Stage 12 of 12
Scale-up
Improve cost, capacity, resilience, and geographic reach.
Entry criteria
- Launch performance and demand are measurable
- Core production and support processes are stable
- Improvement priorities are evidence-based
Required activities
- Increase capacity and automate appropriate processes
- Reduce cost through controlled design and sourcing changes
- Qualify second sources and additional sites
- Plan new markets, indications, and product variants
Expected deliverables
- Capacity and cost-reduction roadmap
- Second-source qualifications
- Validated process improvements
- Market and portfolio expansion plan
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Cost changes undermining verified performance
- Quality-system strain during rapid growth
- Uncoordinated geographic or portfolio expansion
Exit criteria
- Capacity, quality, and unit economics meet scale targets
- Supply continuity risks have active mitigations
- Expansion changes remain controlled and traceable
Suggested next actions
- Reassess roadmap maturity regularly
- Use field evidence to drive portfolio decisions
- Maintain resilient suppliers and quality systems
Find your next move
Build confidence in scale-up.
Map your current evidence and gaps to the capabilities needed for this stage.