Custody Before Crisis is a digital stockpile built on one design rule, least disclosure. A producer receives the least data sufficient to build a qualified part, at the moment it is authorized, under a license signed in advance, and every release leaves an auditable record. Instead of transferring a whole technical data package, the network releases an enumerated slice: e.g., in our case study example vial geometry, tolerances, acceptance tests, and the inspection plan, while media formulation, sensor chemistry, and instrument firmware never leave the design owner. We ground the concept in the 2024 blood culture bottle shortage, where intellectual property rather than capacity blocked a second source.
The Orchestrator Group brings software that already runs. Under NIST cooperative agreement 70NANB22H011, administered through MxD, our team built the Rx Product Marketplace Orchestrator to proof-of-concept stage, pairing a producer capability graph with multi-echelon optimization and physics-based unit process models. This project distinctly produces new concepts that stand apart from the earlier work but that can also build upon the team's earlier work. The team spans Wayne State University, Oregon State University, the University of Dayton, and GEOSPAK LLC, covering regulated manufacturing, controlled data handling, optimization, and clinical acceptance.
Paul Kremer, Kyoung-Yun Kim, Karl Haapala, Gul Kremer, Carolyn Psenka, Ahmed Elhabashy, Shengyu Liu