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New Medical Device Quality Study Finds Regulatory Environment is Boosting Quality Spending, Especially for Large Companies

CHAPEL HILL, N.C., March 27, 2015 /PRNewswire/ -- The quality function within the medical device sector carries an intimidating job description: ensure products meet quality standards at every stage of the product life cycle. Facing tight budgets and escalating regulations, quality leaders also have the challenge of balancing quality and safety with managing costs and risk.

Those who don't effectively balance these priorities risk funding and staffing for the quality function as well as marketplace failure and regulatory scrutiny.

For the third consecutive year, research and consulting leader Best Practices, LLC has conducted a primary research project to give medical device quality leaders current insights into the critical aspects of running an effective quality group. Staffing metrics, current and future spending levels and drivers, and budget allocations for key quality activities are a few of the top-line topics addressed in "Benchmarking Medical Device Quality 2014-15: Managing Costs While Ensuring Quality & Safety."

This study is a comprehensive overview of the quality function that not only benchmarks specific quality spend and staffing data but also the spend and metrics for any and all quality and compliance-related activities done by other functions, such as regulatory affairs and operations.

More than half of the participating companies saw spending increase for the quality function over the past three years, with an average spending increase of 1.5% for the full benchmark class and 6.5% for the large companies in the study, according to the new report. Regulatory requirements, business expansion/new products, and integration activities were cited as some of the principal forces behind the increased quality spend.

Key Topics addressed in the 158-page report include:
  • Quality spend levels and inclusions /exclusions
  • Future quality spend drivers & normalizers
  • Acquisition & integration levels
  • Future pitfalls & challenges for the quality function
  • Quality staffing levels
  • Volume of change requests, complaints, CAPAs, and NCEs
  • Budget allocations for key quality activities including: compliance; inspection/ production; non-conforming; product support; other quality activities
  • Degree of quality responsibility across key activity areas
  • Use of offshoring and outsourcing in low-wage labor markets for quality activities

For this study, Best Practices, LLC engaged executives at 21 leading medical device companies to participate in a comprehensive custom benchmarking survey. Almost half - 48% - of the participants were at the vice president level.

To access the full report or to download a complimentary summary, click on the following link:

For related research, visit our Best Practices, LLC Web site at


Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.

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