Professional Usability Testing
UX Optimization Research


What We Do

Our mission is to help you make complex technology simple and simple technology empowering.


How We Work

Usability Testing

We employ science-based research methodologies. This ensures that our research findings are focused on delivering actionable and reliable insights with the proper concern for statistical power and reliability. We offer a wide range of research options focused on delivering the proper balance between data reliability and cost.

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Our methods and professional project management experience covers all major development models include sprint testing for AGILE. We are well known for the testing and optimization of complex products and systems. By complex, we mean any product or system which is business-critical and requires rapid response user testing and optimization. All usability testing research programs are managed by a certified human factors engineering professional (BCPE).

Users We Test

Usability TestingIn our 40+ years of experience conducting professional usability testing programs, we have developed extensive experience with many critical user populations ranging from COPPA age children to individuals of advanced age with severe medical conditions.

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We routinely conduct studies involving complex user populations ranging from business executives, millennials, teens, military and DOD staff, Wall Street traders, physicians, healthcare providers, families, and many other populations. Our participants are all recruited by independent agencies based on criteria developed by our firm. We are deeply experienced with formal protocol development, IRB submissions, and related coordination. In testing involving FDA related matters, we offer industry-leading access to testing populations with a wide range of medical conditions.

What We Test

Our methods and expertise cover a wide range of product and system categories. At the highest conceptual level we specialize in four forms of human-technology testing and UX optimization.
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Screen-Based Products

  • Web Site Interfaces
  • Mobile Interfaces
  • Mobile Apps
  • Consumer Software
  • Commercial Software
  • Data Visualization

MAURO UsabilityHuman-Computer Interaction (HCI) testing: We have deep professional expertise in testing screen-based human-computer interaction systems ranging from consumer e-com website interfaces to highly complex commercial software systems. Our expertise in this area includes extensive experience with mobile applications and related interfaces.
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Physical Products

  • Hand-held Devices
  • Consumer Products
  • Commercial Products
  • Industrial Products
  • Transportation

Physical Products TestingPhysical products testing: we have deep testing experience with physical products ranging from simple hand-held devices to large industrial machinery. It is important to note that many of our projects cover products with complex HCI interfaces. In these projects, we routinely test and optimize both aspects of such products.
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Medical Products

  • Drug Delivery Devices
  • Patient Monitoring
  • Complex Imaging
  • Software FDA apps
  • Surgical devices
  • Complex FDA Processes

Medical Products TestingMedical products and systems testing: our third area of specialization is medical devices, instructions for use and training systems for consumer and professional HCP applications. This expertise ranges from consumer-facing drug delivery devices to highly complex surgical technology.(Contact) (RFQ)

UX Optimization

  • Consumer cross-platform
  • Commercial systems
  • Medical systems
  • Transportation systems
  • Process control systems
  • Data Security

User ExperienceUser Experience (UX) Optimization: our fourth area of specialization is whole system user experience optimization. These projects involve investigation of a user’s entire engagement with a given product or service. These projects routinely focus on investigation and identification of overall user experience performance and areas of meaningful optimization. We do not fill conference room with sticky notes but alternatively employ rigorous anthropological research methods combined with business process modeling.
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Standard Methods Employed to Optimize Your Solutions

Over 30 years conducting usability analysis: We are fluent in all critical usability research methods and pioneered the use of several of these methods in the U.S. in the early 1970s. In all projects, we employ the appropriate methods required to answer your complex business questions.

Lab-Based Usability Testing

Lab-based usability testing

Starting in 1976, we were the first U.S. consulting firm to create a testing lab and conduct research using this methodology. This method is effective in exploring high-level usability of products and services.
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It provides visualization of user interactions based on a limited number of tasks. Your development team can view the entire process from behind a one-way mirror, providing compelling evidence of usability issues. Lab-based testing works well for identifying interactions that are having a universally negative impact on the user experience.

Large Sample Online Testing

Large-sample on-line usability testing

Online large sample user testing lets your users access an interactive survey and complete tasks on your interface at their own home or place of business, 24/7.
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The statistical reliability of the large sample size helps you confidently make major decisions related to the creation or redesign of business-critical applications and websites. This method is exceptionally powerful when combined with a lab-based / eye-tracking study.

Formative User Testing

Formative user testing

We have executed complex formative studies across a wide range of medical devices covering hardware, software, drug delivery, surgical and imaging modalities.
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We have worked with large internal client teams as a highly experienced HFE subject matter and usability testing resource. We have created complex SOWs, protocol, and pursued related IRB approves, and are highly effective with complex, iterative, large sample formative studies based on AGILE development methods.

Summative Testing

Summative user testing for FDA approval

We specialize in the design, approval management, execution and delivery of large sample rapid-response summative usability testing studies.
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MUS routinely delivers robust studies with 500-1000 respondents in compressed time frames. We are well known for the quality of our research methods and compliance-related performance for demanding clients facing complex FDA approvals. MUS is an approved and preferred vendor for leading biotech, pharmaceutical, and medical device manufacturers. We are fully versed in CFR 21 Part 11 compliance requirements and maintain research methods within compliance.

Environmental User Testing

Environmental usability testing

It is well understood that complex product usability is a combination of users’ interactions with the product or system and the environment in which such interactions take place.
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MUS has extensive experience in the design and execution of complex usability and user engagement research related to complex medical and industrial environments. We employ well understood and industry proven research methods to identify and resolve usability issues that flow from a given operational environment where many factors are commonly at play. We have extensive experience with both cognitive and ergonomic environment audits and have executed such research for many leading corporations and government agencies.


Heuristics/best practices reviews

Our reviews are undertaken by certified human factors engineering professionals and provide you with immediate feedback on critical usability and user experience issues present in your product or system.
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This methodology is a powerful method for structuring the thinking of the development team in terms of the dimensions that impact user performance and satisfaction. This methodology works well for providing professional usability feedback during rapid AGILE-style development programs.


