Project Management in Medical Technology
In the highly regulated field of medical technology, excellent project management isn’t just a nice-to-have; it’s the critical factor for ensuring your innovations succeed on time, within budget, and with full regulatory compliance. Guiding a medical device from its initial concept through market launch and beyond demands more than standard methods. It requires a deep understanding of specific challenges, regulatory requirements (like MDR, ISO 13485), and interdisciplinary dynamics.
And here’s a little spoiler: According to ISO 13485 (Chapter 6, “Resource Management”, if you want to look it up), project management isn’t optional; it’s a must-have. The standard knows why planning and flexible resource control are incredibly valuable for staying on track.
As your experienced partner in project management, I offer not just theoretical knowledge but, more importantly, practical expertise gained from successfully developing medical devices. I understand the complexities and pitfalls, and I’ll help you proactively manage them.
My Project Management Services Include:
Strategic Project Planning & Initiation:
- Jointly defining clear project goals, scope, and deliverables, aligning with your company’s strategy.
- Creating detailed project plans, including phase planning, time, cost, and resource planning, integrating regulatory milestones (e.g., Design Reviews, Verification & Validation phases, submissions) from the very beginning.
- Stakeholder analysis and developing an effective communication strategy.
Execution & Control:
- Leading and coordinating interdisciplinary project teams (development, regulatory affairs, quality assurance, production, marketing, etc.).
- Continuously monitoring project progress regarding time, budget, quality, and scope.
- Proactively managing issues and changes to identify deviations early and take corrective action.
- Regular reporting to management and other stakeholders.
Integrated Risk Management (according to ISO 14971):
- Risk management isn’t an isolated process; it’s an integral part of my project management philosophy. I ensure risks are continuously identified, evaluated, and that measures are effectively implemented and their effectiveness verified.
- Risk management isn’t an isolated process; it’s an integral part of my project management philosophy. I ensure risks are continuously identified, evaluated, and that measures are effectively implemented and their effectiveness verified.
Ensuring Design Control & Documentation:
- Overseeing and guiding Design Input, Output, Review, Verification, Validation, and Transfer activities.
- Guaranteeing complete and compliant documentation (e.g., in the Design History File – DHF).
Supplier & Partner Management:
- Coordinating and managing external development partners, suppliers, or testing laboratories.
- Coordinating and managing external development partners, suppliers, or testing laboratories.
Methodological Flexibility:
- Applying suitable project management methods (classical, agile, or hybrid), depending on the project phase and the specific requirements of your company and product.
- Applying suitable project management methods (classical, agile, or hybrid), depending on the project phase and the specific requirements of your company and product.
Project Crisis Intervention & Turnaround Management:
- If projects stall, I analyze the situation, identify core problems, and develop pragmatic solutions to get your project back on track.