Capability example

An adherence device specified from the hand that has to use it.

Injection force taken from a component datasheet, not from the population. Respecified from measurement, then validated with real users.

All capability examples

Sector

Drug delivery

Device type

Connected reusable injector with adherence logging

Services involved

Design and development, new product introduction

Duration

13 months, concept to design freeze

The challenge

A force figure nobody had measured.

The activation force in the requirement set came from a spring datasheet. The intended population included patients with reduced grip strength, which is precisely the group most likely to be self-injecting and least likely to complete the task. Nobody had asked whether the number was achievable, and a usability study late in development would have found out expensively.

What we did

Measured first, specified second.

We characterised grip and pinch strength across the intended population, set the activation force below the fifth percentile with margin, and reworked the mechanism to reach it without losing dose control. Human factors then ran formative studies through development rather than a single summative at the end, so the changes that came out of them were cheap.

What it took

The connectivity stack, not the mechanism.

The mechanism converged quickly. Certification of the wireless stack did not, and it sat on the critical path for eleven weeks because a module change late in development invalidated the earlier testing. The lesson went into the platform requirements: the radio module is a controlled item with the same change discipline as a fluid path component, not a part that engineering swaps for availability.

The outcome

What came out of it.

Activation force at or below the 5th percentile of measured population hand strength.
62 participants in the summative usability study across the intended user groups.
0 use errors recorded on the critical task in the summative study.
Radio module reclassified as a controlled item, with change discipline to match.