COPPA-age user testing

With the formal approval of the COPPA by U.S. Congress, the requirements related to the design of websites for children under the age of 12 took a dramatic turn.
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If you are developing web-based services of any type and your user base is known to include COPPA-age users, you must adhere to a more rigorous set of standards when designing your site and testing the site with COPPA-age users. MUS has extensive experience with special requirements related to testing a wide range of products and websites for this specific user profile. We are well versed in the special issues surrounding safety, confidentiality, and compensation related to COPPA testing. We are also experienced with the design and conducting of group focus sessions and related parental participation for this age group. Our specialized experience includes a focus on information access UI design and parental controls related to COPPA-age users.

User Guide Testing

User guide testing

We have extensive experience in the design and testing of IFU (instructions for use) and user guide systems.
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We work with clients to ensure that FDA guidance and mandated human factors engineering performance criteria are met for IFU and RG (reference guide) components of medical and drug delivery devices. We are especially adept at consumer-facing IFU design, testing and/or optimization. MUS provides subject matter expertise, HFE audits, content analysis, information design, IFU design, visual design analysis, cognitive task analysis and formal usability testing during development to confirm HFE performance is verified and documented.

Reference Guide

Reference guide testing

As medical devices become more complex and the general user population becomes more diverse, there is a demand for the design and testing of compressed IFU content in the form of Reference Guides (RG).
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We have specialized research methods and document protocols for the design, testing, and validation of RG materials. MUS provides subject matter experts, HFE audits, content analysis, information design, visual design analysis, cognitive task analysis and formal usability testing during development to confirm HFE performance is verified and documented.

Behavioral Data Mining

Behavioral data-mining

This method is highly effective when used with business-critical applications related to the creation or redesign of large or complex websites, web applications, and preparation for selection of new CMS systems.
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This methodology examines data files covering structured and unstructured responses of your customers or users. This process can also profile the relative effectiveness of your various document types and interfaces by determining how well-written and well-formatted your existing content is, based on the needs and expectations of your primary user profiles. This methodology provides deep insight into unstructured and structured user-generated content, such as message boards, blogs, forums and fixed document types. This methodology creates detailed behavior profiles and knowledge maps of an entire system’s content structure.


Ethnographic and field research

We employ ethnographic and field research as targeted studies involving a smaller number of users to develop a comprehensive understanding of how customers engage with technology and systems on a daily or even weekly basis.
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This methodology follows users during their entire daily life, recording observations for the specific purpose of identifying unmet needs and areas of innovation that can only be discovered by a detailed recording of user behavior in their natural living and working environments.


Media and cross-platform testing

A primary business problem all large media companies face today is how to successfully migrate their traditional media properties to the interconnected and increasingly transparent delivery platforms of TV, web, mobile, and virtual.
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We have worked with the world’s most successful media companies to design and execute complex, cross-platform usability and user experience studies that address this difficult customer engagement problem. Our research methods have proven effective in helping major media companies understand and optimize their migration to successful new media business models.

Cognitive Modeling

Cognitive Modeling of Complex UI Usability and Design

In complex products and systems, there is often a mismatch between user expectations and usability performance.
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These issues are often revealed during the execution of formal usability testing. However, the actual root cause of such misalignment is not usually revealed at the level of specificity required to rapidly make changes to the UI design that result in dramatic improvements in user acceptance and overall usability. Therefore, MUS offers clients a specialized service linked to usability testing that provides your development team with a reliable cognitive model of the interface as tested in conjunction with a detailed description of the relationships between UI design and the users’ higher-level cognitive processes. This expertise allows for the identification and resolution of problems in the UI design that map objectively to how users think about, learn and interact with your product or service. Cognitive modeling is a well understood formal methodology employed by MUS in a wide range of projects.

Persona Development

Persona Development

Understanding your critical user profiles (personas) is critical to understanding how to create and support a successful product or service.
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For more than 25 years, we have created complex user profiles for a wide range of products and services, ranging from personas for cancer patients to brokers executing trades on the floor of the New York Stock Exchange. In all of these projects, we employ a combination of professional user testing, observational research, and interview methodologies to develop interactive persona solutions that combine the latest data with the most appropriate and reliable research methods.

Mauro Usability Science Neuroscience-Based Human Factors Testing and UX Optimization Expertise Profile

Mauro Usability Science: Validated Testing Methodologies Applied To Complex Product Usability and UX Optimization Problems

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  • Neuroscience-based Metaverse and VR/AR User Engagement and Usability Testing: MUS has a long history of conducting complex user engagement research in virtual worlds, including screen-based and headset-based VR and AR metaverse applications. We conducted the largest virtual world longitudinal study in history focusing on the discovery and definition of complex behavioral factors and business variables extending over a one-year period. In this regard, we specifically conducted a detailed analysis of in-world device and object manipulation and primary and secondary purchase decision-making related to virtual products, avatar design, modification and manipulation, social group formation, displacement, and group problem-solving. Our research provided clients with ground-breaking insights on the relationship between virtual world brand engagement and engagement with branded products and services in the real world.

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  • Neuroscience-based Metaverse and VR/AR User Engagement and Usability Testing: MUS has a long history of conducting complex user engagement research in virtual worlds, including screen-based and headset-based VR and AR metaverse applications. We conducted the largest virtual world longitudinal study in history focusing on the discovery and definition of complex behavioral factors and business variables extending over a one-year period. In this regard, we specifically conducted a detailed analysis of in-world device and object manipulation and primary and secondary purchase decision-making related to virtual products, avatar design, modification and manipulation, social group formation, displacement, and group problem-solving. Our research provided clients with ground-breaking insights on the relationship between virtual world brand engagement and engagement with branded products and services in the real world.

