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This Combined Synopsis/Solicitation opportunity from Department Of Defense was posted on May 9, 2016. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Boston Scientific Implantable Cardioverter Defibrillator

Closed
N00259-16-T-0131Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 334510
New
Federal
Automated Ultrasound-Based, Super Intelligence (SI)-Enabled Fracture Detection
Solicitation # BARDA-FY27-10192026
The Center for Biomedical Advanced Research and Development Authority (BARDA) has issued Sources Sought Notice BARDA-FY27-10192026 to identify innovative medical countermeasure technologies for the rapid triage of musculoskeletal injuries, such as fractures and soft tissue injuries of extremities. This request for information is intended for planning and market research purposes to assess commercially available or nearing-commercial technologies that utilize Super Intelligence (SI) and machine learning for automated ultrasound-based fracture detection. The goal is to find standalone, point-of-care devices that can operate in emergency departments, urgent care centers, and austere field settings without relying on traditional imaging infrastructure like X-ray or CT scans. The desired technology must feature automated volumetric capture, 3D-rotatable modeling, and SI-enabled image processing that outperforms human imaging experts and has undergone FDA 510k clearance processes. BARDA is interested in ruggedized, portable units with sufficient battery life for disaster response, interoperability with electronic health record systems, and minimal training requirements for non-specialist operators. Potential acquisition strategies being explored include direct purchases, leases, or vendor-managed inventory arrangements. Interested small businesses and other than small business concerns under NAICS code 334510 must submit their capabilities statements by 1:00 p.m. Eastern Time on November 18, 2026. Submissions must include separate Technical and Business Representation sections, each limited to 10 pages in 12-point Times New Roman font, and be emailed to Justin Moore and Richard Hall. Responses should detail the company's manufacturing capabilities within the United States, regulatory maturity, supply chain resilience, and cybersecurity standards for handling sensitive patient health information.
Barda - Aspr / Daappo / Barda Dcma

POSTED

about 23 hours ago

DEADLINE

in 28 days

General Info

Contract Value

$29,500

NAICS

334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing

Place of Performance

Naval Medical Center San Diego 34800 Bob Wilson Drive, SAN DIEGO, CA, 92134, USA

Set-Aside

NONE

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

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Timeline

PhaseClosed
Posted

Combined Synopsis

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Defense → Naval Medical Center San Diego Ca
Contacts2 people available
OfficeSAN DIEGO, CA, 92134-5000, USA
Office AddressSAN DIEGO, CA, 92134-5000, USA
Contacts
Margaret H. BabbittContract Specialist
Christopher J. JennenSupervisory Contract Specialist

