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AN43--508-21-2-1103-0148/ Prototype Development/ Atlanta CVNR (VA-21-00039067)

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36C24E21Q0064Federal

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The Veterans Administration Atlanta VA Research and Development Group plans to negotiate a sole source contract with the Global Center for Medical Innovation (GCMI) for the development of a prototype wearable, non-invasive electroretinography (ERG) diagnostic device aimed at early detection of diabetic retinopathy. GCMI will collaborate closely with VA researchers to design and produce the device, which will include the wearable frame, integrated electronics, light stimulus, and user interface. The company is situated near the Atlanta VA, facilitating timely and direct collaboration. Moreover, GCMI possesses regulatory expertise to ensure compliance with necessary standards, including FDA requirements, enabling rapid prototype development. This intent notice is not a solicitation for competitive proposals, but other interested and capable vendors may submit capability statements by a specified deadline to be considered. The decision to proceed without competition remains at the Government's discretion. The contracting officer for this procurement is Elaine DiBucci, located in Pittsburgh, PA, who can be contacted via email for capability submissions. This contract falls under NAICS code 339113, relating to medical equipment manufacturing, and highlights the VA's focus on innovative, cutting-edge medical device development tailored to improve veteran healthcare outcomes.

General Info

VA plans sole source contract with GCMI to develop wearable ERG device detecting diabetic retinopathy.

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

PA

Set-Aside

NONE

Documents

1
DOCX, Low priorityspecial-notice
Low

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special-notice

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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → Rpo East (36C24E)
Contacts1 person available
OfficePITTSBURGH, PA, 15212, USA
Office AddressPITTSBURGH, PA, 15212, USA
Contacts
Elaine F DiBucciContracting Officer

Full Description

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The Veterans Administration Atlanta VA Research and Development Group intends to negotiate on a sole source basis with Global Center for Medical Innovation (GCMI) to provide services relating to the development of a prototype device that is wearable, non-invasive ERG diagnostic system to detect early stage diabetic retinopathy (DR) . GCMI will work with VA researchers to create a wearable frame, electronics, light stimulus encased in the device, and design a device interface. GCMI is located in the greater Atlanta area, which is important to enable them to work closely with the Atlanta VA researchers in the development of this product. GCMI has the regulatory specialists on staff to ensure all documentation, schematics, etc. meet regulatory requirements (such as FDA device requirements) and have the ability to produce the protype in a short time frame. This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Friday, February 26, 11AM, EST. Interest/capability statements may be sent to Elaine DiBucci at contact@example.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.

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