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  • Neuroscience-based Product Feature Set Definition & Use Case Validation Methodology: MUS offers clients a validated neuroscience-based data capture system that is designed to provide robust and reliable data focused on identification and delivery of a validated core set of products use-cases and detailed feature sets. The structured testing methodology is designed to provide product development management and design teams with validated MVP use case structures and feature sets focused on the delivery of the most salient features that are likely to drive adoption and long-term product utilization. Utilizing a combination of product feature simulations and structured data capture, the methodology specifically identifies core feature sets that will have the highest emotional salience, desirability, value, and emotional resonance for the projected user groups.

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  • UX Research-Driven MVP Development: The business objective for this methodology is the structured identification of the minimum viable product (MVP) based on the most salient feature sets likely to positively impact acquisition and longer-term utilization. The MUS methodology is applicable for consumer product testing, medical device testing, and more complex system testing across different technologies and industries. MUS’ approach can be combined with targeted sampling to provide insights into the behaviors of users dependent on specific user profiles. The methodology utilizes proprietary data capture methods including but not limited to GSR, EMG, MFEA, High-performance Eye-tracking combined with robust peer-reviewed and validated ratings and scaling systems.

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  • Applied Cognitive Task Analysis (ACTA) Research: Many complex design programs today proceed without a robust and validated understanding of user needs. This leads directly to the design and production of features and entire feature sets in software and hardware products that do not meet the needs and expectations of critical users or purchasers of such systems. To directly address this complex problem, MUS has developed and validated a methodology based on ACTA that focuses on capturing robust data from potential users of a new system or users of a current system undergoing enhancement. The MUS methodology captures data from a targeted range of users utilizing a highly scripted and structured interview sequence comprised of three segments: 1) Task Diagram Interview 2) Knowledge Audit and 3) Simulation Interview. This specific MUS methodology is especially useful in capturing complex procedural data from highly skilled experts including surgeons, trading specialists, and other highly focused experts. The MUS methodology is focused on the alignment of the potential users’ mental model with new features and functions of the product under development. The ACTA methodology can capture highly reliable and insightful data through the application of high-density use case video simulations and other development stimuli.

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  • Specialized Wearable Comfort and Fit Acceptability Studies: The measurement and optimization of user comfort and device stability when interacting with all manner of wearable devices including wrist/arm and head-mounted products is a complex and challenging human factors research problem. Our research team has a deep understanding of the formal research literature and validation methodologies related to acute and chronic pain measurement and comfort optimization. We have developed and validated methodologies for measuring comfort and pain in a wide range of wearable applications including smartwatches, AR glasses, VR headsets, and, other complex combinations of all three platforms, We offer clients a range of testing modalities including short team comfort assessment and extending to longitudinal wear pattern and comfort analysis. We have undertaken major studies for leading wearable device development teams on a global basis. Our experience also extends to complex studies involving device fit and sizing for consumer populations.

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  • Development of Technology Based on Subjective Well-Being (SWB) Research: There is a great deal of formal discourse today related to the negative impact that new technologies have on those who consume and utilize such systems. It is a fact that business performance has been the driving force behind some of our most aggressive and successful technology-based products and social media systems. This singular focus has led to the development of product development methodologies that do not consider in any meaningful manner the SWB of those who utilize these products and services. Having seen this effect firsthand, MUS has developed and validated a specific product development methodology that structurally integrates leading SWB research into early product development. This methodology specifically focuses on the development and refinement of features and feature sets for hardware and software products that map to peer-reviewed research on SWB. In this critical regard, SWB drives product development through the use of feature set simulations and focused user testing to validate both the overall approach and detailed UX optimization.

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  • Data-Driven Persona / User Profile Development Based on Voice of Consumer (VOC) Research Data: Persona development has been a component of UX research for over a decade, yet much of this form of user profile development lacks both technical rigor and underlying supporting research. MUS has developed and validated a robust persona development methodology based on VOC research conducted with respect to a specific product category or application area. The MUS persona development methodology is based on a combination of actual consumer research conducted specifically for such development, or data captured during other forms of product development research. Persona profiles developed by MUS can be linked to a wide range of complex marketing data including validated TAM and other relevant opportunity dimensions. MUS persona methodology is based on data validated using consumer online surveys and or lab-based testing. The MUS methodology produces highly reliable persona data for use in subjective and objective testing of product concepts based on a data-driven methodology. The MUS persona profiles are supported by video use-case simulations and critical live interview data integrated with valid market research generated either by MUS or purchased from leading data vendors that partner with MUS.

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  • 3D Spatial Tracking for Large Product Configurations: MUS has been a leading provider of sub-millimeter 3D spatial tracking human factors research for handheld and other small products and devices. Based on requests from clients, we have now added the ability to create fully articulated virtual 3D models of larger products and devices and link virtual products to their actual real-world products in real-time. MUS now has the capability to directly track such products through multiple channels, each channel with 6 degrees of freedom, while being utilized by users in simulated or actual use-case research. Our virtual tracking systems capture live 3D tracking data that is integrated in real-time with up to 24 other data channels covering visual, physiological, and subjective performance datasets. This methodology allows our team to create custom API interfaces with a range of data analysis and data integration platforms. The MUS system allows for on-the-fly data aggregation of device and product movement based on a variety of parameters.

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  • Video Game Software Engagement Optimization and Usability Validation: Video gaming is a massive and rapidly expanding area of technological development that in terms of market exceeds all other forms of entertainment combined. The cost of developing an engaging and successful game is now exceedingly high and the risks of failure increase with every iteration of a gaming franchise. MUS offers video game development teams a series of science-based user testing systems that can be applied at any stage of game development. Our methodologies utilize the latest science-based testing covering physiological, biomechanical, and neuroscience testing methods combined with subjective gameplay ratings. Our combined data stream analysis provides game development teams with robust feedback on all critical aspects of game development including game engagement, persistence, subjective quality, and longitudinal engagement. Our human factors testing system can be utilized to test game concepts, modifications to existing game franchises, entirely new gaming concepts, and to validate learning and skill acquisition performance leading to dramatic improvements in gaming adoption. This MUS methodology also captures data that drives product innovation related to gaming product hardware including seating, display design, input devices, lighting, workstation design, headset, and VR/AR interface hardware.

