Beyond the Dashboard: Understanding the True Complexity of Medical Device Project Management
- Mark Torres
- 2 days ago
- 4 min read
Medical device development is inherently complex. Teams respond to this complexity by creating detailed project plans—thousands of tasks, mapped dependencies, critical paths, and comprehensive dashboards. These tools are valuable, but they often miss something crucial.
The Limitations of Traditional Project Tracking
We've all seen well-structured projects with perfect documentation still struggle with execution. Teams report green status while fundamental issues simmer beneath the surface. Why does this happen?
Traditional project management tools excel at capturing what needs to be done and when. They're less effective at revealing how work is actually progressing and why certain challenges persist.
The "Soul" of Project Management
Effective project management in medical device development requires understanding what we call the project's "soul"—the human dynamics, unspoken challenges, and emerging patterns that determine success or failure.
This includes:
Team dynamics: How people are actually collaborating (not just what they're reporting)
Knowledge gaps: What team members understand versus what they think they understand
Risk patterns: Issues that haven't yet surfaced in formal reporting
Workflow reality: How processes actually function versus how they're documented
Four Principles for Managing Complex Development Projects
1. Prioritize Clarity Over Complexity
Teams need to understand how their individual contributions connect to the bigger picture. When someone sees only a line item with a due date, they're operating without context.
In practice: Transform team meetings into storytelling sessions. Instead of status reports, ask each function to share their accomplishments, next tasks, risks, and challenges. As the PM, weave these updates together with narrative and visual aids—show how the software team's cybersecurity work enables the regulatory team's 510(k) submission, which allows manufacturing to begin production planning. End each meeting by outlining "what may happen next in the project" based on current progress.
2. Practice "Gemba" for Project Management
In lean manufacturing, "gemba" means going to where the work actually happens. For project managers, this means having substantive conversations with team members about their work.
In practice: This doesn't require formal, recurring one-on-ones (people already have too many meetings). Instead, know your people and understand how they work. Drop by the lab during testing, join informal coffee conversations, or walk with someone to their next meeting. A casual "How's the biocompatibility testing really going?" while grabbing lunch often reveals more than a formal status update. The key is being genuinely interested in understanding their work and challenges.
3. Understand Your Levers of Influence
Adding a deadline to a task outlines potential downstream consequences, but it doesn't execute the work—it primarily adds pressure. Effective project managers understand the full range of levers available:
Resources: People, equipment, budget allocation, and vendor relationships
Skills and capacity: Training, expertise, workload distribution, and cross-training opportunities
Time: Schedule adjustments, sequencing, and parallel work streams
Scope: Work definition, prioritization, and phased approaches
Motivation: Recognition, autonomy, purpose, and career development
Process: Workflow optimization, decision-making authority, and communication channels
Environment: Physical workspace, tools, and technology access
In practice: When verification testing is behind schedule, resist the urge to simply move the deadline. Instead, ask: Do we have the right test equipment? Does the team understand the protocols? Can we run tests in parallel? Should we bring in additional expertise? Would clearer acceptance criteria help? The solution might be resources, training, process changes, or scope adjustments—rarely just more pressure.
4. Embrace Adaptive Leadership
Medical device projects rarely unfold exactly as planned. Regulatory feedback, technical discoveries, and market changes require course corrections. The most effective project managers develop intuition about when to hold steady versus when to pivot.
In practice: Notice when your tools aren't serving the team. If that detailed dashboard sits unused in meetings, or if team members consistently misinterpret the risk register, adapt. Maybe the software team needs a simple kanban board instead of complex tracking. Perhaps the regulatory team prefers narrative updates over status indicators. Give people what they really need to succeed, not what the methodology prescribes. Sometimes the best project management is invisible—enabling work rather than monitoring it.
The Challenge of Developing Intuitive Project Management
These capabilities are difficult to measure and impossible to certify. They develop through experience, reflection, and mentorship. Organizations often rely on formal metrics and structured processes because they're tangible and measurable, even when they provide limited insight into project health.
Moving Forward
Successful medical device project management requires more than following prescribed methodologies. While project management frameworks, design controls, and regulatory compliance processes provide essential structure, the human element determines whether projects truly succeed.
The most effective project managers blend technical expertise with intuitive leadership. They understand FDA requirements and ISO 13485 standards while also reading team dynamics and adapting their approach to individual needs. They manage timelines and budgets while fostering collaboration and innovation.
This human-centered approach to project management becomes even more critical as medical device development grows increasingly complex—with connected devices, cybersecurity requirements, combination products, and evolving regulation on the use of artificial intelligence in medical devices.
