HUMAN FACTORS & USABILITY RESEARCH
We integrate human factors throughout, creating safer, more effective devices that users love.
By embedding human factors considerations at every phase, we help clients create devices that prioritize user safety, optimize effectiveness, and maximize user satisfaction.
Our comprehensive suite of human factors services includes:
Preliminary analyses and risk assessments
User research and contextual inquiries
Formative usability evaluations and design optimization
Comprehensive human factors validation testing
Regulatory support and submission preparation
Through this holistic approach, we ensure that the user remains central throughout the development lifecycle, ultimately leading to medical devices that are safe, intuitive, and truly enhance patient outcomes.
Leveraging our international presence and cutting-edge facilities enhances our ability to deliver effective solutions globally. Partner with us to leverage the power of human factors in your medical device development journey.
HUMAN FACTORS & USABILITY RESEARCH
We integrate human factors throughout, creating safer, more effective devices that users love.
By embedding human factors considerations at every phase, we help clients create devices that prioritize user safety, optimize effectiveness, and maximize user satisfaction.
Our comprehensive suite of human factors services includes:
Preliminary analyses and risk assessments
User research and contextual inquiries
Formative usability evaluations and design optimization
Comprehensive human factors validation testing
Regulatory support and submission preparation
Through this holistic approach, we ensure that the user remains central throughout the development lifecycle, ultimately leading to medical devices that are safe, intuitive, and truly enhance patient outcomes.
Leveraging our international presence and cutting-edge facilities enhances our ability to deliver effective solutions globally. Partner with us to leverage the power of human factors in your medical device development journey.
HUMAN FACTORS & USABILITY RESEARCH
We integrate human factors throughout, creating safer, more effective devices that users love.
By embedding human factors considerations at every phase, we help clients create devices that prioritize user safety, optimize effectiveness, and maximize user satisfaction.
Our comprehensive suite of human factors services includes:
Preliminary analyses and risk assessments
User research and contextual inquiries
Formative usability evaluations and design optimization
Comprehensive human factors validation testing
Regulatory support and submission preparation
Through this holistic approach, we ensure that the user remains central throughout the development lifecycle, ultimately leading to medical devices that are safe, intuitive, and truly enhance patient outcomes.
Leveraging our international presence and cutting-edge facilities enhances our ability to deliver effective solutions globally. Partner with us to leverage the power of human factors in your medical device development journey.
Purpose-Built Research Facilities
Conduct your human factors studies in our state-of-the-art simulated use environments designed specifically for medical device evaluations.
Realistic clinical and home-use simulated environments
Comprehensive recording and observation capabilities
Full study management services from recruitment to reporting
IRB/Ethics submission handling and regulatory compliance
Expert staff to ensure smooth execution of your studies
Purpose-Built Research Facilities
Conduct your human factors studies in our state-of-the-art simulated use environments designed specifically for medical device evaluations.
Realistic clinical and home-use simulated environments
Comprehensive recording and observation capabilities
Full study management services from recruitment to reporting
IRB/Ethics submission handling and regulatory compliance
Expert staff to ensure smooth execution of your studies
Purpose-Built Research Facilities
Conduct your human factors studies in our state-of-the-art simulated use environments designed specifically for medical device evaluations.
Realistic clinical and home-use simulated environments
Comprehensive recording and observation capabilities
Full study management services from recruitment to reporting
IRB/Ethics submission handling and regulatory compliance
Expert staff to ensure smooth execution of your studies
Market Insights
Our skilled and creative team delivers market and user insights to ensure products meet genuine needs, appeal to users, and function effectively in real-world settings.
Our comprehensive suite of Market Insights services can provide you with:
Deep insights using qualitative and quantitative methods
Knowledge on user needs and perceptions, market opportunities, and competitive insights
Refined strategies through workshops, focus groups, and online tools
User-centric product design and optimization recommendations
Early user insights for efficient development
With stunning viewing facilities and in-house recruitment, our research covers international markets and languages. Partner with us to leverage the power of market insights in your medical device development journey.
