Top Companies Offering Usability Engineering for Medical Devices

Published: September 2024


In order to enhance device safety and efficacy, and enhance the user experience, the medical device developers have started relying on the human factors and usability engineering service providers from early stages of device development.We analyzed over 210 companies offering usability engineering for medical devices. In this article, discover 5 top companies and their capabilities in this industry.


Over the years, adverse events related to the use of medical devices have been on the rise. This has raised concerns amongst the healthcare professionals regarding the errors arising from the use of medical devices (either for treatment or diagnostic purposes), which can potentially cause patient harm. These errors often stem from inadequate device design, especially when complicated user interfaces are involved. In addition, any technological advancements in medical devices can pose a challenge for end users, if proper training is not provided to them. The devices have to be designed in a way that these are user-friendly and have less likelihood of any user error. Moreover, as patient care continues to shift from hospitals to home or community settings, less experienced users (such as patients and caregivers) must be capable of safely operating these complex medical devices. In order to ensure the safety of medical devices, various advanced methods and technologies are being developed within the MedTech industry. One prominent example of such a process is the introduction of human factors and usability engineering during the designing and development of medical devices. 

In the evolving landscape of MedTech industry, device developers have begun to understand the importance of human factors and usability engineering for designing and development of medical devices (including autoinjectors, combination products, surgical robots and drug delivery devices). To facilitate this integration, developers often rely on specialized service providers working in this domain for integration of any step of the process. Typically, medical device developers seek these services early in the product development lifecycle (often before the design phase) in order to ensure a user-centered design approach and compliance with regulatory guidelines. It is worth mentioning that outsourcing business operations to third-party companies provides valuable opportunities for developers to obtain unbiased feedback / opinions and enables timely improvements in both device design and user interface

Roots Analysis has conducted an exhaustive study on Human Factors and Usability Engineering Services Market featuring the current market landscape and future opportunity for the companies offering human factors and usability engineering for medical devices, over a span of 11 years.

Table of Contents

Below, we have listed (in alphabetical order), the top 5 companies offering usability engineering for medical devices. 

  1. Aptar Digital Health
  2. BAYOOMED
  3. Bold Insight
  4. ClariMed
  5. Greenlight Guru

Top Companies Offering Usability Engineering for Medical Devices

Interested in exploring all 210+ companies offering usability engineering for medical devices and their recent initiatives?

Discover Below the Details on 5 Top Companies Offering Usability Engineering for Medical Devices

Let us deep dive to understand the activity of the 5 top companies offering human factors and usability engineering for medical devices (shortlisted on the basis of company size (mid-sized companies having 51-500 employees), offer and year of establishment (post-2012) and offer services for training in this domain) in the human factors and usability engineering services market. It is essential to note that the selection of top players can differ substantially according to the defined criteria.

Through Recent Acquisition of Healint, Aptar Digital Health is Focused on Enhancing its Offerings for Digital Health Deployment

1. Aptar Digital Health

Aptar Digital Health (a division of Aptar Pharma) specializes in design and manufacturing of a diverse range of products, including active material science solutions, dispensing products and drug delivery devices. Through the recent acquisitions of Gateway Analytical, Nanopharm and Voluntis, Aptar Digital Health claims to offer a comprehensive suite of digital health solutions focused on enhancing the user’s experience with the integration of robust technology platforms. Additionally, the company utilizes various technologies, such as connected hardware, mobile and web technology in their digital medical devices in order to create customizable, agile designs for various therapeutic areas.

Aptar Digital Health: Company Details

Key Parameters Description
Company Logo Aptar Digital Health Top Companies Offering Usability Engineering for Medical Devices
Year of Establisment   2021
Number of Employees  51-200
Headquarter Aptar Digital Health, Headquarter

Aptar Digital Health: Service Portfolio

Parameters Details
Type of Service Offered
  • Concept Phase: User Research, Use Error Risk
    Analysis and Management
  • Development and Designing: Task Analysis,
    Prototype Development and Designing, Interface
    Development and Designing
  • Verification and Validation: Usability Inspection,
    Formative Studies, Summative Studies
  • Documentation / File Compilation
  • Packaging and Labeling
  • Post Market Surveillance
  • Regulatory Guidance
  • Training
  • Other Services: Benchmarking Analysis
  • Software Engineering: Yes
Type of Medical Device Tested 
  • Diagnostic Devices
  • Digital Health Solutions 
  • Drug Delivery Devices
  • Software as Medical Devices
  • Surgical Devices
  • Therapeutic Devices


Recent Initiatives by Aptar Digital Health in MedTech Domain: In June 2024, the company announced the collaboration with SHL Medical, in order to integrate its Software as Medical Devices (SaMD) platform with the latter company’s connected device technologies to provide comprehensive solutions to its patients on injectable therapies to optimize the patient’s experience with self-injectable therapies.

