Signal variability, integration breakdowns, and manufacturing drift are usually present long before a team sees them. They rarely show up in early testing. They surface in validation, when the design is locked, the timeline is tight, and every change is expensive.
A working prototype is not the same as a system that holds up across real users, environments, and production constraints. We focus on finding those gaps early, while there is still time to address them cleanly.
We have been doing this work for 25 years, helping MedTech teams move from promising concepts to systems that perform reliably in validation, production, and the field.