Roots Analysis has done a detailed study on Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030, covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

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Key Market Insights
 Over time, a number of medical devices have been recalled due to various reasons; therefore, presently, HFE and usability testing is being perceived as a fundamental necessity in order to drive product development efforts
 Currently, more than 90 companies claim to offer human factors engineering and usability testing services, catering to needs across different stages of the medical device development process
 The market landscape is highly fragmented, featuring the presence of several well-established players and new entrants, many of which have varied service portfolios, focused on different types of medical devices
 Players involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and gain an advantage over competitor firms
 As device developers continue to rely on specialty service providers for critical inputs on device design, the HFE and usability testing services market is anticipated to register double digit growth in the long term

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Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Context and Background
3.2. Overview of Human Factors Engineering and Usability Testing
3.2.1. Human Factors Engineering (HFE)
3.2.2. Usability Testing
3.2.3. Ergonomics and Hedonomics
3.3. Human Factors Considerations for Medical Device Design
3.3.1. Users
3.3.2. Use Environment
3.3.3. Device-User Interface

3.4. Human Factors and Usability Testing Process
3.5. Advantages of Outsourcing HFE Testing Operations
3.6. Risks and Challenges Associated with Outsourcing HFE Testing Services
3.7. Key Considerations for Selecting an HFE and Usability Testing Partner

4. REGULATORY LANDSCAPE
4.1. Chapter Overview
4.2. Key Regulatory Authorities on Human Factors and Usability Testing Services
4.3. Regulatory Landscape in North America
4.3.1. FDA Recognized Standards on Human Factors
4.3.2. FDA Guidance Documents related to Human Factors
4.3.3. FDA Human Factors Engineering Process

4.4. Regulatory Landscape in Europe
4.4.1. EU-Recognized Standards on Human Factors
4.4.2. EU Human Factors Engineering Process

4.5. Human Factors Engineering Pathway: Comparison of Guidelines in the US and EU
4.5.1. Alignment between Regulations in the US and EU
4.5.2. Abbreviated Human Factors Engineering and Usability Testing

4.6. Concluding Remarks

5. SERVICE PROVIDER LANDSCAPE
5.1. Chapter Overview
5.2. Human Factors Engineering and Usability Testing Service Providers for Medical Devices: Overall Market Landscape
5.2.1. Analysis by Year of Establishment
5.2.2. Analysis by Company Size
5.2.3. Analysis by Location of Headquarters
5.2.4. Analysis by Types of Certifications Obtained
5.2.5. Analysis by Types of Medical Device Designed
5.2.6. Analysis by Types of Human Factors Engineering and Usability Testing Services Offered
5.2.6.1. Analysis by Types of Services Offered in the Concept Phase
5.2.6.2. Analysis by Types of Services Offered in the Design and Development Phase
5.2.6.3. Analysis by Types Services Offered in the Verification and Validation Phase
5.2.7. Analysis by Other Services Offered

5.3. Human Factors Engineering and Usability Testing Service Providers for Medical Devices Software: Overall Market Landscape
5.3.1. Analysis by Year of Establishment
5.3.2. Analysis by Company Size
5.3.3. Analysis by Location of Headquarters

6. COMPANY COMPETITIVENESS ANALYSIS
6.1. Chapter Overview
6.2. Assumptions and Key Parameters
6.3. Methodology

6.4. Company Competitiveness Analysis
6.4.1. Human Factors Engineering and Usability Testing Service Providers based in North America
6.4.2. Human Factors Engineering and Usability Testing Service Providers based in Europe
6.4.3. Human Factors Engineering and Usability Testing Service Providers based in Asia
Pacific / RoW

7. COMPANY PROFILES
7.1. Chapter Overview
7.2. Service Providers in North America
7.2.1. Agilis
7.2.1.1. Company Overview
7.2.1.2. Service Portfolio
7.2.1.3. Future Outlook

7.2.2. Human Factors Consulting Service
7.2.2.1. Company Overview
7.2.2.2. Service Portfolio
7.2.2.3. Future Outlook

7.2.3. Human Factors MD
7.2.3.1. Company Overview
7.2.3.2. Service Portfolio
7.2.3.3. Future Outlook

7.2.4. User wise
7.2.4.1. Company Overview
7.2.4.2. Service Portfolio
7.2.4.3. Future Outlook

7.2.5. Ximedica
7.2.5.1. Company Overview
7.2.5.2. Service Portfolio
7.2.5.3. Future Outlook

7.3. Service Providers in Europe
7.3.1. Austrian Center for Medical Innovation and Technology (ACMIT)
7.3.1.1. Company Overview
7.3.1.2. Service Portfolio
7.3.1.3. Future Outlook

