Phase 1: Discovery (weeks 1–4)
Start with a single use case, not an enterprise-wide transformation. The best candidates are devices that already generate clinical data but transmit it manually or not at all.
- Bring together R&D, IT, quality assurance, and regulatory teams. Agree on success criteria.
- Scope the regulatory impact of adding connectivity early, not after the architecture is built.
- Assess your team's cloud and security capabilities so you know where you need external expertise.
Outcome: a validated use case, a prioritised architecture blueprint, and a clear team plan.







