Problem:
RBC Medical Innovations faced the challenge of managing multiple complex medical device development projects simultaneously. Each project required precise coordination between mechanical, electrical, software, and systems engineering teams while maintaining strict FDA compliance standards. The company needed to protect its gross margin while delivering innovative medical solutions on time and within budget.
Tasks and Actions:
As Technical Program Manager, I managed four concurrent development programs: a head trauma treatment device, a pancreatic cancer treatment prototype, an AI-powered lab culture analysis system, and a major software architecture overhaul. The role required tracking engineering costs across disciplines, maintaining project timelines, and ensuring clear communication with stakeholders while preserving profit margins.
I implemented a comprehensive project tracking system to monitor all engineering activities. Each day began with reviewing time entries against planned estimates, allowing early detection of potential overruns. When tasks threatened to exceed estimates, I worked with team leads to adjust resources or refine approaches before costs escalated. The stakeholder communication strategy centered on transparent reporting. I created custom dashboards for each project showing real-time progress, cost tracking, and milestone completion. These dashboards became the foundation for weekly client meetings, where we discussed requirement refinements and project status.
Requirements management proved critical for controlling scope and costs. I established a formal change control process that evaluated the impact of requirement changes on timelines and budgets. This process helped clients understand the trade-offs between feature requests and project constraints.
For the head trauma treatment device, I coordinated between mechanical engineers designing the physical device and software developers creating the control systems. The project demanded careful timing of interdependent tasks to prevent delays in FDA submission preparation.
The pancreatic cancer treatment prototype required extensive collaboration with the client's research team. I scheduled regular technical reviews to ensure the development aligned with clinical requirements while maintaining progress toward regulatory milestones as this was a wildly ambitious project with first-ever built technology.
The lab culture analysis software project merged traditional development with machine learning components. I structured the project to allow parallel development of the AI models and user interface, reducing overall timeline risk.
The software re-architecture project demanded careful planning to prevent disruption of existing systems. I created a phased approach that allowed incremental testing and validation while maintaining system availability.
Results:
All four projects stayed within their allocated budgets, protecting RBC's target 40% gross margin on total contracts exceeding $2 million. The structured approach to requirement management and cost control prevented scope creep that often plagues medical device development.
Medical device development requires balancing innovation with practical constraints. Success comes from maintaining clear communication channels between engineering teams and stakeholders while actively managing project scope and resources. Early detection of potential overruns proves essential for maintaining margins. Daily monitoring of engineering time allows for quick adjustments before small variances become significant problems. Requirements management directly impacts project success. A formal change control process helps stakeholders understand how their decisions affect project outcomes and costs.
The experience gained from managing diverse engineering disciplines and keeping those metrics in an easy to recall format, improves the ability to estimate and plan future projects. This knowledge helps any company provide more accurate proposals and timelines to potential clients.
