SERVICES

User Research

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Conducting design research at the start of a project is critical to understanding your users’ needs, especially those that are unmet or unarticulated. Where market research takes the macro view - understanding what features a product should have - design research takes an in-depth view to uncover how those features should be implemented. For medical devices, design research is required to document user profiles, use environments, and critical tasks.

 

Result: A comprehensive set of user requirements that drive design and reduce time to market - the return on investment can be hundredfold!

User Research Services:

• Contextual inquiry (ethnography)

• In-depth interviews

• Focus groups

• Buddy groups

• Diary studies

• Online communities

• Workflow mapping

• Online card sorting

• Task and workflow analysis

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User Interface Design

We have decades of experience helping companies develop user-friendly, safe, and effective user interfaces – for consumer products to software, websites, kiosks, handhelds, and surgical systems. We follow an organized and iterative design process that starts with understanding users' needs, engages users in testing prototypes of increasing fidelity, and results in a UI design specification ready for implementation.

 

In the case of medical devices, the user interface includes all aspects of the system with which users or patients interact. These include the hardware, software, documentation, labeling, and training. We can help.

 

Result: Well-designed products that meet regulatory approval and succeed in the marketplace. 

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UI Design Services:

• Ergonomic analysis

• Anthropometrics

• Information architecture

• Interaction design

• Wireframes

• Instructions for use (IFU) design

Deliverables:

• Hardware design inputs

• User interface specification (UI Spec)

• UI Wireframes

• Draft IFUs

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Usability Testing

There is simply no substitute for putting your designs-in-progress in front of real users to see if they are able to perform tasks. Usability testing is a well-established method for gathering this feedback in a structured way to drive design decisions. For medical devices, usability validation testing is required for regulatory approval, and must be conducted according to strict guidelines.

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We have conducted hundreds of usability tests of everything from automobile navigation systems to financial websites to surgical devices. Beth is co-author of Moderating Usability Tests: Principles and Practices for Interacting with Joseph Dumas (Elsevier, 2008).

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Result: Data-driven design decisions; improved user experience, safety, and competitive advantage.

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Types of Usability Tests:

• Early prototype tests

• Cognitive walkthroughs

• Directional and preference tests

• Formative usability tests

• Baseline and benchmark tests

• Remote usability tests

• HF/UE validation tests for FDA

Testing Services & Deliverables:

• Protocol development

• Test planning

• Participant recruitment & compensation

• Moderation and data collection

• Data analysis and synthesis

• Reporting

• Design recommendations

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Expert Reviews

Sometimes it makes sense to have one or more human factors experts review your product design before conducting a test with users, to catch any obvious usability issues. We conduct expert reviews based on HF principles, decades of experience, industry standards, and design heuristics to deliver specific recommendations for improvement.

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Result: A list of design improvements that can be made before spending budget on user testing.

 

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Medical Device Regulatory Advice

Medical device manufacturers often need expert guidance on designing and scoping a human factors/usability engineering (HF/UE) program for a device or system. We have extensive experience helping clients implement usability engineering programs that meet the requirements of IEC 62366-1 and the U.S. FDA. Considerations include whether it is a new or legacy device, the device class (I, II, or II), known use errors, and level of risk. 

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Result: A properly scoped HF/UE effort for a given program; avoiding costly delays due to inadequate HF/UE submissions.

Regulatory Guidance Services:

• IEC 62366-1 and FDA Guidance audits

• HF/UE plan development

• Documentation gap analysis

• Review of FDA responses

• HF/UE process development

• Use-related hazards and risks analysis

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Training and Workshops

One of our favorite things to do is teach people about human factors and usability. We provide custom training workshops ranging from “lunch and learns” to two- and three-day interactive workshops.

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Result: Get your teams quickly up to speed on critical topics in human factors and usability.

 

Sample topics have included:

 

• Usability engineering in medical device development

• Design research methods and when to use them

• Usability testing basics

• Moderating usability tests (based on the book by Dumas & Loring)

• Medical device HF standards and guidance

• Conducting research in the OR

• Intro to human factors

• Intro to user interface design

• Designing for older consumers

• Use-related risk management

• Maximizing impact through user research

• Market research versus design research