Your hybrid project is developing a medical device that requires FDA approval. The hardware development follows a stage-gate process with formal reviews, while the software uses an adaptive approach with continuous integration. The regulatory affairs team has raised concerns that the adaptive software approach lacks sufficient documentation and traceability for FDA submission. The software team argues that their automated testing and version control provide better traceability than traditional documentation. The regulatory deadline for submission is in four months, and both teams are at an impasse. Delays in resolving this could jeopardize the regulatory approval timeline. What should you prioritize?

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Accepted Answer

The correct answer is C. This scenario requires integrating compliance requirements with hybrid delivery approaches by mapping existing artifacts to regulatory needs rather than assuming a methodology change is required (ECO Process Task 1.1: Execute project with urgency required to deliver business value; Process Task 2.5: Plan and manage scope). The key is to validate whether adaptive practices already provide required traceability in different forms before adding overhead. Facilitating a collaborative mapping session allows the team to discover that automated test records, version control logs, and continuous integration artifacts may satisfy FDA requirements when properly organized and presented. Option B is the main distractor because while bringing in a consultant adds expertise, it delays action when time is critical and may not be necessary if internal collaborative analysis reveals the adaptive artifacts already meet requirements. The difficult aspect is recognizing that regulatory compliance doesn't mandate specific methodologies—it mandates outcomes (traceability, documentation, validation)—which can be achieved through different means. A facilitated session leverages the expertise of all parties to find solutions rather than defaulting to authority-based decisions.

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