Delivering scientifically rigorous, FDA-guided human factors and usability research for medical devices on a global basis since 1975.
Our mission is to provide leading pharmaceutical and medical product development teams with industry-leading, scientifically valid, professional human factors and usability testing expertise that meets and exceeds FDA guidance and professional best practices for human factors science. We count among our clients the world’s most successful and innovative corporations, startups and governmental agencies. Our expertise includes assisting major clients with FDA responses and warning letter submissions.
We employ rigorous, validated, science-based human factors and usability research methodologies developed over decades of experience. We are an acknowledged provider of industry-leading advanced human factors testing methodologies for medical products. This ensures that our research findings are focused on delivering actionable and reliable insights with the proper concern for statistical power and reliability. Our focus is on meeting and exceeding FDA human factors guidance in all research studies. We offer our clients a wide range of research options focused on delivering the proper balance between data reliability and cost. Our experience in respondent sampling strategies is driven by a deep understanding of population distributions based on complex clinical and medical requirements. Our clients tell us that we are the gold-standard in terms of human factors and usability testing expertise and data quality. All medical product usability testing research programs are managed by a certified human factors engineering professional (BCPE).
Based on over 50 years of experience conducting professional usability testing programs, we have developed extensive expertise with many critical user populations, ranging from COPPA age children to individuals of advanced age with severe medical conditions. We are known for studies that deal with complex healthcare provider (HCP) and patient populations. All of our studies are based on robust respondent sampling and validation strategies. We are especially adept at studies involving difficult HCP populations, including surgeons and other medical specialists. Our methodologies include group-based Applied Cognitive Task Analysis prior to usability and human factors testing.
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.
Our methods and expertise cover a wide range of medical product and system categories. At the highest conceptual level, we specialize in five forms of medical technology testing and UX optimization.
We have deep professional expertise in testing GUI screen-based human-computer interaction systems for critical medical applications Our expertise in this area includes extensive experience with mobile applications and related interfaces. We hold a wide range of utility patents in GUI design and usability engineering and are approved as experts in intellectual property related to GUI design and human factors usability testing for leading corporations and startups.
We have deep testing experience with handheld drug delivery devices. Our research services includes industry-leading testing methodologies including Newtonian force measurement, 3D spatial tracking, electromyography (EMG), electroencephalography (EEG), micro-facial expression analysis (MFEA) and additional neuroscience-based methods. All advanced testing methods are fully validated and owned directly by the firm. Our clients utilize our human factors and usability testing expertise on projects ranging from early concept testing to full validation studies for FDA final submission. We have a wide range of expertise in the optimization of drug delivery devices. We are especially effective in dealing with more complex consumer-facing devices that require rigorous HFE methods and related testing. We have deep experience in formative and summative studies for FDA submission.
Our human factors and usability team has decades of experience with concept development, prototype testing and optimization of complex medical imaging systems. We have been on the ground floor of several major medical imaging technologies including NMR and CT. We have received industry-leading awards for this research. We have extensive experience in the design and testing of ergonomic workstations for medical imaging systems.
One of the most complex medical technology problems today is the successful integration of robotic systems with surgical teams to achieve new levels of surgical performance. Our team has conducted extensive human factors research and usability testing for leading medical robotics platforms. Our specialized expertise in this area focuses on the proper allocation of functions between the robotics system and the surgical team. We execute a wide range of advanced research methods including Applied Cognitive Task Analysis (ACTA) and simulation validation testing. We also provide special expertise in professional HFE research related to hand ergonomics and biomechanics. This expertise provides the scientific basis for handheld surgical device optimization.
We have extensive experience in the design and testing of instructions for use (IFU) and related systems. We work with clients to ensure that FDA guidance and mandated human factors engineering performance criteria are met for IFU and reference guide (RG) components of medical and drug delivery devices. We are especially adept with consumer-facing IFU design, testing and/or optimization. MUS provides subject matter expertise, HFE audits, content analysis, information design, IFU design, design analysis, cognitive task analysis, and formal usability testing during development to confirm HFE performance is verified and documented. We also have extensive experience with post-market surveillance studies to understand user compliance with IFU in the real world and opportunities for IFU and/or training optimizations.
With over 50 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. Our core human factors and usability testing services are broken down by formative or summative studies and whether traditional or advanced methods are applied in such studies.
We have executed complex formative studies across a wide range of medical devices covering hardware, software, drug delivery device, surgical and imaging modalities.
Read More 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 approvals, and are highly effective with complex, iterative, large sample formative studies based on AGILE development methods.
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.
