CASE STUDY
Case Study: AGA Medical
Executive Summary
AGA Medical, a pioneer in designing and manufacturing minimally-invasive devices for heart and vascular defect corrections, faced challenges with a paper-based system that hindered efficient change execution. By implementing Agile PLM, they not only accelerated product development but also achieved a remarkable 83% speed increase in closing product change orders. This transformation led to a significant reduction in effort and time for processes supported by Agile. Moreover, their successful transition from paper to electronic systems garnered high praise from FDA and auditors. Dive into this case study to discover how AGA Medical revolutionized their operations in a short span.
Client Case at a Glance
- Customer: AGA Medical
- Industry: Medical Devices
- Revenue: USD ~ $150M
- Headquarters: Plymouth, MN
- Employees: 400 Worldwide
Client Objectives
- Executing Change Quickly/Efficiently Prohibited by Paper-based System
- Averaged 12 product change orders (COs) completed per month, 26 days from submit to closed
- Controlling Paper (Rev) Used on Floor – Labor Intensive, Risky
- Change Impacts – Limited Visibility of Critical Information
- Change History For Process & Complete Product Tree
- Active Deviations to Current Approved Build
- Non-conformance Incidents and Yield Problems
- Corrective Action / Preventive Actions
- Approved Manufacturers
The Solutions
- Implementation Service
- Agile Product Collaboration
- Agile Quality Management
- Agile Product Portfolio Management
Results
- Implemented Agile PLM in only 4 months
- Accelerated product development by 76% more change orders a month, 83% faster
- Grew from 12 CO’s a month, 26 days long; to 50 CO’s a month, 4.5 days long
- 20-40% reduction in effort and time for processes supported by Agile
- Received high praise from FDA and auditors for significantly reducing their on-site audit time
- Engineer adoption 100%; fast, simple
- 100% electronic procedure used by all employees
“The FDA and Notified Body Auditors were astounded by what we were able to achieve with Agile PLM. They had never seen a company able to move from paper to electronic with such success. Agile PLM has helped us do some amazing things in a very short amount of time.”
Next Steps: Thinking About Propel for QMS? Let’s Talk.
If you’re considering Propel PLM for document control, compliance, or full QMS management, Domain Systems can help you navigate potential roadblocks and ensure a smooth transition.