Benchmarking Medical Device Quality: The Global Role of Quality in Inspection/Production, Software Validation and Product Support 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 inspection/production, software validation and product support activities.

This study presents benchmarks around the role of quality across several key inspection/production activities, including supplier quality, labs, software validation, pre-clinical quality assurance and design validation/verification. The study also looks at the role of quality in these activities in company sites and low-wage markets and through vendors in low-wage markets.

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

KEY TOPICS

• Inspection/Production Activities for Quality Across Global Markets
• Quality Role with Supplier Issues
• Software Validation Activities for Quality Across Global Markets
• Lab Activities for Quality Across Global Markets
• Product Support Activities for Quality Across Global Markets
• Universe of Learning: Key Demographics of Participating Companies

• Role of Quality Across Eight Key Inspection/Production Activities
• Role of Quality Across Eight Key Inspection/Production Activities in Low-Wage Markets at Company Sites and by Third-Party Vendors
• Number and Ratio of Direct Material Suppliers Used
• Percentage of Incoming Batches Requiring Detailed Inspection
• Percentage of Software Validation Activities Performed Across Five Functions
• Percentage of Production Batches that Undergo Quality Analysis in an Off-Floor Laboratory
• Role of Quality Across Four Key Product Support Activities
• Role of Quality Across Four Key Product Support Activities in Low-Wage Markets at Company Sites and by Third-Party Vendors
• If Quality Leads/Supports Design Control, What is the Degree of Involvement for your Quality Unit Regarding 11 Design Control Processes
• Identify How Quality Costs Tied to Design Control Activities are Budgeted
  

• Suppliers/$100 Million in 2012 Revenue: Benchmark participants currently maintain an average of 959 direct suppliers for materials. On average, companies use 104 suppliers per $100 million (US) in corporate revenue. At incoming receipt, two-thirds of companies in the benchmark class require personnel to perform a detailed inspection for up to 70% of incoming batches.
  
• Responsibilities in Inspection/Production: Quality most often leads (at 64-91% of companies overall) processes associated with the following work areas: Inspection/Production, especially in Supplier Quality, Incoming Inspections, Product Release, and Final Inspections. Labs and Floor Inspections are the processes least often led by Quality. 40% of the participants in the large company segment conduct 51-100% of inspection/production activities at company sites, while the activities most often outsourced to third-party vendors are Calibration and Labs.
  

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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