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Products & Services Customer Service Customer Relationship Management

Best Practices in Postmarketing Surveillance and Complaint Resolution Management at Medical Device Firms

ID: PCS-213


13 Info Graphics

44 Data Graphics

350+ Metrics

11 Narratives

Pages: 73

Published: Pre-2019

Delivery Format: Shipped


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An effective postmarketing surveillance and customer complaint resolution system enables medical device companies to harness insights from customer feedback to drive critical safety and business improvements. However, if not streamlined, the postmarketing surveillance and complaint resolution process can prove to be time-consuming and expensive for many companies, resulting in less than optimal outcomes.

Best Practices, LLC undertook benchmarking research to probe the best practices employed by leading medical device companies to manage their postmarketing surveillance and complaint resolution systems in order to identify safety issues, resolve problems, spot trends and develop insights that drive process improvements in the global medical device marketplace. This report delivers MDR/MDV post market surveillance benchmarks in the global market, with a special focus on the United States, European Union, Australia and Japan.

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

Study Snapshot

Best Practices, LLC engaged 20 leaders involved in the management of postmarketing surveillance and resolution systems from 20 leading medical device companies through a benchmarking survey. Nearly two-thirds of benchmark partners serve at the director level or above.

Research insights are presented in two segments:
Large Companies (annual revenue equal to or greater than $2 billion), n = 12 and Small to Mid-sized Companies (annual revenue less than $2 billion), n = 8

Key topics covered in this report include:

  • Complaint Sources and Reception
  • Complaint Triage
  • Complaint Workflow
  • Complaint Follow-Up
  • Complaint Identification and Analysis
  • Complaint Recording
  • Complaint Timing
  • Compliance Levels
  • Outsourcing, Training and Development
  • Quality Financial Resources and Staffing

Key Findings

Sample key insights uncovered from this report are noted below. Detailed findings are available in the full report.

1. 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 is 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.

2. 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.
Table of Contents

I.Executive Summarypgs. 3-9
Research Overviewpg. 4
Respondents Backgroundpg. 5
Key Insightspgs. 6-7
Study Segmentationpg. 8
II.Group Structure, Roles and Responsibilitiespgs. 9-14
III.Adverse Events and Complaint Sources / Receptionpgs. 15-21
IV.Complaint Triagepgs. 22-28
V.Complaint Workflowpgs. 29-38
VI.Complaint Follow-Uppgs. 39-42
VII.Complaint Identification and Analysispgs. 43-47
VIII.Complaint Reportingpgs. 48-50
IX.Complaint Timingpgs. 51-54
X.Compliance Levelspgs. 55-58
XI.Outsourcing, Training and Developmentpgs. 59-65
XII.Quality Financial Resourcing and Staffingpgs. 66-69
XIII.Business Demographicspgs. 70-72
XIV.About Best Practices, LLCpg. 73

    List of Charts & Exhibits

    Group Structure, Roles and Responsibilities
    • Structure employed for managing complaints within participating organizations – total benchmark class and large companies vs. small to mid-sized companies
    • Groups having primary leadership role and support role for listed complaint management activities
    • Interview narratives on harmonization of complaint systems across business units/therapy areas
    • Interview narratives on creating standard SOPs for more efficient integration of new business units into the complaint system

    Complaint Sources and Reception
    • Sources from which benchmark companies received product-specific quality complaints in the past 90 days
    • Whether benchmark partners proactively mine social media (Facebook, Twitter etc.) for complaints?
    • Social media resources mined by benchmark partners
    • Classification of complaints regarding medical devices
    • Total complaint volume: Average number of complaints received by benchmark companies from all channels
    • Number of open customer complaints processed by participants at any given time
    • Number of open complaint investigations processed by benchmark partners at any given time

    Complaint Triage
    • Functional responsibility of listed facets of complaint resolution process – total benchmark class and large companies vs. small to mid-sized companies
    • Automation of complaint resolution process – total benchmark class and large companies vs. small to mid-sized companies
    • Automated facets in complaint resolution process
    • Interview narratives on automation of complaint resolution process

    Complaint Workflow
    • Employee groups responsible for assessing complaints
    • Timing of medical review - before or after MDR submission
    • Types of medical safety review – total benchmark class and large companies vs. small to mid-sized companies
    • Number of doctors and nurses comprising the medical safety review team
    • Medical reviews conducted by doctors or nurses – total benchmark class and large companies vs. small to mid-sized companies
    • Percentage of complaints investigated versus percentage of complaints not investigated but justified using documented rationale such as a white paper or engineering study (known issue)
    • Whether medical team actively updates the risk file based on reviews?

    Complaint Follow-Up
    • Percentage of follow-up activities for medical device complaints conducted via e-mails, telephone/ call center and other mediums
    • Percentage of follow-ups conducted by medical professionals
    • Methodology used to investigate single incidents
    • Methods used to combine/group complaints into common issues for later investigation

    Complaint Identification and Analysis
    • Reporting of regulatory/MDR/MDV complaints from the diverse sources
    • Complaint closure time and reporting time frame

    Complaint Timing
    • Major impacts identified as a result of the new EU 15-day reporting time frame
    • Lifecycles monitored by benchmark partners and the acceptable cycle times
    • Frequency of monitoring the cycle times

    Compliance Levels
    • Compliance level (in percentage) attached to the internal process performance target or goals
    • Whether action taken on complaints having a lengthy cycle time, even if the company has reached acceptable compliance levels?
    • Frequency of sharing metrics with management at management reviews

    Outsourcing, Training and Development
    • Most common activities contracted out to third-party vendors
    • Department responsible for adverse event training
    • Adverse events training methods
    • Measuring the effectiveness of training – total benchmark class and large companies vs. small to mid-sized companies
    • Effective tactics and approaches for using the complaints process to generate business improvements

    Quality Financial Resourcing and Staffing
    • Estimated total spend of the Quality function in 2016 for medical devices and related services
    • Percentage of total Quality (GCP, GLP, GMP, GxP) function budget and FTEs (full-time equivalent employees) allocated to critical Quality channels
    • Role of Quality function in funding and managing listed nonconforming activities
    • Total number of FTEs engaged in medical device operations/businesses in 2016