In an industry as highly regulated as medical devices, having all information about the design and production process of each product in one place is more than a nice-to-have. Using a single system to manage the product, quality, and design controls is key to delivering a safe and effective product on time. My company, Apical Instruments, helps companies design and manufacture complex devices, while complying with the U.S. Food and Drug Administration (FDA) regulations and ISO standards. The need to comply with both FDA regulations and the ISO 13485 standard regarding medical devices makes paper-based systems inefficient and untenable. Yet, when I arrived at Apical Instruments, I was not surprised to see that there was legacy software in place for managing some design control functions. Unfortunately, the system was set up such that revising a part still entailed extensive work and documentation. Additionally, although the system was being used for quality system documents, it wasn’t being used for bills of materials (BOMs). As a contract manufacturer with over 10,000 total parts to manage for our customers, it was difficult to track revisions and changes effectively. During the design process, a single customer may have several top-level assemblies, numerous subassemblies, and as many as five engineering change orders (ECOs) each week. At times we had up to 10 different projects going on simultaneously with three to five ECOs per week for each one. This combined change volume was difficult to manage, so our old system just wasn’t viable long term. After careful assessment of our needs and a detailed review of several product lifecycle management (PLM) systems, with full support of our CEO, Bruno Strul, we selected Arena because it also provided a single solution encompassing a quality management system (QMS). With Arena’s solution, we have had enormous productivity gains, passed FDA audits more easily, and increased overall customer satisfaction.
Productivity gainThe increase in productivity is attributed to four main areas:
- Having all design and production-related documents in one place.
- Being able to search for a specific document by customer.
- Having an efficient way to handle all ECOs.
- Streamlining how we track customer feedback and responses.