The Challenge
Velico Medical set out to develop a groundbreaking system—FrontlineODP™ (On-Demand Plasma)— designed to spray-dry human plasma to be stored, transported, and used more reliably than frozen plasma.
The Goal
• Eliminate major supply-chain constraints associated with frozen plasma.
• Enable blood centers to move from freezing to spray-drying.
• Allow rehydration at the point of care in minutes.
• Support emergency transfusion needs across hospitals, first responders, maternal care, military units, and trauma teams worldwide.
The device required highly complex systems engineering, advanced control of the drying and thermal-management processes, and a design that supported efficient manufacturing, serviceability, and eventual FDA submission.
Velico needed the right development partner with:
• Deep multidisciplinary engineering strength: systems, software, electronics, and mechanical to create a safe, reliable, production-ready system.
• An ability to collaborate with Velico’s nascent engineering team in creating new innovation processes, systems and capabilities.
• Experience designing for an FDA PMA submission.
The Solution
Sunrise Labs (now Suntra MedTech Solutions) led end-to-end systems engineering for the FrontlineODP drying system, using an Agile methodology to ensure tight alignment between Velico, Suntra, and multiple external partners.
Key elements included:
Systems engineering leadership
• Defined and integrated system-level architecture for the drying system.
• Enabled rapid iterations and continuous cross-functional collaboration.
Multidisciplinary engineering execution
Suntra provided the full suite of engineering required to bring the plasma drying system to life:
• Software development and control systems.
• Electronics and hardware design.
• Mechanical engineering, including integration, fixture design, and process schematics.
• Thermal management development to ensure consistent, safe, and repeatable plasma drying.
Design for Serviceability (DFS)
The team ensured the device incorporated DFS principles to streamline maintenance, reduce downtime, and enable future service workflows.
Regulatory & quality support
The full development process was managed under Suntra’s Quality Management System, generating all required technical documentation and test results for:
• Clinical testing
• FDA submissions
Innovation to reduce regulatory burden Suntra MedTech, developed its Software Independent Safety System (SWISS), which removed the need for the device to be classified as a pressure vessel, resulting in significantly simplifying regulatory pathways.
The Impact
Through close cross-team collaboration and disciplined engineering execution, Suntra delivered a robust, manufacturable, clinically ready on-demand plasma system. The Velico engineering team strengthened its capabilities and was well-prepared for the hand-off from Suntra.
Key outcomes
• Accelerated development: Technical challenges were resolved with minimal program impact due to early alignment and Agile collaboration.
• Smooth manufacturing transfer: Engineering units were built and tested at Suntra, and Suntra coordinated with contract manufacturer Cogmedix to identify and mitigate risks early in the transfer process.
• Regulatory efficiency: SWISS design eliminated a major regulatory constraint, reducing complexity and supporting a more streamlined FDA submission.
• Global clinical impact: FrontlineODP is positioned to become a critical tool in trauma care—rehydrating plasma in minutes and enabling lifesaving treatment worldwide.
What Makes Us Proudest
The Frontline ODP system is expected to save thousands of lives annually by bringing rapid, reliable plasma access to operating rooms, ICUs, emergency departments, maternity wards, military medics, and first responders everywhere.