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 medical product or system.
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We have conducted extensive professional human factors engineering heuristics on complex medical products, drug delivery devices, imaging systems, patient EMRs and related processes. We have created and utilized specialized heuristics rule sets directed at FDA HE 75 guidelines. We provide extensive design optimization recommendations with verified HFE performance improvements. Our clients tell us that we have the most rigorous and insightful professional heuristics expertise in the medical products human factors engineering field. MUS has executed many complex heuristics programs across a wide range of medical devices covering hardware, software, drug delivery, surgical and imaging modalities. Our heuristics programs have formed the basis for design and development of new generations of medical products. We work closely with large internal client teams as a highly experienced HFE subject matter resource in support of all heuristics-based recommendations.
Starting in 1976, we were the first U.S. human factors research firm to create a testing lab and conduct research using this methodology. This method is effective in exploring high-level usability of medical products and services.
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Lab-based usability testing 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.
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.
We have the extensive capability to execute numerous complex research projects simultaneously. Our core staff of research professionals plans and executes studies based on an extensive set of formal and well-understood methodologies and procedures.
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We also have the ability to execute complex research projects in highly compressed time frames by running simultaneous testing sessions at one or several facilities in a stacked data-gathering format. Over the years, we have developed a large body of independent research professionals including moderators, recruiting agencies, testing facilities and professional support staff, including HCPs and physicians, that we can call upon to execute complex studies, always under our detailed and formal direction. In terms of data analysis, we have the extensive capability to execute complex statistical analysis through our connections with Columbia Business School, where a partner of the firm teaches market research and business statistics at the graduate and Ph.D. levels. We offer several levels of complex market research including device configuration analysis and optimization.
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.
Despite the best efforts of drug delivery manufacturers to design devices and related labeling/packaging to convey safe and effective use to intended users, once the device reaches market after FDA approval, users may exhibit use errors, operational difficulties, and intentional misuse of the device in their use natural environment.
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This can lead to device complaints and warning letters from the FDA. We have extensive experience executing post market surveillance studies to understand actual use procedures followed by users in their natural use environment. Such studies often require sampling from multiple geographic locations to understand the full scope of user behaviors, as well as factors impacting proper device use such as workplace training, workplace environment, education, and prior device experience.
If you are facing a complex, business-critical and time-sensitive FDA response, we specialize in providing highly focused and experienced usability testing and human factors engineering optimization expertise. Our experience and focus is on addressing such matters as rapidly and rigorously as possible. We have a track record with these complex problems.
With the formal approval of COPPA by U.S. Congress, the requirements related to the design of medical products for children under the age of 12 took a dramatic turn.
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If you are developing medical products or 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 and testing 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 conduct 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.
We have extensive experience in the design and testing of medical product 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.
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.
This method is highly effective when used with business-critical applications related to the creation or redesign of large or complex medical websites, medical 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.
We employ medical ethnographic and field research as targeted studies involving a smaller number of users to develop a comprehensive understanding of how users 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.
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.
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.
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.
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We offer a high-precision sensor system to record micro-levels of object motion as users interact with a medical product or other physical object. The system provides a highly refined view of the impact of design configuration on a user’s ability to manipulate a medical device or product in a 3D space. It also imparts a vast dataset that is used to optimize package designs or other objects. The methodology provides robust A/B testing and the ability to track micro-motions for optimizing handheld interfaces.
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Force is measured by a network of sensors and related software and hardware that can interface with almost any medical product, service, drug delivery solution, or related component of a larger design. It allows for highly accurate measurement of forces required on the part of the user to manipulate a solution’s overall design or individual component parts during use. This method can be utilized to generate formal user design criteria and related functional specifications, in terms of force exertion and manipulation.
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Provides a high-resolution view of the physiological effort involved in the manipulation of medical product design solutions or concepts. It records the activity of core muscle groups involved in the manipulation of a design solution and provides a direct physiological measure of user effort, which often is highly correlated with user preferences.
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A data stream that provides insights into how the user attends to the visual aspects of a medical device design solution in real-time. Combined with other forms of data capture, it imparts robust insights into the visual attention differences between design concepts that impact user behavior and acceptance. It can be utilized in lab-based settings, as well as “in the wild” data capture, utilizing specialized mobile data-capture glasses.
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An artificial intelligence-based system for capturing the expressed emotional responses of users viewing or interacting with medical device design solutions. This can include products, environments, printed material, and video content. It allows for deep and compelling insights into which features and/or combinations of features in a design solution elicit expressed emotions. Our system has been extensively validated in bench and pilot studies to confirm data capture quality and reliability.