Further details on recent initiatives taken by Aptar Digital Health as well as other companies offering usability engineering for medical devices have been provided in detail in the report.

With More Than 800 Customers, BAYOOMED claims to have Extensive Portfolio of Services for Medical and Pharmaceutical Companies

2. BAYOOMED 

Bayoomed, a part of the BAYOONET, is currently engaged in the development of advanced medical devices, primarily focused on digital health applications, digital therapeutics (DTx) and medical device software. The company leverages its extensive expertise in software development for medical and pharmaceutical products to guide clients on selecting the most suitable technology for their product needs.

BAYOOMED: Company Details

Key Parameters Description
Company Logo Bayoomed Top Companies Offering Usability Engineering for Medical Devices
Year of Establisment   2021
Number of Employees  51-200
Headquarter Bayoomed, Headquarter

BAYOOMED: Service Portfolio

Parameters Details
Type of Service Offered
  • Concept Phase: User Research, Use Error Risk Analysis
    and Management
  • Development and Designing: Task Analysis, Prototype
    Development and Designing, Interface Development
    and Designing
  • Verification and Validation: Usability Inspection,
    Formative Studies, Summative Studies
  • Documentation / File Compilation
  • Post Market Surveillance
  • Regulatory Guidance
  • Training
  • Software Engineering: Yes
Type of Medical Device Tested 
  • Dental Equipment
  • Diagnostic Devices


Recent Initiatives by BAYOOMED in MedTech Domain: In June 2024, the company participated in several conferences to gain reputation in the domain, these include HLTH Europe 2024, Medtech Day 2024, health.tech, and
PDA – Parenteral Drug Association – Medical Devices and Connected Health Conference 2024.

Further details on recent initiatives taken by BAYOOMED as well as other companies offering usability engineering for medical devices have been provided in detail in the report.
 


Bold Insight Actively Supports its Clients in UX Research Across Complete Product Development Cycle

3. Bold Insight    

Bold Insight (a part of ReSight Global) is a research-oriented company that offers UX and human factors research services to its customers for the development of effective medical devices. Furthermore, the company operates through three research laboratories located in the US (2) and the UK (1) to support the development of various types of medical devices used at various locations (including home, hospitals and clinics). It is worth noting that the firm’s research laboratories are equipped with real-time video and audio streaming capabilities, which enables the researchers to capture and analyze data, remotely.

Bold Insight: Company Details

Key Parameters Description
Company Logo Bold Insight Top Companies Offering Usability Engineering for Medical Devices
Year of Establisment   2018
Number of Employees  51-200
Headquarter Bold Insight, Headquarter

Bold Insight: Service Portfolio

Parameters Details
Type of Service Offered
  • Concept Phase: User Research, Use Error Risk Analysis
    and Management
  • Development and Designing: Task Analysis, Prototype
    Development and Designing, Interface Development
    and Designing
  • Verification and Validation: Usability Inspection,
    Formative Studies, Summative Studies, Remote Usability Studies
  • Documentation / File Compilation
  • Packaging and Labeling
  • Regulatory Guidance
  • Training
  • Other Services: Competitive Analysis
  • Software Engineering: Yes
Type of Medical Device Tested 
  • Connected Health Devices
  • Dental Devices
  • Diagnostic Devices
  • Digital Health
  • Drug Delivery Devices
  • Software as Medical Devices
  • Surgical Devices
  • Therapeutic Devices
  • Wearables


Recent Initiatives by Bold Insight in MedTech Domain: In April 2024, the company, in collaboration with Eli Lilly and Company, co-published an article “Improving medical device usability by reducing complexity using a novel predictive models-based user interface assessment tool” in “Human Factors in Healthcare” journal dedicated to the development of a tool that aims to improve usability of medical device

Further details on recent initiatives taken by Bold Insight as well as other companies offering usability engineering for medical devices have been provided in detail in the report.

