Analytical Research

Cognitive Walk-Through

Have you ever wondered what the experience is like for a person using your product for the very first time? Will they be able to perform a task the way you intended? Are there any likely stumbling blocks? We can help you answer these questions using a cognitive walk-through–a formalized, reliable method for describing a new user’s potential actions and thoughts when performing a task. This method details the specific sequence of action steps a user should perform to complete a task. It reveals the difficulties a user may encounter given their knowledge and experience, and the feedback provided by the system. A cognitive walk-through provides fast and valuable feedback for the designer to gain a glimpse of the likely experience of a novice, and is often performed before the final product is produced using early mock-ups of the design (e.g., paper prototypes).

Competitive Evaluation

How does your system compare to the competition? We can provide an objective perspective comparing the usability and desirability of two systems, head-to-head. Results may allow you to downscale further development of irrelevant features or make key improvements, so you can proceed confidently to develop and market a better and more likable product.

Expert Review

Core’s team of human factors professionals have experience with products and systems ranging from wearable user interfaces and custom underwater equipment for communicating with dolphins to print-based instructions for use and optimal design of office spaces. When it comes to user interactions with products and systems, no one has seen it all, but we have seen quite a bit. Our expert review process allows us to draw on our experience with what has worked and what has not to help guide your product’s development into the future.

Functional/Task Analysis

A great way to understand where people will have difficulty using a system is to describe each of the steps necessary to operate the system. Steps have sub-steps. For instance, I have to drive to get to work; To drive, I have to get into my car; To get into my car I have to unlock the door; To unlock the door, I have to take out my keys; To take out my keys, I have to reach into my pocket; To reach into my pocket, I have to angle my hand in a certain way; If I cannot angle my hand in a certain way, I can not get to work. To use even a simple new product requires a complex hierarchy of actions, and each can go wrong for a variety of reasons. Carefully outlining each step by analyzing the cognition, perception, and action necessary to accomplish that step begins the creation of a task analysis. Considering the risks that may occur if there is a problem at each sub-step can help us understand and predict where important problems are likely to occur. This breakdown can also help us verify that problems are designed out of your product and that the associated risks are mitigated as low as possible.

Heuristic Analysis

Decades of expertise in product development have led to the creation of heuristics rules of thumb that guide designs toward usability. The application of these rules of thumb has been empirically validated to quickly and effectively infuse designs with better usability. At Core, we are experienced at identifying which set of heuristics may best apply, and we use these heuristics to structure an evaluation of your product’s design.

Human Factors Analysis / User Analysis

User analysis and user testing together can tell you what will happen when your product reaches the world. User analysis includes careful consideration of the environments in which products will be used (will it be dark? wet? noisy?), who will use the product (experts? novices? very young or old people?), and what will the product be used for (what are the goals of users?).

Following user analysis comes user testing. Based on the characteristics of users that were identified, representative users will be recruited and tested in an environment that simulates the essential characteristics of the real-life environment, which were also identified. Human Factors Analysis allows us to answer the following question: How do people who are representative of future real-life users actually use your product when they are in an environment that simulates the real-world?

Threshold Analysis

Core provides regulatory advice to companies developing generic, abbreviated new drug applications (ANDAs) to be comparable to an existing reference listed drug (RLD) user interface already on the market. In some cases, human factors studies for the ANDA device may not be required as previous human factors research can be leveraged to provide evidence that the devices are comparable. In order to determine "comparability", FDA requests a threshold analysis to be performed between the RLD and ANDA user interfaces. During early product design phases, Core can perform a risk-based analysis of the ANDA and RLD drug-device interfaces to help drive design so that the ANDA may be considered substitutable. Alternatively, Core can conduct a threshold analysis after a device has been designed to present the comparability for FDA review.

FDA GUIDANCE DOCUMENT - Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry - JANUARY 2017

Observational Research

Contextual Inquiry

How do people engage with a device in their real life, whether they are at work, at home, or in a public space? Contextual inquiries are field research where we observe people using a system, ask them about their interactions, and get real-time feedback from real users. This process allows us to determine and report back how the system of interest is situated in the environment and how it is actually used.

Formative Usability Testing

The best thing you can do to improve the usability of a product is empirically test aspects of the product early in development. Forward-thinking, long-term optimization of quality requires iterative formative testing in which actual users, even if only a few users, engage with aspects of the product. Iterative testing constantly improves products — and also cuts off problems at the pass. The worst time to discover a serious usability problem is after product launch, resulting in a recall. The second-worst time is pre-market but after product development is otherwise complete, when even minor changes require costly re-engineering and re-tooling. However, if you put early versions of your product in the hands of users, it is easier - and more desirable - to make adjustments according to how people actually use your product. There is no substitute for empiricism in design; Real users will always surprise you. It is far better to be aware sooner rather than later. Formative studies can start off simple. Depending on your product, a formative study could start early in development using just a piece of paper with a drawing on it. We can help you design effective formative studies tailored to your product. In addition, we can help you determine design changes based on formative results.

International User Research Interviews/Surveys

Core is located in Bala Cynwyd, PA, just across the street from Philadelphia. However, our network extends around the world, and we conduct studies everywhere.

Labeling Comprehension Studies

How do you know that your product’s instructions are understandable to the people who will actually need them and use them? Keep in mind that half of U.S. citizens read at or below an eighth-grade reading level, and writing at an eighth-grade level is not just a simple formula of short sentences with small words. Whether it is a necessary step in your product’s regulatory process or you just want to know how people will interpret what you have written, Core can develop and implement empirical tests employing representative users to determine just what people take away from each key step in the instructions.

Self-Selection Studies

A well-designed self-selection study tells you about how people decide if and when to use your product based on information you are providing to them. How do people go about deciding they are going to use your product in the first place? If your label warns people away, is the warning comprehensible and effective? This is far from a trivial problem, and a self-selection study is sometimes part of a product’s regulatory requirements (“This product is only for people above the age of 4” “This product is only for people with a BMI>35” “Do not use after 10:00PM” [but what if you are traveling between time zones?]). Self-selection studies tell us both about safe usage (to ensure that people who should not use the product do not use it) and about marketing (to determine what percentage of people who encounter the product decide to use it for themselves).

Summative Usability Testing

Summative testing is more than confirming a product meets the needs of its users. Summative testing demonstrates that all hard work has paid off by confirming that your product is safe and effective. A summative test allows representative users to complete tasks using a production model of your product (or its functional equivalent). Summative testing is the only place where “everything comes together” to make sure, before it reaches the market, that a product can be used safely and effectively. We like to say that during summative testing there should be no surprises and nothing more to learn about your product. Passing a summative test gives confidence that your product can be used, and used safely. See Formative Testing for how to prepare for a Summative Test.