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We provide highly detailed biomechanical analysis for all major and minor body parts and related kinetic chains. We have extensive formal education and training in complex biomechanics specifically focused on hand-arm and upper body interactions including fine manipulation of complex handheld medical user interfaces and related interactions.
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A data stream utilized to measure the intensity of users’ emotional responses to medical device designs, device complexity, IFU comprehension, and device design concepts as they interact with an actual device, simulated device, or content related to a design solution. It generates insights that users frequently cannot articulate using traditional interview methods. Used in combination with other methodologies.
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Widely promoted as a means of assessing consumer response to all manner of device design solutions, this system offers insight into users’ higher-level cognitive processes as they interact with medical device design solutions or view solutions in various media. It can produce critical insights into the cognitive workload associated with the use of a medical device and related IFU content. It can be utilized in conjunction with eye-tracking data.
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A data capture and professional audit system that yields highly detailed data on the time, errors, and confusion present when a user interacts with a given medical product design solution. The system is designed to produce usability testing insights for use in design optimization and can be utilized to identify performance problems captured in prior HFE studies that are known to produce errors and confusion, thus allowing for the removal of such design features during early design development. The system is based on the creation of a database of device design HFE performance ratings correlated with device interface design features.
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A data capture system designed to determine whether changes to a design or related interface are going to have a major negative impact on previous users of the system. Combined with other data streams, it reveals which design changes will have a negative, neutral, or positive impact on a given design solution. This system can also utilize various data streams to address FDA guidance related to threshold analysis and other product verticals.
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Software-based data capture systems that allow for the calculation/estimation of the cognitive workload associated with understanding and using medical products by specific user populations. It provides an objective measurement of how much cognitive effort design solutions require on the part of users during various, critical interaction sequences or simply when viewing the design solution without interaction.
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Our team has decades of experience dealing with complex physical anthropometry research ranging from application and extension of existing data to the research and development of proprietary data for special applications. We have chaired two ANSI committees on civilian anthropometry and physical biomechanics. We have produced research studies focused on the identification of critical user design criteria and related analysis of published standards proffered by among other agencies the FDA.
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A data capture and behavior modeling system that allows for the creation of software-based predictive models of user behavior, based on input from other data capture systems discussed above. It provides a rapid means of assessing the relative impact that medical product design solutions will have on users’ ability to locate, integrate, and take action on critical content, features, or functions without creating complex physical models, simulations, or test setups.
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An extensive array of online data capture systems based on professionally audited and tested survey tools that integrate seamlessly into the data capture streams discussed above. The system utilizes a combination of industry-standard and proprietary question sets, ranking systems, and scales to capture the subjective responses to medical product design solutions in a range of research settings. The system can be utilized to support design concept testing, including the implementation of advanced methods.
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Our team has extensive experience testing and optimizing package design variables including opening mechanisms, overall package configuration/form factor, labeling, and even impact of pharmacy label on critical information uptake by users. 3D tracking has been employed to identify a preferred package design based on efficiency of manipulation. Eye-tracking has been employed to understand clarity of opening mechanism to inform opening mechanism selection for a particular package design configuration. Such methodologies are supplemented with subjective response questions, producing robust objective and subjective data to inform package design decisions.
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The data capture modalities discussed above individually produce massive amounts of real-time data. When the data streams are combined, they create truly staggering amounts of data that require specialized data integration and data analysis tools. Working with industry-leading data integration systems and supported by the development of proprietary software, these new systems form a critical bridge between data and insights.
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Due to the complex nature of the data integration streams required to execute robust HFE evaluations, it is necessary to utilize advanced data clipping, scrubbing, and statistical analysis routines. To solve this problem, there are proprietary data capture and analysis tools that allow for effective execution of the complex statistical analysis required to provide clients with reliable design research suitable for making major corporate investments in specific design solutions or directions. The data stream aggregation tool interfaces with audited and industry-standard advanced statistical software systems.
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We have extensive experience running repeated measure medical product studies ranging from 3 weeks up to 36 months. We are well-known for these types of studies. Any of the methods above can be utilized individually or in combination with longitudinal studies. We also have the capability to produce both hardware and software components for such sessions. Our sessions can be run in-house or in any lab located in a secure setup. We are highly-experienced with several online user testing systems and have deep experience with Qualtrics and related advanced testing functions.
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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.
We have published papers on SSRN analyzing the appropriateness of FDA human factors and usability testing guidance for producing medical products that are safe and effective for intended users once in the marketplace. Below is a list of our key medical products human factors and usability testing papers on SSRN. Click the paper title to access the full paper on SSRN.
