Medical Device Development Work Breakdown Structure
This is a practical guide to building a work breakdown structure for a medical device development project — a deliverable-oriented decomposition of the whole scope into manageable work packages, adapted to the realities of developing a regulated medical device.
What a Work Breakdown Structure is
A work breakdown structure is a deliverable-oriented decomposition of the whole scope into manageable work packages. For the full concept and how it works in general, see Work Breakdown Structure. On a medical device development project it plays the same role, tuned to this kind of work.
Why it matters for a Medical Device Development project
Medical Device Development projects live or die on developing a regulated medical device. A well-built work breakdown structure gives the team a shared, explicit reference for exactly that — reducing ambiguity, aligning stakeholders, and making problems visible early enough to act. Skipping it, or doing it generically, is how medical device development projects drift into avoidable delay and cost.
What to include
- Top-level deliverables
- Sub-deliverables
- Work packages (8–80 hours)
- WBS numbering
- WBS dictionary entries
Medical Device Development-specific considerations
Tailor the work breakdown structure to the risks that most often derail medical device development projects:
- Regulatory approval (FDA/CE)
- Design verification
- Quality-system compliance
Example
On a real medical device development project, the work breakdown structure would be shaped by developing a regulated medical device. In particular, it should explicitly account for the project’s biggest risks — regulatory approval (FDA/CE), design verification, quality-system compliance — rather than treating them as afterthoughts.