Guidance from validated prototype to reliable, compliant production.
Operating leadership and technical judgment through the phases that determine whether the business actually works — scale-up, choosing and managing a CDMO, manufacturing transfer, and the leadership gaps that show up in between.
Manufacturing Scale-Up & Tech Transfer Strategy
Determining whether the organization can move from prototype to commercial production without unacceptable yield loss, cost escalation or delay — and putting the right manufacturing partners in place to get there.
Scale-Up Readiness Assessment
An evaluation of product, process, people, equipment, suppliers and manufacturing economics — answering the question a board or sponsor actually needs answered: is this company ready to scale?
CDMO Selection
An independent search for the right manufacturing partner: requirements, long list to short list, site audits, scoring, and contract expectations. Truestead accepts no referral fees or compensation from any CDMO.
CDMO Governance
Holding your CDMO accountable after the contract is signed: performance scorecards, quarterly business reviews, change-control oversight and escalation support, on a monthly retainer.
MANUFACTURING READINESS REVIEW (DFM/DFA)
Pre-validation and/or pre-production review catching cost, yield, tolerance, and assembly risks — plus a cost-reduction plan — before tooling and processes are locked in.
VALUE STREAM MAPPING
Mapping a manufacturing line — pre-production or already running — to make it as efficient as possible within its current validated state, flagging which improvements would trigger revalidation and which wouldn't, and closing with a prioritized roadmap of quick wins versus longer-term investments.
GLOBAL MANUFACTURING TRANSFER
Advisory guidance on cross-border production transfer, informed by direct U.S. and German operating experience, including EU MDR considerations.
Scale-up often exposes a leadership gap before it exposes a manufacturing one. See Fractional GM & VP Engineering for interim operating support.