7.3.2. Auxergo
7.3.2.1. Company Overview
7.3.2.2. Service Portfolio
7.3.2.3. Future Outlook

7.3.3. THAY Medical
7.3.3.1. Company Overview
7.3.3.2. Service Portfolio
7.3.3.3. Future Outlook

7.4. Service Providers in Asia Pacific
7.4.1. Ergotech
7.4.1.1. Company Overview
7.4.1.2. Service Portfolio
7.4.1.3. Future Outlook

7.4.2. Jonathan Bar-Or Industrial Design
7.4.2.1. Company Overview
7.4.2.2. Service Portfolio
7.4.2.3. Future Outlook

8. COST IMPLICATIONS RELATED TO HUMAN FACTORS ENGINEERING AND USABILITY TESTING PROCESS
8.1. Chapter Overview
8.2. Steps involved in Human Factors Engineering and Usability Testing Process
8.3. Cost Distribution across the Different Steps of Human Factors Engineering and Usability Testing Process
8.3.1. Costs Associated with Contextual Inquiry
8.3.2. Costs Associated with Task Analysis
8.3.3. Costs Associated with Human Factors Assessment for Device Design
8.3.4. Costs Associated with Formative Studies
8.3.5. Costs Associated with Risk Analysis
8.3.6. Costs Associated with Use Error Analysis
8.3.7. Costs Associated with Summative Studies
8.3.8 Costs Associated with Regulatory Document Preparation

9. CASE STUDY: MEDICAL DEVICE RECALLS AND ROLE OF HUMAN FACTORS ENGINEERING
9.1. Chapter Overview
9.2. Medical Device Recalls
9.3. Five Major Medical Device Recalls Till-date
9.3.1. West Pharmaceutical’s Fluid Transfer Systems
9.3.2. Magellan Diagnostics’ Blood Lead Testing Systems
9.3.3. Cook Medical’s Catheters
9.3.4. Abbott’s Cardiac Pacemakers
9.3.5. CareFusion’s Alaris Pump Module
9.4. Human Factors Engineering: Managing the Risk of Device Recalls
9.4.1. Cost Saving Potential Associated with Human Factors Engineering and Usability Testing

10. MARKET FORECAST AND OPPORTUNITY ANALYSIS
10.1. Chapter Overview
10.2. Key Assumptions and Forecast Methodology
10.3. Overall Human Factors Engineering and Usability Testing Services Market for Medical Devices, 2020-2030

10.4. Human Factors Engineering and Usability Testing Services Market: Distribution by Type of Tools Used, 2020, 2025 and 2030
10.4.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools, 2020-2030
10.4.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools, 2020-2030

10.5. Human Factors Engineering and Usability Testing Services Market: Distribution by Types of Steps Involved in Usability Testing, 2020, 2025 and 2030
10.5.1. Human Factors Engineering and Usability Testing Services Market for Contextual Analysis, 2020-2030
10.5.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis, 2020-2030
10.5.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis, 2020-2030
10.5.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies, 2020-2030
10.5.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis, 2020-2030
10.5.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis, 2020-2030
10.5.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies, 2020-2030
10.5.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation, 2020-2030

10.6. Human Factors Engineering and Usability Testing Services Market: Distribution by Device Class, 2020,2025 and 2030
10.6.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices, 2020-2030
10.6.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices, 2020-2030
10.6.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices, 2020-2030

10.7. Human Factors Engineering and Usability Testing Services Market: Distribution by Geography, 2020,2025 and 2030

10.7.1. Human Factors Engineering and Usability Testing Services Market in North America, 2020-2030
10.7.1.1. Human Factors Engineering and Usability Testing Services Market in North America: Distribution by Types of Tools, 2020-2030
10.7.1.1.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools in North America, 2020-2030
10.7.1.1.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools in North America, 2020-2030

10.7.1.2. Human Factors Engineering and Usability Testing Services Market in North America: Distribution by Types of Steps Involved in Usability Testing, 2020-2030
10.7.1.2.1. Human Factors Engineering and Usability Testing Services for Contextual Analysis in North America, 2020-2030
10.7.1.2.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis in North America, 2020-2030
10.7.1.2.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis in North America, 2020-2030
10.7.1.2.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies in North America, 2020-2030
10.7.1.2.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis in North America, 2020-2030
10.7.1.2.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis in North America, 2020-2030
10.7.1.2.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies in North America, 2020-2030
10.7.1.2.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation in North America, 2020-2030

10.7.1.3. Human Factors Engineering and Usability Testing Services Market in North America: Distribution by Distribution by Device Class, 2020-2030
10.7.1.3.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices in North America, 2020-2030
10.7.1.3.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices in North America, 2020-2030
10.7.1.3.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices in North America, 2020-2030

10.7.2. Human Factors Engineering and Usability Testing Services Market in Europe, 2020-2030
10.7.2.1. Human Factors Engineering and Usability Testing Services Market in Europe: Distribution by Types of Tools, 2020-2030
10.7.2.1.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools in Europe, 2020-2030
10.7.2.1.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools in Europe, 2020-2030