Early-Stage Exploratory Research
Gain a deep and rich understanding of real-world experiences, perspectives, pain-points, and needs across various stakeholders including individuals with conditions, caregivers, and healthcare providers. Our immersive approach also utilizes qualitative and quantitative methods.
Utilize ethnography, exploratory interviews, online communities, and focus groups to provide context, meaning, and actionable insights
Translate insights into strategic recommendations to develop offerings that authentically meet real needs
Market Insights
Understand the MedTech market landscape and competitive environment while learning about how these are perceived by key stakeholders through comprehensive research.
Identify user experiences and unmet needs concerning competitor devices and market opportunities
Uncover the purchase processes and drivers for your product or service
Uncover market opportunities, price points, preferences, and perceptions
Marketing Communications
Ensure your marketing materials resonate with your target audience, driving engagement and actionable responses.
Utilize workshops, focus groups, and online tools to refine strategies and drive desired outcomes
Employ a tailored approach to develop marketing materials from scratch or pre-existing ideas
Product Feedback and UX
Obtain user-friendly, appealing, and safe insights to ensure your products are designed with user needs and preferences in mind regardless of it being in the early stages or nearing completion.
Gather insights to ensure products are designed with the user’s needs in mind
Facilitate integration of user insights to shape efficient and user-centric designs
Market Insights
Our skilled and creative team delivers market and user insights to ensure products meet genuine needs, appeal to users, and function effectively in real-world settings.
Our comprehensive suite of Market Insights services can provide you with:
Deep insights using qualitative and quantitative methods
Knowledge on user needs and perceptions, market opportunities, and competitive insights
Refined strategies through workshops, focus groups, and online tools
User-centric product design and optimization recommendations
Early user insights for efficient development
With stunning viewing facilities and in-house recruitment, our research covers international markets and languages. Partner with us to leverage the power of market insights in your medical device development journey.
Early-Stage Exploratory Research
Gain a deep and rich understanding of real-world experiences, perspectives, pain-points, and needs across various stakeholders including individuals with conditions, caregivers, and healthcare providers. Our immersive approach also utilizes qualitative and quantitative methods.
Utilize ethnography, exploratory interviews, online communities, and focus groups to provide context, meaning, and actionable insights
Translate insights into strategic recommendations to develop offerings that authentically meet real needs
Market Insights
Understand the MedTech market landscape and competitive environment while learning about how these are perceived by key stakeholders through comprehensive research.
Identify user experiences and unmet needs concerning competitor devices and market opportunities
Uncover the purchase processes and drivers for your product or service
Uncover market opportunities, price points, preferences, and perceptions
Marketing Communications
Ensure your marketing materials resonate with your target audience, driving engagement and actionable responses.
Utilize workshops, focus groups, and online tools to refine strategies and drive desired outcomes
Employ a tailored approach to develop marketing materials from scratch or pre-existing ideas
Product Feedback and UX
Obtain user-friendly, appealing, and safe insights to ensure your products are designed with user needs and preferences in mind regardless of it being in the early stages or nearing completion.
Gather insights to ensure products are designed with the user’s needs in mind
Facilitate integration of user insights to shape efficient and user-centric designs
Market Insights
Our skilled and creative team delivers market and user insights to ensure products meet genuine needs, appeal to users, and function effectively in real-world settings.
Our comprehensive suite of Market Insights services can provide you with:
Deep insights using qualitative and quantitative methods
Knowledge on user needs and perceptions, market opportunities, and competitive insights
Refined strategies through workshops, focus groups, and online tools
User-centric product design and optimization recommendations
Early user insights for efficient development
With stunning viewing facilities and in-house recruitment, our research covers international markets and languages. Partner with us to leverage the power of market insights in your medical device development journey.
