Amina works between the hospital and the workshop. Her group has taken two diagnostic platforms through first-in-human studies without losing the plot, or the patients.
She is useful to startups who have a prototype and a sudden interest in the MHRA.
Her opening question is almost always about workflow rather than technology. Where in the clinical pathway does this sit, who holds it, what are their hands doing at that moment, and what happens to it between patients. A surprising number of well-funded devices have no satisfactory answer to the last of these.
She is firm that usability work belongs at the beginning. Eight clinical users and two days of structured observation, conducted while the design can still change, routinely prevent a redesign that would otherwise cost a year. Teams resist this until they have watched the recordings.
Selected projects
Named work, with a sentence of context each.
Point-of-care assay formative usability
Ran a formative study with eleven nursing staff that identified three design faults, one of which would have made the device unusable in single-handed operation. All three were fixed before tooling.
Wearable monitor first feasibility study
Designed and delivered an early feasibility study in a clinical research facility, including the governance pack that the sponsor had assumed would take a fortnight.
Reprocessing route redesign
Identified late in development that a sensor housing could not be reliably decontaminated, and led the redesign to a single-use consumable with a reusable reader.
Working with Shah
She works best with teams who arrive with a device, a photograph and an honest description of what is not finished. The first engagement is often a short regulatory and usability gap analysis, which is inexpensive and tends to reorder the whole development plan.
She will not act as a clinical figurehead. Her name goes on work she has done, and she is happy to explain that distinction to an investor.
Looking for
Clinically grounded problems and manufacturers who can hold a tolerance.
Probably not for
Teams who would like a clinical endorsement before there is any clinical evidence to endorse.
Credits and contributions
- Chief investigator on two first-in-human device studies
- Contributor to national guidance on usability evidence for diagnostic devices
- Regular reviewer for a research ethics committee