Hardware Agility does not replace the V-model, it complements it.
The exploration and technical validation phases benefit from short iterations to reduce risk. Industrialisation then follows a proven sequential process.
The exploration, feasibility and technical validation phases are characterised by uncertainty. Short iterations make it possible to:
Once the product is stabilised, industrialisation demands rigour and traceability:
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The transition between iterative and sequential approaches is not arbitrary. It relies on objective criteria that ensure the product is ready for industrialisation.
The hybrid model has been designed to integrate regulatory constraints from the outset, not as an afterthought. Normative requirements structure the early-stage iterations and guarantee a smooth transition to industrialisation.
Decision traceability, document management, design reviews at each cycle. Iterative deliverables feed directly into the quality system.
Medical devices: risk management (ISO 14971) integrated into cycles, DHF (Design History File) progressively populated.
Pharma & biotech: formal equipment validations, IQ/OQ/PQ protocols prepared during the Agile phase, executed during the industrial phase.
Aerospace: certification objectives defined from the earliest cycles, automated requirements-to-tests traceability, audits at each milestone.
Key principle: Normative requirements are not a barrier to hardware agility, they define its guardrails. Each iteration respects the quality and regulatory criteria applicable to the current development phase.
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