Medical device software architecture · Field notes

Architecture that holds up in a medical device.

I'm Rakesh Chittineni, a principal software engineer and architect. I write about how regulated, connected and cloud-based medical device software is designed, and where it quietly goes wrong.

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Framework

Resilient MedTech
Architecture Framework

The Blast Radius PrincipleClinical operations isolated from corporate IT.
Designing for the "Dark Day"Safe operation when the cloud is unavailable.
Intentional ModernizationResilience built in while legacy is modernized.
Sovereign Systems, Not Silent FleetsHumans keep authority over high-impact decisions.

Resilience and speed of innovation are not a trade-off. Read the framework →

16+years in software engineering

14+years in healthcare and medical device platforms

2clouds in production, Azure and AWS

5healthcare software organizations, from imaging to clinical trials to devices

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A reading path through SaMD architecture

New to the site? These six steps take you from where to draw boundaries to how to test your own platform. Each one takes a minute or two.

The framework
Four principles for platforms that keep working when it matters most.
Foundations
How to think before the first box is drawn, and where to draw the lines.
Standards as architecture
Each standard is a design requirement in disguise.
Traceability and the DHF
Evidence is a chain, and gaps hide where standards meet.
Patterns for connected systems
Messaging, modernization and trust, in a regulated setting.
Production and self-check
Post-market readiness is decided at design time. Then test yourself.