We help leading medical and pharmaceutical entities develop devices, products, and systems that meet rigorous and verified human factors engineering and business performance requirements with a focus on meeting FDA Human Factors Guidance.
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Founded in 1975, we have a proven history in solving complex man-machine interface problems in the medical products category. Our professional staff holds advanced degrees in HFE or related design and development fields. Our principal investigators are certified human factors engineering professionals (BPCE) and have many years of experience with complex medical product design and testing.
We specialize in the design and execution of complex, large-sample summative usability studies that require 90-1000 respondents. We are well versed in FDA warning letter response issues related to the human factors engineering performance of individual or multiple drug delivery devices and related support platforms. These projects include delivery devices, hardware design, GUI software design, instructions and user reference guides as well as related professional user training components.
We practice the science of medical device optimization and usability engineering by employing properly powered studies and methodologies that verify usability performance to high levels of reliability.
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We are fully 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. The following is a brief summary of our methodology and expertise experience.
We execute complex formative studies across a wide range of medical devices covering hardware, software, drug delivery, surgical and imaging modalities. We have worked with large internal client teams as a highly experienced HFE subject matter and usability testing resource. We create and oversee complex SOWs, protocols, and 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. 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.
We can execute fast and effective usability testing utilizing live drugs and related production or prototype delivery mechanisms 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 we have a history of iterative and large sample formative studies utilizing live drugs and production devices.
We were the first consulting firm to use eye tracking and behavior tracking in consumer product usability testing applications as well as in visual appearance design research. This methodology is effective in determining exactly what the user is viewing and in what sequence. Data from this methodology can be used to solve a wide range of complex user interface design problems clustered around sequence and dwell time when scanning and interacting with websites, computer displays, products, package designs and printed materials, including advertising.
Online large sample user testing allows users to access an interactive survey and complete tasks on your interface wherever they are and whenever they want. The statistical reliability of the large sample size allows companies to confidently make major decisions related to the design of business-related applications and websites. This method is exceptionally powerful when combined with a lab-based/eye-tracking study.
Behavioral data mining examines data files covering structured and unstructured responses of your users. This methodology creates detailed behavior profiles and knowledge maps of a system’s content structure. It can provide deep insight into user-generated content, such as message boards, blogs, forums and fixed document types. Based on the needs and expectations of your primary user profiles, this process can also decide the effectiveness of your various document types and interfaces by determining how well written and well formatted your existing content is. This method is highly effective when used with business-critical functions related to the design of large or complex websites and web applications. It is also effective when selecting new CMS systems.
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.
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.
Medical device and systems hardware is also more complex and demanding than ever before. In hardware development, 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 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.
Mobile apps that interface with human biomedical variables are now slated for FDA oversight. In this new field of man-machine development, we work with our clients to ensure that FDA guidance related to human factors engineering performance is documented and employed in the development of app-based systems that must respond to FDA oversight. MUS provides subject matter expertise, HFE audits, cognitive task analysis, UI design and formal usability testing during development to confirm HFE performance is verified and documented before, during and after approval by the FDA.
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.
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.
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. 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.
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, in which we work closely with large internal client teams as a highly experienced HFE subject matter resource in support of all heuristics-based recommendations.
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 (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). We have specialized research methods and development protocols for the design, testing, and validation of RG materials. MUS provides subject matter expertise, 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.
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. 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.
With over 40 years of experience in medical hardware and software development, we have optimized combination medical systems for a very wide range of users including, many different patient profiles with complex and advanced medical conditions, physicians, surgeons, and a wide range of HCPs.
We specialize in the optimization of complex interfaces between patients, healthcare professionals and advanced hardware and software medical technology combinations. Our special expertise in rigorous medical device usability testing is a cornerstone of our success.
Drug Delivery Devices
We have a wide range of expertise in the optimization of drug delivery devices. We are especially effective 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.
Imaging Systems
We have deep experience in optimization of medical imaging system and related user testing programs. We have extensive experience in the design and testing of ergonomic workstations for medical imaging systems.
Surgical
We provide special expertise in professional HFE research related to hand ergonomics and biomechanics. This expertise provides the scientific basis for hand-held surgical device optimization.
Software + Hardware
We combine rigorous and science-based software and hardware user testing and design optimization methods to solve complex medical system usability and user engagement problems where users interface with complex medical information through software and hardware combinations.