10.7.2.2. Human Factors Engineering and Usability Testing Services Market in Europe: Distribution by Types of Steps Involved in Usability Testing, 2020-2030
10.7.2.2.1. Human Factors Engineering and Usability Testing Services for Contextual Analysis in Europe, 2020-2030
10.7.2.2.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis in Europe, 2020-2030
10.7.2.2.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis in Europe, 2020-2030
10.7.2.2.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies in Europe, 2020-2030
10.7.2.2.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis in Europe, 2020-2030
10.7.2.2.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis in Europe, 2020-2030
10.7.2.2.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies in Europe, 2020-2030
10.7.2.2.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation in Europe, 2020-2030

10.7.2.3. Human Factors Engineering and Usability Testing Services Market in Europe: Distribution by Distribution by Device Class, 2020-2030
10.7.2.3.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices in Europe, 2020-2030
10.7.2.3.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices in Europe, 2020-2030
10.7.2.3.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices in Europe, 2020-2030

10.7.3. Human Factors Engineering and Usability Testing Services Market in Asia Pacific, 2020-2030
10.7.3.1. Human Factors Engineering and Usability Testing Services Market in Asia Pacific: Distribution by Types of Tools, 2020-2030
10.7.3.1.1. Human Factors Engineering and Usability Testing Services Market for Generative Tools in Asia Pacific, 2020-2030
10.7.3.1.2. Human Factors Engineering and Usability Testing Services Market for Evaluative Tools in Asia Pacific, 2020-2030
10.7.3.2. Human Factors Engineering and Usability Testing Services Market in Asia Pacific: Distribution by Types of Steps Involved in Usability Testing, 2020-2030
10.7.3.2.1. Human Factors Engineering and Usability Testing Services for Contextual Analysis in Asia Pacific, 2020-2030
10.7.3.2.2. Human Factors Engineering and Usability Testing Services Market for Task Analysis in Asia Pacific, 2020-2030
10.7.3.2.3. Human Factors Engineering and Usability Testing Services Market for Design Analysis in Asia Pacific, 2020-2030
10.7.3.2.4. Human Factors Engineering and Usability Testing Services Market for Formative Studies in Asia Pacific, 2020-2030
10.7.3.2.5. Human Factors Engineering and Usability Testing Services Market for Use Risk Analysis in Asia Pacific, 2020-2030
10.7.3.2.6. Human Factors Engineering and Usability Testing Services Market for Known Use Error Analysis in Asia Pacific, 2020-2030
10.7.3.2.7. Human Factors Engineering and Usability Testing Services Market for Summative Studies in Asia Pacific, 2020-2030
10.7.3.2.8. Human Factors Engineering and Usability Testing Services Market for Regulatory Document Preparation in Asia Pacific, 2020-2030

10.7.3.3. Human Factors Engineering and Usability Testing Services Market in Asia Pacific: Distribution by Distribution by Device Class, 2020-2030
10.7.3.3.1. Human Factors Engineering and Usability Testing Services Market for Class I Devices in Asia Pacific, 2020-2030
10.7.3.3.2. Human Factors Engineering and Usability Testing Services Market for Class II Devices in Asia Pacific, 2020-2030
10.7.3.3.3. Human Factors Engineering and Usability Testing Services Market for Class III Devices in Asia Pacific, 2020-2030

10.7.4. Human Factors Engineering and Usability Testing Services Market in Rest of the World, 2020-2030

11. CASE STUDY: IMPACT OF COVID-19 PANDEMIC ON HUMAN FACTORS ENGINEERING AND USABILITY TESTING SERVICES MARKET
11.1. Chapter Overview
11.2. Impact of the COVID-19 Pandemic on the Approval of Medical Devices
11.2.1 The US Scenario
11.2.2. The European Scenario
11.3. Impact of COVID-19 Outbreak of Human Factors Engineering and Usability Testing Process
11.4. Impact of Future Market Opportunity for Human Factors Engineering and Usability Testing Market
11.5. Recuperative Strategies for CMO Business
11.5.1. Strategies for Implementation in the Short / Mid Term
11.5.2. Strategies for Implementation in the Long Term

12. SWOT ANALYSIS
12.1. Chapter Overview
12.2. Strengths
12.3. Weaknesses
12.4. Opportunities
12.5. Threats
12.6. Concluding Remarks

13. CONCLUSION
13.1. Chapter Overview
13.2. Key Takeaways

14 EXECUTIVE INSIGHTS
14.1. Chapter Overview
14.2. DCA Design International
14.2.1. Company Snapshot
14.2.2. Interview Transcript: Daniel Jenkins, Head of Research (Human Factors and Interaction)
14.3. THAY Medical
14.3.1. Company Snapshot
14.3.2. Interview Transcript: Greg Thay, Managing Director (THAY Medical)

15. APPENDIX 1: TABULATED DATA

16. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
[email protected]