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  • Large-Scale Office Ergonomic Analysis and Planning Methodology: For over 30 years, MUS has been a leading provider of office ergonomic analysis and large-scale office planning research. We have provided extensive ergonomic analysis and supporting functions for major corporate office design programs and new facility construction. Our specialized methodologies have been applied in the analysis and design of large-scale office planning projects of more than a million square feet for leading corporate clients. This specific methodology covers workplace analysis related to team collaboration, meeting spaces, individual offices, and related supporting infrastructure analysis. Included in this specific methodology is the design and optimization of individual workstations to meet the latest ergonomic and human factors performance requirements focused on improving employee performance and on-site job satisfaction. Our methodologies specifically include detailed ergonomic analysis and ratings of current office furniture products based on the application of our advanced ergonomic performance design criteria. The MUS methodology specifically provides detailed furniture purchase recommendations based on validated ergonomic performance. This same methodology has also been applied to many complex industrial manufacturing facilities ranging from the production of fine jewelry to nuclear power generation control rooms. Our expertise in this area is widely recognized and sought after by leading architecture and internal space planning development teams.

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  • Medical Device and Combination Product FDA Human Factors Validation Testing: MUS has a long and industry-validated history conducting complex medical design human factors analysis as required for FDA approval of medical devices, complex combination products, and software. We have deep experience testing such systems with complex patient and HCP populations with a wide range of medical conditions and co-morbidities. Our work in this research area is based on the application of advanced neuroscience-based testing methods combined with rigorous observational testing methods validated in hundreds of medical device human factors testing programs. MUS’s experience in this area of research includes extensive experience with a wide range of drug delivery devices including PFS, auto-injectors, and complex on-body drug delivery devices. The MUS methodology is based on the latest research in IFU content/format analysis and optimization. MUS is the only human factors research firm invited to speak at the FDA on advanced human factors testing methodologies in the design and validation of medical devices. In addition to our expertise in this area, MUS has also written about industry-wide problems with user profile development and patient recruiting.

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  • Personal At-Home Workstation Ergonomic Analysis and Optimization: The pandemic has driven millions of hardworking and talented employees to work from home. It is a fact that, in most cases, employee home working conditions were never optimized for ergonomics or productive long-term working configurations. Without basic considerations for ergonomic performance, at-home workstations can have a long-term negative impact on employee health, emotional well-being, and productivity. At the request of major clients, MUS has developed an at-home ergonomic workstation assessment and optimization checklist that can be specifically tailored to the needs of employees working from home, whose primary interface with the company and colleagues is through screen-based workstation configurations. The assessment and ergonomic workstation set up optimization system provides detailed prescriptive and procedural recommendations for each employee based on basic ergonomic principles including workstation configuration, seating adjustment, display placement, reflective and visual fatigue reduction, acoustic and sound management, task and general lighting, and temperature and equipment safety planning. The ergonomic assessment also includes recommendations on work pacing, rest spacing, virtual meetings, and scheduling considerations. The ergonomic assessment and recommendations are based in part on employee response to an online audit survey covering their current workstation and at-home set up. The MUS recommendation system can be customized based on individual corporate objectives, privacy requirements and related employee policy issues.

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  • Intellectual Property (IP) Litigation Supporting Research Methodologies: Intellectual property litigation is rapidly becoming a critical aspect of complex product development programs. Today, design teams involved in the development of business-critical products are focusing extensive resources on the protection of their most valuable IP assets through aggressive IP litigation. In this context, MUS has supported the world’s leading corporations as IP experts both at trial and as litigation consultants. We have participated in over 75 major IP cases. In most complex IP litigation, opposing parties execute consumer research to explore and validate IP infringement. Much of this form of research does not strictly meet the formal tests put forth by the legal governing bodies proffering research study design requirements to be utilized in formal legal proceedings. Many studies today are found invalid by the court due to this expanding problem. Having observed this problem, MUS has committed significant funding to the development and validation of litigation research methodologies that directly deal with the problem of study design that does not meet formal legal constructs. In this regard, MUS has developed, validated, and utilized in actual litigation a formal methodology known as the Empirical Ordinary Observer Test (EOOT), which has been accepted by the court and has withstood three aggressive Daubert challenges. For more information on this methodology, please select this link to view our litigation support services.

Neuroscience-Based Design Research

We have an international reputation for creating and formalizing advanced testing methodologies that offer insights and actionable recommendations that go well beyond what is normally provided by standard user testing programs provided by others. The following is a brief description of methods we combine to produce robust research into the user engagement and usability of your product or service. The following advanced testing methods were developed by MAURO UX LABS.

EEG Utilization In Assessing Cognitive Impact of Design Variables

Over the past decade, electroencephalography (EEG) technology has undergone a massive reduction in terms of cost and setup complexity. This has led to the introduction of a wide range of lower-powered EEG systems that offer data on cognitive processes with varying levels of reliability. The use of EEG in design research has been limited and, when executed, of often questionable quality. Recording the electrical activity of the brain at the surface of the scalp using EEG is an advanced user testing methodology that requires high levels of formal understanding, reliable hardware, and robust software for analysis and visualizations.
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Prior to introducing EEG methods into our suite of design research tools, MUS executed an extensive and detailed analysis of EEG hardware platforms and software data analysis systems to determine if such systems offer the proper balance of cost, signal reliability, data aggregation and statistical analysis. With this data, we have structured our EEG research methodology to address design research questions that focus on cognitive workload, valance (approach/avoidance) and engagement. We have conducted proprietary analysis using EEG systems and available research literature to determine objectively where EEG methods provide unique insights above what we can gain from our other neuroscience-based methods. A benefit of EEG is that it can measure cognitive and affective responses in the absence of a behavioral report or even subjective awareness. A critical fact to keep in mind is that an EEG testing system is only an effective research tool if the system is configured, maintained and calibrated by trained and experienced research professionals. All MUS research staff that design studies, set up systems, calibrate and run EEG studies have advanced degrees in fields such as psychology and neuroscience with extensive professional experience and academic training in a wide range of EEG modalities and data acquisition platforms. We know from experience that EEG methods can add a robust view into individuals’ high-level cognitive functions as they interact with and respond to technology-based products and systems of many different configurations. However, EEG is a testing modality that currently demands the expertise of trained neuroscience professionals who understand objectively when and how EEG data is beneficial. MUS has this capability.

