In many early-stage MedTech programs, architecture is inherited rather than chosen. A prototype is built to prove a clinical concept, then becomes the de facto architecture for the product.
That sequence creates predictable problems. Hardware, firmware, application software, and cloud services end up as separate projects with unclear interfaces. Cybersecurity is added after the fact. Verification becomes difficult because responsibilities are distributed without a documented rationale.
Deciding architecture deliberately means defining what the system must do, where each function lives, how components communicate, how data is protected, and how each requirement will eventually be verified. It is a design activity, not a documentation activity.
Teams that make these decisions early spend less time rebuilding and far less time explaining their product to reviewers.