The Food and Drug Administration (FDA) is seeking quotes for a two-phase research initiative to support the development, evaluation, and benchmarking of AI/ML-enabled wearable medical devices that monitor cardiac physiological signals. The project involves developing a comprehensive inventory of publicly available physiological datasets and creating an original, annotated clinical dataset for public dissemination. Phase 1 includes a systematic review of existing datasets, and Phase 2 involves designing and executing a clinical study to collect synchronized physiological data (BP, PPG, ECG, accelerometry) from 50 healthy subjects. The contractor must ensure raw signal access, robust synchronization, and de-identification of data. All work requires close collaboration with FDA subject matter experts, with FDA review and written concurrence needed before finalization of protocols, datasets, analyses, and manuscripts. The contract type will be firm-fixed-price. Offerors must demonstrate specific qualifications in federal collaboration, clinical study experience, AI/ML expertise, and wearable dataset analysis.
Deliverables are due according to a schedule starting with a project management plan within 30 days of contract award, followed by Phase 1 deliverables within 90 days, clinical study design within 180 days, data collection completion within 335 days, and final study report/dataset within 365 days of contract award.
Payment requests must be submitted electronically through the U. S. Department of Treasury's Invoice Processing Platform (IPP). Payment is based on the government's acceptance of the entire task or tangible product deliverables invoiced, and certification of satisfactory services and accurate labor charges.
The contract will be awarded to the responsible offeror whose proposal is most advantageous, considering price and non-price factors. Non-price factors include technical capability, relevant experience, and relevant past performance, which are equally important and more important than price. Price is considered when non-price factors are essentially equal.
Offerors must demonstrate a federal collaboration and publication record, successful execution of at least five clinical studies, hospital affiliation within 10 miles of the study site, over ten years of AI/ML expertise in health/biomedical data, over seven years of wearable dataset analysis experience, authorized laboratory and medical personnel, capability to acquire necessary equipment, and ability to access raw signals from at least three distinct ECG/PPG wearable device brands.
Submissions that contain macros, macro-referenced files, or executable files may be considered nonresponsive and will not be viewed or opened by the government, leading to disqualification without additional time for correction.
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