Medical Device Complaint Management Market Size, Share & Trends Analysis Report By Service (Complaints Log/Intake, Product Surveillance & Regulatory Compliance), By Region, And Segment Forecasts, 2019 - 2026

Published: Jan, 2019 | Pages: 111 | Publisher: Grand View Research
Industry: Medical Devices | Report Format: Electronic (PDF)

The global medical device complaint management market size is expected to reach USD 10.2 billion by 2026, according to a new report by Grand View Research, Inc. It is anticipated to register a CAGR of 7.6% during the forecast period. Increasing use of software to support the entire complaint management process is propelling the growth.

The transition from paper-based to digital system for tracking complaints is boosting growth of the market. Incidents are recorded and the data automatically drives the investigation and resolution workflow. Companies experience more complete documentation along with the reduction in the turnaround time. The complaints management solution provides advanced analytics and reporting tools for augmented management oversight. The software also streamlines the submissions with standard reporting for the EU, FDA, Japan, Health Canada, and Australia.

For instance, the U.S. FDA encourages consumers, patients, and healthcare professionals to give voluntary reports of important adverse events, and/or product issues to MedWatch, FDA's Safety Information and Adverse Event Reporting Program or by means of the mobile app known as MedWatcher. The app radically simplifies and accelerates the process of reporting by providing users with a four-step form submitted electronically to the FDA.

Regulators are gradually concentrating on handling customer complaints, product safety, and device vigilance. This is not only true in developed countries, but also in emerging economies such as India. The Indian government introduced medical devices regulation program, Materiovigilance Programme of India (MvPI) with focus on safety data collection, synchronization of international laws, regulations, and standards encourages medical device organizations to evaluate their existing procedures of product development and post-marketing surveillance.

Further key findings from the report suggest:

• Product surveillance and regulatory compliance emerged as the largest segment owing to greater emphasis put on product surveillance by regulatory agencies

• North America held the largest market share in 2017 owing to stern regulatory requirements and heavy monetary fines in this region. All the device manufacturers, importers, and distributors are required to comply with the complaint and record requirement

• Some of the key players operating in the medical device complaint management market include IQVIA, Wipro, Tata Consulting Services, SAS, Sparta Systems, Parexel International Corporation, Biovia, AssurX, MasterControl, and Freyr.

 Table of Contents

Chapter 1 Report Scope
                  1.1 Segment Market Scope
                  1.2 Regional Scope
                  1.3 Estimates and Forecast Timeline

Chapter 2 Methodology
                  2.1 Research Methodology
                      2.1.1 Information procurement
                  2.2 Information or Data Analysis
                  2.3 Market Formulation & Validation
                  2.4 Region Wise Market Calculation
                      2.4.1 Region Wise Market: Base Estimates
                      2.4.2 Global Market: CAGR Calculation
                  2.5 Region Based Segment Share Calculation
                  2.6 Model Details
                      2.6.1 Commodity flow analysis (Model 1)
                      2.6.2 Volume price analysis (model 2)
                  2.7 List of Secondary Sources
                  2.8 List of Primary Sources
                  2.9 List of Abbreviations

Chapter 3 Objectives
                  3.1 Objective - 1: Understanding the market dynamics
                  3.2 Objective - 2: Understanding the market estimates and forecasts
                  3.3 Objective - 3: Understanding the attributes such as strategy framework, competitor categorization
                  3.4 Objective - 4: Understanding the key end-users, technological, application and product scopes

Chapter 4 Executive Summary

Chapter 5 Market Definition

Chapter 6 Industry Outlook
                  6.1 Market Segmentation
                  6.2 Business Segment Trends
                      6.2.1 Product business analysis
                      6.2.2 Regional business analysis
                  6.3 Market Variable Analysis
                      6.3.1 Market driver analysis
                          6.3.1.1 Increasing use of automated system
                          6.3.1.2 Introduction of mobile apps
                      6.3.2 Market restraint analysis
                          6.3.2.1 Employees ability to use the process
                  6.4 Penetration & Growth Prospect Mapping
                  6.5 Business Environment Analysis tools
                      6.5.1 SWOT Analysis, by PEST
                      6.5.2 Porter's five forces analysis
                      6.5.3 Industry Analysis - Ansoff Matrix