Through Acquisitions of User-Wise and Harvey Medical, ClariMed Aims to Set a Global Footprint to Support the Multinational Clients in Conducting Human Factors Studies

4. ClariMed

ClariMed is a US-based company that offers a comprehensive range of human factors and usability engineering services in order to support biotechnology, MedTech and pharmaceutical companies to deliver life-changing medical solutions. Notably, the company supports its clients to meet the United States Food and Drug Administration (USFDA) regulatory requirements for medical devices and ensures compliance with the evolving safety and regulatory standards. It is worth noting that the company offers eLearning modules and seminars to assist their clients with a deeper knowledge of human factors and usability engineering, as well as to foster a shared understanding of best practices in medical device development.

ClariMed: Company Overview

Key Parameters Description
Company Logo ClariMed Top Companies Offering Usability Engineering for Medical Devices
Year of Establisment   2022
Number of Employees  51-200
Headquarter ClariMed, Headquarter

ClariMed: Service Portfolio

Parameters Details
Type of Service Offered
  • Concept Phase: User Research, Use Error Risk
    Analysis and Management
  • Development and Designing: Prototype
    Development and Designing, Interface Development
    and Designing
  • Verification and Validation: Usability Inspection,
    Formative Studies, Summative Studies
  • Documentation / File Compilation
  • Post Market Surveillance
  • Regulatory Guidance
  • Training
Type of Medical Device Tested 
  • Diagnostic Devices
  • Drug Delivery Devices
  • Laboratory Equipment
  • Surgical Devices
  • Robotics


Recent Initiatives by ClariMed in MedTech Domain: In January 2024, the company expanded their quality assurance services, which includes audits, complaint management, design control, document control, QMS maintenance, production control, risk management services in their portfolio in order to meet stringent quality standards and enhance medical device development.

Further details on recent initiatives taken by ClariMed as well as other companies offering usability engineering for medical devices have been provided in detail in the report.

Greenlight Guru Is Actively Engaged in Organizing Educational Webinars Focused on the Development Process of Medical Devices 

5. Greenlight Guru

Greenlight Guru is an Indianapolis-based company engaged in providing electronic data capture (EDC) software and cloud-based solutions to the MedTech industry. The company offers a comprehensive suite of solutions / services for product development, clinical data management, quality management and training of medical devices. As per the company’s website, the company has served more than 1,100 companies around the world for the development of their medical devices.

Greenlight Guru: Company Overview
 

Key Parameters Description
Company Logo Greenlight Guru Top Companies Offering Usability Engineering for Medical Devices
Year of Establisment   2013
Number of Employees  201-500
Headquarter Greenlight Guru, Headquarter

Greenlight Guru: Company Overview

Parameters Details
Type of Service Offered
  • Concept Phase: Use Error Risk
  • Analysis and Management
  • Development and Designing: Prototype
  • Development and Designing
  • Documentation / File Compilation
  • Post Market Surveillance
  • Regulatory Guidance
  • Training
Type of Medical Device Tested   Software as Medical Devices


Recent Initiatives by Greenlight Guru in MedTech Domain: In July 2023, the company entered into a collaboration with AIShield, in order to enhance artificial intelligence (AI) security and risk management for AI-enabled medical devices

Further details on recent initiatives taken by Greenlight Guru as well as other companies offering usability engineering for medical devices have been provided in detail in the report.

What About the Other Companies Offering Usability Engineering for Medical Devices Around the World?

The above presentation features five top companies selected from a pool of over 210 players that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

Sources

  1. https://aptardigitalhealth.com/news/aptar-digital-health-announces-acquisition-of-healint/
  2. https://aptardigitalhealth.com/wp-content/uploads/2024/05/PR-May-29-2024-Aptar-Digital-Health-IonaMind.pdf
  3. https://boldinsight.com/news/bold-insight-and-eli-lilly-and-company-co-publish-journal-article-on-novel-assessment-tool-to-enhance-medical-device-usability
  4. https://www.clarimed.com/press-head-of-quality-and-qa-services