FDA Focused Medical Systems

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 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.

Large Scale Formative Studies for FDA Approval

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.

Large Scale Summative Studies for FDA Approval

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.

Live Drug Device Usability Studies

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.

Eye-tracking and Behavior Tracking

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

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

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.

FDA HFE Regulatory Response

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.

HFE Testing Software

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.

HFE Testing Hardware

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.

HFE Testing Mobile Medical Apps

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 Studies

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.

Ergonomic Analysis and Optimization

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.

Lab-Based, Small Group 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. 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.

Professional Medical Device Heuristics

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.

Instructions For Use Testing

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.

User 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). 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.

Ethnographic and Clinical 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. 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.

Advanced Drug Delivery Device Design

• Complex professional human factors engineering heuristic frameworks for use in the creation of market-leading device configurations with verified usability performance (special experience in screen-based UI design).
• Development of comprehensive professional human factors engineering design guidelines and templates for new generation of personal drug delivery devices that exceeds HE75 specifications.
• Function allocation analysis and segmentation of functions between the patient, HCP, and physician to reduce risk and increase success rates for patient-mediated drug delivery design solutions.
• Development of internal (proprietary) usability testing methods designed to reduce frequency and cost of formative and summative studies (AGILE).
• Development of drug delivery device design solutions supported by rapid usability performance verification focused on fast FDA approval.
• Design and development of new devices and related IFU systems that offer clients a significant opportunity for IP assets and related innovations resulting in market leadership and protectable solutions.

Pharmacoeconomics and Clinical Trial Support

• Clinical trial support for medical devices and home health technology (including DME).
• Focus on user-centered design methodologies (for product and service offerings) as well as downstream usability testing both pre- and post-clinical trial analysis.
• Pharmacoeconomic analysis—including effect size, cost-benefit, and usability impact analysis—that can aid in pricing, costing, and marketing program design.
• Large-sample formative and summative usability studies for FDA approval including extensive IFU analysis and development for devices in production but with low usability performance.
• Client references: Home health technology firm (in-home medical maintenance technology) prostate oncology trial support (injectable and oral antineoplastics), pain management device design (both device selection and injection site preference)

Practical Customer Segmentation

• Patient market segmentation vs. device design analysis for multiple drug applications using single device configurations.
• Patient segmentation for joint pain and fracture drug study to support downstream product marketing and launch design (multi-national).
• Side-by-side segment comparison studies for competitor drug effectiveness (propensity scoring and propensity adjustment models for better cohort matching and comparison).
• Regulatory support for oncology patient segmentation/approvals resulting in targeted indication and longer patent extension (use patent given prior segment effectiveness).
• Extensive device comparison analysis and trade-off analysis using advanced feature/function distribution modeling correlated with customer behavior and product selection criteria.
• Client references: Biotechnology firms (oncology), pharmaceutical research firms and CROs (joint pain/fracture study), asthma market research studies and regulatory support (segment comparison studies)

Regulatory Strategy Improvement

• Economic modeling of different scenarios for approval; broad approval for basic device design vs. targeted designs, by segment, with the intention to extend the patent to other segments later in the drug life-cycle.
• Cost-benefit analysis of pursuing initial device approval vs. “fast-follower” approval with additional/new indications approvals.
• Forward-looking segment profitability has given various firm and competitor development scenarios (competitive “war-gaming” economics).
• Client references: Home healthcare technology firms (post-clinical study), pain management device design and regulatory approval studies (war-gaming)

Apple Watch UX Design and Usability Testing

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.

