Wide Angle Agile Principles
Wide Angle Agile reframes core priorities for regulated environments, inspired by the Agile Manifesto:
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Integrated compliance over end-of-project remediation
Compliance is not a phase or a checkpoint—it is part of the daily workflow. -
Continuous risk management over delayed risk documentation
Risks are identified, assessed, and mitigated as designs evolve, not after they are finalized. -
Stakeholder-ready documentation over sprint-only outputs
Documentation exists to support decisions, audits, and patient safety—not just velocity. -
Adaptable structure over rigid frameworks
Processes, tools, and ceremonies evolve based on what works for a unique team in a regulated context. -
Cross-functional ownership over functional handoffs
Engineering, regulatory, and clinical partners share responsibility for outcomes from day one. -
Audit readiness over audit panic
Traceability and design controls are maintained continuously, not reconstructed under pressure. -
Learning-driven iteration over blind speed
Iteration is purposeful, informed by data, risk, and regulatory constraints—not motion for motion’s sake.
Both sides matter—but in regulated product development, the left is often the constraint that determines success. This framing is inspired by the Agile Manifesto (Beck et al., 2001), adapted for highly regulated, hardware-driven product development.