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» Products & Services » » Quality, Compliance and Regulatory » Assuring Quality Programs

Benchmarking Medical Device Quality: Using Offshoring and Outsourcing in Low-Wage Markets and Top Challenges for Quality

ID: 5248


Features:

5 Info Graphics

19 Data Graphics

300+ Metrics


Pages/Slides: 33


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: Using Offshoring and Outsourcing in Low-Wage Markets and Top Challenges for Quality"

STUDY OVERVIEW

Medical device and diagnostics companies devote significant resources to ensure their products meet quality standards at every stage of the product lifecycle. With device organizations expansion into emerging markets, quality leaders are balancing between doing quality activities in low-wage markets using in-house staff at company sites or through third-party vendors in low-wage markets.

This study presents benchmarks around the use of offshoring and outsourcing for quality activities in low-cost markets. In particular, the research reviews to what extent quality leaders use in-house staff or third party vendors for more than 30 quality activities in low-wage markets. The study also reviews what quality leaders believe will be their biggest challenges in the coming years.

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

KEY TOPICS

  • Offshoring and Outsourcing: Organizations Prefer Quality Activities Being Handled In-house Instead of Through Third Party Vendors
  • Regulatory Scrutiny, Internal Complexity, Efficiencies and Cost Pressures Challenge Quality Leaders for Next Two Years
  • Universe of Learning: Key Demographics of Participating Companies

SAMPLE KEY METRICS
  • Percentage of Quality Assurance Activities done in Low Wage Markets at Company Sites versus Third Party Vendors for: Compliance, Inspection/Production, Non-Conforming, Product Support and Other Activities
  • Top Three Quality Challenges Leaders Anticipate for the Next Two Years
SAMPLE KEY FINDING
  • Quality Relies on Company Sites for Compliance Activities: While as many as 58% of benchmarked companies conduct Compliance activities in low-wage markets, most do these with company employees at company sites. No more than 18% of participants outsource Compliance activities to third-party vendors in these markets.
  • Inspection/Production  Activities Also Performed at Company Sites: Across the benchmark class, up to 60% of the participants conduct some Inspection/Production activities with company employees at company sites in low-wage markets. No more than 18% use third-party vendors in these markets for any of the Inspection/Production activities examined.
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


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