Benchmarking Medical Device Quality: The Global Role of Quality in Compliance and Non-Conforming Activities

STUDY OVERVIEW

Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle, from R&D to post-market activity. Facing tight budgets and escalating regulations, quality leaders are continually evaluating their group's role in compliance and non-conforming activities. Likewise, a quality group's efficiency with handling CAPAs and complaints in general are key measures of effectiveness.

This study presents benchmarks around the role of quality in compliance and non-conforming activities, including those taking place at company sites in low-cost areas of the world. The research also includes ratios around complaints and cycle times for CAPAs.

This study includes a Large Company and a Total Benchmark Class segment

KEY TOPICS

• Compliance Activities for Quality Across Global Markets
• Non-Conforming Activities for Quality Across Global Markets
• Cycle Times for CAPAs
• Complaints and Using Virtual Reviews/Automation
• Universe of Learning: Key Demographics of Participating Companies

• Role of Quality Across Six Key Compliance Processes
• Role of Quality Across Six Key Compliance Processes in Low-Wage Markets at Company Sites and by Third-Party Vendors
• Estimate of Objects (BOMs, etc.) Received by Quality Function
• Percentage of Company's Released and Effective Documents That Were Changed or Updated in 2012
• Number of Change Requests or Engineering Change Orders Your Quality Organization Assesses Per Year
• Role of Quality Across Eight Key Non-Conforming Processes
• Role of Quality Across Eight Key Non-Conforming Processes in Low-Wage Markets at Company Sites and by Third-Party Vendors
• Number of Corrections and Removals/Field Actions in Past Year
• Average Time (in days) for CAPA Cycle Times
• Number of Complaints Received by Company in Past Year
• Complaints Per $100 Million in Revenue
• To What Extent Does Your Company Utilize Virtual Inspections(Photos or Video) to Determine Root Cause of Product Complaints
• Role of Quality Across Seven Additional Process Areas
• Role of Quality Across Seven Additional Process Areas in Low-Wage Markets at Company Sites and by Third-Party Vendors
• Number of Events (CAPAs and NCIs) Currently Open at Your Company)
  

• Complaints/$100 Million in 2012 Revenue: On average, benchmarked companies handled about 1,999 complaints per $100 million in corporate revenue during the last year. To determine root cause of product issues and complaints, benchmark partners at 64% of companies use virtual inspection (such as photos and videos). However, only 9% use these extensively in complaint resolution. In the large company segment, all companies use virtual review, with 17% using it extensively.  
• Responsibilities in Additional Quality Activities: Additional process areas where Quality often leads (82% of companies) include Quality Project Time and Corporate Quality Administration. The Quality function most often plays a support role in Continuous Improvement, Six Sigma, and M&A Due Diligence. Many participants in the large company segment use company sites in low-wage markets to conduct additional activities, with 40% using these sites for a majority of Six Sigma, Continuous Improvement, Management Time, Quality Project and Non-Quality Project Time activities. All the large company participants make some use of third-party vendors for Continuous Improvement projects.
  

Industries Profiled:
Manufacturing; Medical Device


Companies Profiled:
3M Company; KCI; BARD; Cochlear; Boston Scientific; Lake Region Medical; Edwards Lifesciences; Stryker Neurovascular; Medtronic; UreSil; Terumo Corporation; WelchAllyn

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