Our client, Velico Medical, Inc.
, of Beverly, MA, asked Sunrise Labs to collaborate on the development of a life-saving technology; the FrontlineODP™
* (On Demand Plasma) system for spray drying human plasma. This new system will enable blood centers to spray dry versus freeze plasma for transfusion, solving many of the supply chain issues associated with frozen blood products. FrontlineODP™ rehydrates with sterile water at the point of care in under five minutes and is ideal for use in all emergency transfusion settings including operating rooms, intensive care, emergency departments, maternitywards, for civilian first responders and the military. FrontlineODP™ will be an important addition to the trauma care toolkit and is expected to save thousands of lives each year around the world.
Sunrise Labs Solution
Sunrise Labs led systems engineering for the Drying System using Agile Methodology to enable close collaboration between Sunrise, Velico, and other partners. In addition to systems engineering, Sunrise led software, electronics, and mechanical design, along with implementation and testing of the Dryer System. Our contributions to the development of the drying process, thermal management, and process schematics, helped ensure this very complex device included Design for Serviceability (DFS). The entire system was managed under the Sunrise Labs' Quality Management System to provide technical documentation and test results necessary for Clinical Testing and FDA submissions.
Close team collaboration resulted in several technical challenges being addressed with minimal program impact. Engineering units built and tested at Sunrise, and early collaboration on supply chain with the Contract Manufacturer (Cogmedix
) resulted in rapid identification and mitigation of risks during transfer to manufacturing and manufacturing ramp up. Sunrise's Software Independent Safety System (SWISS) eliminated complexity by removing the regulatory classification of the device as a pressure vessel.
*Development of the FrontlineOPD™ System is funded by the Biomedical Advanced Research and Development Authority (BARDA)
, within the Office of the Assistant Secretary for Preparedness and Response
in the U.S. Department of Health and Human Services under Contract No. HHSO100201200005C.