Most technology transfers that run into trouble show warning signs early. They are easy to miss because the project plan looks on track: equipment is moving, documents are being written, and dates are holding. These five signs are worth watching for, whether the transfer is between your own sites or to a CDMO.
1. The process is not stable at the sending site
A transfer moves whatever process exists today, including its problems. If the sending site has rising nonconformances, a yield that varies from lot to lot, or steps that depend on rework, those problems will move too, and the receiving site will have less experience solving them.
Before the transfer starts, look at the sending site's recent yield, scrap, and nonconformance trends. If the process is not stable, fix it first or plan the transfer around stabilizing it.
2. Success is not defined before the transfer begins
A transfer plan built around moving and installing equipment can report steady progress right up to the first qualification run. The real measure is whether the receiving site can make conforming product at the expected yield and rate.
The plan should define that measure up front: acceptance criteria for yield, cycle time, and quality at the receiving site, agreed before the transfer begins.
3. Process knowledge is moving only on paper
Work instructions, drawings, and validation reports carry most of what the receiving site needs. They rarely carry everything. Experienced operators and engineers know which settings drift, which materials behave differently, and which early signs point to a problem.
If the receiving team has not spent time on the sending site's floor, and the sending team is not planning to support the first builds at the receiving site, that knowledge will be learned again the hard way.
4. No one owns the transfer from start to finish
Transfers cross organizational lines. The sending site, the receiving site, quality, supply chain, and regulatory each own a part. When no single person owns the outcome, decisions wait for meetings, issues bounce between teams, and the schedule slips a week at a time.
A transfer needs one owner with the authority to make tradeoffs across those groups and the time to do it.
5. The schedule assumes every qualification run passes the first time
A schedule with no room for a failed run is a schedule that will slip. Qualification runs fail for ordinary reasons: a fixture adjustment, a measurement method that needs work, or a material lot that behaves differently.
A realistic plan allows time for at least one repeat of the critical runs and keeps enough bridge inventory from the sending site to cover it.
What to do if you see these signs
None of these signs means a transfer will fail. Each one means the plan carries more risk than the schedule shows. The earlier a team sees them, the easier they are to address, usually by adjusting the plan rather than the deadline.
Which of these warning signs have you seen most often on a transfer?
Chris Steadham is the founder and principal of Truestead Advisors and has spent 30+ years in medical device product development, manufacturing scale-up and general management. Planning a transfer between sites or to a CDMO? Start a conversation.