Early-Stage Exploratory Research
Gain a deep and rich understanding of real-world experiences, perspectives, pain-points, and needs across various stakeholders including individuals with conditions, caregivers, and healthcare providers. Our immersive approach also utilizes qualitative and quantitative methods.
Utilize ethnography, exploratory interviews, online communities, and focus groups to provide context, meaning, and actionable insights
Translate insights into strategic recommendations to develop offerings that authentically meet real needs
Market Insights
Understand the MedTech market landscape and competitive environment while learning about how these are perceived by key stakeholders through comprehensive research.
Identify user experiences and unmet needs concerning competitor devices and market opportunities
Uncover the purchase processes and drivers for your product or service
Uncover market opportunities, price points, preferences, and perceptions
Marketing Communications
Ensure your marketing materials resonate with your target audience, driving engagement and actionable responses.
Utilize workshops, focus groups, and online tools to refine strategies and drive desired outcomes
Employ a tailored approach to develop marketing materials from scratch or pre-existing ideas
Product Feedback and UX
Obtain user-friendly, appealing, and safe insights to ensure your products are designed with user needs and preferences in mind regardless of it being in the early stages or nearing completion.
Gather insights to ensure products are designed with the user’s needs in mind
Facilitate integration of user insights to shape efficient and user-centric designs
Evidence Based Testing
From expert human factors review of early prototypes to end-to-end formative testing in preparation for your validation study, we help you optimize your medical product design through the usability engineering process.
Formative Usability Study Preparation, Coordination and Execution & Reporting
Participant Recruitment for Usability Studies (Lay Users & Healthcare Professionals)
Design Improvements or Expert Review of Medical Product User Interfaces
Cognitive Walk Throughs
Surveys
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
HF Validation
The Human Factors Validation process evaluates medical device usability to ensure safety, effectiveness, and ease of use for intended users in their environment. The focus includes:
Identifying usability issues early in development
Optimizing design for enhanced user experience
Reducing use errors and associated risks
Gathering user feedback to inform design decisions
Ensuring compliance with usability regulations
By addressing usability early, this process optimizes your device design, enhancing user experience and regulatory compliance.
Contact us to leverage our HF Validation expertise for your medical device's success.
Design Validation
The Human Factors Engineers at ClariMed bring a unique perspective to Design Validation, focusing on user needs, usability, and real-world performance. The offerings encompass a full range of Design Validation services, including:
User needs validation
Design performance evaluation
Functionality testing
Human Factors/Usability validation studies
Continually assessing and improving a medical device’s design, we help maintain alignment with user expectations and intended use.
This is not a one-time process. Device design changes, whether due to post-market surveillance data, customer feedback, complaints, corrective or preventive actions (CAPAs), risk management updates, or any other factors. Therefore, the validation processes must be revisited and updated accordingly. This commitment to continuous improvement ensures that devices remain safe, effective, and aligned with user needs throughout their lifecycle.
Contact us to discover how our Design Validation expertise can benefit your medical device.
Market Claims
Substantiate your product marketing messages with scientific evidence and build credibility with customers and healthcare professionals.
Support marketing messages with rigorous scientific evidence
Differentiate your products from competitors
Reduce the risk of legal challenges or regulatory enforcement actions
Demonstrate a commitment to transparency and responsible marketing practices
Contact us to discover how our Market Claims expertise can benefit your medical device.
Low-risk Clinical/HF Studies
Gather real-world evidence of device safety, effectiveness, and usability in a clinical setting to support regulatory submissions and inform device design improvements.
Identify potential use-related risks and unintended consequences in a clinical setting
Support regulatory submissions and market approval for low-risk devices
Inform device design improvements and user training programs
Build confidence in device performance and user acceptance prior to full-scale clinical trials
Contact us to discover how our expertise can benefit your medical device.
Evidence Based Testing
From expert human factors review of early prototypes to end-to-end formative testing in preparation for your validation study, we help you optimize your medical product design through the usability engineering process.
Formative Usability Study Preparation, Coordination and Execution & Reporting
Participant Recruitment for Usability Studies (Lay Users & Healthcare Professionals)
Design Improvements or Expert Review of Medical Product User Interfaces
Cognitive Walk Throughs
Surveys
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
HF Validation
The Human Factors Validation process evaluates medical device usability to ensure safety, effectiveness, and ease of use for intended users in their environment. The focus includes:
Identifying usability issues early in development
Optimizing design for enhanced user experience
Reducing use errors and associated risks
Gathering user feedback to inform design decisions
Ensuring compliance with usability regulations
By addressing usability early, this process optimizes your device design, enhancing user experience and regulatory compliance.
Contact us to leverage our HF Validation expertise for your medical device's success.
Design Validation
The Human Factors Engineers at ClariMed bring a unique perspective to Design Validation, focusing on user needs, usability, and real-world performance. The offerings encompass a full range of Design Validation services, including:
User needs validation
Design performance evaluation
Functionality testing
Human Factors/Usability validation studies
Continually assessing and improving a medical device’s design, we help maintain alignment with user expectations and intended use.
This is not a one-time process. Device design changes, whether due to post-market surveillance data, customer feedback, complaints, corrective or preventive actions (CAPAs), risk management updates, or any other factors. Therefore, the validation processes must be revisited and updated accordingly. This commitment to continuous improvement ensures that devices remain safe, effective, and aligned with user needs throughout their lifecycle.
Contact us to discover how our Design Validation expertise can benefit your medical device.
Market Claims
Substantiate your product marketing messages with scientific evidence and build credibility with customers and healthcare professionals.
Support marketing messages with rigorous scientific evidence
Differentiate your products from competitors
Reduce the risk of legal challenges or regulatory enforcement actions
Demonstrate a commitment to transparency and responsible marketing practices
Contact us to discover how our Market Claims expertise can benefit your medical device.
Low-risk Clinical/HF Studies
Gather real-world evidence of device safety, effectiveness, and usability in a clinical setting to support regulatory submissions and inform device design improvements.
Identify potential use-related risks and unintended consequences in a clinical setting
Support regulatory submissions and market approval for low-risk devices
Inform device design improvements and user training programs
Build confidence in device performance and user acceptance prior to full-scale clinical trials
Contact us to discover how our expertise can benefit your medical device.
Evidence Based Testing
From expert human factors review of early prototypes to end-to-end formative testing in preparation for your validation study, we help you optimize your medical product design through the usability engineering process.
Formative Usability Study Preparation, Coordination and Execution & Reporting
Participant Recruitment for Usability Studies (Lay Users & Healthcare Professionals)
Design Improvements or Expert Review of Medical Product User Interfaces
Cognitive Walk Throughs
Surveys
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
HF Validation
The Human Factors Validation process evaluates medical device usability to ensure safety, effectiveness, and ease of use for intended users in their environment. The focus includes:
Identifying usability issues early in development
Optimizing design for enhanced user experience
Reducing use errors and associated risks
Gathering user feedback to inform design decisions
Ensuring compliance with usability regulations
By addressing usability early, this process optimizes your device design, enhancing user experience and regulatory compliance.
Contact us to leverage our HF Validation expertise for your medical device's success.
Design Validation
The Human Factors Engineers at ClariMed bring a unique perspective to Design Validation, focusing on user needs, usability, and real-world performance. The offerings encompass a full range of Design Validation services, including:
User needs validation
Design performance evaluation
Functionality testing
Human Factors/Usability validation studies
Continually assessing and improving a medical device’s design, we help maintain alignment with user expectations and intended use.
This is not a one-time process. Device design changes, whether due to post-market surveillance data, customer feedback, complaints, corrective or preventive actions (CAPAs), risk management updates, or any other factors. Therefore, the validation processes must be revisited and updated accordingly. This commitment to continuous improvement ensures that devices remain safe, effective, and aligned with user needs throughout their lifecycle.
Contact us to discover how our Design Validation expertise can benefit your medical device.
Market Claims
Substantiate your product marketing messages with scientific evidence and build credibility with customers and healthcare professionals.
Support marketing messages with rigorous scientific evidence
Differentiate your products from competitors
Reduce the risk of legal challenges or regulatory enforcement actions
Demonstrate a commitment to transparency and responsible marketing practices
Contact us to discover how our Market Claims expertise can benefit your medical device.
Low-risk Clinical/HF Studies
Gather real-world evidence of device safety, effectiveness, and usability in a clinical setting to support regulatory submissions and inform device design improvements.
Identify potential use-related risks and unintended consequences in a clinical setting
Support regulatory submissions and market approval for low-risk devices
Inform device design improvements and user training programs
Build confidence in device performance and user acceptance prior to full-scale clinical trials
Contact us to discover how our expertise can benefit your medical device.
Study Operations
With our expert study operations team, we efficiently manage all aspects of human factors and clinical studies.
Our comprehensive study operations services streamline the complex processes involved in conducting clinical studies and user research. From IRB management to participant recruitment, facility coordination, and procurement, we ensure that your studies are executed seamlessly and in compliance with regulations.
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
IRB Conduct
Navigate the Institutional Review Board (IRB) submission and approval process with our expert guidance and support.
Prepare and submit IRB applications and supporting documents
Communicate effectively with IRB staff and committee members
Address IRB questions and concerns promptly
Obtain and maintain IRB approval throughout the study
Recruitment
Identify, screen and enroll the right participants for your clinical studies and user research.
Develop targeted recruitment strategies and materials
Identify potential recruitment channels and partners
Screen potential participants for eligibility
Obtain informed consent from participants
Manage participant scheduling and communication
Facilities
Conduct your studies in appropriate and compliant settings with our facility management services.
Identify and select appropriate facilities for your studies
Ensure that facilities meet regulatory and protocol requirements
Manage facility scheduling and logistics
Coordinate with facility staff and stakeholders
Procurement
Access the necessary materials, equipment and services for your studies with our procurement expertise.
Identify and select qualified vendors and suppliers
Negotiate contracts and pricing to ensure cost-effectiveness
Manage vendor and supplier relationships
Ensure timely delivery of materials, equipment, and services
Study Operations
With our expert study operations team, we efficiently manage all aspects of human factors and clinical studies.
Our comprehensive study operations services streamline the complex processes involved in conducting clinical studies and user research. From IRB management to participant recruitment, facility coordination, and procurement, we ensure that your studies are executed seamlessly and in compliance with regulations.
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
IRB Conduct
Navigate the Institutional Review Board (IRB) submission and approval process with our expert guidance and support.
Prepare and submit IRB applications and supporting documents
Communicate effectively with IRB staff and committee members
Address IRB questions and concerns promptly
Obtain and maintain IRB approval throughout the study
Recruitment
Identify, screen and enroll the right participants for your clinical studies and user research.
Develop targeted recruitment strategies and materials
Identify potential recruitment channels and partners
Screen potential participants for eligibility
Obtain informed consent from participants
Manage participant scheduling and communication
Facilities
Conduct your studies in appropriate and compliant settings with our facility management services.
Identify and select appropriate facilities for your studies
Ensure that facilities meet regulatory and protocol requirements
Manage facility scheduling and logistics
Coordinate with facility staff and stakeholders
Procurement
Access the necessary materials, equipment and services for your studies with our procurement expertise.
Identify and select qualified vendors and suppliers
Negotiate contracts and pricing to ensure cost-effectiveness
Manage vendor and supplier relationships
Ensure timely delivery of materials, equipment, and services
Study Operations
With our expert study operations team, we efficiently manage all aspects of human factors and clinical studies.
Our comprehensive study operations services streamline the complex processes involved in conducting clinical studies and user research. From IRB management to participant recruitment, facility coordination, and procurement, we ensure that your studies are executed seamlessly and in compliance with regulations.
