Below are a few of the project SIM Solutions has completed for our clients. Contact us if you'd like us to help with your medical device project.
Product Development & Remediation: Infusion Pumps
SIM Solutions' staff helped a global infusion pump manufacturer improve the safety profile of their flagship large volume pump. By analyzing data from log files, complaints, and MDRs, we were able to pinpoint the primary sources of pump stoppage during infusion, which can have serious consequences. The client implemented these safety improvements in a subsequent design cycle. Their FDA-imposed import ban was removed and their warning letter was lifted upon achieving successful 510(k) clearance of the improved pump system.
In addition to remediating their legacy product's Design History File (DHF), we also helped the client develop requirements and analyze cost trade-offs for their next generation large volume infusion pump. We applied Model Based Systems Engineering techniques in an agile product development environment using MagicDraw SysML models for software behavior, hardware requirements, and risk analysis. We worked with their team to develop and submit numerous invention records and patent applications as a result of the innovative product development process which we championed.
Big Data System Development
SIM Solutions worked with this Fortune 500 client's R&D, manufacturing, quality, regulatory, and complaint handling departments to develop user needs, functional requirements, detailed requirements, and interface specifications for a Windows-based PC application to download log files from all medical devices across the globe. We interfaced closely with the software development teams and manufacturing/service support teams to perform design transfer activities to successfully deploy the application to all of the client's service centers.
Our staff also provided systems engineering and verification & validation (V&V) support to develop a Big Data relational database which compiled information from multiple data sources, including the aforementioned log files, and generated formal complaint reports for the client's complaint-handling system. Both software applications were launched and deployed successfully to the client's global service centers. We helped the client parse through this Big Data to find meaningful usability metrics. This data-driven approach led to several design improvements and the publication of a paper in the ISPD journal, Peritoneal Dialysis International, which we co-authored.
Systems Engineering: Use Case Development
A series of system-level SysML use cases was created for this client's IV administration set device and associated disposables/consumables. These use cases capture the dynamic behavioral responses by the system and relevant users and stakeholders by detailing scenario-driven threads through the functional requirements. This model-based systems engineering (MBSE) method is the industry-leading mechanism for product development, providing traceability to requirements, verification and validation, risk management, user needs, labeling, training, and manufacturing design transfer. This project is expected to help R&D and marketing develop the right product to address previous issues associated with product complaints and unanticipated failures by gaining a deep understanding of the scenarios and environments in which the product will be used.
Systems Engineering: Peritoneal Dialysis Machine Safety Improvements
As experts in fluid systems, SIM Solutions was chosen to serve in the client's Lead System Designer (LSD) role. This role consisted of working with the client's marketing, clinical, and outsourced R&D organization to analyze adverse event data to develop software improvement concepts. These concepts were implemented in an embedded software upgrade to improve product safety regarding patient and clinician use error. In addition, we helped the client create extensive labeling changes to their patient operator's manual and nurse trainer's manual to facilitate usability. Other technical activities included review and approval of system and software requirements, requirements traceability matrix, risk analysis, and design changes to support the software upgrade.
We also worked with the client to create self-guided materials to troubleshoot alarms. SIM Solutions assisted in the creation and execution of human factors studies to ensure patients were able to properly utilize the new software and troubleshooting materials to reduce use errors.
Other systems engineering support activities for this client included providing technical assistance for multiple CAPA's (Corrective Action Preventative Action) and serving as a subject matter expert during multiple FDA inspections. The client achieved FDA 510(k) approval for the software update upon the completion of a successful FDA inspection which we supported.
Verification and Validation (V&V): Medical Device Embedded Software Upgrade
A SIM Solutions consultant served as Verification and Validation manager for a Class II medical device embedded software upgrade. Responsibilities included hiring and training a team of test technicians and test engineers, writing and reviewing test cases, validating test methods, improving functional and software requirements for testability, creating and maintaining the verification and validation project schedule and budget estimates, and tracking anomalies to resolution.
Design Transfer to Manufacturing/Service for Peritoneal Dialysis Devices
SIM Solutions provided technical expertise to assist a Fortune 500 client with design transfer activities for both new and serviced/refurbished peritoneal dialysis devices. Support activities included Product Performance Qualification (PPQ) test creation and execution, and manufacturing Installation Qualification / Operational Qualification / Performance Qualification (IQ/OQ/PQ) process validation. We were able to successfully demonstrate that refurbished devices met the same key safety and performance requirements as brand new devices. This project was part of the client's FDA warning letter commitment to improve process validation. Immediately after the project was completed and a successful FDA inspection was achieved (which we supported), the client's FDA warning letter was lifted.