We have also published extensively in online Medical Product journals on topics including analyses of current FDA guidance, advanced human factors usability testing methods, medical device usability testing in the age of COVID-19, and factors and challenges related to executing human factors usability testing. Below is a list of our medical products human factors and usability testing articles published in online medical product journals. Click the article title to access the full article.
We are often asked to present seminars/webinars on our advanced human factors usability testing methods and medical product cases, as well as professional heuristics and cognitive task analysis. We have presented such seminars/webinars for major corporations, long-standing pharmaceutical clients, academic institutions, research software/hardware technology providers, and general audiences. Below is a list of seminars/webinars we have presented in the recent past. Seminars/webinars that are available for viewing on YouTube are hyperlinked below.
A list of our awards can be found HERE.
The following project thumbnails cover high-profile and other relevant program experience.
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Executed an applied cognitive task analysis (ACTA) to assess how the benefits of an enabling technology for thoracolumbar decompression and fusion spine procedure outweigh the risks from the perspective of 8 non-biased surgeons.
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The ACTA also aimed to improve understanding of cognitive skills, expertise, strategies, judgments, and decision-making required for each of the tasks/subtasks involved in the computer-aided surgery, as well as determine whether the enabling technology effectively reduces cognitive and physical workload for surgeons. Opportunities for optimization of the enabling technology were also captured and reported.
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Executed a study to understand the impact of drug viscosity and volume, as well as PFS device physical parameters (e.g., finger flange extender, plunger design, barrel design) and injection location on acceptable injectability. Also, examined the distribution of force during plunger press down in x, y, and z axes to understand the extent of off-axial force exhibited by representative users. A tri-axial force measurement platform was custom-developed for this off-axial force assessment.
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Executed two studies to inform the device design and related IFU for an opioid overdose drug. High-performance eye-tracking was employed to gain robust insights into how addiction clinic personnel and first responders interact with the device and IFU and apply information gathered from the IFU to perform all tasks necessary for successful drug administration.
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Executed a rapid response agile IFU redesign for a complex multi-vial adapter system to effectively and efficiently resolve critical error patterns leading up to formal FDA validation. Eye-tracking was employed to understand user visual attention distribution / information uptake for each IFU iteration tested and inform modifications moving toward the final validated IFU design.
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Conducted a series of studies examining high viscosity intravitreal drug delivery optimization with multiple pre-filled syringe device concepts. A high-fidelity intravitreal (eye-injection) injection simulator was custom-designed for these studies. Retina specialists and ophthalmologists were sampled.
Conducted extensive usability and information transfer analysis of online content categories and presentation formats focused on defining information structures that had the greatest impact on clinical outcomes of cancer patients.
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FDA Human Factors Engineering Guidance Is Now Serious Business. 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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In numerous multi-year engagements, MNM conducted complex human factors engineering research and product design programs for leading medical and pharmaceutical entities covering imaging systems, drug delivery devices, emergency care / ICU systems and surgical devices with a focus on both software driven, screen-based interfaces and hardware configurations. MNM has executed large sample formative and summative studies for FDA approval. MNM received the Alexander C. Williams Award / Human Factors and Ergonomics Society for medical systems design.
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Executed product design programs for leading medical and pharmaceutical clients covering complex clinical modalities including: imaging, drug delivery, surgical, emergency processes and patient management systems related to FDA HE 75 requirements and testing procedures. Clients include Pfizer, Becton Dickenson, Johnson and Johnson, Raytheon, GE and others.
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Conducted several usability testing programs for MarchOfDimes.com focusing on optimization of mission-critical engagement pathways. Executed studies utilizing both a small-sample lab-based methodology and large-sample online behavior tracking. Provided detailed optimization recommendations for improving giving conversions and access to critical content on the site.
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We specialize in design, approval management, execution and delivery of large sample rapid-response summative usability studies. 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 clients facing complex FDA approvals. MUS is a preferred vendor for leading biotech, pharmaceutical and medical device manufactures. We are fully versed in CFR 21 Part 11 compliance requirements and maintain research methods within compliance.
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Executed complex analysis of the relationship between cancer information presentation frameworks and patient clinical outcomes. Identified key knowledge domains for cancer patients based on analysis of 2.5 million message board posts between cancer patients, doctors and HCPs. Provided robust view of relationship between information presentation format and clinical outcomes.
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Conducted on-site field research covering complex ICU procedures related to patient hydration systems, monitoring devices and HCP training and device management processes. Developed new sterile water hydration system that reduced critical set up and utilization errors and reduced training for HCPs. Patents awarded for solution.
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Conducted extensive professional human factors engineering heuristics on complex medical products, drug delivery devices, imaging systems, patient EMRs and related processes. Created and utilized specialized heuristics rule sets directed at FDA HE 75 guidelines. Provided extensive design optimization recommendations with verified HFE performance improvements. Clients include GE, Johnson and Johnson, Pfizer and others.
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Medical packaging is viewed by the FDA as a critical component of usability and must be considered in the HFE evaluation of drug delivery devices and products. We work with leading clients to ensure that FDA guidance human factors engineering performance criteria are documented and employed in the development of packaging for FDA approval. MUS provides subject matter expertise, HFE audits, information analysis, cognitive task analysis and formal usability testing during development to confirm HFE performance is verified and documented before, during and after approval by the FDA.
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If you must perform rapid-response usability testing utilizing live drugs and related production or prototype delivery mechanisms, we can execute your programs in a safe, efficient and productive manner. We have extensive experience with the special problems and operating procedures required to conduct usability testing under these complex conditions. We are especially adept at complex SOWs, protocols, and related IRB approvals and have a history with complex, iterative, large sample formative studies utilizing live drugs and production devices.
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Conducted extensive in-field research at leading US medical centers related to radiological procedures and patient handling factors. Created optimization strategy for improving both patient safety and department-level throughput. Provided extensive input into man-machine aspects of several lines of new medical imaging systems. Conducted on-site usability testing and concept verification studies.
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Conducted complex human factors engineering risk analysis related to installed MRI systems in a wide range of clinical settings. Produced detailed task analysis and prepared conceptual solutions related to warnings for patients and individuals coming into contact with invisible high-energy magnetic fields. Produced and tested for comprehensive architectural signage and HCP training procedures to mitigate core risk factors.
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MNM designed and executed focus groups and large-sample on-line study focused on understanding the special information needs and resource profiles of families with children on spectrum. Executed complex analysis of use, trust and sharing of online, autism-related content in small social networks. Developed UX optimization strategy focused on rapidly changing information sharing behaviors as a function of social media technology.
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Executed a series of complex usability and UX optimization studies for leading medical non-profit entities. Developed overall and detailed testing methodology focused on identification and resolution of key factors leading to low conversion rates for online contributions. Conducted series of focus groups, one-on-one interviews, lab-based studies and online large-sample sessions. Data provided significant insight into usability-based problems and a wide range of other business-critical factors including policy and giving-strategy development.
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Medical device and system hardware is more complex and demanding than ever. We work with our clients to ensure that FDA guidance and human factors engineering performance criteria are documented and employed in the development of hardware-based systems that must meet FDA approval. As in software development, MUS provides subject matter expertise, HFE audits, cognitive task analysis and formal usability testing during development to confirm HFE performance is verified and documented before, during and after approval by the FDA.
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Today, medical device software is more complex and demanding than ever before. We work with our clients to ensure that rigorous FDA guidance and mandated human factors engineering performance criteria are documented and employed in the development of software-based systems that must meet FDA approval. MUS provides subject matter expertise, HFE audits, cognitive task analysis and formal usability testing during development to confirm HFE performance is verified and documented.
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Our clients tell us that we have the most rigorous and insightful professional heuristics expertise in the medical products human factors engineering field. MUS has executed many complex heuristics programs across a wide range of medical devices covering hardware, software, drug delivery, surgical and imaging modalities. Our heuristics programs have formed the basis for design and development of new generations of medical products; we work closely with large internal client teams as a highly experienced HFE subject matter resource in support of all heuristics-based recommendations.
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Medical device and system hardware ergonomic performance is rapidly becoming a factor that determines success in the marketplace and acceptance by the FDA. MUS provides subject matter expertise, ergonomic audits, ergonomic task analysis and formal ergonomic testing for the specific purpose of developing rigorous ergonomic performance criteria for use in device design, testing and certification. We employ complex ergonomic data gathering methods to aid our clients in the creation of robust, science-based ergonomic performance criteria.
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We have extensive experience in the design and testing of IFU systems. We work with clients to ensure that FDA guidance and mandated human factors engineering performance criteria are met for IFU and RG components of medical and drug delivery devices. We are especially adept with consumer-facing IFU design, testing and/or optimization. MUS provides subject matter expertise, HFE audits, content analysis, information design, IFU design, design analysis, cognitive task analysis and formal usability testing during development to confirm HFE performance is verified and documented.
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.
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.
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.
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.
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.
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.
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.