Product Assessments

Usability testing is a key building block for good design. It’s also the foundation upon which FDA and other regulatory agencies have built their human factors guidelines. Usability assessments cast light on design problems that negatively impact how people use and experience your product.

We provide a set of usability assessment tools, suited to answering different questions at different points in your product development cycle.

Solves These Problems

	Our customers tell us our device is difficult to learn and awkward to use. But where exactly are the problems?
	We are about to invest heavily in the development of a new generation of product. But how can we be sure we have a winner?
	How do we validate that the design of our new product meets our users' requirements and is easy to learn and use?
	How can we improve our chances of a speedy clearance through FDA?
	Customers tell us that our competitor's product is simpler to use. Why?

Types of Product Assessments

Concept Validation. Before you build it, find out if your device will satisfy the real needs of patients or healthcare practitioners. Using storyboards and concept mockups, we can help users "see and touch" your device before you spend money on engineering.

Expert Review. Our human factors experts review your current product or late-cycle developments to identify and prioritize design issues that could affect safety and usability. We'll help you harvest low hanging fruit (small changes that can have a noticeable impact), point to documentation and training changes that could mitigate risk, and prioritize areas in need of attention for future releases.

Usability Testing. Put your product or late cycle development through it’s paces. Usability testing puts your product in the hands of users and has them complete real usage scenarios under our observation. We’ll measure how well people do and where they have problems, and provide you with a video summary of key findings. Seeing is believing.

Pre-Market Submission Studies. Speed clearance of your device by validating your designs with real users. We can design and conduct pre-market studies that will help to address reviewers' concerns about design validation. Pre-market validation studies do double duty by providing a valuable source of "user performance" data for marketing.

Competitive Profiling. Losing market share to a competitor with a better reputation for user-friendliness? We can help close the competitive gap by identifying what's good and not so good about competing products. With comparative testing, we can measure the usability of products in head-to-head, user-based assessments.

Benefits

	Concept Assessments	Expert Review	Usability Testing*	Pre-Market Submission
Identifies and prioritizes design problems
Validates user requirements
Provides evidence of design controls
Generates feedback from actual users
Conducted in actual usage context (hospitals, clinics, or patient homes)
Can be performed early or late in development process
Can be conducted internationally

Our Approach

We'll work with you to define the best approach given the questions you have and the state of your developments. Once we've agreed on a test strategy, we’ll conduct a kickoff meeting with your team, work with them to develop a study protocol, and for user-based evaluations, screen and recruit study participants. We’ll conduct the study, analyze the results, and present key insights in a presentation to your team. We’ll also document the results in a written report suitable for inclusion in your design history file.

Deliverables

Written report for inclusion in design history file or FDA submission. PowerPoint presentation presenting key insights, including prioritized list of design strengths and problems.

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