CAPM Practice: Explain when it is appropriate to use a predictive, plan-based approach

This is a textbook case for a hybrid approach. The evolving clinical use cases call for adaptive discovery (iterative engagement with medical teams, prototyping). But FDA 510(k) requirements mandate formal design controls, documented verification and validation — inherently predictive. A thoughtful hybrid sequences adaptive discovery first to finalize requirements, then transitions to predictive execution for the formal regulatory submission process.

**Why not A:** "Predictive planning with weekly agile sprints" is internally contradictory. Weekly sprints are an adaptive mechanism, and combining them with predictive planning without a clear phase-based transition strategy creates confusion. The hybrid approach in option C provides a structured transition from adaptive discovery to predictive execution.

**Why not B:** A purely predictive approach would attempt to lock down clinical use cases before they are fully refined, creating risk of building a device that does not meet actual clinical needs. The evolving use cases require adaptive discovery methods before transitioning to predictive regulatory compliance.

**Why not D:** A purely adaptive approach would not adequately address the formal documentation, design controls, verification, and validation required by FDA 510(k). Regulatory submissions demand structured, traceable documentation that adaptive methods alone do not inherently produce.