Medical Products Usability Testing and Design Expertise

• Physical ergonomics and design criteria systems development
• Specialized hybrid HFE / clinical studies
• Comprehensive formal UCD methodology consulting
• Documentation systems design
• Intellectual property consulting on HFE innovations
• Patient needs analysis (in-situ interviews and observations)
• Physician needs analysis (in-situ interviews and observations)
• HCP needs analysis (in-situ interviews and observations)
• Hospital executive and admin staff analysis (interviews)
• Development of executive interviews and needs analysis
• Medical device feature and function market research
• Complex feature/function trade-off analysis
• Formal HFE due diligence for component device selection
• Executive interviews and needs analysis (medical systems)
• Complex task analysis
• Cognitive task analysis
• Medical device feature and function market research
• Complex feature/function trade-off analysis
• Formal HFE due diligence for component device selection
• Ergonomic assessments (product and workstation design)
• Electronic medical records (EMR) (information analysis and design)
• Biomechanical reviews (specialization in hand-held devices)
• Professional heuristics analysis
• Error event modeling and simulation for risk analysis
• Formative studies for wide range of medical products
• Hardware design configuration modeling
• Hardware design configuration testing
• Software use-case modeling and analysis
• Software GUI design
• Screen-based GUI simulation development
• Software GUI usability testing and verification (EMRs, EHRs)
• Summative testing (numerous methodologies)
• Complex statistical analysis for small and large sample studies
• Decision modeling and purchase decision impact analysis
• Complex patient information seeking behavior research
• Impact of information delivery on patient outcomes
• Complex IFU task analysis, graphic design, and testing
• IP litigation support and expert witness services
• Scope-of-work documentation for complex programs
• Specialized testing procedure development and verification
• Interface with clinical study groups and related designs
• Complex respondent recruiting and screening
• Error analysis and optimization
• Hybrid HFE + clinical study design and execution

Pharmaceuticals

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).

Medical Device Market Research

Business modeling and market research for consumer-oriented health products/promotion retail offerings (including customer segmentation).

Executive Education and Academia

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.

Payors (Health Plans)

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.

Providers

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 policy

Healthcare Reform, “Meaningful Use,” CMS pricing/reimbursement change impact analyses, program evaluation and global public health advisory support (Russia, China).

Experience

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.

Integrated Approach

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.

Apple Watch UX Design and Usability Testing

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.

Medical Products Usability Testing and Design Expertise (Listing)

• Physical ergonomics and design criteria systems development
• Specialized hybrid HFE / clinical studies
• Comprehensive formal UCD methodology consulting
• Documentation systems design
• Intellectual property consulting on HFE innovations
• Patient needs analysis (in-situ interviews and observations)
• Physician needs analysis (in-situ interviews and observations)
• HCP needs analysis (in-situ interviews and observations)
• Hospital executive and admin staff analysis (interviews)
• Development of executive interviews and needs analysis
• Medical device feature and function market research
• Complex feature/function trade-off analysis
• Formal HFE due diligence for component device selection
• Executive interviews and needs analysis (medical systems)
• Complex task analysis
• Cognitive task analysis
• Medical device feature and function market research
• Complex feature/function trade-off analysis
• Formal HFE due diligence for component device selection
• Ergonomic assessments (product and workstation design)
• Electronic medical records (EMR) (information analysis and design)
• Biomechanical reviews (specialization in hand-held devices)
• Professional heuristics analysis
• Error event modeling and simulation for risk analysis
• Formative studies for wide range of medical products
• Hardware design configuration modeling
• Hardware design configuration testing
• Software use-case modeling and analysis
• Software GUI design
• Screen-based GUI simulation development
• Software GUI usability testing and verification (EMRs, EHRs)
• Summative testing (numerous methodologies)
• Complex statistical analysis for small and large sample studies
• Decision modeling and purchase decision impact analysis
• Complex patient information seeking behavior research
• Impact of information delivery on patient outcomes
• Complex IFU task analysis, graphic design, and testing
• IP litigation support and expert witness services
• Scope-of-work documentation for complex programs
• Specialized testing procedure development and verification
• Interface with clinical study groups and related designs
• Complex respondent recruiting and screening
• Error analysis and optimization
• Hybrid HFE + clinical study design and execution