Regulated SaaS (medical-device manufacturers) · United States, remote-first
Regulated SaaS modernization
Modernization of a regulated SaaS product already in operation for medical-device manufacturers: separate per-customer infrastructure consolidated into one shared platform.
Problem
The product was already in operation for medical-device manufacturers, with separate infrastructure for each customer. It had to be modernized while improving delivery speed, cost, and operational reliability, within FDA and EU MDR requirements.My responsibility
Director of Engineering, answering to the CEO and investors. I owned the architecture, led four engineering managers, hired the Costa Rica team, and set the operating model.Key decisions
- Consolidate separate per-customer infrastructure into one shared SaaS platform.
- Use application-level multi-tenancy, identifying and separating customers logically.
- Keep Neo4j as a source of data.
Implementation
Next.js web app and dashboard, deployed on AWS Amplify with CI/CD · Next.js APIs · PostgreSQL for configuration, operations, and audit logs · Neo4j as a source of data · Redis for query caching · Encrypted Amazon S3 storage with isolated buckets · Auth0 authentication for the B2B dashboard · Public B2C application with no mandatory sign-inContract governance
Vendor delivery under MSA, SOW, and T&M agreementsScale
- Distributed, remote-first engineering organization
- Four engineering managers, each with a team of about five engineers
- Engineering organization grew by 50%
Result
- Approximately 80% lower cloud infrastructure costs
- Customer onboarding cut from 4 to 6 weeks to 1 to 3 days
- Approximately 80% of manual customer-onboarding work automated
- Delivery cycle reduced from four weeks to one
Lesson
Cost, speed, and reliability improved together because the operating model was redesigned as one system, not optimized in isolated parts.