Manufacturing Made Simple Podcast
Oct 7, 2026 · 26 min · 7 segments
The stage-gate framework applied to both personal care and pharmaceutical product development. Andrew walks throughgo/no-go decision checkpoints, scale-up challenges, contract manufacturer selection…
Andrew CheungHost
[upbeat music] The Stage-Gate framework is a product development processing model developed back in the nineteen eighties, and has obviously been refined over the decades through extensive study of why some products succeed commercially and why others fail.
Product development is not a continuous activity that proceeds from concept to launch without pause.
It is a series of stages separated by gates where formal decision points at which a cross-functional team evaluates the available evidence and makes an explicit decisions about whether the project should proceed, be redirected, or be stopped.
It is a binary decision, go or no-go, which is based on whether the project has met the defined criteria for proceeding to the next stage.
Those criteria are defined before the stage even begins, not at the gate after the work is already done.
This matters because the criteria defined at the gate are subjected to the commercial pressures to proceed.
Criteria defined before the stage begins are more likely to reflect what the project actually needs to demonstrate to be ready for the next phase of investment.
Why does the Stage-Gate framework exist, you might ask? Well, because product development failures are expensive, and the expense increases dramatically as you move further down the development process.
A bad idea identified at the concept stage costs the time of one or two people for a few weeks.
The same bad idea identified at the end of phase three clinical trials or after a commercial manufacturing run has been produced and released costs millions of dollars and months or years of elapsed time.
The Stage-Gate framework is designed to create structured decision points that terminate weak projects early when the cost of stopping is low, rather than being late when the cost of stopping is catastrophically high.
In personal care manufacturing, the stage-gate framework is well established in large, sophisticated companies, but often absent or informal in smaller ones.
In pharmaceutical manufacturing, the equivalent is embedded in the regulatory framework itself.
The IND phase one, phase two, phase three NDA sequence essentially forces a stage-gate structure through regulatory requirement.
But even in pharmaceutical development, the internal discipline of defining decision criteria before each stage and making explicit go, no-go decisions based on them rather than on commercial pressure is something that separates high-performing development organizations from average ones.
[upbeat music] The Stage-Gate framework is a product development processing model developed back in the nineteen eighties, and has obviously been refined over the decades through extensive study of why some products succeed commercially and why others fail.
Product development is not a continuous activity that proceeds from concept to launch without pause.
It is a series of stages separated by gates where formal decision points at which a cross-functional team evaluates the available evidence and makes an explicit decisions about whether the project should proceed, be redirected, or be stopped.
It is a binary decision, go or no-go, which is based on whether the project has met the defined criteria for proceeding to the next stage.
Those criteria are defined before the stage even begins, not at the gate after the work is already done.
This matters because the criteria defined at the gate are subjected to the commercial pressures to proceed.
Criteria defined before the stage begins are more likely to reflect what the project actually needs to demonstrate to be ready for the next phase of investment.
Why does the Stage-Gate framework exist, you might ask? Well, because product development failures are expensive, and the expense increases dramatically as you move further down the development process.
A bad idea identified at the concept stage costs the time of one or two people for a few weeks.
The same bad idea identified at the end of phase three clinical trials or after a commercial manufacturing run has been produced and released costs millions of dollars and months or years of elapsed time.
The Stage-Gate framework is designed to create structured decision points that terminate weak projects early when the cost of stopping is low, rather than being late when the cost of stopping is catastrophically high.
In personal care manufacturing, the stage-gate framework is well established in large, sophisticated companies, but often absent or informal in smaller ones.
In pharmaceutical manufacturing, the equivalent is embedded in the regulatory framework itself.
The IND phase one, phase two, phase three NDA sequence essentially forces a stage-gate structure through regulatory requirement.
But even in pharmaceutical development, the internal discipline of defining decision criteria before each stage and making explicit go, no-go decisions based on them rather than on commercial pressure is something that separates high-performing development organizations from average ones.
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