Case StudyInfusion Pump Software, System Design and V&V
About This Project
Clients developing updating, or remediating infusion pumps rely on Full Spectrum expertise. Full Spectrum has focused engineering practices in software and system design, system integration, system compliance, V&V of the system and software and experience with various infusion pump technologies. Infusion technologies include syringe technology, peristaltic, ambulatory, combination delivery devices and ACE controllers.
- Challenges
- Approach & Solution
- Outcomes
• Infusion pumps are critical for drug delivery, both in a hospital environment and at home. Delivery of some drugs may be life-sustaining and require careful attention to FDA guidance and regulatory standards to assure safety.
• Infusion pumps are frequently tied to field actions and get significant regulatory scrutiny, before release and after.
• Infusion pump clients need support to add features, design the UI, firmware software, create and perform software V&V, perform worst-case system testing, perform accuracy testing, support client regulatory submissions, address field actions.
• Systems and software design and implementation need to assure consistent and reliable delivery and safety architectures.
• Plans for development include design and development, software development, V&V, configuration management, issue management, risk management planning. • Development processes used for hardware and software apply iterative set of milestones and integration points.
• The design of software requires extensive safeguards, diagnostics, logging ang notifications and alarming features to instruct users of risks to the patient.
• Full Spectrum provides solutions that have the added assurance demonstrated through V&V and through regulatory clearance.
Clients have closure to field actions applying our solution, which is frequently reviewed by regulatory agencies.
• Product and software are applied in usability testing and eventually launched for market.
• Full Spectrum has a successful track record of client clearances and launches and result in return customers for further feature improvements.