Benchmarking Medical Device Quality: Factors that Increase/Decrease Quality Spend and Managing Acquisitions

STUDY OVERVIEW

Medical device and diagnostics companies make significant investments - both in spending and staffing - to ensure their products meet quality standards. With millions spent on quality, organizations are continually evaluating factors that increase or decrease quality spend. On a separate, but related, issue, the pace of acquisitions in the device sector has forced many organizations to deal with issues revolving around integration of quality systems - a factor that can greatly influence spend.

This study presents benchmarks around the process management and regulatory factors quality leaders think will increase quality spend the most in the next two years and the simplification and continuous improvement factors they believe will decrease quality spend the most during the same period. The study also presents metrics and insights around acquisitions, including quality integration at acquired sites and the move to global quality systems.

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

KEY TOPICS

• Future Quality Spend Drivers: Complexity, High Change Rates and Regulatory Scrutiny
• Future Quality Spend Normalizers: Simplification, Standardization, Divestitures & Automation
• Fully Integrating Independent Quality Systems & Acquisitions Supports Standardization & Simplification

• Ranking of Process Management Factors that Increase Quality Spend
• Ranking of Regulatory Factors that Increase Quality Spend
• Ranking of Simplification Factors that Decrease Quality Spend
• Ranking of Continuous Improvement Factors that Decrease Quality Spend
• List of Regulatory Issue Present at Company
• Number of Acquisitions in the Past Three Years
• Percentage of Acquisitions with Realizable Revenues
• Quality Integration at Acquired Sites
• Gauge Extent of Move to Global Quality System
• Estimate Number of SOPs within Quality Organization
  

• Factors Increasing Quality Support Spend: Complexity in product mix, product family, and manufacturing network received the highest impact ratings when it comes to prompting investment increases in Quality spend. The total benchmark class also spotlights high change rates for design and manufacturing processes – along with standardization initiatives – as other sources of increasing Quality Support spending in the next two years. The large company segment indicated that the impact of Regulatory infractions on Quality Support spend increases is much higher than did the overall benchmark class. Half of large companies ranked consent decrees as having high impact on costs compared to only 25% of the overall benchmark class.
  

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