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Open Source Patient-Controlled Analgesic Pump Requirements Documentation.
Summary
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.
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.