Managing Medical Device Customer Complaint and Resolution Systems: Reporting, Identification and Follow-Up

STUDY OVERVIEW

An effective customer complaint and resolution system enables medical device organizations to efficiently process and utilize customer complaints to address product issues and improve business operations.

However, if not streamlined, the customer complaint resolution process can prove to be time-consuming and expensive for many companies, resulting in poor business and operational results.

Best Practices, LLC undertook benchmarking research to probe the best practices employed by leading medical device companies to manage their customer complaint and resolution systems in order to resolve problems, spot trends and develop insights that drive process improvements in the global medical device marketplace, specifically the United States, European Union, Australia and Japan.

The MDR/MDV post market surveillance benchmarks in this study will serve as a reference for medical device leaders in optimizing their current complaint and resolution system.

KEY TOPICS

• Complaint Workflow
• Complaint Follow-Up
• Complaint Identification and Analysis
• Complaint Recording
• Complaint Timing
• Compliance Levels

KEY METRICS

• Does your company perform a medical review before or after MDR submission?
• How many doctors and nurses comprise the medical safety review team?
• What percentage of follow-ups is conducted by medical professionals?
• What methodology do you use to investigate single incidents? Is it significantly different from handling cluster complaint?
• How do you report regulatory/MDR/MDV complaints from listed sources?
• How frequently do you share metrics with management at management reviews?

SAMPLE KEY FINDINGS

Complaint Workflow:

• Medical safety reviews are conducted before MDR submission in most cases, and are performed in cases of death, serious injury, and potential for harm. Medical review teams vary significantly from company to company from teams of only Doctors, Nurses or other staff, to mixed teams containing all three groups.
• Respondents investigate ~75% of all complaints.

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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