen� to be defined as the ability to operate on either at any time, or is the requirement met fully by being able to only operate on one or the other? RESPONSE: The requirement ""able to use ambient air or low pressure oxygen"" refers to either ambient air or low pressure oxygen at any time. The requirement is met if the device can operate in at least one of the environments. 4.����� Is �low pressure oxygen� nominally 50 psi? or what is the definition of �low pressure oxygen�? RESPONSE: A Low Pressure Oxygen Source is typically provided by a concentrator or liquid cylinder at pressures less than 50 psi.� Ventilators compatible with Low pressure Oxygen Sources can use oxygen supplied from a low pressure oxygen source < 10 PSI (< 69 BAR, < 69 kPa) such as a flow meter. This is often compatible with aeromedical evacuation. 5.����� The �Testing and Validation� � �Clinical Data� section asks to �provide information on preclinical and/or clinical data collected on the device to support regulatory approval�.� The information provided to the FDA easily exceeds 15 pages.� Is this asking for a summary and some examples? RESPONSE: A summary and some examples of information provided to the FDA is sufficient. *************************************************************************************************************** W911QY-20-S-0010 This Sources Sought Notice (SSN) is posted to conduct market research for capabilities from potential sources for a medical device/software that integrates commercially available FDA devices, novel non-medical devices (drug and tourniquet sensors) and automated (hands-free, voice-free) software to capture Tactical Combat Casualty Care (TC3) card information with the ability to transmit this data over the DoD tactical satellite network for Medical Treatment Facilities.� The device/software must be able to receive this data from the DoD tactical network and display in a standard hospital Intensive Care Unit (ICU) dashboard format.� This requirement must meet airworthiness, DoD Information Assurance protocols (DISA Risk Management Framework), and FDA medical device clearance (if necessary). This is a SSN for planning purposes only, as defined in FAR 15.201(e). This is not a solicitation for proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this SSN. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback. This information will support USAMMDA�s Project Management Office Warfighter Health Performance and Evacuation (PMO WHPE), Transport Telemedicine Systems (TTS) Program to increase Warfighter patient outcomes and long-term healthcare outcome through a medical data communication integrated solution that bridges the gap between documentation and existing medical devices to collect patient data and transmit it in near-real-time to the deployed medical treatment facilities (MTFs). � As such, TTS is seeking the following information on current industry capabilities for a system capable of managing six patients using a single low cost device that has the ability to integrate data from sensors to automatically capture and transmit vital signs and treatments interventions for use by the United States Army Special Operations Command: Description of definition the system architecture for the MEDHUB Line Medic Kit, Mobile Ad-hoc Networking (MANET) system network, Mobile MEDHUB Patient Awareness Support System (MPASS) Dashboard, Mobile Medication Management Systems (M3S), canine veterinary documentation and tactical communications platform integration of both the Air and Ground Ambulance Vehicles based on the United States Government (USG) PMEC. Description of software release schedules and test plans to support unit and system level testing. Description of how contractor shall work in concert with System, Simulation, Software and Integrated Directorate (S3I) Army Interoperability Lab (SAIL) and USG to develop the detailed network architecture to integrate the MEDHUB systems for MANET networks. Description of how the contractor shall conduct system integration and testing of MANET networks prior to final evaluation events. The testing shall be conducted with contractor�s test plan that involve both ground and air platforms. A description of system�s ability to meet DoD Information Assurance protocols (DISA Risk Management Framework), and FDA medical device clearance (if necessary). The availability to test the device on a simulated DoD tactical mesh network. SUBMISSION INSTRUCTIONS: All written responses must be received within fifteen (15) days of issuance of this SSN. Submissions should: (1) Use Microsoft Word or Adobe Portable Document Format (PDF); (2) Be sent to the POC identified below by email only; (3) Be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this SSN; (4) Include a single company point of contact with name, title, address, telephone and fax numbers, and e-mail address(s); and (5) Not exceed 10 single sided pages in total (not including cover page and cover letter). Material that is advertisement only in nature is not desired. Please address responses to this notice to the Government Contracting Officer, Richard Totten: richard.w.totten2.civ@mail.mil. Please title the response with the announcement number, company name, and date. All questions must be submitted in writing via email. No telephone inquiries will be accepted.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/1337af80adc14b1a8a99169162c4710c/view)
- Record
- SN05652319-F 20200512/200510230143 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |