Driving Quality Across Supply Chain to Highest Levels
Customer Company Size
SME
Region
- America
Country
- United States
Product
- IntraOp® Mobetron®
- Arena
- Arena Analytics
Tech Stack
- Arena Platform
- Arena Analytics
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Productivity Improvements
- Digital Expertise
Technology Category
- Analytics & Modeling - Predictive Analytics
- Functional Applications - Enterprise Resource Planning Systems (ERP)
- Application Infrastructure & Middleware - Data Visualization
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Quality Assurance
- Product Research & Development
Use Cases
- Predictive Quality Analytics
- Regulatory Compliance Monitoring
- Remote Asset Management
Services
- Software Design & Engineering Services
- System Integration
- Training
About The Customer
IntraOp Medical Corporation is the pioneer in portable electron-beam Intraoperative Radiation Therapy (IORT). The IntraOp® Mobetron® has transformed cancer treatment by bringing radiation technology into the operating room, uniting radiation oncology and surgery. For patients and their families, this means markedly shorter treatment and recovery times, improved outcomes, greater comfort, and quality of life. To ensure the teams execute on product realization at the highest levels of quality and adhere to regulations, IntraOp uses Arena for their critical product and quality management processes.
The Challenge
As an FDA-regulated company, IntraOp must not only design and produce a complex product with electro, mechanical, and software components, but do so while meeting all FDA 21 CFR 820, EU Medical Device Directive (MDD), ISO 13485, Health Canada, and other regulations requirements. So IntraOp needed more than a system to manage all the product details, changes to product, and collaboration efforts with the teams. They also needed a quality management solution to ensure absolute regulatory compliance. IntraOp chose the Arena platform for both product and quality management. After IntraOp implemented Arena to manage the product and quality processes, the team took the next step to business analytics with Arena Analytics. They wanted Analytics to provide critical day-to-day insights into quality process progress as well as provide confidence that they can meet regulatory requirements.
The Solution
IntraOp chose the Arena platform for both product and quality management. After implementing Arena to manage the product and quality processes, the team took the next step to business analytics with Arena Analytics. They wanted Analytics to provide critical day-to-day insights into quality process progress as well as provide confidence that they can meet regulatory requirements. As An Nguyen, Director of Regulatory Affairs and Quality Assurance, shares, 'Information from the Arena Quality module, such as CAPA and nonconformances visualized through the Arena Analytics dashboard, allows us to monitor the up-to-date performance of our product process, see the areas and suppliers which have unfavorable quality trends, and plan for our improvements or preventive actions.' Before implementing Arena Analytics, IntraOp depended on lengthy, labor-intensive manual data crunching to see what was happening with quality processes. 'Before Arena Analytics, we had to export quality process information to Excel, then use pivot tables and charts to manually create dashboards. Now, with Analytics we monitor quality performance and see our up-to-date progress automatically. The value of Arena Analytics is very high,' explains An.
Operational Impact
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