FDA Optimized Usability Testing System

Pharmaceutical companies can now have their new drugs rejected by the FDA based on how usable and understandable the delivery device and labeling is for the intended patient population. This new factor has for the first time placed professional usability testing and human factors engineering at the core of successful drug development and market acceptance. MAURO Usability Science (founded 1975) has completed a four-year development effort focused on providing leading drug device development groups with a robust new suite of highly focused and powerful new testing methods designed to meet FDA human factors guidance. These new techniques provide multi-dimensional and scientifically valid data on patient interactions with the entire drug delivery patient experience. Select MORE below for a detailed review of benefits and functions.
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New Data Capture Methods Provide Robust Insights

  • 3D spatial tracking
  • Newtonian force measurement
  • High Definition Electromyography
  • High-resolution eye tracking
  • Micro-facial expression analysis
  • Automated task analysis and data capture
  • Cognitive workload analysis
  • Information foraging theory

New Data Capture Methods Demand Advanced Data Analysis

These new methods produce vast amounts of new data that would be useless without advanced data aggregation and data analysis methods. To ensure the highest level of FDA compliance, MUS has developed proprietary and certified hardware/software systems that combine these new advanced testing methods into a unified data collection steam that provides unprecedented hard data on the human factors engineering performance of drug delivery devices, instructions for use, package design and dosing information.

Addressing The FDA Guidance on Bio-Similar HFE Performance

The new MUS methods are effective in resolving the complex problem facing companies planning to release bio-similar drugs that are required to meet the new FDA Threshold Guidance. Within the field of professional human factors engineering science, this new FDA Guidance is well understood to be a potentially serious and costly factor in securing FDA approval.

New System Utilized On All Device and Labeling Types

Over 40 studies involving a wide range of FDA-driven device HFE performance enhancements utilized the MUS data capture and aggregation system.

Types of Device Tested Using New MUS System

  • Single action auto-injectors
  • Complex action auto-injectors
  • Advanced fully electronic auto-injectors
  • On-body injectors involving complex data presentation
  • Multiple entirely new drug delivery configurations and methods
  • PFS devices for common and high viscosity drug delivery
  • Multi-use vials and related injection devices
  • Drug delivery monitoring Apps/software
  • Drug dosing (complex and simple)
  • Instructions for use (simple and highly complex data)
  • Reference Guides
  • Drug-device and drug package design
  • Pharmacist device interaction analysis
  • Threshold and learning transfer analysis

Who Is MAURO Usability Science?

Founded in 1975 MUS is a leading provider of professional usability testing and human factors engineering expertise. We have executed over 4,000 major HFE research projects. The recipient of prominent awards for usability research MUS is known for the development of advanced science-based usability testing methodologies. MUS has been a primary provider of professional usability testing and human factors engineering expertise to leading pharmaceutical and medical device manufactures for more than 40 years. This extensive history provides a clear view of just how vital the new human factors engineering FDA guidance is for companies seeking FDA approval. For more information contact Charles L. Mauro CHFP or read on for additional system capabilities and benefits.

How The MUS System Reduces The Risk of FDA Rejection

The new data capture methodologies combine into a unified data stream that produces for the first time a highly refined view into the actual human factors engineering performance of drug delivery devices and related labeling to be utilized by a wide range of patient populations. The combined data reduces the risk of FDA rejection by providing development teams and the FDA with scientifically valid human factors engineering performance data that verifies overall system HFE performance.

Understanding The Total Patient Experience Saves Costs

The new MUS system can provide multi-dimensional and scientifically valid data on patient interactions with the entire drug delivery experience. This new capability allows development teams to resolve use errors by properly allocating enhancements between hardware design, labeling and HCP moderated training. Optimizing the entire patient experience is the cost-effective approach to gaining FDA approval. This approach allows development executives to allocate HFE improvements to that portion of the total user experience that has the most significant impact on reducing risk and reducing development costs. The MUS system is used to determine the usability of the following key components of the total patient experience.

Patient Experience Data Capture and Optimization

  • Drug-device manipulation (cross all use-cases)
  • Instructions for use human factors analysis
  • Drug Device labeling human factors analysis
  • Drug dosing information sheets human factors analysis
  • Drug-device and drug package design human factors analysis
  • HCP training system design human factors analysis
  • Pharmacy interactions and drug-device acquisition

Objectively Understanding Patient Limitations

While FDA HFE guidance is an essential and critically important component for producing correctly human factored drug delivery mechanisms FDA guidance does not provide detailed human factors engineering specifications for most target patient populations that suffer from well understood physical and cognitive limitations when compared to healthy individuals.

Filling In Where FDA Guidance Leaves Off

We know from over 40 years conducting professional usability testing and human factors research that detailed human factors specification for patient populations that have unique limitations is not available in the existing research data. Missing research data makes drug delivery device usability testing more complicated due to a lack of capabilities for target patient populations. This lack of objective data on patient limitations does not reduce a corporation’s duty to create a usable product under FDA guidance. Such missing data includes but is not limited to the following key variables.

Missing patient physiological and biotechnical factors

  • BMI index and sub-cutaneous fat levels
  • Body, arm, hand and finger size ranges
  • Finger, hand and arm strength profiles
  • Dexterity profiles

Missing patient cognitive factors

  • Vision profiles
  • Reading comprehension levels
  • Color blindness profiles
  • Hearing and hearing loss profiles
  • General attitude toward self-injection and drug delivery devices

Automatic Collection of Missing Patient Data

Missing patient performance data has a significant impact on whether or not patients will interact with a drug delivery device and labeling system in a manner that meets FDA guidance. The MUS data capture system provides development teams with robust data on the capabilities of their specific patient populations. The MUS system automatically includes data on patient baseline capabilities that reduce the risk of an FDA rejection based on a failure to design for the intended patient population.

