Sector
Drug delivery
Device type
Mechanical autoinjector platform
Services involved
New product introduction, contract manufacturing
Duration
11 months, design freeze to sustained production
The challenge
Accurate on the bench, drifting on the line.
Delivered volume sat comfortably inside specification across the engineering builds. It moved as soon as the process left the people who had designed it. Nothing was out of tolerance and nothing was clearly wrong, which is the hardest version of this problem: a capable design running on a process nobody had characterised.
What we did
Characterised the process before validating it.
We identified the parameters that actually move delivered volume, then ran capability studies on each before writing a single validation protocol. Design for manufacturing changes went back into the design where a tolerance was doing work that a feature could do instead. Only once the process was understood did we run installation, operational and performance qualification, against acceptance criteria derived from the measured variation rather than from the specification limits.
What it took
One spring supplier, three lots, two behaviours.
Delivered volume tracked a spring rate that met its drawing in every lot. The drawing allowed more variation than the device could absorb. Rather than tighten a purchase specification and hope, we measured across lots, established the real distribution, and changed the design so the assembly compensated for it. The tolerance stayed where the supplier could hold it and the device stopped caring.
The outcome
What came out of it.
- Process capability of 1.51 on delivered volume across 3 consecutive validation lots.
- 18,000 units built and released in the first year of sustained production.
- Scrap held at 1.9 percent through the first four production quarters.
- A released manufacturing package with controlled work instructions and change control in place.
Services involved
The disciplines behind this programme.
New product introduction
Design transfer, design for manufacturing, pilot builds and process validation.
See the serviceContract manufacturing
Sustained production, functional test, quality release and supply.
See the serviceThey ran as one programme against a single plan, with one named programme lead accountable for the whole of it.
More examples
Other programmes.
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Point-of-care diagnostic
Therapeutic
Implant-adjacent controller
Drug delivery
Connected adherence device
Placeholder figure, to be replaced with verified data before launch.
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