A Safe and Practical Cycle for Team-Based Development and Implementation of In-House Clinical Software

Area of Science:

• Medical Physics
• Health Informatics
• Software Engineering

Background:

• A lack of published guidance exists for clinical software development and implementation.
• Ensuring patient safety in clinical software is paramount.
• In-house development requires a structured approach for reliability.

Purpose of the Study:

• To describe a robust, in-house clinical software development and implementation cycle.
• To facilitate the safe treatment of all patients using custom software.
• To provide a replicable model for clinical software processes.

Main Methods:

• A phased approach including design, development, physics testing, clinical testing, and release.
• Incorporation of clear communication, defined roles, commissioning, and feedback loops.
• Utilizing formal hazard analysis for high-risk software and incident learning for continuous improvement.

Main Results:

• The described process ensures transparency and high expectations for custom software supporting patient care.
• Applied to 16 treatment planning system scripting programs since 2013.
• Demonstrated successful implementation of a team-based software release process.

Conclusions:

• The described methodology is implementable across diverse practice settings, with or without dedicated development resources.
• Key recommendations include a written policy, phased testing, and independent oversight.
• This rigorous process enables continuous monitoring and mitigation of high-risk hazards.