For More Information

Contact Email Charles L. Mauro CHFP For more information on our FDA Guidance usability testing and human factors engineering system.

Environmental Navigation Eye Tracking

Environmental Navigation Eye-Tracking & Workload Analysis

One of the most complex usability and UX optimization research problems is developing robust insights into how customers or users navigate and make decisions in large 3D spaces like pedestrian way-finding in cityscapes, museums, retail stores, and a wide range of other environments. As a means of specifically addressing this problem, we have developed a specialized methodology known as Environmental Navigation Eye-Tracking or ENET. The system is designed to produce robust insights into how visitors to large environmental spaces interact with, navigate and make decisions as they move about freely. The ENET methodology employs state-of-the-art eye-tracking technology/glasses interfaced with a data collection device the size of a typical smartphone. The system offers unencumbered navigation of large 3D spaces and the tracking of a wide range of visual information seeking behaviors.
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What makes our ENET system different: Head-mounted eye tracking has been utilized in a number of settings by agencies that tend to have minimal understanding of the underlying technology and cognitive processes. This lack of understanding routinely leads to studies which are underpowered and that report incorrect data. We were the first usability research firm in the US to employ eye-tracking systems on a routine basis (1976). We have a deep understanding of how to design studies that produce reliable results based on extensive understanding of the strengths and limitations of head-mounted eye tracking technology. Our statistical analyses and data analysis processes have been designed to produce the most reliable data possible from these new testing methodologies. The ENET methodology has been utilized in studies requiring high levels of research rigor including work executed for leading pharmaceutical companies related to FDA device submissions. Other applications include pedestrian way-finding and traffic warning systems, driver cognitive workload, museum navigation studies and others.
How the methodology works: Participants in our ENIT studies are fitted with specialized glasses that can be fully corrected for vision requirements so that there is no loss of viewing acuity. The data capture glasses are utilized in conjunction with a study design created by our professional staff which involves respondents undertaking various tasks just as they would when navigating a large-scale 3D environment for the first time or during a repeat visit. Respondents are entirely free to navigate without interruption or hindrance from the data gathering technology.

advertising and brand research

Advanced Content Development, Advertising and Promotional Testing Programs

It can be difficult to understand how consumers may respond to specific content, branding, advertisements and other forms of promotional material. By utilizing advanced methodologies including eye-tracking, micro-facial expression analysis, galvanic skin response (GSR), and subjective response surveys we can gain powerful insight into both the psychological and physiological response that consumers have to these types of materials. These data streams can be collected across various types of media including static advertisements, dynamic advertisements, branding variations, or any other screen-based material to test respondent reactions. Data can be compared across variations of a single stimuli (i.e. color, size, duration of presentation, etc.) to determine which version generates the greatest positive feedback and vice versa. In combination, these methodologies have the ability to identify key impact factors that cannot otherwise be captured.
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How the methodology works: Participants undergo structured presentation of isolated branding-related content or larger branded webpage concepts. Eye-tracking will be used to examine relative salience of and engagement with such content. Micro-facial expression analysis will be used to capture the expressed emotional responses of users viewing or interacting with the content. GSR will be utilized to measure the intensity of emotional responses to such content. EEG may be employed to inform higher-level cognitive processes required when using the website or application, such as cognitive workload. Subjective response will be employed to verify insights gathered from the above-mentioned data streams, as well as assess communication of intended branding attributes and messaging.

Emotional Tracking

Advanced Emotional Response User Testing

Many business-critical development programs today can benefit from advanced emotional user response testing. We offer best in class emotional testing methodologies that can provide deep insights into your users or viewers emotional response to a wide range of design-based stimuli. Our emotional response testing methods rely on scientifically valid psychophysical measurement systems designed to produce highly actionable insights on how your users are responding to a wide range of products, printed materials, advertising content and software-based interaction frameworks.
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We own, maintain and continually upgrade all critical emotional testing systems including micro-facial expression analysis, EEG, EMG and GSR modalities. These systems can be combined to produce key insights into cognitive workload and related impact on user emotional response to all manner of programmed stimuli. Our emotional state tracking systems are integrated into a common data stream with advanced eye-tracking data capture technology and can be integrated into other data streams to provide a robust parallel view of user response to your creative content before, during and after implementation. We work directly with leading hardware and software vendors to develop specialized data capture systems for critical industry verticals including medical products, entertainment, advertising, package design, information content optimization and new product development for both hardware and software applications.

Advanced Consumer Preference Testing

Advanced Consumer Preference Testing

For clients who require robust consumer preference testing, we offer specialized testing options including paired, replicated and repetitive case testing, conjoint and multinomial / multi-selection testing. Our research team is highly experienced with Panel / longitudinal testing, data analysis, including fixed and random effects modeling over time focused on learning decay, growth and sustained performance. Our research team is also experienced with partial-factorial and full-factorial research designs (for saturation / large multivariate choice testing.
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Our expertise also includes sample size determinations such as stratification, clustering, and other methods to obtain maximum value from small (or expensive) sampling frames. The MUS director of advanced consumer testing has authored major texts on advanced study design and teaches at Columbia Business School.

3D Spatial Tracking UX Optimization

3D Spatial Tracking UX Optimization

For usability and UX optimization studies that require a detailed understanding of how a given design or series of designs are manipulated in the 3D space, we employ proprietary and industry-leading 3D spatial tracking methodologies. When combined with EMG-based research, these methods provide you with unprecedented insights into user engagement with hand-held and hand-manipulated devices across a wide range of product categories.


