Case Study: Bigfoot Biomedical achieves traceable, regulatory-ready medical device development with Intland Software's codeBeamer ALM

How Bigfoot Biomedical, a Silicon Valley-based MedTech company uses codebeamer to facilitate complex medtech development processes

Bigfoot Biomedical, a Milpitas-based medtech startup founded by parents of children with Type 1 Diabetes, is developing a connected Class 3 diabetes system (sensor, AI-backed insulin pump, and companion apps). Their lean Agile team faced a critical challenge: fragmented tooling (Jama + JIRA) produced unreliable syncs and poor Word exports, forcing manual spreadsheets and jeopardizing end-to-end traceability required for IEC 62304, ISO 14971 and FDA compliance.

To address this, Bigfoot implemented codeBeamer ALM (using Intland’s medical templates) as a single digital system of record, configuring it in-house to link requirements, risks, sprints, tests and CI results. The consolidation restored automated traceability, simplified QMS reporting, improved cross-team collaboration, scaled to 80+ users, and enabled continuous test integration and a pathway toward sustained audit readiness.

Bigfoot Biomedical

Alan Schachtely

Director Software Engineering