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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Agile Stage-Gate combines milestone governance (go/no-go at each gate) with iterative execution between gates. This is the model we recommend for regulated R&D projects.
Unlike the classical Stage-Gate (sequential, rigid), Agile Stage-Gate introduces sprints between each gate. The team works in short iterations to explore and validate, then presents results to the steering committee at each gate. Go/no-go decisions are based on evidence of progress (validation reports, risk analyses, test results), not on forecast schedules.
Advantages of Agile Stage-Gate for industry:
Every sector, every organisation has its own constraints. We support you in building a bespoke hybrid management model.
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.
The V-model is a sequential process where each phase (specification, design, validation) follows the next with formal milestones. Agile is iterative: functional increments are delivered at each 2-4 week cycle. In industrial R&D, hybrid management combines both: Agile in uncertain upstream phases (exploration, feasibility, technical validation) then V-model for industrialisation where requirements are stabilised. The transition point depends on context: technological maturity (TRL), regulatory constraints, specification stability.
Agile Stage-Gate is a project management model that combines milestone governance (go/no-go at each gate) with iterative execution between gates. The team works in sprints between each milestone to explore and validate, then presents evidence of progress (validation reports, test results, risks mitigated) to the steering committee. Unlike the classical Stage-Gate (sequential, rigid), Agile Stage-Gate allows pivoting between gates if field data demands it. This is the model we recommend for regulated R&D projects (ISO 9001, ISO 13485, DO-178C).
The combination of Agile and V-model follows one principle: use iterative methods where uncertainty is high, sequential methods where requirements are stabilised. In practice: upstream phases (TRL 1-4) run in Agile sprints with iterative POCs. When the proof of concept is validated and specifications are frozen, industrialisation switches to a classical V-model. Transition criteria are objective: proven technology, stabilised specifications document, locked-down supply chain.
Yes. Neither ISO 9001 nor ISO 13485 requires a specific sequential process. They require traceability, document management and design reviews. Agile iterations feed the quality system at each cycle: industrial sprint reviews as validation milestones, documented deliverables at each iteration, decisions traced in the technical backlog. The hybrid model integrates these requirements from the start, not as an afterthought.
The switch from Agile to V-model occurs when technical uncertainty is sufficiently reduced. Objective criteria: proof of concept validated by tests, specifications frozen and accepted, regulatory requirements integrated, supply chain locked down, major risks resolved. The classic mistake: switching too early (residual uncertainties that prove costly in the industrial phase) or too late (unnecessarily extended time-to-market).
A project under high uncertainty is steered through feasibility sprints (2-4 weeks) that each answer a specific technical question. Agile Stage-Gate structures governance: between each gate, the team iterates freely. At each gate, the committee evaluates demonstrated maturity (not declared) and decides: continue, pivot or stop. This approach embraces uncertainty instead of denying it through predictive planning.
Yes. DO-178C does not prescribe a specific development process, it defines certification objectives by criticality level. Agile Stage-Gate aligns naturally with these objectives: each gate corresponds to a certification milestone, requirements-to-tests traceability is built iteratively between gates, and audits rely on documented sprint reviews. The Scrum4DO178C approach (documented by IEEE) confirms this compatibility.
Specification changes are normal in R&D - they are a sign that the project is learning. Hybrid management absorbs them via a prioritised technical backlog: each change is evaluated (impact, cost, risk) and integrated into the next sprint if priority warrants it. The sprint review with the internal customer (or technical committee) validates choices at each cycle. The rule: accept changes in upstream phases (agile), freeze them during industrialisation (V-model). The Agile Stage-Gate materialises this transition point.
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