Electromyography / Physiological Effort Testing

For projects which require an understanding of the physiological effort required in the successful manipulation of a product or device, we offer a robust and industry proven testing methodology utilizing electromyography combined with physical force measurement. This specialized testing method utilizes the electromyographic potential of major muscle groups involved in manipulation of products ranging from auto-injector drug delivery devices to large-scale industrial equipment. Our EMG methodology is often combined with 3D spatial tracking and Newtonian force measurement systems.
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We have utilized EMG-based methods for more than 40 years and have a strong theoretical and technical understanding of when to apply this powerful methodology to help you optimize the UX performance of a product or system.

Specialized Eye-Tracking for UX Optimization

Specialized Eye-Tracking for UX Optimization

The overwhelming number of eye-tracking studies executed in usability testing sessions today are executed improperly and often report findings that are incorrect. We were the first UX research consulting firm to utilize formal eye-tracking methodology in 1975. We own, maintain, and manage our own eye-tracking systems and work with leading academic and research professionals to conduct robust, properly powered studies that help clients define complex problems related to visual scanning and cognitive processing of visual information.
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We have a strong theoretical and practical understanding of eye-tracking and related applications including modeling of complex cognitive workload factors. Our methods are especially attuned to the evaluation of the appearance of products, package design, complex instructions and the design of screen-based interfaces.

Newtonian Force Measurement

Newtonian Force Measurement

The forces that your users exert in the operation of your product are a critical aspect of how they rate the overall UX design. Forces are well known to impact judgments of overall interface quality, skill acquisition, and peer recommendations. We have executed studies ranging from the forces required to open a package of drug delivery devices to button forces on touch screens for smartphones. Our methodology utilizes a robust and industry proven force measurement systems that are entirely portable and wireless.
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This allows for the instrumentation of almost any aspect of the consumer’s interaction with a product or system. Our systems are designed and maintained to the highest levels of calibration and data production performance. Force measurement is often combined with EMG-based data gathering to produce robust UX data picture of your customer’s interaction with your product.

Multi-Factorial Visual Design Testing and Optimization

Multi-Factorial Visual Design Testing and Optimization

The physical appearance design of your product, website or UX service offering has become one of your essential intellectual property and brand-building assets. Yet appearance design and visual style are far more complex to measure and optimize that most realize. For projects where you are basing major investments on the appearance design of a business critical product or service, we offer a robust visual design testing methodology, which combines psychometric scaling systems, combined with eye-tracking and physiological/neurological sensing modalities.
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This combination of methods provides you with not only reliable and appropriately powered data but complex factor analysis covering salient visual design attributes critical in optimizing the visual and aesthetic design of your essential product or service.

Ergonomic Optimization Tool Set

Ergonomic Optimization Tool Set

Government research indicates that approximately 80% of all workplace injuries, which result in job loss and sick leave, are associated directly with ergonomically related defects in the workplace or workplace tools and workstations. To mitigate such problems we offer a robust and industry-proven workplace ergonomic optimization toolkit and associated ergonomic optimization research methodology. We have conducted formal workplace audits in a wide range of corporate settings ranging from executive office suites to high-capacity production line workstations.
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We have received major awards for ergonomic optimization methodology development and workplace optimization. These same ergonomic optimization methods are frequently employed in the design, testing and updating of stand-alone products across many industry sectors.

Cognitive Learning Decay Modeling

Cognitive Learning Decay Modeling

The single most important UX design objective for any product or service is to make certain that the solution is to learn not necessarily easy to use. To a great extent, the ability of your user to rapidly acquire the necessary skills, rules, and knowledge required for them to be quickly productive is at the heart of true UX optimization. Thus testing and optimizing skill acquisition and understanding learning decay (how fast they forget how to use key features) is well understood to drive early acceptance, feature utilization and peer-recommendation.
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We offer you a highly structured and statistically robust methodology based on the latest thinking in mental model development. The testing methodology has been utilized by leading international pharmaceutical companies and leading high technology entities in the creation of systems which are easy to learn and minimize learning decay.

Mobile Device Utilization and Cognitive Asset Allocation

Mobile Device Utilization and Cognitive Asset Allocation

As data-intensive and complex mobile devices enter our utilization patterns certain ways in which we deal with the external world become attenuated. A central question in this transition is the extent to which our inwardly directed attention (interacting with a mobile device) impacts our situational awareness. This is a non-trivial question as we have seen traffic deaths associated with texting expand dramatically. This problem is sufficiently complex and so important that it requires a formal methodology for assessing the redistribution of cognitive assets between portable hand-held or wearable devices and the environment in which we navigate, make decisions, take risks and interact socially.
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To address such research questions we offer you a structured methodology for investigating the impact that your technology may or may not have on the situation awareness of those who use your technology. This methodology which combines various testing methodologies including eye-tracking, cognitive modeling, ethnographic observational research and psychometric testing provides you with deep insight into how cognitive resources are being allocated by your users in the real world as they interact with your latest technology. Our testing system has been utilized on projects ranging from assessing pedestrian behavior when using mobile devices to the layout and optimization of robotic assembly tasks within a traditional assembly line.

Wearable Eye-Tracking for UX Optimization

Wearable Eye-Tracking for UX Optimization

In addition to specialized eye-tracking discussed above, we routinely deliver studies to leading clients utilizing a fully portable eye-tracking methodology. In these studies, we employ industry-proven eye-tracking glasses which allow the research participant to navigate any environment from retail stores to traffic cross-walks without interference or restrictions. This methodology allows for the real-time documentation of your customer’s visual scanning behavior as they undertake scripted tasks, navigate complex environments, drive or otherwise interact with vehicles or machinery, make complex retail purchases or interact with portable devices and apps in real time.
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Our specialized eye-tracking glasses can be fitted with custom corrective lenses so that individuals are free to participate in our studies without concern for their own corrective glasses.

