Access. Intelligence. Excellence

Advanced Search

Home > Products & Services > Benchmarking Reports > Customer Service > Customer Relationship Management

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

Features:

13	Info Graphics
44	Data Graphics
350+	Metrics
11	Narratives

Pages: 73

Delivery Format: Shipped

Call 919-403-0251

ID: PCS-213

License Options: price info

Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.

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.

Benchmark Class
Study Snapshot
Key Findings
View TOC and List of Exhibits

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 Summary	pgs. 3-9
	Research Overview	pg. 4
	Respondents Background	pg. 5
	Key Insights	pgs. 6-7
	Study Segmentation	pg. 8
II.	Group Structure, Roles and Responsibilities	pgs. 9-14
III.	Adverse Events and Complaint Sources / Reception	pgs. 15-21
IV.	Complaint Triage	pgs. 22-28
V.	Complaint Workflow	pgs. 29-38
VI.	Complaint Follow-Up	pgs. 39-42
VII.	Complaint Identification and Analysis	pgs. 43-47
VIII.	Complaint Reporting	pgs. 48-50
IX.	Complaint Timing	pgs. 51-54
X.	Compliance Levels	pgs. 55-58
XI.	Outsourcing, Training and Development	pgs. 59-65
XII.	Quality Financial Resourcing and Staffing	pgs. 66-69
XIII.	Business Demographics	pgs. 70-72
XIV.	About Best Practices, LLC	pg. 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

Related Research

Contact Center Excellence: Developing & Maintaining a World-Class Contact Center

A must-have for all contact center executives, this series is critical for driving call center success... (ID CSS-63)
Companies Profiled: A Leading Pharmaceutical Company, Aliant Telecom, American Airlines, American Express, read more ...

Price: $17928.00 Free Excerpt Available

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

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... (ID PCS-213)
Companies Profiled: Abbott, Accelerate Diagnostics, Alcon, AstraZeneca, read more ...

Price: $4800.00 Free Excerpt Available

Customer Complaint Resolution Excellence: Capturing Insights to Drive Business Improvements

Complaint resolution groups fulfill a key role not just in resolving customer complaints involving service claims and other issues, but also in capturing critical customer feedback and data from which to drive quality and continuous improvement in the supply chain and throughout the organization... (ID PCS-210)
Companies Profiled: 3M, Abbott Laboratories, Amway Global, Agilent Technologies, read more ...

Price: $3550.00 Free Excerpt Available

ACCESS AND INTELLIGENCE FOR ACHIEVING WORLD-CLASS EXCELLENCE

Quick Links