Medical Device Supply Chain Services

Follow-on contract for Supply Chain SME support. The OST requires contractor logistics and supply chain management expertise to support Office of Supply Chain Resilience (OSCR) shortages and horizon scanning training and implementation activities. The primary objectives of this contract are to provide the OST OSCR with logistics and supply chain management (SCM) subject matter expertise (SME) support related to medical device (including those marketed under an Emergency Use Authorization, EUA) supply chain resilience against shortages, as well as preparedness, response and related activities. The requirements outlined in the SOW for this award are necessary for the uninterrupted support from medical device supply chain subject matter expertise. This is expertise that is not resident within the FDA, HHS, or USG, but it is of critical need for OSCR to conduct its mission protecting patients in the US from medical device supply chain disruptions and shortages. This work involves: Applying logistics and supply chain subject matter knowledge and expertise to collect and analyze data related to logistics and supply chains for medical devices, including the raw materials, components, and services necessary to manufacture and distribute them; Investigations and analyses related to assessments of medical device supply chains and mitigation options to avoid and/or mitigate shortages or significant disruptions, including providing medical device supply chain and patient impact consultations to inform OHT regulatory decisions; and, Developing reports and supply chain illuminations regarding medical device supply chain management, including sourcing of raw materials, finished materials, manufacturing, and supporting services and processes (e.g., sterilization, transportation, etc.) for medical devices.