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Products & Services Quality, Compliance and Regulatory Assuring Quality Programs

Benchmarking Medical Device Quality: The Global Role of Quality in Inspection/Production, Software Validation and Product Support Activities

ID: 5245


Features:

5 Info Graphics

29 Data Graphics

400 Metrics


Pages/Slides: 40


Published: Pre-2014


Delivery Format: Online PDF Document


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "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

SAMPLE KEY METRICS
  • 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
SAMPLE KEY FINDING
  • 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.
METHODOLOGY
Best Practices, LLC engaged 12 medical device organizations in this research. Nearly half of the participants serve as vice presidents in Quality. Eleven of the 12 benchmark companies are based in the United States.

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

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.