01 · The challenge
The client had a validated assay and a benchtop optical rig the size of a microwave. To raise their next round they needed a handheld device in clinicians’ hands fast, without locking in design decisions they would regret under design controls.
02 · What we did
- 01
Framed requirements with the clinical team, separating what had to be true for the study from what could wait for the commercial design.
- 02
Ran three parallel optical architectures on the bench in week three and picked the winner on data, not opinion.
- 03
Designed a two-shot enclosure printed in SLA and finished to production-intent CMF, with a cartridge slot clinicians could load with gloves on.
- 04
Built and screened 40 units in-house, each with a calibration record traceable to a reference standard.
03 · The outcome
All 40 units completed the study with no field failures. The design history file we delivered became the starting point for their commercial program, which we continue to support.
“They worked like an extension of our own R&D team, just with a machine shop down the hall.”