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, defining processes, tools, and documentation for IEC 62304 compliance.
• 📌 Mentored and trained staff on best practices for systems and software development.
• 📌 Led the development of FDA-compliant software, including C++ embedded Console software and Windows .NET WPF Remote Monitoring applications.
• 📌 Redesigned the prototype software with robust architecture, error handling, customer features, and ISO 13485 risk controls, achieving significant cost savings.
• 📌 Defined dynamic software behaviors using model-based engineering and state machine methodologies.
• 📌 Delivered a Remote Monitoring Laptop application with a scripting engine for full simulation, enabling hardware-independent software development.
• 📌 Implemented automated testing frameworks to validate software behaviors and ensure quality.
• 📌 Streamlined defect tracking and configuration using Jira and Bitbucket.

Result

Commercialized the product software in-house, rewriting it with good design patterns, error handling, customer features, and ISO 13485 risk controls. The final in-house solution cost only 20% of the vendor-developed prototype software.