Chapter 7 Medical Device Complaint Management: Product Estimates and Trend Analysis
                  7.1 Medical Device Complaint Management Market: Service Movement Analysis
                  7.2 Complaints Log / Intake
                      7.2.1 Complaints Log / Intake Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.2.2 Receive Complaints
                          7.2.2.1 Receive Complaints Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.2.3 Classify the Issue
                          7.2.3.1 Classify the Issue Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.2.4 Record Issue
                          7.2.4.1 Record Issue Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                  7.3 Product Surveillance & Regulatory Compliance
                      7.3.1 Product Surveillance & Regulatory Compliance Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.3.2 Reportable/Non Reportable
                          7.3.2.1 Reportable/Non Reportable Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.3.3 Medical Device Vigilance/Medical Device Reporting
                          7.3.3.1 Medical Device Vigilance/Medical Device Reporting Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.3.4 Field Action
                          7.3.4.1 Field Action market Estimates and Forecasts, 2014 - 2026 (USD Million)
                  7.4 Returned/ Non-Returned Product Analysis
                      7.4.1 Returned/ Non-Returned Product Analysis Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.4.2 Complaint Investigation
                          7.4.2.1 Complaint Investigation Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.4.3 Root Cause Analysis, Testing
                          7.4.3.1 Root Cause Analysis, Testing Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.4.4 Corrective/Preventive Action
                          7.4.4.1 Corrective/Preventive Action Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                  7.5 Resolve & Closure
                      7.5.1 Resolve & Closure Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.5.2 Complaint Summary
                          7.5.2.1 Complaint Summary Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      7.5.3 Customer Letter Creation
                          7.5.3.1 Customer Letter Creation Market Estimates and Forecasts, 2014 - 2026 (USD Million)

Chapter 8 Medical Device Complaint Management: Regional Estimates and Trend Analysis
                  8.1 Medical Device Complaint Management Market: Regional Movement Analysis
                  8.2 North America
                      8.2.1 North America Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.2.2 U.S.
                          8.2.2.1 U.S. Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.2.3 Canada
                          8.2.3.1 Canada Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                  8.3 Europe
                      8.3.1 Europe Medical Device Complaint Management Market Estimates and Forecasts , 2014 - 2026 (USD Million)
                      8.3.2 U.K.
                          8.3.2.1 U.K. Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.3.3 Germany
                          8.3.3.1 Germany Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                  8.4 Asia Pacific
                      8.4.1 Asia Pacific Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.4.2 Japan
                          8.4.2.1 Japan Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.4.3 China
                          8.4.3.1 China Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                  8.5 Latin America
                      8.5.1 Latin America Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.5.2 Brazil
                          8.5.2.1 Brazil Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.5.3 Mexico
                          8.5.3.1 Mexico Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                  8.6 MEA
                      8.6.1 MEA Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.6.2 South Africa
                          8.6.2.1 South Africa Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
                      8.6.3 Saudi Arabia
                          8.6.3.1 Saudi Arabia Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)

Chapter 9 Company Profiles
                  9.1 Strategic Framework
                  9.2 Company Profiles
                      9.2.1 IQVIA
                          9.2.1.2 Company Overview
                          9.2.1.3 Financial Performance
                          9.2.1.4 service Benchmarking
                          9.2.1.5 Strategic Initiatives
                      9.2.2 Parexel
                          9.2.2.1 Company Overview
                          9.2.2.2 Financial Performance
                          9.2.2.3 Service Benchmarking
                      9.2.3 SAS
                          9.2.3.1 Company Overview
                          9.2.3.2 Financial Performance
                          9.2.3.3 Service Benchmarking
                      9.2.4 Wipro
                          9.2.4.1 Company Overview
                          9.2.4.2 Financial Performance
                          9.2.4.3 Service Benchmarking
                      9.2.5 Tata Consulting Services
                          9.2.5.1 Company Overview
                          9.2.5.2 Financial Performance
                          9.2.5.3 Service Benchmarking
                          9.2.5.4 Strategic Initiatives
                      9.2.6 Sparta Systems
                          9.2.6.1 Company Overview
                          9.2.6.2 Service Benchmarking
                          9.2.6.3 Strategic Initiatives
                      9.2.7 Freyr
                          9.2.7.1 Company Overview
                          9.2.7.2 Service Benchmarking
                      9.2.8 Biovia
                          9.2.8.1 Company Overview
                          9.2.8.2 Service Benchmarking
                          9.2.8.3 Strategic Initiatives
                      9.2.9 Assurx
                          9.2.9.1 Company Overview
                          9.2.9.2 Service Benchmarking
                      9.2.10 MasterControl
                          9.2.10.1 Company Overview
                          9.2.10.2 Service Benchmarking
                          9.2.10.3 Strategic Initiatives

