Managing Medical Device Customer Complaint and Resolution Systems: Structure, Resourcing and Staffing

STUDY OVERVIEW

Best Practices, LLC undertook benchmarking research to probe the best practices in managing customer complaint and resolution systems to spot trends and develop insights for the global medical device marketplace, specifically the United States, European Union, Australia and Japan.

This study will serve as a reference for medical device leaders in optimizing their current complaint and resolution system by benchmarking their functional/departmental performance against that of industry peers.

KEY TOPICS

• Group Structure, Roles and Responsibilities
• Complaint Sources and Reception
• Complaint Triage
• Outsourcing, Training and Development
• Quality Financial Resources and Staffing

KEY METRICS

• Which group at your company has the primary leadership role for the following complaint management activities?
• During the past 90 days, from which sources did your company receive product-specific quality complaints regarding medical devices?
• Please estimate the average number of complaints regarding medical devices your company receives from all channels per month
• At any given time, approximately how many open complaint investigations related to medical devices are you processing?
• What are the three most common activities that get contracted out to third-party vendors?
• How do you measure the effectiveness of adverse event training?

SAMPLE KEY FINDINGS

Complaint Sources and Reception:

• Complaints are primarily received by email and phone calls and are generally about device malfunctions.
• The number of open complaints at any given time are around 5100, while companies receive 4400/month indicating the number of open complaints is growing. This problem will only continue with more rigorous reporting requirements from the FDA. Companies must be more efficient in closing complaints to combat the rising numbers.

METHODOLOGY

Industries Profiled:
Health Care; Pharmaceutical; Diagnostic; Medical Device; Biotech


Companies Profiled:
Abbott; Accelerate Diagnostics; Alcon; AstraZeneca; Avedro; Baxter Healthcare; Beckman Coulter; Boston Scientific; C. R. Bard; Edwards Lifesciences; ICU Medical; Marian; Medtronic; MicroPort; MID Labs; Needle Tech Products; Ortho-Clinical Diagnostics; PerkinElmer; Stryker; Zimmer Biomet

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