Achieving Closed-Loop Design Control Across the Organization
Company Size
200-1,000
Region
- America
Country
- United States
Product
- Arena
- Nano-Pulse Stimulation (NPS)
Tech Stack
- Quality Management System (QMS)
- Design Control System
- Analytics Dashboards
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
Technology Category
- Application Infrastructure & Middleware - Data Visualization
- Functional Applications - Enterprise Resource Planning Systems (ERP)
- Functional Applications - Product Lifecycle Management Systems (PLM)
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Predictive Maintenance
- Regulatory Compliance Monitoring
- Remote Collaboration
Services
- System Integration
- Training
About The Customer
Pulse Biosciences is a company that is pioneering a novel and proprietary platform technology called Nano-Pulse Stimulation (NPS). This technology uses nanosecond pulsed electric fields to induce cancer cells in tumors to die naturally by triggering the adaptive immune system response. The company is focused on providing drug-free treatments for some cancers, thereby reducing toxicology. To achieve this mission, Pulse Biosciences relies on Arena to manage all aspects of quality management processes, from BOM creation to design controls, device history file (DHF), records keeping, and training management.
The Challenge
When evaluating solutions, Pulse Biosciences knew what they needed—one place for all product lifecycle and quality management processes. Guneet Bhogal, Quality Assurance Specialist, shares, “We wanted to have a closed-loop system with everyone collaboratively working on the same current product definition, through the same processes, to the same goals.” For medical device companies like Pulse Biosciences, predictability and consistency are not only good, but critical. Prior to implementing Arena, Pulse Biosciences’ product processes were paper-based, and the team expended extensive efforts to track everything manually and ensure compliance.
The Solution
Pulse Biosciences implemented Arena’s full suite of solutions to manage their quality and product lifecycle processes. Arena helps with DHF, project management, supplier management, CAPA, and all quality actions like NCMRs and change control. The system also manages training, ensuring compliance and traceability. Collaboration and access anytime around the world are crucial for Pulse Biosciences, especially when team members are performing clinical trials or on vacation. Arena provides the necessary security and tracking for urgent changes, regardless of location. All employees, from the CEO to engineers to the clinical team, use Arena. The company also uses Arena Analytics dashboards for management review boards to track progress and identify areas for improvement.
Operational Impact
Quantitative Benefit
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