Benchmarking Medical Device Quality 2014-15: M&A Impact and Improvement Approaches

STUDY OVERVIEW

Medical device and diagnostics companies spend millions to ensure their products meet quality standards at every stage of the product lifecycle. While they continually strive to ensure quality and safety in their company's products, quality leaders must also keep an eye on costs at the same time. Balancing these goals is a challenging task in today's environment of frequent mergers/acquisitions and regulatory change.

To help quality leaders better deal with issues around M&A and effectiveness, Best Practices, LLC undertook this study to explore the impact of M&A and integration efforts on the quality function as well as what types of programs quality leaders are using to improve their effectiveness. Research findings provide evidence-based benchmarks around these issues so quality leaders can compare their efforts with industry peers.

This study contains a Large Company Segment (LCS) that is made up of 11 companies.

KEY TOPICS

• Acquisitions & Quality Function Integration
• Quality Metrics, Improvement Approaches & Controls
• Top Challenge Areas for Quality Organizations

• Total acquisitions made since 2012
• Number of acquisitions since 2012 that had immediate realizable revenue
• Percentage of acquired facilities where quality staff and systems have been fully integrated
• Models that best describe current and future state of your quality system
• Effectiveness of approaches by which quality supports rapid M&A integration
• Number of SOPs for quality organization at three levels
• Effectiveness of approaches to develop quality systems that respond rapidly to problems
• Effectiveness of approaches to tie quality controls to quality attributes of products
• Which KPIs are used in dashboard to assess quality performance
• Effectiveness of these metrics for determining the risk your distribution poses to quality function
• Current statistical confidence level for the product classes listed
• Top three challenges your quality function will face in next 1-2 years
  

• Approaches that Improve Flexibility: Approaches most often rate “Highly Effective” are simplification, early warning systems and performance dashboards. More than half of benchmark class and large companies consider failure mode effect analysis highly effective for quality control. 56 percent of large companies and 47% of benchmark companies also find product drawings very effective for QC.

• Best Practices, LLC designed and deployed a custom benchmarking survey to executives at 21 leading Medical Device companies.  This study has two segments: Total Benchmark Class (TBC) made up of 21 companies and a Large Company Segment (LCS) that is made up of 11 companies.

Industries Profiled:
Medical Device; Pharmaceutical; Health Care


Companies Profiled:
3M Pharmaceuticals; DePuy Synthes; Baxter Healthcare; Atri Cure; Beckman Coulter; BMC Medical; Becton Dickinson; Bio Tek; Boston Scientific; Cook Medical; Covidien; Endologix; Edwards Lifesciences; Helmer Scientific; Ethicon; GE Healthcare; Medtronic; BARD; Haemonetics Corporation; Invacare Corporation; Lake Region Medical

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