The largest potential cost in medical device manufacturing isn’t labor rate or cost of material. Instead, it is the cost of bad quality. Brand reputation depends on a medical device manufacturer’s ability to put superior quality product where it is promised, when it is promised. Any failure that keeps that process from happening hurts a device manufacturer’s reputation. When manufacturing is outsourced, reputation is also outsourced. As a result, the quality culture at a contract manufacturer is often a differentiating factor worthy of careful analysis. While third-party quality certifications validate that a quality management system that checks all the audit boxes exists, they don’t do a good job of validating whether all levels of employees are fully engaged in ensuring product and service quality.

Forefront Medical Technology believes that instilling a strong quality culture requires both rigorous processes and training programs that provide employees at all levels with the knowledge and tools to understand their contribution to ensuring product and service quality. This whitepaper looks at the building blocks for that level of engagement which include:

• A robust training program which gives employees the knowledge and tools to excel at their jobs
• Core quality disciplines that help eliminate defect opportunities
• Well-defined processes for product development and commercialization
• A Best Practice award program which rewards employees with continuous improvement suggestions.

Read the full whitepaper here.