Situation

A medical device startup contracted a vendor to develop a capital equipment console for a medical procedure. However, the relationship deteriorated when costs rose to three times the initial estimate.

Task

Shoreview Technologies was tasked with establishing systems and software engineering competencies to bring the product development in-house.

Action

• Established systems and software engineering functions, including compliant processes, tools, and documentation.
• Mentored staff on best practices for systems and software development.
• Led development of FDA-compliant embedded console software and Windows .NET remote monitoring applications.
• Redesigned the prototype software with stronger architecture, error handling, customer features, and ISO 13485 risk controls.
• Defined dynamic software behaviors using model-based engineering and state machine methods.
• Delivered a remote monitoring laptop application with a scripting engine for full simulation.
• Implemented automated testing frameworks and streamlined defect tracking with Jira and Bitbucket.

Result

The product software was commercialized in-house with modern design patterns, better error handling, customer-ready features, and ISO 13485 risk controls. The final in-house solution cost only 20% of the vendor-developed prototype software.