Ethnographic TUXO Optimization Data Gathering

Ethnographic TUXO Optimization Data Gathering

UX optimization on a broader scale is about understanding the core needs, limitations and expectations of users as they interact with your service or product across its entire life-cycle. It is well understood that gathering such data, analyzing that data and providing actionable insights is a complex and time-consuming process which must be governed by science, not design methods. We do not fill conference rooms with sticky notes but alternatively apply robust methods from the human factors engineering and anthropological sciences to help you understand the total user experience optimization (TUXO) of your customers.
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We offer you a highly structured, data-driven research methodology that is customized for each TUXO project. Our methodology has been utilized to investigate and optimize entire systems and communities ranging from the world’s largest international refugee NGO to the military recruit intake system for the Department of Defense. Other projects have focused on consumer products and medical service delivery as essential industry sectors where such methods are known to be essential.

Virtual World Avatar Behavior Tracking and UX Optimization

Virtual World Avatar Behavior Tracking and UX Optimization

With the advent of low-cost VR technology and more advanced VR software, the world is about to experience a restart of the VR user experiences. For clients attempting to navigate this complex and for the most part amazing new dimension of UX design, we offer user testing and UX optimization methods which offer deep insights into the psychological and physiological underpinnings of VR user experiences. Our methods have been utilized to conduct the largest in-world avatar behavior tracking and socialization study ever conducted.
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We have applied our methodology to help clients understand the psychological engagement individuals have been their real-world being and their synthetic avatar personalities. We have conducted the largest study ever fielded investigating the impact of VR experiences on brand engagement and purchase intent with real-world products. Our methodology has been utilized on a wide range of demographic profiles ranging from COPPA age children, teens, adults and military personnel.


The following project thumbnails cover high-profile and other relevant program experience.

Screen-Based Products

Physical Products

Medical Products

UX Optimization

Special Expertise

The following are a series of special UX Optimization and Usability Testing application areas where we have developed deep experience. These are just a few of the many industry sectors where we have produced outstanding results for leading clients and startups.

Complex MedicalComplex medical device HFE and user testing

We have been deeply involved in complex medical device human factors engineering research, design, and testing for more than 35 years. Our experience includes design and execution of formative and summative usability testing programs for complex medical devices and software as defined under FDA guidelines. We are well versed in all related formal testing protocols as required by various regulatory agencies. Our research experience includes complex recruiting and testing programs for large sample medical device testing.

Based on our extensive experience in user interface design for both software and hardware applications, we are uniquely qualified to solve complex human factors engineering problems early in formative development. This experience saves you the expense of complex and costly redesign later in the development cycle.

At MUS we employ AGILE and robust user interface simulations to model and test medical device design solutions during formative development phases. We are also experienced in the design and testing of all related procedures and instructional materials for complex medical device management and user training. We have extensive experience with many clinical modalities and patient/caregiver/HCP profiles.

Senior partners of the firm also have extensive experience as expert witnesses in complex litigation related to utility and design patents and related matters. We have represented many of the world’s leading corporations as experts in product design, user interface design and human factors engineering. We are well versed in the all major aspects of intellectual property protection and litigation related to medical device design and use.

Mobile UsabilityMobile usability testing and UX optimization

It is generally well understood that the world of screen-based interactions of all types are rapidly migrating to presentation on mobile devices. This migration presents development teams with a special set of user experience design problems. Specifically, the ultimate usability of mobile devices extends across two domains: the physical ergonomics of the device and the interaction framework of the screen-based functions and features. We are uniquely qualified in both device ergonomics and user interface usability testing. Our experience includes usability engineering and UI design for mobile systems running at the heart of the world economy today. We offer clients robust and industry-proven mobile usability testing and UX optimization expertise, custom configured to meet your specific development objectives, lead times and user profile requirements. We employ specialized mobile device usability testing methods that can produce large data sets in short time frames, thus increasing the statistical reliability of data generated in usability testing programs. We have consulted for the world’s leading mobile device companies providing expertise in usability testing, UX optimization, and expert heuristics audits.

Trading SystemTrading systems usability testing programs

Over the past 15 years, we have executed usability testing programs for several of the world’s primary markets and market makers, including major projects for the New York Stock Exchange, Goldman Sachs, Trading Technologies, Inc., Wit Capital/Soundview, and other leading financial institutions. We have financial trading systems experience covering all phases of usability research, including business objectives development, needs analysis, task analysis, trading floor ethnography, and cognitive modeling of high-risk decision making. We have developed usability testing programs for a wide range of profiles and have extensive experience analyzing and developing consumer online systems including home banking, trading, and financial planning. Our trading solutions are running at the heart of the world economy.

Media and Cross PlatformMedia and cross-platform testing

A primary business problem all large media companies face today is how to successfully migrate their traditional media properties to the 4 interconnected and increasingly transparent delivery platforms of TV, web, mobile, and virtual. We have worked with the world’s most successful media companies to design and execute complex, cross-platform usability and user experience studies that address this difficult customer engagement problem. Our research methods have proven effective in helping major media companies understand and optimize their migration to successful new media business models.

Gaming and Virutal RealityGaming and virtual reality testing

Online gaming and virtual reality are two of the primary forces of the “NEW” new media. Avatar-based interfaces allow customers to play in synthetic environments, creating a staggering opportunity for those who understand the psychological impact and the primary customer experience design challenges. Effective and reliable research in these new virtual worlds and gaming interfaces drives success. At MUS, we have pioneered research programs for some of the largest gaming and virtual world commercial projects in recent history. Using these new methods for conducting research in gaming and virtual worlds, we have developed a deep understanding of the user and avatar behaviors and related functions that drive deep immersion and expand in-world social networking participation. Our research services have been used extensively to answer critical user experience questions related to how customers respond to gaming and virtual world interfaces.

Persona DevelopmentPersona development

Understanding your critical user profiles (personas) is critical to understanding how to create and support a successful product or service. For more than 25 years, we have created complex user profiles for a wide range of products and services, ranging from personas for cancer patients to brokers executing trades on the floor of the New York Stock Exchange. In all of these projects, we employ a combination of professional user testing, observational research, and interview methodologies to develop interactive persona solutions that combine the latest data with the most appropriate and reliable research methods.