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A Device Has Clearance But Production Keeps Slipping. What Usually Causes That?
Clearance and manufacturability are separate problems, and programs treating them as one sequence tend to stall at exactly this point. Medical device commercialization requires a validated, repeatable process, and clearance says nothing about whether one exists. The common cause is tooling. Devices validated on prototype parts face a choice once commercial volume arrives: manufacture on tooling that differs from what validation covered, or revalidate. Neither option is quick.
A second cause is documentation. Medical device design transfer moves more than a design. Tool drawings, material certifications, process parameters, and qualification data all belong in the package, and the process settings established during tool debug require capturing rather than living in operator memory.
Programs that avoid the stall plan tooling against the validation schedule instead of treating them as separate tracks, producing production intent samples in validation quantities from a process reflecting the eventual production method.