Instructions for use
We offer clients an integrated professional human factors engineering and medical system optimization process combination. We understand that the usability of any business-critical medical device or system is based on the interactions between the device, the user, and user training. All projects utilize an integrated function allocation decision model when determining device/system usability performance.
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. We also have the ability to execute complex research projects in highly compressed time frames by running simultaneous testing sessions on 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.
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The Apple watch is arguably the most significant innovation in medical information data gathering and information display. However, along with this profound new level of capability comes the need for rigorous and professionally executed Apple Watch and iPhone UX design and user testing. We have extensive experience in the design and execution of rapid-response user testing for complex consumer-facing mobile products and software applications. Much of this experience relates directly to our deep working knowledge of FDA HFE guidelines and related formative and summative usability testing. We are fully versed in the SDK of the Apple Watch and related UX design capabilities and limitations.
When compared to other firms offering medical device design expertise we provide a far broader range of services including advanced large-sample usability testing (FDA), economic modeling and complex drug delivery analysis. Our senior research staff consults on a regular basis with NIH and the FDA on complex medical research methods and outcomes.
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Pre-clinical data analysis including pharmaco-economic modeling, FDA/clinical trial support (oncology/NCI support), claims data mining, and post-trial (Phase IV) effectiveness/outcome evaluation. Recent work in payor/provider formulary restructuring and pharmacovigilance (adherence to drug/prescribing regiments for subpopulations).
Business modeling and market research for consumer-oriented health products/promotion retail offerings (including customer segmentation).
Advanced graduate and executive instruction on health policy and management, strategic analysis, organizational behavior, and program evaluation including executive training in HFE, UCD, design documentation and user testing. Peer-reviewed authorship focusing on cancer drug pricing, oncology diagnoses and prescribing patterns, provider practice cost structures, and NIH funding/grant processes.
Post-merger integration, national account sales and marketing restructuring (including benefits consulting partnerships and RFP support), claims analytics and medical management program development. Medical policy design, network “stitching” (including carve-out economics and partner selection) and provider credentialing/contracting process optimization.
Product and service design, marketing, accountable care support and medical home concept development/piloting. Health plan integration, transfer pricing optimization, withhold analyses and renegotiations and revenue capture optimization.
Healthcare Reform, “Meaningful Use,” CMS pricing/reimbursement change impact analyses, program evaluation and global public health advisory support (Russia, China).
Founded in 1975, we have a proven history solving complex man-machine interface problems in the medical products category. Our professional staff holds advanced degrees in HFE or related design and development fields. Our principal investigators are certified human factors engineering professionals (BPCE) and have many years of experience with complex medical product design and testing. We specialize in design and execution of complex, large-sample summative usability studies requiring 90-1000 respondents. We are well versed in FDA warning letter response issues related to human factors engineering performance of individual or multiple drug delivery devices and related support platforms. These projects include delivery devices, hardware design, GUI software design, instructions for use, user reference guides and related professional user training components.
We offer clients an integrated professional human factors engineering perspective; we understand that the usability of any business-critical medical device or system is based on the interactions between the device, the user, and user training. All projects utilize an integrated function allocation decision model when determining device/system usability performance.
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. We also have the ability to execute complex research projects in highly compressed time frames by running simultaneous testing sessions on 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.
The Apple watch is arguably the most significant innovation in medical information data gathering and information display. However, along with this profound new level of capability comes the need for rigorous and professionally executed Apple Watch and iPhone UX design and user testing. We have extensive experience in the design and execution of rapid-response user testing for complex consumer-facing mobile products and software applications. Much of this experience relates directly to our deep working knowledge of FDA HFE guidelines and related formative and summative usability testing. We are fully versed in the SDK of the Apple Watch and related UX design capabilities and limitations.
The following project thumbnails cover high-profile and other relevant program experience.
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.
10
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.
11
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.
12
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.
13
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.
15
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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Designed and executed complex, on-site field research covering high-energy radiation treatment procedures and related patient handling requirements. Executed complex cognitive task analysis and provided detailed recommendations for machine configuration optimization related to human factors engineering performance. Produced and tested various man-machine optimization options leading to improved HFE performance.
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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.
18
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.
19
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.
20
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.
21
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.
22
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.