Chapter 10 KOL Commentary
                  10.1 Key Insights
                  10.2 KOL Views

Chapter 11 Recommendations

List of Tables

Table 1 List of secondary sources
Table 2 List of Abbreviation
Table 3 Leading market players anticipated to witness highest growth
Table 4 Global Medical Device Complaint Management Market Estimates & Forecasts, by Services 2014 - 2026 (USD Million)
Table 5 Global Medical Device Complaint Management Market Estimates & Forecasts, by Region, 2014 - 2026 (USD Million)
Table 6 North America Medical Device Complaint Management Market Estimates & Forecasts, by Country, 2014 - 2026 (USD Million)
Table 7 North America Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 8 U.S. Medical Device Complaint Management Market Estimates & Forecasts, by Service 2014 - 2026 (USD Million)
Table 9 Canada Medical Device Complaint Management Market Estimates & Forecasts, by Service 2014 - 2026 (USD Million)
Table 10 Europe Medical Device Complaint Management Market Estimates & Forecasts, by Country 2014 - 2026 (USD Million)
Table 11 Europe Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 12 U.K. Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 13 Germany Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 14 Asia Pacific Medical Device Complaint Management Market Estimates & Forecasts, by Country 2014 - 2026 (USD Million)
Table 15 Asia Pacific Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 16 Japan Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 17 China Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 18 Latin America Medical Device Complaint Management Market Estimates & Forecasts, by Country 2014 - 2026 (USD Million)
Table 19 Latin America Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 20 Mexico Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 21 Brazil Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 22 MEA Medical Device Complaint Management Market Estimates & Forecasts, by Country 2014 - 2026 (USD Million)
Table 23 MEA Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 24 South Africa Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)
Table 25 Saudi Arabia Medical Device Complaint Management Market Estimates & Forecasts, by Service, 2014 - 2026 (USD Million)

List of Figures

Fig.1 Market research process
Fig.2 Information procurement
Fig.3 Primary research pattern
Fig.4 Market research approaches
Fig.5 Value chain based sizing & forecasting
Fig.6 QFD modelling for market share assessment
Fig.7 Market formulation & validation
Fig.8 Medical device complaint management market segmentation
Fig.9 Market driver relevance analysis (Current & future impact)
Fig.10 Market restraint relevance analysis (Current & future impact)
Fig.11 Penetration & growth prospect mapping
Fig.12 SWOT analysis, by factor (political & legal, economic and technological)
Fig.13 Porter's five forces analysis
Fig.14 Ansoff matrix analysis
Fig.15 Medical device complaint management market product outlook: Key takeaways
Fig.16 Medical device complaint management market: service movement analysis
Fig.17 Complaints log / intake market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.18 Receive complaints market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.19 Classify the issue market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.20 Record issue market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.21 Product surveillance & regulatory compliance market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.22 Reportable/non reportable market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.23 Medical device vigilance/medical device reporting market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.24 Field action market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.25 Returned/ non-returned product analysis market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.26 Complaint investigation market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.27 Root cause analysis, testing market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.28 Corrective/preventive action market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.29 Resolve & closure market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.30 Complaint summary market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.31 Customer letter creation market estimates and forecasts, 2014 - 2026 (USD Million)
Fig.32 Regional market place: Key takeaways
Fig.33 Medical device complaint management market: Regional movement analysis
Fig.34 North America Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.35 U.S. Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.36 Canada Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.37 Europe Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.38 U.K. Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.39 Germany Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.40 Asia Pacific Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.41 Japan Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.42 China Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.43 Latin America Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.44 Brazil Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.45 Mexico Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.46 MEA Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.47 South Africa Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.48 Saudi Arabia Medical Device Complaint Management Market Estimates and Forecasts, 2014 - 2026 (USD Million)
Fig.49 Strategy framework
Fig.50 Market participant categorization