With a global network of usability experts and state-of-the-art facilities, ClariMed offers unmatched expertise in optimizing your medical product designs. Partner with us to leverage the power of human factors in your medical device development journey.
IRB Conduct
Navigate the Institutional Review Board (IRB) submission and approval process with our expert guidance and support.
Prepare and submit IRB applications and supporting documents
Communicate effectively with IRB staff and committee members
Address IRB questions and concerns promptly
Obtain and maintain IRB approval throughout the study
Recruitment
Identify, screen and enroll the right participants for your clinical studies and user research.
Develop targeted recruitment strategies and materials
Identify potential recruitment channels and partners
Screen potential participants for eligibility
Obtain informed consent from participants
Manage participant scheduling and communication
Facilities
Conduct your studies in appropriate and compliant settings with our facility management services.
Identify and select appropriate facilities for your studies
Ensure that facilities meet regulatory and protocol requirements
Manage facility scheduling and logistics
Coordinate with facility staff and stakeholders
Procurement
Access the necessary materials, equipment and services for your studies with our procurement expertise.
Identify and select qualified vendors and suppliers
Negotiate contracts and pricing to ensure cost-effectiveness
Manage vendor and supplier relationships
Ensure timely delivery of materials, equipment, and services
User Needs
Methodically evaluate user requirements, preferences, and challenges to ensure device design aligns with user expectations.
Identify user requirements and preferences through surveys, focus groups, and interviews
Inform device design decisions with user-centric insights
Ensure alignment between device design and user needs
Create user needs specifications and design recommendations
User Needs
Methodically evaluate user requirements, preferences, and challenges to ensure device design aligns with user expectations.
Identify user requirements and preferences through surveys, focus groups, and interviews
Inform device design decisions with user-centric insights
Ensure alignment between device design and user needs
Create user needs specifications and design recommendations
User Needs
Methodically evaluate user requirements, preferences, and challenges to ensure device design aligns with user expectations.
Identify user requirements and preferences through surveys, focus groups, and interviews
Inform device design decisions with user-centric insights
Ensure alignment between device design and user needs
Create user needs specifications and design recommendations
Contextual Inquiry
Understand real-world device use and identify areas for improvement through observational research.
Gain insights into how devices are used in real-world scenarios through field observations and user interviews
Identify usability issues and areas for improvement
Inform device design and user training with contextual insights
Develop contextual inquiry reports with user insights and design recommendations
Contextual Inquiry
Understand real-world device use and identify areas for improvement through observational research.
Gain insights into how devices are used in real-world scenarios through field observations and user interviews
Identify usability issues and areas for improvement
Inform device design and user training with contextual insights
Develop contextual inquiry reports with user insights and design recommendations
Contextual Inquiry
Understand real-world device use and identify areas for improvement through observational research.
Gain insights into how devices are used in real-world scenarios through field observations and user interviews
Identify usability issues and areas for improvement
Inform device design and user training with contextual insights
Develop contextual inquiry reports with user insights and design recommendations
Ethnographic
Gain a holistic understanding of the user experience and inform user-centered design through immersive research.
Understand user needs, beliefs, and practices in their cultural and social context
Identify cultural and social factors influencing device use
Inform user-centered design and product strategy with ethnographic insights
Develop ethnographic research reports with user insights and design recommendations
Ethnographic
Gain a holistic understanding of the user experience and inform user-centered design through immersive research.
Understand user needs, beliefs, and practices in their cultural and social context
Identify cultural and social factors influencing device use
Inform user-centered design and product strategy with ethnographic insights
Develop ethnographic research reports with user insights and design recommendations
Ethnographic
Gain a holistic understanding of the user experience and inform user-centered design through immersive research.
Understand user needs, beliefs, and practices in their cultural and social context
Identify cultural and social factors influencing device use
Inform user-centered design and product strategy with ethnographic insights
Develop ethnographic research reports with user insights and design recommendations
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
Let's work together!
Contact us to discuss how we can advance your medical device development efforts together.
