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Open Source Patient-Controlled Analgesic Pump Requirements Documentation.

Brian R Larson, John Hatcliff, Patrice Chalin

... International Workshop on Software Engineering in Health Care. International Workshop on Software Engineering in Health Care

|June 17, 2014

Summary

This summary is machine-generated.

A detailed requirements document for a Patient-Controlled Analgesic (PCA) pump was created to aid medical device research. This non-proprietary artifact aims to improve academic and industry collaboration in medical device development.

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Area of Science:

Medical device development
Software engineering for healthcare

Background:

Innovation in medical devices is crucial due to the dynamic nature of healthcare.
Lack of realistic, non-proprietary development artifacts hinders academic research and industry-regulatory collaboration.
Existing research and pedagogical activities can be advanced with shared development artifacts.

Purpose of the Study:

To present a detailed requirements document for a Patient-Controlled Analgesic (PCA) pump.
To provide a realistic, non-proprietary artifact to facilitate research and development in medical devices.
To foster collaboration between academia, industry, and regulatory authorities.

Main Methods:

Developed a comprehensive requirements document following the US Federal Aviation Administration's (FAA) Requirements Engineering Management Handbook (REMH).
Document includes domain overview, use cases, safety and security requirements, and system architecture.
Leveraged experience from releasing a similar document for a cardiac pacemaker.

Main Results:

A 60+ page requirements document for a PCA pump has been created.
The document adheres to established requirements engineering methodologies.
The artifact is designed to be a valuable resource for the formal methods and software engineering communities.

Conclusions:

The released PCA pump requirements document can significantly enable research.
This artifact can stimulate pedagogical activities and collaborative projects.
Facilitating access to realistic development artifacts is key to advancing medical device innovation.