Full Description

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Combined Synopsis/Solicitation For Boston Scientific Implantable Cardioverter Defibrillator 1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation N00259-16-T-0131 is being issued as a Request for Quotation. This notice and the incorporated provisions and clauses are those in effect through the Federal Acquisition Regulations (FAR). All responsible sources may submit a proposal. 2. The North American Industry Classification System (NAICS) code is 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing. Offerors must be registered in the System for Award Maintenance (SAM) at http://www.sam.gov, in order to be considered for award. 3. FAR Clauses 52.212-1 through 52.212-5 apply to this procurement. For the exact text and wording of clauses and provisions please see http://farsite.hill.af.mil. The Government contemplates an award of a Firm Fixed Priced purchase order contract resulting from this solicitation. 4. Description of services: This requirement is for a vendor to supply trunk stock of Boston Scientific implantable cardioverter defibrillators (ICDs) for a procedure scheduled for May 17, 2016 at 0900 hrs. Pacific time. The specific make/model number is dependent on patient anatomy, and therefore cannot be predicted in advance. However, one model specifically must be included: At least one (1) SubQ Single Chamber device is required. The device must maintain a heart rate of 60-100 beats per minute. The provider must be able to program/adjust the device to a heart rate requirement based on the patient's needs. At least one (1) SubQ lead is also required, with electrodes at the tips which are placed in the heart chamber(s) to communicate with the heart and device. Pacemaker service is required. Routine interrogation service, every 3 to 6 months or as needed, to maintain the life of the device for as long as the patient has the device. On-site support is required during implantation. Provider must be a subject matter expert on their supplies and how they pertain to the Subcutaneous Single Chamber ICD procedure. This combined synopsis & solicitation notice is a request for competitive quotations. Therefore, all capability statements or quotations received prior to the RFQ close date will be considered by NMCSD. 5. The Government will award a single purchase order contract resulting from this RFQ to the responsible offeror whose offer represents the best value in terms of technical capability and price. All non-price factors (i.e., technical capability and past performance) are significantly more important than price. 6. Offerors must submit representations and certifications in accordance with the provision at FAR 52.212-3 Offeror Representations and Certifications-Commercial Item. (Accessible at the FAR Site, http://farsite.hill.af.mil 7. Offers are due on May 12, 2016 at 1400 hrs Pacific Time. All questions/inquiries must be submitted to the contract officer via electronic mail (e-mail) not later than 1400 hrs Pacific Time on May 12, 2016. Inquiries submitted via telephone calls will be re-directed to an e-mail submission. Submit offers or any questions to the attention of Margaret Babbitt and copy to Chris Jennen via email to: margaret.h.babbitt.civ@mail.mil and christopher.j.jennen.civ@mail.mil, respectively. Offerors who fail to complete and submit the requirements above may be considered non-responsive. NAVY COMMERCIAL ACCESS CONTROL SYSTEM (NCACS) PROGRAM IMPLEMENTATION INSTRUCTION (August 2011) (a) In accordance with CNICNOTE 5530 dated May 2, 2011, NCACS credentialing should be established in order to avoid unnecessary delay at military installation entry control points (ECP). (b) NCACS guidance for Vendors/Contractors to obtain a pass is accessible through the following website: http://www.cnic.navy.mil/regions/cnrsw/installations/navbase_san_diego/om/force_protection/rapid_gate.html. For more information or to enroll in the NCACS Program call: 1.877.727.4342. For Naval Base San Diego Pass and Decal Office, call: 1.619.556.1653 (c) Vendors, contractors, suppliers and other service providers shall present their pass upon entry at ECP. The solicitation document and incorporated provisions and clauses are those in effect through FAC 2005-86. This acquisition incorporates the following FAR clauses: 52.204-13 Systems for Award Management Maintenance (JUL 2013) 52.212-4 Contract Terms and Conditions - Commercial Items (JUL 2013) 52.211-17 Delivery of Excess Quantities (SEP 1989) 52.247-34 F.O.B Destination (NOV 1991) 252.203-7000 Requirements Relating to Compensation of Former DoD Officials (SEP 2011) 252.204-7012 Safeguarding of Unclassified Controlled Technical Information (DEV) (OCT 2015) 252.204-7008 Compliance with Safeguarding Covered Defense Information Controls (DEV) (OCT 2015) 252.225-7001 Buy American and Balance of Payments Program (DEC 2012) 252.225-7002 Qualifying Country Sources as Subcontractors (DEC 2012) 252.225-7048 Export Controlled Items (JUNE 2013) 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports (JUN 2012) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JUL 2013) 52.204-10 Reporting Executive Subcontract Awards (JUL 2013) 52.219-28 Post Award Small Business Program Representation (JUL 2013) 52.222-3 Convict Labor (JUNE 2003) 52.222-19 Child Labor - Cooperation with Authorities and Remedies (MAR 2012) 52.222-21 Prohibition of Segregated Facilities (FEB 1999) 52.222-26 Equal Opportunity (MAR 2007) 52.222-36 Affirmative Action for Workers with Disabilities (OCT 2010 52.222-50 Combating Trafficking in Persons (MAR 2, 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) 52.232-33 Payment by Electronic Funds Transfer - System for Award Management (JUL 2013) 52.212-1 Instructions to Offerors - Commercial Items (JUL 2013) 52.212-2 Evaluation - Commercial Items (JAN 1999) The following factors shall be used to evaluate offers in descending order of importance: FACTOR 1: Technical Capability; defined as the ability of the products to meet the salient characteristics needed. FACTOR 2: Delivery Schedule; is defined as the lead time necessary to receive the product. FACTOR 3: Price; the government shall conduct a price evaluation of all technically acceptable offers with acceptable delivery schedules. Technical capability and delivery schedule, when combined, are significant evaluation factors that will be most advantageous to the Government. Contractors who do not meet both of the first two factors will not undergo a price evaluation. 52.212-3 Offeror Representations and Certifications - Commercial Items (JUL 2013) 52.204-7 System for Award Management (JUL 2013) 252.203-7998 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements (DEV) 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address (es): http://farsite.hill.af.mil/VFFARa.htm (End of provision) 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es): FAR Clauses: http://farsite.hill.af.mil/VFFARa.htm DFAR Clauses: http://www.acq.osd.mil/dpap/dars/dfars/index.htm (End of clause) The Government will only consider firm fixed price quotations. Offeror must complete and submit with the quotations FAR provision 52.212-3 Offeror Representations and Certifications - Commercial Items (JUL 2013). The provision can also be submitted at https://www.sam.gov. Contractor must be registered to the System for Award Management (SAM) prior to award. A nine digit Data Universal Numbering Systems (DUNS) number provided by Dun and Bradstreet is required to register. The website address for SAM registration is https://sam.gov Electronic submission of Quotes: Quotations shall be submitted electronically by email to tiffanie.l.sutgrey.civ@mail.mil. Email submissions are limited to 2MB. The submitter should confirm receipt of email submissions.

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