Benchmarking Medical Device Quality 2014-15: Inspection and Production Activities

STUDY OVERVIEW

Medical device companies must produce quality products and meet compliance standards. Understanding how to balance these goals is challenging, especially with the ever-changing regulatory landscape. Undoubtedly, the quality function plays a significant role in ensuring that its organization meets these goals efficiently and effectively.

Best Practices, LLC undertook this study to help quality leaders better understand inspection and compliance activities within the quality function. The study includes metrics around the level of ownership the quality function has for key inspection/production activities, the extent of inspection/production quality activities performed in low-wage markets, and supplier and software issues related to inspection and production activities. Research findings provide evidence-based benchmarks around these issues so quality leaders can compare their efforts with industry peers.

This study contains a Large Company Segment (LCS) that is made up of 11 companies.

KEY TOPICS

• Inspection/Production Activities
• Working with Suppliers
• Software Management Issue

• Scope of Responsibility of the Quality Organization in Inspection/Production
• Process for Isolating Critical to Quality Parameters
• Inspection/Production Quality Assurance Activities Conducted at Company Sites in Low-Wage Markets
• Inspection/Production Quality Assurance Activities Conducted by Third-Party Vendors in Low-Wage Markets
• Location of Toxicology/Biocompatibility Internal Inspections
• Number of Active Clinical Trials
• Active Clinical Trials to Internal Clinical Trial Audits
• Number of Audits at Investigational Clinical Sites
• Direct Material Suppliers Per $100 Millions In Revenue
• Percent Incoming Batches Requiring Detailed Inspections
• Off-Floor Lab Testing of Production Batches
• Metrics Used to Assess Supply Chain Risk
• Effectiveness of Production Risk Metrics
• Document Types Reviewed by Software Quality Assurance
• Groups Owning Software Validation Activity
  

• Compliance Leads Top Challenges: The benchmark class identified regulatory issues or compliance (24%) operations/processes/structures (24%), and talent management issues (16%) as the top three types of industry challenges facing them in the coming 12 to 24 months.

• Best Practices, LLC designed and deployed a custom benchmarking survey to executives at 21 leading Medical Device companies.  This study has two segments: Total Benchmark Class (TBC) made up of 21 companies and a Large Company Segment (LCS) that is made up of 11 companies.

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