SAM #70RSAT26RFI000021

DHS Seeks Industry Collaboration for Rapid Cyanide Detection Medical Device Prototypes

The Department of Homeland Security (DHS) Science and Technology Directorate's Chemical Security Analysis Center (CSAC) is seeking industry collaboration for the development of medical device prototypes to detect human cyanide exposure. - Government Buyer: - Department of Homeland Security (DHS), Science and Technology Directorate (S&T), Chemical Security Analysis Center (CSAC) - Office of Procurement Operations, SCI TECH ACQ DIV - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Products/Services Requested: - Engineering, testing, and manufacturing of medical device prototypes for rapid cyanide detection in humans - Services include biomarker selection and validation, regulatory navigation (including FDA experience), cost estimation, and scalable manufacturing - Development of a handheld device deployable by first responders - Collaboration to advance DHS's patented human biomarker system for cyanide exposure detection - Unique or Notable Requirements: - Demonstrated expertise in chemical medical countermeasures and hazardous substance detection technologies - Experience with prototype engineering, regulatory approval, and manufacturing scale-up - Ability to collaborate under a Cooperative Research and Development Agreement (CRADA) - Focus on rapid, deployable solutions for emergency response scenarios

Description

This Request for Information (RFI) supports the Department of Homeland Security (DHS) Science and Technology (S&T) Directorate’s efforts to conduct market research in support of the Chemical Security Analysis Center (CSAC).

DHS S&T is tasked with researching and organizing the scientific, engineering, and technological resources of the United States and leveraging these existing resources into technological tools to help protect the homeland. S&T Chemical Security Analysis Center (CSAC) is the only federal studies, analysis, and knowledge management center for assessing critical chemical dependencies, emerging threats and technologies, and accidental or intentional chemical events in the United States. CSAC supports the homeland security community by providing a crucial knowledge repository of chemical threat information, design and execution of laboratory and field tests, and a science-based threat and risk analysis capability, among other services.

DHS has patented a human biomarker system and method for cyanide exposure detection. In order to advance the patented technology, S&T CSAC is looking to enter into a Cooperative Research and Development Agreement (CRADA) with relevant collaborator(s) to inform a development pathway for its cyanide exposure detection system. This collaboration will expand interaction with industry to ensure that first responders and the American public are afforded access to state-of-the-art detection technology solutions that save lives.

The objective of this RFI is to gather detailed insights from companies and consortia engaged in the engineering, testing, and manufacturing of medical device prototypes relevant to the detection of human cyanide exposure. DHS seek collaborator(s) with expertise in chemical medical countermeasures, particularly those that can demonstrate a robust background in developing detection technologies for hazardous substances, including past projects and relevant experience. Responses should outline the engineering and design processes utilized in creating prototypes, including biomarker selection and validation methodologies, as well as comprehensive cost estimates and timelines for development from proof of concept through regulatory approval and manufacturing. Additionally, respondents should provide information on navigating the regulatory landscape for medical devices, including experience with agencies like the Food and Drug Administration (FDA), and detail their manufacturing capabilities, including scalability and compliance with industry standards.

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