Case StudyMulti-Channel Infusion and Diuretic System
About This Project
Our client, an early-stage company, was working on a novel fluid management system to get through IDE for clinical trials. Delivery challenges with the existing vendor had already delayed clinical trials and eroded client confidence in the outcome. This is a Class III medical device.
- Challenges
- Approach & Solution
- Outcomes
• The client had been working with another vendor for over a year. Timelines were slipping. Technical challenges continued to mount, with progress blocked in some critical areas for over 8 months.
• Supply constraints had driven less than ideal hardware selection.
• Engagement required integration and collaboration with both the client and existing multi-disciplinary 3rd party vendor teams.
• Worked closely with client as lead software development partner for over a year.
• Conducted thorough gap analysis and backlog development to yield realistic estimate to complete.
• Drove prioritization of requirements, top- down architecture, and targeted activities to pull in dates and focus on top priorities.
• Assembled a comprehensive development team including systems engineering, application level and embedded software development, and verification
• Coordinated compliance testing with NRTL.
• Client expanded Full Spectrum allocation of scope, eventually replacing 3rd party vendor for all software development.
• Multiple technical challenges were resolved, unblocking project progress, limiting hardware rework, and minimizing budget spend.
• Predictable milestones enabled client to work towards their IDE submission.
• NRTL Certification in progress for submission to FDA.