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

• 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
  

• 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.
  

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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