From recall to resilience.
%20with%20Awards.avif)
take notice//
When production halts
and audits begin,
getting back to market
is only part of the problem.
The work is finding what failed underneath.
Countries reached
New point-of-care market. 3,500+ analyzers installed.
Frameworks still in use
Shaping launches long after handoff.
(the condition)
In 2008, a Class II FDA recall halted production and distribution across Siemens' diagnostics division.
I entered through a narrow assignment: translate interface sketches into software-ready artifacts.
Within weeks it was clear the brief was pointing at a symptom.
Recalls don't announce themselves.
By the time a recall is declared,
the system has been usually failing quietly for years.
(the diagnosis)
The user interface problem was real.
Underneath it: a specification problem.
Underneath that, a documentation problem.
Underneath that, a usability problem —
testing that didn't reflect how these products performed
in the hands of the people who depended on them.
The organization had resources, expertise,
and genuine commitment to human health.
What was missing was infrastructure
that could hold all of that together at scale.
(the work)
I built the operating infrastructure to connect capable functions around a shared system:
Usability and safety evidence.
Documentation systems.
Labeling and production.
Cross-functional governance.
The dependencies revealed a larger assignment: connecting the work across functions into one operating system.
(the proof)
Xprecia Stride was the first proof point.
The system could carry intent from framework to launch.
It marked Siemens’ entry into point-of-care coagulation testing: a handheld device, co-developed with universal Biosensors, delivering lab-quality PT/INR results at the bedside and in the clinic.
CE Mark, 2014,
European launch, 2015.
FDA 510(k) clearance, 2016.
It was the first point-of-care PT/INR device cleared under new FDA rules published that year.
Safe for professional point-of-care use.
Clear under clinical pressure.
Rigorous enough for FDA review.
The system wasn't proven by one launch.
It was proven by what the next launch didn't have to rebuild.
Far exceeds other medical devices.
All system elements integrate good design principles, usability, and state‑of‑the‑art enhancements to improve the testing experience for patients and professionals. The level of quality and design far exceeds other medical devices.
The frameworks didn't retire when the engagement ended.
They became the platform Siemens carried into its next generation of point-of-care diagnostics.
A decade later, people inside that work still find ways to tell me it mattered. That's something.
(the evidence)
(the numbers)
Installed analyzers
Serving hospitals & clinical settings worldwide.
Regulatory precedent
First under new FDA rules, 2016
Design awards
Red Dot, iF Design, Australian Good Design Gold, 2015.
European market entry
CE Mark received in December 2014.
