12-stage product lifecycle
See the whole path—and the next right move.
A practical, stage-aware path through product definition, evidence, regulatory work, manufacturing, launch, and growth.
Product realization is connected work
Each stage defines what good progress looks like, the evidence you should retain, and the capabilities that can help close gaps.
Teams often work across several stages at once. The roadmap is a decision framework, not a rigid waterfall.
Opportunity definition
Define the clinical need, users, market, and initial intended use.
Product definition
Translate the opportunity into user needs, requirements, and claims.
Feasibility
Retire the highest technical, clinical, and commercial uncertainties.
Development planning
Align the regulatory path, quality system, resources, and development plan.
Detailed design
Develop controlled hardware, software, mechanical, and optical designs.
Prototype
Build alpha and beta units that represent the evolving product design.
Design verification
Demonstrate that design outputs meet approved design inputs.
Validation
Confirm the product meets user needs in its intended use environment.
Regulatory
Submit the evidence package and respond to regulatory authorities.
Manufacturing transfer
Establish repeatable production, tooling, suppliers, and process controls.
Launch
Coordinate market release, distribution, support, and post-market controls.
Scale-up
Improve cost, capacity, resilience, and geographic reach.
Find your next move
Unsure where your product sits on the roadmap?
Use the readiness assessment to identify your current stage, material gaps, and three prioritized actions.