Services · Phase 5
Manufacturing transfer and commercialization for medical devices and combination products.
Move from development into production, suppliers, assembly, test, and launch — with DFM/DFA, process validation, supplier qualification, and launch-risk reduction in parallel rather than in sequence.
When teams call us in
- A product is approaching design freeze and manufacturing readiness is uncertain.
- DFM/DFA gaps are surfacing late and tooling or process risk is climbing.
- A supplier or contract manufacturer is being onboarded and process readiness needs to be assessed.
- A launch is approaching and the team needs a launch-risk reduction plan that ties product, process, and regulatory.
How we approach it
- Design-for-manufacture in parallel with design controls, not after design freeze.
- Process capability and supplier qualification driven by critical-to-quality flow-down — not just first-piece inspection.
- Launch readiness measured across product, process, supplier, documentation, and regulatory dimensions.
- Scale-up planning that addresses real volume risk: tooling life, fixturing, automation, yield, and supplier capacity.
Typical deliverables
- Manufacturing transfer plan and gating.
- DFM/DFA review and remediation plan.
- Process FMEA aligned to ISO 14971 and the design risk file.
- Supplier qualification plan and audit readiness.
- Process validation strategy (IQ/OQ/PQ) with control plans and capability studies.
- Launch readiness assessment with named risk owners.
Frequently asked questions
- When should manufacturing engagement start?
- Earlier than most programs assume. DFM and process readiness are most valuable while the design is still tractable. Treating manufacturing transfer as a hand-off after design freeze is the single most common cause of late-stage rework, late tooling changes, and slipped launches. We engage during design engineering when possible and lead the formal transfer when the program is ready.
- Do you work with internal manufacturing or contract manufacturers?
- Both. We have led transfers into internal sites and into contract manufacturers, and have run engineering ownership opposite both. The mechanics are similar; the politics, documentation, and supplier-management posture differ — and we structure the engagement accordingly.
- How do you handle process validation?
- Process validation (IQ/OQ/PQ) is structured against critical-to-quality flow-down from the design risk file, not first-piece inspection. We design the validation strategy alongside the manufacturing process so PFMEA, control plans, capability studies, and validation protocols form one consistent package — not parallel deliverables.
- Can you support scale-up beyond the initial launch volume?
- Yes. The principals have led scale-up at unit volumes from prototype quantities through 300K–1M unit/year, including 50–75% unit-cost reduction work via design and process optimization. Scale-up planning addresses tooling life, fixturing, automation, yield, and supplier capacity in parallel — not as serial concerns.
Preparing for transfer or launch?
Engagements typically start with a scoping call to map the transfer plan, supplier posture, and launch timeline.